82_FR_54582 82 FR 54361 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

82 FR 54361 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

Page Range54361-54385
FR Document2017-25010

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, 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 82 Issue 221 (Friday, November 17, 2017) 
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54361-54385]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6152]


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 54362]]


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) for in vitro diagnostic devices for detection of the 
Zika virus in response to the Zika virus outbreak in the Americas. FDA 
issued these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, 
Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, 
among other things, conditions on the emergency use of the authorized 
in vitro diagnostic devices. The Authorizations follow the February 26, 
2016, determination by the Secretary of Health and Human Services (HHS) 
that there is a significant potential for a public health emergency 
that has a significant potential to affect national security or the 
health and security of U.S. citizens living abroad and that involves 
Zika virus. On the basis of such determination, the Secretary of HHS 
declared on February 26, 2016, that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostic tests for 
detection of Zika virus and/or diagnosis of Zika virus infection, 
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 Siemens Healthcare Diagnostics, Inc. is 
effective as of September 18, 2017; the Authorization for Chembio 
Diagnostic Systems, Inc. is effective as of September 27, 2017.

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, 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 ensure 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.
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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

[[Page 54363]]

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 
Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is 
a significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves Zika virus. 
On February 26, 2016, 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 tests for detection of Zika virus and/or diagnosis of 
Zika virus infection, subject to the terms of any authorization issued 
under section 564 of the FD&C Act. Notice of the determination and 
declaration of the Secretary was published in the Federal Register on 
March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare 
Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an 
EUA for the ADVIA Centaur Zika test, subject to the terms of the 
Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc. 
requested, and on September 27, 2017, FDA issued an EUA for the DPP 
Zika IgM Assay System, subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the internet at https://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 two in vitro diagnostic devices for 
detection of Zika virus subject to the terms of the Authorizations. The 
Authorizations in their entirety (not including the authorized versions 
of the fact sheets and other written materials) follow and provide an 
explanation of the reasons for issuance, as required by section 
564(h)(1) of the FD&C Act:
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    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-25010 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54361 The following is a summary of the with the reporting requirements of time involved in different recalls of estimated annual burden hours for FDA’s recall regulations, recognizing FDA’s regulated products. recalling firms (manufacturers, that there may be a vast difference in the FDA estimates the burden of this processors, and distributors) to comply information collection and reporting collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR section responses per burden per Total hours respondents responses respondent response Firm initiated recall (§ 7.46) and recall communications (§ 7.49) .............................................................................. 2,853 1 2,853 25 71,325 Recall status reports (§ 7.53) ............................................... 2,853 13 37,089 10 370,890 Termination of a recall (§ 7.55(b)) ....................................... 2,853 1 2,853 10 28,530 Total .............................................................................. ........................ ........................ ........................ ........................ 470,745 1 There are no capital costs or operating and maintenance costs associated with this collection of information. I. Total Annual Reporting total number of annual responses equal recall. The Agency estimates it will 71,325. receive 2,853 responses annually based A. Firm Initiated Recall and Recall Communications B. Recall Status Reports on the average number of terminations over the past 3 fiscal years. The total We request firms that voluntarily We request that recalling firms annual responses of 2,853 multiplied by remove or correct foods and drugs provide periodic status reports so FDA the average burden hours of 10 per (human or animal), cosmetics, medical can ascertain the progress of the recall. response equals a total number of hours devices, biologics, and tobacco to This request only applies to firms with of 28,530. immediately notify the appropriate FDA active recalls, and periodic status District Office of such actions. The firm reports are estimated to be reported II. Total Annual Third-Party Disclosure is to provide complete details of the every 2 to 4 weeks. This collection of Burden recall reason, risk evaluation, quantity information will generate approximately produced, distribution information, 2,853 responses annually, based on the Recall Communications. We request firms’ recall strategy, and a contact average number of recalls over the last that firms notify their consignees of the official as well as requires firms to 3 fiscal years, 8,560. The number of recall and to provide recipients with a notify their direct accounts of the recall respondents multiplied by the number ready means of reporting to the recalling and to provide recipients with a ready of responses per respondents (13) equals firm. Under this portion of the means of reporting to the recalling firm. a total number of annual responses of collection of information, the Agency Under these portions of the collection of 37,089. The total number of responses, estimates firms will provide 4,433,562 information, the Agency estimates it 37,089, multiplied by an average burden notifications annually based on the will receive 2,853 responses annually hours of 10 per response equals a total number of respondents/consignees based on the average number of recalls of 370,890 total hours. (2,853) multiplied by the number of over the last 3 fiscal years. The number disclosures per respondent (1,554). The of responses multiplied by the number C. Termination of a Recall total number of hours is 248,279 (based of respondents equals 2,853. The We provide the firms an opportunity on 4,433,562 multiplied by 0.056 average burden hours, 25, multiplied by to request in writing that FDA end the hours). TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR section burden per Total hours respondents per disclosures disclosure respondent Recall communications (§ 7.49) ........................................... 2,853 1,554 4,433,562 0.056 248,279 1 There are no capital costs or operating and maintenance costs associated with this information collections. FDA regulates many different types of (1,554) results in a burden per DEPARTMENT OF HEALTH AND products including, but not limited to, disclosure estimate of approximate HUMAN SERVICES medical products, food and feed, hours (25 hours per recall/1,554 cosmetics, and tobacco products. FDA disclosures/recall = 0.056 hours). Food and Drug Administration notes that not all third-party disclosures Dated: November 9, 2017. sradovich on DSK3GMQ082PROD with NOTICES provided by firms to their consignees [Docket No. FDA–2017–N–6152] are similar in nature and may entail Anna K. Abram, different methods and mediums of Deputy Commissioner for Policy, Planning, Authorizations of Emergency Use of In communication. FDA estimates the Legislation, and Analysis. Vitro Diagnostic Devices for Detection burden for third-party disclosure per [FR Doc. 2017–24923 Filed 11–16–17; 8:45 am] of Zika Virus; Availability recall event to be an average of 25 hours. BILLING CODE 4164–01–P This burden estimate factored out to the AGENCY: Food and Drug Administration, average number of consignees per recall HHS. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1

