82_FR_2374 82 FR 2369 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

82 FR 2369 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 5 (January 9, 2017)

Page Range2369-2378
FR Document2017-00084

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 Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by ELITechGroup Inc. Molecular Diagnostics. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows 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 Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

Federal Register, Volume 82 Issue 5 (Monday, January 9, 2017) 
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2369-2378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00084]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4586]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for an in vitro diagnostic device for detection of the Zika virus in 
response to the Zika virus outbreak in the Americas. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by ELITechGroup Inc. Molecular Diagnostics. The 
Authorization contains, among other things, conditions on the emergency 
use of the authorized in vitro diagnostic device. The Authorization 
follows 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 Authorization, which includes an explanation of 
the reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of December 9, 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

[[Page 2370]]

determination by the Secretary of Defense that there is a military 
emergency, or a significant potential for a military emergency, 
involving a heightened risk to U.S. military forces of attack with a 
biological, chemical, radiological, or nuclear agent or agents; (3) a 
determination by the Secretary of HHS that there is a public health 
emergency, or a significant potential for a public health emergency, 
that affects, or has a significant potential to affect, national 
security or the health and security of U.S. citizens living abroad, and 
that involves a biological, chemical, radiological, or nuclear agent or 
agents, or a disease or condition that may be attributable to such 
agent or agents; or (4) the identification of a material threat by the 
Secretary of Homeland Security under section 319F-2 of the Public 
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect 
national security or the health and security of U.S. citizens living 
abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue 
an EUA only if, after consultation with the HHS Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health, and the Director of the Centers for Disease Control and 
Prevention (to the extent feasible and appropriate given the applicable 
circumstances), FDA \1\ concludes: (1) That an agent referred to in a 
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of 
scientific evidence available to FDA, including data from adequate and 
well-controlled clinical trials, if available, it is reasonable to 
believe that: (A) The product may be effective in diagnosing, treating, 
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under 
section 564, approved or cleared under the FD&C Act, or licensed under 
section 351 of the PHS Act, for diagnosing, treating, or preventing 
such a disease or condition caused by such an agent; and (B) the known 
and potential benefits of the product, when used to diagnose, prevent, 
or treat such disease or condition, outweigh the known and potential 
risks of the product, taking into consideration the material threat 
posed by the agent or agents identified in a declaration under section 
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no 
adequate, approved, and available alternative to the product for 
diagnosing, preventing, or treating such disease or condition; and (4) 
that such other criteria as may be prescribed by regulation are 
satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the 
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 November 28, 2016, ELITechGroup Inc. 
Molecular Diagnostics requested, and on December 9, 2016, FDA issued, 
an EUA for the Zika ELITe MGB[supreg] Kit U.S., subject to the terms of 
the Authorization.

III. Electronic Access

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

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an in vitro diagnostic device for 
detection of Zika virus subject to the terms of the Authorization. The 
Authorization in its entirety (not including the authorized versions of 
the fact sheets and other written materials) follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the FD&C Act:
BILLING CODE 4164-01-P

[[Page 2371]]

[GRAPHIC] [TIFF OMITTED] TN09JA17.077


[[Page 2372]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.078


[[Page 2373]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.079


[[Page 2374]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.080


[[Page 2375]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.081


[[Page 2376]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.082


[[Page 2377]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.083


[[Page 2378]]