54362 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices ACTION: Notice. I. Background Agency concludes that the statutory Section 564 of the FD&C Act (21 criteria are satisfied. Under section SUMMARY: The Food and Drug 564(h)(1) of the FD&C Act, FDA is U.S.C. 360bbb–3) as amended by the Administration (FDA) is announcing the required to publish in the Federal Project BioShield Act of 2004 (Pub L. issuance of two Emergency Use Register a notice of each authorization, 108–276) and the Pandemic and All- Authorizations (EUAs) (the and each termination or revocation of an Hazards Preparedness Reauthorization Authorizations) for in vitro diagnostic authorization, and an explanation of the Act of 2013 (Pub L. 113–5) allows FDA devices for detection of the Zika virus reasons for the action. Section 564 of the to strengthen the public health in response to the Zika virus outbreak FD&C Act permits FDA to authorize the protections against biological, chemical, in the Americas. FDA issued these introduction into interstate commerce of nuclear, and radiological agents. Among Authorizations under the Federal Food, a drug, device, or biological product other things, section 564 of the FD&C Drug, and Cosmetic Act (the FD&C Act), intended for use when the Secretary of Act allows FDA to authorize the use of as requested by Siemens Healthcare HHS has declared that circumstances an unapproved medical product or an Diagnostics, Inc. and Chembio exist justifying the authorization of unapproved use of an approved medical Diagnostic Systems, Inc. The emergency use. Products appropriate for product in certain situations. With this Authorizations contain, among other emergency use may include products EUA authority, FDA can help ensure things, conditions on the emergency use and uses that are not approved, cleared, that medical countermeasures may be of the authorized in vitro diagnostic or licensed under sections 505, 510(k), used in emergencies to diagnose, treat, devices. The Authorizations follow the or 515 of the FD&C Act (21 U.S.C. 355, or prevent serious or life-threatening February 26, 2016, determination by the 360(k), and 360e) or section 351 of the diseases or conditions caused by Secretary of Health and Human Services PHS Act (42 U.S.C. 262). FDA may issue biological, chemical, nuclear, or (HHS) that there is a significant an EUA only if, after consultation with radiological agents when there are no the HHS Assistant Secretary for potential for a public health emergency adequate, approved, and available Preparedness and Response, the that has a significant potential to affect alternatives. Director of the National Institutes of national security or the health and Section 564(b)(1) of the FD&C Act security of U.S. citizens living abroad Health, and the Director of the Centers provides that, before an EUA may be and that involves Zika virus. On the for Disease Control and Prevention (to issued, the Secretary of HHS must basis of such determination, the the extent feasible and appropriate declare that circumstances exist Secretary of HHS declared on February given the applicable circumstances), justifying the authorization based on 26, 2016, that circumstances exist FDA 1 concludes: (1) That an agent one of the following grounds: (1) A justifying the authorization of referred to in a declaration of emergency determination by the Secretary of emergency use of in vitro diagnostic or threat can cause a serious or life- Homeland Security that there is a tests for detection of Zika virus and/or threatening disease or condition; (2) domestic emergency, or a significant diagnosis of Zika virus infection, subject that, based on the totality of scientific potential for a domestic emergency, to the terms of any authorization issued evidence available to FDA, including involving a heightened risk of attack under the FD&C Act. The data from adequate and well-controlled with a biological, chemical, radiological, Authorizations, which include an clinical trials, if available, it is or nuclear agent or agents; (2) a explanation of the reasons for issuance, reasonable to believe that: (A) the determination by the Secretary of are reprinted in this document. product may be effective in diagnosing, Defense that there is a military DATES: The Authorization for Siemens treating, or preventing (i) such disease emergency, or a significant potential for Healthcare Diagnostics, Inc. is effective or condition; or (ii) a serious or life- a military emergency, involving a as of September 18, 2017; the threatening disease or condition caused heightened risk to U.S. military forces of Authorization for Chembio Diagnostic by a product authorized under section attack with a biological, chemical, Systems, Inc. is effective as of 564, approved or cleared under the radiological, or nuclear agent or agents; September 27, 2017. FD&C Act, or licensed under section 351 (3) a determination by the Secretary of of the PHS Act, for diagnosing, treating, ADDRESSES: Submit written requests for HHS that there is a public health or preventing such a disease or single copies of the EUAs to the Office emergency, or a significant potential for condition caused by such an agent; and of Counterterrorism and Emerging a public health emergency, that affects, (B) the known and potential benefits of Threats, Food and Drug Administration, or has a significant potential to affect, the product, when used to diagnose, 10903 New Hampshire Ave., Bldg. 1, national security or the health and prevent, or treat such disease or Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad, condition, outweigh the known and 0002. Send one self-addressed adhesive and that involves a biological, chemical, potential risks of the product, taking label to assist that office in processing radiological, or nuclear agent or agents, into consideration the material threat your request or include a fax number to or a disease or condition that may be posed by the agent or agents identified which the Authorizations may be sent. attributable to such agent or agents; or in a declaration under section See the SUPPLEMENTARY INFORMATION (4) the identification of a material threat 564(b)(1)(D) of the FD&C Act, if section for electronic access to the by the Secretary of Homeland Security applicable; (3) that there is no adequate, Authorizations. under section 319F–2 of the Public approved, and available alternative to Health Service (PHS) Act (42 U.S.C. FOR FURTHER INFORMATION CONTACT: the product for diagnosing, preventing, 247d–6b) sufficient to affect national Carmen Maher, Office of or treating such disease or condition; sradovich on DSK3GMQ082PROD with NOTICES 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 be prescribed by regulation are satisfied. Once the Secretary of HHS has 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 of the FD&C Act, FDA may 1 The Secretary of HHS has delegated the number). authorize the emergency use of a drug, authority to issue an EUA under section 564 of the SUPPLEMENTARY INFORMATION: device, or biological product if the FD&C Act to the Commissioner of Food and Drugs. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1

Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54363 section 564(c)(4) of the FD&C Act. Zika virus and/or diagnosis of Zika Authorizations are available on the Because the statute is self-executing, virus infection, subject to the terms of internet at https://www.regulations.gov/ regulations or guidance are not required any authorization issued under section . for FDA to implement the EUA 564 of the FD&C Act. Notice of the authority. determination and declaration of the IV. The Authorizations Secretary was published in the Federal Having concluded that the criteria for II. EUA Requests for In Vitro Diagnostic Register on March 2, 2016 (81 FR Devices for Detection of the Zika Virus issuance of the Authorizations under 10878). On September 8, 2017, Siemens On February 26, 2016, the Secretary of section 564(c) of the FD&C Act are met, Healthcare Diagnostics, Inc. requested, HHS determined that there is a and on September 18, 2017, FDA issued, FDA has authorized the emergency use significant potential for a public health an EUA for the ADVIA Centaur Zika of two in vitro diagnostic devices for emergency that has a significant test, subject to the terms of the detection of Zika virus subject to the potential to affect national security or Authorization. On September 14, 2017, terms of the Authorizations. The the health and security of U.S. citizens Chembio Diagnostic Systems, Inc. Authorizations in their entirety (not living abroad and that involves Zika requested, and on September 27, 2017, including the authorized versions of the virus. On February 26, 2016, under FDA issued an EUA for the DPP Zika fact sheets and other written materials) section 564(b)(1) of the FD&C Act, and IgM Assay System, subject to the terms follow and provide an explanation of on the basis of such determination, the of the Authorization. the reasons for issuance, as required by Secretary of HHS declared that section 564(h)(1) of the FD&C Act: circumstances exist justifying the III. Electronic Access BILLING CODE 4164–01–P authorization of emergency use of in An electronic version of this vitro diagnostic tests for detection of document and the full text of the sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1

54364 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 8, 20!7 Matthew Gee, M.Sc. Senior M"'n:><Jf'r, ''"'l'.u"w"' Siemens lleal!heare Inc. 511 Benedict Avenue N'{ 10591-5097 sradovich on DSK3GMQ082PROD with NOTICES EN17NO17.020</GPH> VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54365 Page 2 — Mr. Gee, Siemens Healthcare Diagnostics Inc. involves Zika virus" Pursuantto section 564(b)(T) ofthe Act (21 U.S.C. § 360bbb—3(b)(1)), and on the basisofsuch determination, the Secretary of HHS then c:i:::clzu*d that cireumstances exist justifying the authorization of the emergencyuse of in vitro diagnostictests for detection of Zikavirus and/or dmgmm s of Zika wms infection, subject to the terms ofany authorization issued under21 U.S.C. ?§ 60&3?}&»3{@1) Having concluded that thecriteria for issuance of this authorization undersection 564(¢) of the Act{I] US.C. § 360bbb—3(c)) are met, | am authorizing the emergencyuse of the ADVIA Centaur Zika test (as described in the Scopeof Authorization section of this letter (Section I1}) in individuals meeting CDC Zika virus clinical eriteria {e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDCZika virus epidemiological eriteria (eig... _ history ofresidence in or travel to a geographicregion with active Zika transmission at thetime of travel, or ather epidemiological criteria for which Zika virus testing may be indicated) (as described in the Scope of Authorization section ofthisletter (Section 11)) for the presumptive qualitative detection of Zika virus infection byauthorized laboratories, subject to the terms of this authorization. 1. Criteria for Issuance of Authorization I have concluded that the emf,rmm}use ofthe ADVIA Centaur Zika test for the presumptive i}l}&;lflflfit detectionofZikavirus IgM antibodies in thespecified population meets the criteria for issuanceofan suthorization under section 564(c) ofthe Act, because I haveconcfuded that: 1. The Zika virus can cause Zika virus infection. a serious or life—threatening disease or condition to humans infected with the virus: Based on the totality ofscientific evidenceavailable to FDA,it is rfita‘;x‘mafiix.to befiew:f i3 tha{ the ADVIA Centaur Zikatest may be effective in diagnosing recent Zik infection, and that the known and potential benefits ofthe ADVIA Centaur Ktkattfit for diagnosing Zika virus infection outweigh the knownand potential risks ofsuch product, when, for presumptive Zika positive results, additional testing (as described in the Instructions for Use document) is performed and/or test results for other patient—matched specimens {using the latest CDCtesting algorithms for the diagnosis of Zika virus infection) are considered; and Thereis no adequate, approved, and available alternativeto the emergency use ofthe o ADVIA Centaur Zika test for diagnosing Zika virus infection." A &mendcd bythe Pandemic and All—Hazards Preparedness Resuthorization Act, Pub. L. No. 113—5, under section S64(bYTYNC) of the Act, the Secretary may make adetermination of a public health emergency, or ofa significant potential for a public health emergency. * HHS— Determination and Declaration Regarding Emergency Uxe ofIn Vitro .’ngflmm Tests for Detection of Zika Firux and‘or DiagnosisofZika Virus Infection.. 81 Fed. Reg. 10878 (March 2, 2 * No other criteria of issuance have beenprescribed by regulation under section 36—4(c)(4) of the Act.

54366 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page C 3 — Mr. Gee, Siemens Healthcare Diagnostics Inc. L Scope of Authorization 1 haveconcluded, pursuant to section 564(&}{ 1;}‘ af the Act. that the scopeofthis authorization is limited to the use of the authorized ADVIA Centaur Zika test by authorized laboratories for the presumptive qualitative detection of Zika virus IgM antibodies in individuals meeting CDC Zika virus climical erfteria (e.g., clinical signs and symptomsassociated with Zika virus infection) and/or CDC Zika virus epidemiclogical criteria (e.g., history ofresidence in or travel to a geographic region with active Zikatransmission at the: time oftravel, or other epidemiolagical criteria for which Zika virus testing maybe indicated) when, for presumptive Zika positive results, additional testing(as described in the Instructions for Use document) is performed® and/or test results for other patient—matched specimens (using the latest CDC testingalgorithms for the diagnosis of Zika virus infection) are considered. The Authorized ADVIA Centaur Zika Test The ADVIA Centaur Zika test is an immunoassay for the in viéo presumptive qualitative detection of Zika virus IgMantibodies in human serum and potassfum EDTA or ithium heparin plasma (each collected alongside a patient—matched serum specimen) specimens and other authorized specimen types from individuals meeting CDCZika virus climical eriteria (eg.. clinical signsand symptoms associated with Zika virus infection) and/or CDCZika virus cepidemiological criteria (e:g., history ofresidence in or travel to a geographie region with active Zika transmission at the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated). The ADVIA Centaur Zika testis comprised ofthe ADVIA Centaur Zika Aband ADVIA Centaur Zika IgM assays. All ADVIA Centaur Zika Ab reactive samples must be tested with the ADVIA Centaur Zika IgM assay. The ADVIA CentaurZika Ab assayis an antibody capture immunoassay using a 2—pass format. In the first pass. coated microparticles (solid phase) areadded to the cuvette, binding antibodies fromthe patient sample.. The captured antibodies are washed and resuspended.. In the second pass, the anti—Zika antibodies captured on the Solid Phase are detected by the addition of NSI1 antigen labeled with acridinium ester (Lite Reagent) for chemiluminescent detection. The ADVIACentaur Zika IgM assay is an IgM capture immunoassay using a 2—pass format. In the first pass, the microparticles, coated with anti—human IgM monoclonal antibody (Solid Phase), are added to the cuveite, binding IgM from the patient sample. The captured IgM antibodies are washed and resuspended, In the second pass, the anti—Zika IgM captured on the Solid Phaseis detected bythe addition of NS1 antigenlabeltedwith acridinium ester (Lite Reagent) for chemiluminescent detection. The ADVIA Centaur Zika test includes useof the ADVIA Centaur XP and/or ADVIA Centautr XPT immunoassayanalyzers, and other authorized instruments. * As discussed in theInstructions for Use document, the additional testing for presumptive Zika IgM positive results is to be performed using the latest CDC testing algorithims forthe diagnosis of Zika virus infection.

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54367 Page 4 — Mr. Gee, Siemens Healthcare Diagnosties Inc. The ADVIA Centaur Zikatest requires the following eontrol materials and assaycalibrators: ADVIA Centaur ZikaM lowcalibrator ® #. ADVIA Centaur ZikaM high calibrator ADVIA Centaur ZikaM Calibrator Assigned Value Card and barcods labels 6. ADVIA Centaur ZikaM Master Curve Card #..00 ADVIA Centaur ZikaM Quality Control o 2x 2 mL —negative control o 2x 2 mL positivecontrol 5. Lot—specific assigned value card and barcodelabels & —ADVIA Centaur ZikaAb Quality Control & 2x 2 mlnegative control o 2 x2 mL positive control <6— Lot—specific assigned value card and barcode labels Quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory‘s standard quality control procedures, The ADVIACentaur Zika test also requires the use ofadditional materials and ancillary reagents commonly used in climical laboratories and thatare describedin the authorized ADVIA Centaur ~Zikatest Instructions for Use: The above described ADVIA Centaur Zika test, whenlabeled consistently with the labeling amhar;zui by H)A entifled "ADVIA Cx:maur ika test" (available at ~bip va fda.gouv MedicalDew . ergencysifuatit #161496—htm), is authorizedto be distributed to and used byauthorized laboratories under this EUA, &espitn the fact that it does not meet certain requirements otherwise required byfederal law. This labeling may be revised by Siemens Healthcare Diagnostics in consultation with, and with concurrence of, the Division of Microbiology Devices (DMDyYOffice of In Vitro Diagnostics and Radiological Health (OTRYy/Center for Devicesand Radiological Health (CDRH) The above described ADVIA Centaur Zika test is authorizedto be accompanied bythe following information pertaining to the emergency use, which is authorized to be made available to healtheare providers and patients: & Fact Sheet for Healthcare Providers® Interpreting ADVIA Centaur Zika Test Results * Fact Sheet for Patients: Understanding Results from the ADVIA Centaur Zika Test Other Fact Sheets developed by Siemens Healthcare Diagnosti¢s in consultation with, and with concurrence of, the Office of Counterterrorism and Emerging Threats (OCETYyOffice of "the Chief Scientist (OCSyYOfficeof the Commissioner (OC) and DMD/OIR/CDRHmay be authorized to accompanytheabove described ADVIA Centaur Zika test and to be made available tohealthcare providers and patients.

54368 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 5 —¥Mr. Gee, Siemens Healthcare DiagnostiesInc. As described in Section TV befow, Stemens Healthcare Diagnostics is also authorized to make available additional information relating to the emergency use oftheauthorized ADVIA Centaur Zikatest that is consistent with, and does not ¢xceed, theterms ofthis letter ofauthorization; T haveconcluded, pursuant to section 564(d)(2) ofthe Act, that it is reasonableto believe that the known and potential benefits ofthe authorized ADVIA Centaur Zika test in the specified population, when used for presumptivequalitative detection ofZika virus IgM antibodies and used consistently with the Scope of Authorization ofthis letter (Section 11), outweigh the known and potential risks of such a product. I have concluded, pursuant to section 564(d)(3) ofthe Act, based on the totality ofsefentific evidenceavailable to FDA,that it is reasonable to believethat the authorized ADVIA Centaur Zika test may beeffective inthe diagnosis ofrecent Zika virus infection, when used consistently with the Scope of Authorization ofthis letter (Seetion 11), pursuantto section. 564(c)(2)(A) ofthe Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusionsdescribed in Section [ above, and concludes that the authorized ADVIACentaur Zika test, when used to diagnose Zika virus infection in the specified. population(as described in the Scope of Authorization ofthis letter (Section 11}), meets the criteria set forth in section 564(c) ofthe Act concerning safety and potential effectiveness. "The emergencyuse of the authorized ADVIA Centaur Zika test under this EUA must be consistent with. and maynot exceed, the terms ofthis letter, including the Scope of Authorization (Seetion T1) and the Condiuons of Authorization (Section [V). Subject to the terms ofthis EUA and under the cirecumstances set forth in the Secretary of HHS‘s determination described above and the Secretary ofHHS‘s corresponding declaration under section 564(b)(1). the ADVIA Centaur Zika test described above is authorized to diagnose Zika virus infection in individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection} and/or CDC Zikavirus epidemiological criteria (e.g., history ofresidence in ortravel to a geographic region with active Zika transmission at the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated). This EUA will cease to be effective when the HHS declaration that cireumstances exist to Fustify the EUA is terminated under section 564(b)(2) ofthe Act or when the EUA is revoked under section 564(g) ofthe Act. HL Waiverof Certain Requirements [ am waiving the following requirements for the ADVIA Centaur Zikatest duringthe duration of this EUA:

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54369 Page 6 —Mr. Gee, Siemens Healthcare Diagnostics Inc. «— ‘Current good manulacturingpractice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, Iabeling, storage, and distribution ofthe ADVIA Centaur Zika test. * Labeling requirements for cleared, approved, or investigational devices, including. labelingrequirements under 21 CFR 80910 and 21 CFR §09.30; except for the intended use statement (21 CFR £09.10(a)(2), (b)(2)); adequate directions for use (21 U:.8.C. 352(F)), (21 CFR 809.10(b)(5), (7), and (8)); any appropriate limitations on the use ofthe 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 Pursuantto section 564 of the Act, Lam establishing the following conditions on this authorization: Siemens Healthcare Diagnostics and Its Authorized fiimrihuwr(s} A. Siemens Healtheare Diagnostics andits authorized distributor(s) will distribute the authorized ADVIA Centaur Zika test with the authorized labeling only to authorized laboratories. Siemens iimhhmm DHiagnostics may request cthanges to the authorized labeling. Such requests will be made by Siemens Healthcare Diagnostics in consultation with, and require concurrence of, DMD/OIR/CDRH. B Siemens Healtheare Diggnosties and its authorized distributor(s) will provide to authorized laboratories theauthorized ADVIA Centaur Zikatest Fact Sheetfor Healtheare Providers and the authorized ADVIA Centaur Zika test Fact Sheet for Patients, and any additional ADVLf\ &mem‘ Zika test Fact Sheets for Healthcare Providers and Patients that OCET/OCS/OCand DMD/OIRVCORH may authorize. C. Siemens Healtheare Diagnostics and its authorized distributor(s) will make available on their websitesthe authorized ADVIA Contaur Zika test Fact Sheet for Healthcare Providers and theauthorized ADVIA Centaur Zika test Fact Sheet for Patients, andany additional ADVIA Centaur Zika test Fact Sheets for Healtheare Providers and Patients that C {0CS/OC and DMDVOIR/CDRH mayauthorize. D. Siemens Healtheare Diagnostics and its authorized distributor(s) will inform authorized laboratories and relevant public health authority(ies)of this EUA, including the terms and conditions herein.

54370 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page7 — Mr. Ciee, Stemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics and its authorizeddistributor(s) will ensure that authorized laboratories using the authorized ADVIA Centaur Zika test have a process in placefor reporting test n.mitb to healthcare providersand relevant public health authorities; as appmprmm Through a process of inventory control, Siemens Healthcare Diagnostics and its authorized distributor(s) will maintain records of device usage. Siemens Healthcare Diagnostics andits authorizeddistributor(s) will collect information on the performance ofthe test. Siemens Healtheare Diagnosticswill report to FDAany suspected occurrerice offalse positive and false negativeresultsand significant deviations from the established pwm:nmnm characteristies ofthe test of which Stemens Héaltheare Diagnostics becomes aware. H. Siemens Healtheare Diagnosties and its authorized distributor(s) are authorized to make available additional information relating to the emergency use of the authorized ADVIA Centaur Zika test that is consistent with, and does not exceed, theterms ofthis letter of authorization. Siemens Healthcare Diagnostics 1. Siemens Healtheare Diagnostics will notify FDA of any authorized distributor(s) ofthe ADVIA Centaur Zikatest, including the name, address, and phone number of any authorized distributor(s). . Siemens Healtheare Diagnostics will provide its authorized distributor(s) witha copy of this EUA, and communicate to its authorizeddistributor(s) any subsequent . amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets, Instructions for Use). . Siemens Ht;‘d theare Diagnostics may request changes to the authorized ADVIA . CentaurZika test Fact Sheet for Healtheare Providers andthe authorized ADVIA Centaur Zika test Fact Sheet for Patients. Siemens Healtheare Diagnostics may also developnew ADVIA Centaur Zika test Fact Sheets for Healthcare Providers and <Patients. if appropriate, and may request changes to such Fact Sheets. All such requests listed inthis conditionof authorization will be made by emens Healthcare [Hagnosties in consultation with, and require concurrence of, OCF (2OCS/OC and DMIDNVOIR/CDRH. — Siemens HealtheareDiagnostics may request theaddition ofother instruments for use with the authorized ADVIA Centaur Zika test. Such requests will be made by Siemens Healthcare Diagnostics in consultation with, and require concurrence of, DMDYOIR/CDREH ated to reporting Zika test results to relevant public healthauthorities, it is ecommended that Siemens Healthcare Diagnostics and anthorized Iaboratories consult with the applicable country, state, or territory health department(s). Actording to CDC. Zika is a nationally notifiable condition (see fittp

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54371 Page8 — Mr. Gee, Siemens Healthcare DiagnosticsInc. M. Siemens Healthcare Diagnosties may request the addition ofother ancillary reagents for use with the authorized ADVIA Centaur Zika test. Such requests will be made by Siemens Healthcare Diagnostics in consultation with, and requireconcurrenceof, DMD/OIR/CDRH, N. Siemens Healthcare Diagnostics may request the addition of other specimentypes for use with the authorized ADVIA Centaur Zika test. Such requests will be made by Siemens Healthcare Diagnostics in consultation with, and require concurrence of, . DMIDV/OIR/CORH, 0. Siemens Healtheare Diagnostics mayrequest the addition ofother control materials for use with the authorized ADVIA Centaur Zika test.. Such requests will be made by Siemens Healtheare Diagnosties in consultation with, and require concurrence of,— DMDV/OIR/CDRH. P Siemens Healtheare Diagnostics mayrequest substitution for or changes to the: —authorized materials used in the detection process ofthe human anti—Zika IgM in the specimen.. Such requests will be made by Siemens Healthcare Diagnostics in consultation with, and require concurrence of, DMD/OIR/CDRH. O Siemens Healtheare Diagnostics will track adverse events andreport to FDA under 21 CFR Part 803. R. Siemens Healthcare Diagnostics will evaluate the performanceof the ADVIA Centaur Zika test with any FDA—recommended or established panel{s) ofcharacterized elimical specimens, and will submit that performance data to FDA. After DMD/OIR/CDRIHT‘s review of and concurrence with the data, Stemens Healthcare Diagnostics will update its labeling, in consultation with, and with concurrenceof, DMDVOIR/CDRH, to reflect the additional testing. _ S.. Siemens Healtheare Diagnostics will assess traceability" ofthe ADVIA Centaur Zika test with any FDA—recommended reference material(s). ~After submission to FDA and DMD/OIR/CDRHM‘s review of and concurrence with the data, Stemens Healthcare Diagnosties will update its labeling to reflect the additionaltesting. T.: Siemens Healthcare Diagnostics will track the performanceof the ADVIA Centaur Zika test and report to DMD/OIR/CDRH on a semi—annual basis— * Traceabilityrefers to tracing analytical sensitivityreactivity back to a FDA—recommended reference material.

54372 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 9 —Mr. Gee, Siemens Healthcare Diagnostics Inc. Authorized Laboratories U. Authorized laboratories will include with reports ofthe results of the ADVIA Centaur Zika test the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients, and any additional ADVIA Centaur Zika test Fact Sheets for Healthcare Providers and Patients that OCET/AOCS/OC and DMD/OIR/CDORH may authorize, Under exigent ctreumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media: . Authorized laboratories will perform the ADVIACentaur Zikatest on only human serum or plasma (potassium EDTA or lithium heparin; eachcollected alongside a patient—matched serumspecimen} specimensor with other authorized specimentypes. If non—serum specimens are used with the ADVIA Centaur Zika test, authorized laboratories responsible for collecting the patient specimen must collect a patient— matched serum specimen, or if this is not possible, an additional serum specimen must be collected soon after the original specimen,. This is to facilitate any additionaltesting that may be required, using thelatest CDC testing algorithms for the diagnosis ofZika virusinfection, to confirm Zika virus infection. X. Authorized laboratories must read the results of the ADV IA Centaur Zikatest on the ADVIA Centaur XP. ADVIA Centaur XPT, or on other authorized instruments.. ¥. Withinthe United Statesand its territories,authorized laboratories willreport all Presumptive Zika Positive results to Siemens Healthcare DHagnosties. Authorized laboratories will report only the final interpretation of algorithm test results (Presumptive Zika Positive, Negative for IgM antibodies to Zika virus, of Negative for antibodies to Zika virus), as described in the Instructions for Use document, to healtheare providers. AA: Authorized laboratories will have a process in place to assure that, for Presumptive Zika: Positive results, additional testing (as described in the Instructions for Use document) is performed and/or test results for other patient—matched specimens, using the latest CDC testing algorithms for the diagnosis of Zika virus infection, are considered. BB Authorized laboratories will have a process in place for reporting test results to healthcare providers and relevant publichealth authorities, as appropriate." * For questions related to reporting Zika test results to relevant public health authorities; it is recommended that Siemens Healthcare Diagnostics and authorized Iaboratories consult with the applicable countr health department(s),. According to CDC, Zika is anationally notiffable condition (see I

Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54373 Authorized laboratories \Vill collect intbrmation on the "''1rfi''""'"'"'" Centaur Zika test and DMDIOIR/CDRH {via Siemens Uealthcare lli:ilglms;tic!>, Its Authorized and Authorized l.aboratories authorized records associated with this notified made available to FDA request FF. All and matter to the use of the authoriz.ed ADVlA Centaur Zika test shall be consistent ·with the authorized Fact Sheets the 1em1s set fhrth in this EllA and the and FDA GG. use of the that This This test has aulhori zed laboratories: This tesl has been virus infection and r\ot for any other i'l>t tbe duration of the declaration that m""'" v""'' the authorization ernergcncy usc of in vitro tests for detection ofZika virus and/or Zika virus infection under of the Act, 21lLS.C l ), unless the authorization is terminated or revoked sooner. sradovich on DSK3GMQ082PROD with NOTICES EN17NO17.029</GPH> VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1

54374 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 11 ~Mr. Gee, Siemens Healthcare Diagnostics Inc. No advertising or promaotional descriptive printed matter relating to the use of the authorized ADVIA Centaur Zika test may represent or suggest that thistest is safe oreffective for the dagnosis of Zika virus infection. The emergency use ofthe authorized ADVIA Centaur Zika test as describedin this letter of authorization must comply with the conditions and all other terms of this authorization. ¥. Duration of Authorization This EUA will be effective until the declaration that efroumstances existjustifyingthe authorization ofthe emergency use of in vifro diagnostic tests for detection of Zika virus and/or diagnosis ofZika virus infection is terminated under section 564(b)(2) ofthe Act or the EUA is revoked under section 564(g) ofthe Act. Sincerely, elsamss | Rachel Sherman, M.D., M.PH. Principal Deputy Commissioner Enclosures

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54375 ADMINISTRATION September 27, 2017 Thomas D. Ippolito Vice President, Clinical and Regulatory Affairs Chembio Diagnostic Systems, Inc. 3661 Horseblock Road Medford,. NY 11763 Dear Mr. Ippolito: This letter is in response toyour request that the Food and Driug Administration (FDA) issue an Emergency Use Authorization(EUA) for emergency use of Chembio Diagnostic Systems, Inc.‘s ("Chembio‘) DPP Zika IgM Assay System for the presumptive qualitative detection of Zika virus [gM antibodies in human serum (plain or separation gel) and fingerstick whole blood, EDTA venous whole blood, or EDTA plasma (eachcollected alongsideapatient~ matched serum specimen ) specimenscollectedfrom individuals meeting the Centers for DiseaseControl and Prevention (CDC) Zika virus clinical criteria (e.g., a history of chmca! signs and symptoms associated with Zika virus infection)and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a :é.wgrapizic regionwith active Zika transmissionat the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § "(fia to perform high or moderate complexity tests, or by similarly qualified non—U.S. laboratories,! pursuant to section 564 of the Federal Food, Drug. and Cosmetic Act (the Act) (21 U.S.C. § 360bbb—3). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after onset of symptoms or risk of exposure, respectively. Where there are reactive results (Le., presumptive Zika I[gMpositive), from the DPP Zika IgMAssay System, confirmation of the presenceofanti—Zika IgM antibodies requires additional testing, as described in the Seope ofAuthorization of this letter (Section I1) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient— matched specimens using the latest CDC testing algorithims for the diagnosis of Zika virus infection.‘ On February 26, 2016, pursuant to section 564(b)(1)(C) ofthe Act (21 U.S.C. §360bbb— > 3(b)(D(C), the Secretary of Health and HumanServices (HHS) determined that thereis a significant potential for a public health emergencythat has a significant potentialto affect }Lrsr ease ofreference, this letter will refer to "laboratories in the Lxmted States that are certified under the Clinical Laboratory Improvement »‘\nmuc{amms of 1988 (CLIA), 42 U.S.C. §263a, to partm’m high or moderate complexity tests, or bysimilarly qualified non—U.8. laboratories®" as "Authort efi iabomtorm * Available at Clast updated on July 34, 2017

54376 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 2 —Mr. Ippolito, Chembio Diagnostic Systems, Inc. national w{,um} or ilw health and security of United States citizens living abroad and that involves Zika virus." Pursuant to section 564(b)(1) of the Act (21 US.C, § 360bbhk—3(b)(1)), and on the basis ofsuch determination, the Secretary of HHS then fiechmi that circumstances exist justifying the authorization ofthe emergency use ofin vitro diagnostic tests for detection of Zikavirus and/or diagnosis of Zika virus infection, subject to theterms ofanyauthorization 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 (31 U.S.C—§ 360bbb—3(c)) are met, T am authorizing the emergencyuse ofthe DPP Zika: IgM Assay System(as described in the Scope of Authorization section of thisletter (Section H)} in individuals meeting CDC Zika virus clinical criteria (e.g., a history ofclimical signs and symptoms associfted with Zika viros infection}y and/ar CDC Zika virus epidemiclogical criteria {e.g.,history ofresidence in or travel to a geographic region withactive Zika transmission at the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated) (as described in the Scope of Authorization section ofthis letter (Section 1)) for the presumptive qualitative detection of Zika virus infection by authorized laboratories, subject to the terms of" this authorization. L Criteria for Issuance of Authorization I have concluded that the emergency use ofthe DPP Zika IgMAssay System for the presumptive qualitative detection of Zika virus IgM antibodies in the specified population meets the criteria for issuance of an authorization under section 564(c) ofthe Act, because I have concluded that: 1. The Zika virus can cause Zika virus infection,a serious or life—threatening disease or condition to humans infected with the virus; 2. Based on the totalityofscientific evidence available to FDA, it is reasonable to believe that the DPP Zika IgM Assay System may be effective in diagnosing recent Zikavirus infection, and that the known and potential benefits of the DPP Zika IgM Assay System for diagnosing Zika: virus infection outweighthe known and potential risks ofsuch product, when, for reactiveresults (Lhe.. presumptive Zika IgMpositive), additional testing (as described in the Instructions for Use document) is performed and/or test results for otherpatient—matched specimens (usingthelatest CDCtesting algorithms for the diagnosis of Zikavirus infection) are considered: and 3. There is no adequate, approved, and available altemnative to the emergencyuse of the PB . r ~ is x « sn a a « $ DPP Zika IgM Assay System for diagnosing Zika virus infection." * As amended by the Pandemic and All—Hazards Preparedness Reauthorization Act, Pub, L. No. 1 13—5, under section 564(b)(1)(C) of the Act, the Secretary may make a determination of a public health emergencey, orof a significant ;mtt:miaf for a gmbim health emergency. . "HHS. Determination and Declaration Regarding Emergency Use ofIn Vitro Diagnostic Tests for Detection of Zike Virus andlor Diagnosix ofZika Firus Infection. 81 Fed: Reg. 10878 (March 2. 23016). * No other criteria ofissuance have been prescribed by regulation under section 564(c)(4) ofthe Act:

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54377 Page 3 —Mr. Ippolito, Chembio Diagnostic Systems, Inc. \IL Scope of Authorization I have concluded, pursuant to section564(d)(1) ofthe Act, that the scape of this authorization is limited to the use of the authorized DPP Zika IgM Assay System by authorized laboratories for the presumptive qualitative detection of Zika virus IgM antibodies in individuals meeting CDC Zika virus clinical criteria(e—g.. a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiclogical criteria(e.g., history ofresidence in or travel to a geographic region with active Zika transmission at the time oftravel, or other epidemiclogical criteria for whichZika virustesting may be indicated) when., for reactive results (Le., presumptive Zika IgMpositive), additional testing (as describedin the Instructions for Use {inmmfim)i8 pcrmmwdfand/or test results for other patient—matched specimens (using the latest CDC testing algorithms for the diagnosis of Zika virus infection) are considered. The Authorized DPP Zika IgM AssaySystem The DPP Zika IgM Assay System is a single—use immumochromatographic lateral flowassay> for the i vitro presumptive qualitativedetection ofZika virus IgM antibodi¢s in human serum {plain or separation gel) and fingerstick whole blood, EDTA venous whole blood, or EDTA plasma (each collected alongside a patient—matched serum specimen) specimens and other authorized specimen types from individuals meeting CDC Zika virus clinical criferia (e.g., a history of elinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eig., history ofresidence in or travel to a geographic region with active Zika transmission at the time oftravel, or other epidemiological criteriafor which Zika virus testingmay be indicated). The DPP Zika IgM Assay Systememploys a dual path platform technology and consists of a Z2 sample path that distributes sample onto a reagent strip containinga TEST (T) areaand a CONTROL(C) area in thetest—control windowofthetest device. The reagentstrip is for the detection of ZIKV EEM antibodies: The test procedureis based on capturing human IgM ies from the patient specimen in the TEST (T) area that is functionalized with Zika NS1 @atignm followed bythe addition of an antibody—binding colored conjfugate. The patient specimenis collected and then diluted with sample buffer before bt:mg applied to the SAMPLE*RUFFERWell#1 ofthe DPP Zika Test Device. The specimen migrates alongthe sample path membrane and is delivered to the TEST (T) area ofthe reagentstrip, where Zika NSI antigens are immobilized.. Zika—specificantibodies. if present in the sample, bind to the immobilized NST antigens in the TEST (T) area, while non—specific antibodies bind to the Protein A in the CONTROL(C) area.. Running buffer is thenadded into the BUFFERWell #2, which hydrates the dried antibody—binding colored conjugatecausingit to migrate to the TEST area.. ZIKV IgM antibodies bound to the TEST (T) area will capture the antibody—binding colored conjugate and detection is performed using. the Chembio DPP Micro Reader, or other authorizedinstruments, that uses assay—specific algorithms to verify the presence of the control line and measure color intensity in the TEST (T) area position: it interprets the results using . presumptive Zika IgM ;}(}sinw}is to &:»& ;_sssrmrmed uzsmg, fiw mmr (J)(usu%dlg,mnhm*; Fflr the dmgms}m ofZika virus infectfon.

54378 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 4 —Mr. Ippolito, Chembio Diagnostic Systems, Inc. assay—specific cut—offvalues, and reports areactive, nonreactive, or invalid result along with a numericalintensity value for the IgM test line. One of the limitations of this test is the possibility of false positive results in patients with a historyof infection with other flaviviruses. For reactive results (Le., presumptive Zika IgM positive), additional testing (as described in the Instructions for Use document) and/or consideration oftest results for other patient—matched specimens, using the latest CDC testing algorithms for the diagnosis of Zikavirus infection,is therefore required to confirm Zika virus infection. The DPP Zika IgM Assay System includes use ofthe DPP Zika Test Device kit and the DPP Micro Reader kit which are comprised of the following materials and instruments. or other authorizedmaterials and instruments: * The DPP Zika Test Device kit individually pouched DPP ZikaTest Devices each witha desiccant pouch, Microsafe tubes, xampicwais transferp ipets, DPP Zika IgM Sample JE Buffer— BLUE:—Cap, DPP Zika IgMRunning Buffer — YELLOWCap, product insert {authorized Instructions for Use) and a quick reference guide. s The DPP Micro Reader kit: DPP Micro Reader, holder case, USB cable and user manual. The DPP Zika IgM Assay System requires the following control materials or other authorized control materials, which are notprovided with the test: a> ~DPP Zika IgM Assay Control Pack: DPP Zika Reactive Control, DPP Nonreactive Control and product insert. The assay controls are usedto verify and assess the assay performance and verify the user‘s ability to properly perform the test and to interpret the results, Quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory‘‘s standard quality control procedures. The DPP Zika IaM Assay System also requires the useof additional materials and ancillary reagents .commonly usedin clinical laboratories and that are described in the authorized DPP Zika IgMAssay System Instructions for Use. The above described DPP Zika IgM Assay System, when labeled consistently with the labeling authorized by FDA entitled "DPP Zika IgM Assay System," "DPP Micro Reader," "DPP Zika 1gM Assay Control Pack," and "DPP Zika IgM Assay System Quick Reference Instructions." (avaimb}e at htpywow. foa c : Sal cySitua ds authorized to be dh&trabnmé m amd used by authm:&d labflxamms under this UIA, dwpste the fact that it does not meet certain requirements otherwise required by federal law. This labeling maybe revised by Chembio in consultation with, and with concurrence of, the Division of Microbiology Devices (DMDYOffice of In Vitro Diagnostics and Radiological Health (OIRyCenter for Devices and Radiological Health (CDRH).

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54379 Page 35 — Mr. Ippolito, Chembio Diagnostic Systems, Inc. The above described DPP Zika IgM Assay System isauthorized to be accompanied by the following information pertaining to theemergency use, which is authorized to be made available to healthoare providers andpatients: * Fact Sheet for Healthcare Providers: Interpreting DPP Zika IgM Assay Systermm Results & Fact Sheet for Patients: Understanding Results from the DPP Zika IgM Assay System Other Fact Sheets developed by Chembio in consultation with, and with concurrence of, the Office of Counterterrorisam and Emerging Threats (OCETYOffice ofthe ChiefScientist (OCSyYOfficeof the Commissioner(OC) and DMD/OIR/CDRH may be authorized to accompany the above described DPP Zika IgM Assay System andto be ma{k available to healthcare providers and patients. As described in Section TV below, Chembio is also authorized to make available additional information relating to the emergency use of the authorized DPP ZikaIoM Assay System that is consistent with, and doesnot mue,& the terms ofthis letter of amhummtmn. 1 have concluded, pursuant to section 564(d)(2) of the Act, thatit is reasonable to believe that the knownand potential benefits ofthe authorized DPP Zika IgM Assay Systemin the specified population, when used for presumptivequalitative detection of Zika virus IgM antibodies and used consistently with the Scopeof Authorization ofthis letter (Section I), outweigh the known and potential risks ofsuch a product. I have concluded; pursuant to section 564(d)(3) ofthe Act, based on themta}ziy of scientific> evidence availableto FDA. that it is reasonable to believe that the authorized DPP Zika IgM Assay System may be effective in the diagnosis of recent Zika virus infection, when used consistently withthe Scope of Authorization ofthis letter (Section T), pursuant to section 56A(c)(2)(A) ofthe Act. FDA has reviewed the scientific information available to FDA, including the information supporting the coniclusions describedin SectionI above, and concludes that the authorized — DPP Zika IgM AssaySystem, when used to diagnose Zika virus infectionin the specified population (as describedin the Scope of Authorization ofthis letter (Section ID)). meets the criteria set forth in section 564(c) ofthe Act concerning safety and potential effectiveness. The emergency use ofthe authorized DPP Zika IgM Assay System under this EUA must be consistent with. and may not exeeed, the terms ofthis letter, including the Scope of Authorization (Section IT) and the Conditions ofAuthorization (Section IV). Suhjcm to the terms of this EUA and underthe circumstances set forth in theSecretary of HHS‘s determination described above andthe Secretary of HHS‘s corresponding declaration under section 564(b)(1). the DPP Zika IgM Assay System described above is authorized to diagnose Zika virus infection in individuals meeting CDC Zika virus clinical criteria (e.g., a history ofclinicalsigns and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e1g., history ofresidence in or travel to a geographic region with active Zika transmissionat the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated).

54380 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 6 ~ Mr. Ippolito, Chembio Diagnostic Systems, Inc. This EUA will cease to be effective when the HHS declarationthat circumstances exist to justify the EUA is terminated under section 564(b)(2) ofthe Act or when the EUAis revoked under section 564(g) ofthe Act. HL Waiver of Certain Requirements Lam waiving the following requirements for the DPP Zika IoM Assay System during the duration of this EUA: & Current good manufacturing practice requirements, including the quality system requirements under21 CFR Part 820 with respect to the design, manufactire, packaging; labeling, storage. and distribution of the DPP Zika IgM Assay System. «/ Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 21 CFR 809.30; except forthe intended use statement (21 CFR 809.10(a)(2). (b)(2)):adequate directions for use (21 U.S.C. 352(f)y, (21 CFR 809.10(b)(35). (7), and (8)); any appropriatelimitations on the use of the device including information required under 21 CFR $09.10(a)(4); and any available information regarding performance ofthe device, including requirements under 21 CFR 809.10(by( 12). IV. Conditions of Authorization Pursuant to section 564 ofthe Act, 1 arm establishing the following conditions on this authorization: Chembio and Its Authorized Distributor(s} A. Chembio and its authorized distributor(s) will distribute the authorizged DPP Zika IgM Assay System with the authorized labelingonly to authorized laboratories. Chembio may request changes to the authorized labeling:. Such requests will be made by Chembio in consultation with, and require concurrence of, DMD/OIR/CDORH. B. Chembic and its authorized distributor(s) will provideto authorized laboratories the authorized DPP Zika IgM Assay System Fact Sheet for Healtheare Providers and the authorized DPPZika IgM Assay System Fact Sheet for Patients, and any additional DPP Zika I[gM Assay System Fact Sheets for Healthcare Providers and Patients that OCET/OCS/OC and DMDVOIR/CDRIHmay authorize. . Chembio and its authorized distributor(s) will make available on their websites the authorized DPP Zika IgM Assay SystemFact Sheetfor Healthcare Providers and the: authorized DPP Zika IgM Assay System Fact Sheet for Patients, and any additional DPP Zika [gMAssay SystemFact Sheets for Healthcare Providersand Patients that OCET/OCS/OC and DMD/OIR/CDRH mayauthorize:

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54382 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 8 —Mr. Ippolito, Chembio Diagnostic Systems, Inc. M. Chembio may request the addition of other instruments for use with the authorized DPP Zika IgMAssay System. Such requests will be made by Chembio in consultation with, and require concutrrence of, DMIYOIR/CDRH. . Chembio may requestthe addition of other ancillary reagents for use with the authorized DPP Zika IgMAssay System. Such requests will be made by Chembio in consultation with, and require concurrence of, DMD/OIR/CDRH . Chembio may request the addition ofother specimen types for use with the authorized DPP Zika IgM Assay System. Such requestswill be made by Chembio in consultation with, and require concurrence of, DMDV/OIR/CDRH: Chembio may request the addition of other control materials Tor use with the authorized DPP Zika I[gM Assay System. Such requests will be made by Chembio in consultation with, and require concurrence of, DMIDVOIR/CDRH, 3. Chembio may request substitution for or changes to the authorized materials used in the detection process of the human anti—Zika IgM in the specimen. Such requests will be madeby Chembio in consultation with, and require concurrence of, DMD/OIR/CDRH. R. Chembio will track adverse events and report to FDA under 21 CFR Part 803. Chembiowill evaluate theperformance of the DPP Zika IgM Assay System with any L FDA—recommendéed or established panel(s) ofcharacterized clinical specimens, and will submit that performance data to FDA. After DMDVOIR/CDRH s reviewof and concurrence with the data, Chembio will update its labeling, in consultation with, and with concurrence of, DMDVOIR/CDRH, to reflectthe additional testing. "— Chembio will ass iss traceability" ofthe DPP Zika IgMAssaySystem with any FDA— recommended reference material(s). After submission to FDA and DMD/OIR/CDRH‘s review of and concurrence with the data, Chembio will update its labelingto reflectthe additional testing. Lh Chembio will track the performance of the DPP Zika IgM Assay System and report to DMD/OIR/CDRH on a semi—annual basis. Authorized Laboratories V. Authorized laboratories will include with reports of the results of the DPP Zika IgM Assay Systemtheauthorized Fact Sheet for Healthcare Providers and the authorized Fact Sheetfor Patients, and any additional DPP Zika IgM Assay System Fact Sheets for Healthcare Providers and Patients that OCET/OCS/OC and DMD/OIR/CDRH may authorize Under exigent circumstances, other appropriate methods for disseminating * fraceability refers to tracinganalytical sensitivityreactivity back to a FDA—recommended reference material.

Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices 54383 Page9 — Mr. Ippolito, Chembio Diagnostic Systems, Inc. these Fact Sheets may be used, which mayinclude mass media. W. Authorized laboratories will perform the DPP Zika IgMAssay Systemon only human . serum (plain or separationgel) and fingerstick whole blood, EDTA venous whole blood, or EDTA plasma {each collected alongside a pativnt—matched serum specimen} specimens or with other authorized specimen types. . If non—serum specimens are used withthe DPP Zika IgM Assay System, authorized laboratories responsible for collecting the patient specimen must collect a patient— matched serum speciimen, or if this is not possible, an additional serum specimen must be collected soon after the origimal specimen.. This is to facilftateany additional testing that may be required, usingthe latest CDCtesting algorithms for the diagnosis of Zika virus infection, to confirm Zikavirus infection. .~ Authorized laboratories must read the resultsoftheDPP Zika IgM Assay System on the DPP Micto Reader or on other authorized instruments. Authorized laboratories must not attempt to interpret the results of the DPP Zika IgM Assay System visually. Within the United States and its territories, authorized laboratories will report all reactive results (1.e., presumptive Zika IgM positive) to Chembio:. Authorized laboratories will have a process in place to ensure that, for reactive results (1.e.. presumptive Zika IgMpositive). additional testing (asdescribed in the Instructions for Use document) is performed and/or testresults for other pmxem»mafihmi specimens, usingthe latest CDC testing algorithms for the diagnosisof Zika virus infection, are considered. BB. Authorized hburfmrtm will have a process in place for reporting test resuim to healtheare providers and relevant public health authorities, as 3ppr{)pmm, CC Authorized Iaboratorieswill collect information on the performanceof the DPP Zika IgM Az,sa Systemand report to DMIVOIR/CDRH(vie email CDRE and Chembio any suspected oceurrenceof false negative and false positive results and significant deviations fromthe established performance characteristies of which they become aware. DD. All laboratory personmnel using the assay must be appropriately trained in performing and inferpreting immunochromatographic techniques, use appropriate laboratoryand personal protective equipment when handling this kit, and use the testin accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the interpretation ofresults of the DPP Zika IgM AssaySystem: For que raié;tui to reporti Zike test results to relevant public health authorities,it is recommended that Chembic and authorized laboratories consult with the applicable countr state, or termitory health department(s) According to CDC, Zika is a nationally notiffable condition (see h

54384 Federal Register/Vol. 82, No. 221 /Friday, November 17, 2017 /Notices Page 10 —Mr. Ippolito, Chembio Diagnostic Systems, Inc. Chembio, Its Authorized Distributor(s), and Authorized Laboratories EE Chembic, its authorized distributor(s}, and authorized laboratories 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 FF. All advertising and y}mmmibnai descriptive printed matter relating to the use of the authorized. DPP Zika IgM Assay System shall be consistent with the authorized Fact Sheets and authorized labeling, aswell as the terms setforth in this EUA and the applicable requirements set forth in the Act and FDA regulations. GG. All advertising and promotional descriptive printed matter relatingto the use ofthe authorizedDPP ZikaIgM Assay Systemshall clearly and conspicuouslystate that: + This test has not been FDA eleared or approved; This test has been authorized by FDA under &n EUA foruse by authorized a laboratories; * This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens: and * Thistestis only authorized for the duration of the declarationthat circumstances exist justifying the authorization ofthe emergencyuse of in vitro diagnostic tests for detection of Zika virus and/or dmgm}ms of Zika virus infection under section 564(b)(1) of the Act. 31 U.S.C. $ 360bbb—3(b)(1). unless the authorization is terminated or revoked sm‘mu No advertising or promotional descriptive printed matter relating to the use of the authorized DPP Zika I[gM Assay System mayrepresent or suggestthat this testis safe or effective for the dngnosm ofZika virus infection. The emergency use of the authorized DPP Zika IgM Assay System as described in this letter ofauthorization must comply with the conditions and all other terms ofthis authorization. ¥. Duration of Authorization This EUAwill be effective until the declaration that circumstances exist justifying the authorization of the emergency use ofin vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection is terminated under section 564(b)(2) of the Aet orthe EUAis revoked under section 564(g) ofthe Act.

Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54385 Dated: November 9, 2017. unmet medical needs in patients with Management Staff (HFA–305), Food and Anna K. Abram, serious or life-threatening diseases or Drug Administration, 5630 Fishers Deputy Commissioner for Policy, Planning, conditions; and describes the Lane, Rm. 1061, Rockville, MD 20852. Legislation, and Analysis. opportunities for sponsors of • For written/paper comments [FR Doc. 2017–25010 Filed 11–16–17; 8:45 am] regenerative medicine therapies to submitted to the Dockets Management BILLING CODE 4164–01–C interact with CBER review staff. Staff, FDA will post your comment, as DATES: Submit either electronic or well as any attachments, except for written comments on the draft guidance information submitted, marked and DEPARTMENT OF HEALTH AND by February 15, 2018 to ensure that the identified, as confidential, if submitted HUMAN SERVICES Agency considers your comment on this as detailed in ‘‘Instructions.’’ draft guidance before it begins work on Instructions: All submissions received Food and Drug Administration must include the Docket No. FDA– the final version of the guidance. [Docket No. FDA–2017–D–6159] ADDRESSES: You may submit comments 2017–D–6159 for ‘‘Expedited Programs on any guidance at any time as follows: for Regenerative Medicine Therapies for Expedited Programs for Regenerative Serious Conditions; Draft Guidance for Medicine Therapies for Serious Electronic Submissions Industry.’’ Received comments will be Conditions; Draft Guidance for Submit electronic comments in the placed in the docket and, except for Industry; Availability following way: those submitted as ‘‘Confidential AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: http:// Submissions,’’ publicly viewable at HHS. www.regulations.gov. Follow the http://www.regulations.gov or at the instructions for submitting comments. Dockets Management Staff between 9 ACTION: Notice of availability. Comments submitted electronically, a.m. and 4 p.m., Monday through SUMMARY: The Food and Drug including attachments, to http:// Friday. 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One copy will include the engaged in the development of such as medical information, your or information you claim to be confidential regenerative medicine therapies with anyone else’s Social Security number, or with a heading or cover note that states FDA’s current thinking on the expedited confidential business information, such ‘‘THIS DOCUMENT CONTAINS development and review of these as a manufacturing process. Please note CONFIDENTIAL INFORMATION.’’ The products. The draft guidance describes that if you include your name, contact Agency will review this copy, including the expedited programs available to information, or other information that the claimed confidential information, in sponsors of regenerative medicine identifies you in the body of your its consideration of comments. The therapies for serious or life-threatening comments, that information will be second copy, which will have the diseases or conditions (referred to in the posted on http://www.regulations.gov. claimed confidential information draft guidance as serious conditions), • If you want to submit a comment redacted/blacked out, will be available including those products designated as with confidential information that you for public viewing and posted on http:// regenerative advanced therapies (which do not wish to be made available to the www.regulations.gov. Submit both FDA refers to as ‘‘regenerative medicine public, submit the comment as a copies to the Dockets Management Staff. advanced therapy’’ (RMAT) written/paper submission and in the If you do not wish your name and designation); describes how the Center contact information to be made publicly sradovich on DSK3GMQ082PROD with NOTICES manner detailed (see ‘‘Written/Paper for Biologics Evaluation and Research Submissions’’ and ‘‘Instructions’’). available, you can provide this (CBER) will work with sponsors and information on the cover sheet and not encourage flexibility in clinical trial Written/Paper Submissions in the body of your comments and you design to facilitate the development of Submit written/paper submissions as must identify this information as data to demonstrate the safety and follows: ‘‘confidential.’’ Any information marked effectiveness of regenerative medicine • Mail/Hand delivery/Courier (for as ‘‘confidential’’ will not be disclosed EN17NO17.041</GPH> therapies being developed to address written/paper submissions): Dockets except in accordance with 21 CFR 10.20 VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1


Document Created: 2017-11-17 05:14:35
Document Modified: 2017-11-17 05:14:35
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 Siemens Healthcare Diagnostics, Inc. is effective as of September 18, 2017; the Authorization for Chembio Diagnostic Systems, Inc. is effective as of September 27, 2017.
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 Citation82 FR 54361 
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