[GRAPHIC] [TIFF OMITTED] TN09JA17.084


    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00084 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2369 default.htm and scroll down to the accommodate persons with disabilities. diagnosis of Zika virus infection, subject appropriate advisory committee meeting If you require accommodations due to a to the terms of any authorization issued link, or call the advisory committee disability, please contact AnnMarie under the FD&C Act. The Authorization, information line to learn about possible Williams at AnnMarie.Williams@ which includes an explanation of the modifications before coming to the fda.hhs.gov or 301–796–5966 at least 7 reasons for issuance, is reprinted in this meeting. days in advance of the meeting. document. FDA is committed to the orderly DATES: The Authorization is effective as SUPPLEMENTARY INFORMATION: conduct of its advisory committee of December 9, 2016. Agenda: On February 23, 2017, the meetings. Please visit our Web site at ADDRESSES: Submit written requests for committee will discuss and make http://www.fda.gov/Advisory single copies of the EUA to the Office recommendations on clinical Committees/AboutAdvisoryCommittees/ of Counterterrorism and Emerging information related to the de novo ucm111462.htm for procedures on Threats, Food and Drug Administration, request for the Sentinel® Cerebral public conduct during advisory 10903 New Hampshire Ave., Bldg. 1, Protection System, a first of a kind committee meetings. Rm. 4338, Silver Spring, MD 20993– embolic protection device to be used Notice of this meeting is given under with transcatheter aortic valve 0002. Send one self-addressed adhesive the Federal Advisory Committee Act label to assist that office in processing replacement (TAVR) procedures. (5 U.S.C. app. 2). FDA intends to make background your request or include a fax number to material available to the public no later Dated: January 4, 2017. which the Authorization may be sent. than 2 business days before the meeting. Janice M. Soreth, See the SUPPLEMENTARY INFORMATION If FDA is unable to post the background Associate Commissioner, Special Medical section for electronic access to the material on its Web site prior to the Programs. Authorization. meeting, the background material will [FR Doc. 2017–00143 Filed 1–6–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: be made publicly available at the BILLING CODE 4164–01–P Carmen Maher, Office of location of the advisory committee Counterterrorism and Emerging Threats, meeting, and the background material Food and Drug Administration, 10903 will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND New Hampshire Ave., Bldg. 1, Rm. the meeting. Background material is HUMAN SERVICES 4347, Silver Spring, MD 20993–0002, available at http://www.fda.gov/ 301–796–8510 (this is not a toll free Food and Drug Administration AdvisoryCommittees/Calendar/ number). default.htm. Scroll down to the [Docket No. FDA–2016–N–4586] SUPPLEMENTARY INFORMATION: appropriate advisory committee meeting link. Authorization of Emergency Use of an I. Background Procedure: Interested persons may In Vitro Diagnostic Device for Section 564 of the FD&C Act (21 present data, information, or views, Detection of Zika Virus; Availability U.S.C. 360bbb–3) as amended by the orally or in writing, on issues pending AGENCY: Food and Drug Administration, Project BioShield Act of 2004 (Pub. L. before the committee. Written HHS. 108–276) and the Pandemic and All- submissions may be made to the contact ACTION: Notice. Hazards Preparedness Reauthorization person on or before February 9, 2017. Act of 2013 (Pub. L. 113–5) allows FDA Oral presentations from the public will SUMMARY: The Food and Drug to strengthen the public health be scheduled between approximately Administration (FDA) is announcing the protections against biological, chemical, 1 p.m. and 2 p.m. Those individuals issuance of an Emergency Use nuclear, and radiological agents. Among interested in making formal oral Authorization (EUA) (the Authorization) other things, section 564 of the FD&C presentations should notify the contact for an in vitro diagnostic device for Act allows FDA to authorize the use of person and submit a brief statement of detection of the Zika virus in response an unapproved medical product or an the general nature of the evidence or to the Zika virus outbreak in the unapproved use of an approved medical arguments they wish to present, the Americas. FDA issued this product in certain situations. With this names and addresses of proposed Authorization under the Federal Food, EUA authority, FDA can help assure participants, and an indication of the Drug, and Cosmetic Act (the FD&C Act), that medical countermeasures may be approximate time requested to make as requested by ELITechGroup Inc. used in emergencies to diagnose, treat, their presentation on or before February Molecular Diagnostics. The or prevent serious or life-threatening 1, 2017. Time allotted for each Authorization contains, among other diseases or conditions caused by presentation may be limited. If the things, conditions on the emergency use biological, chemical, nuclear, or number of registrants requesting to of the authorized in vitro diagnostic radiological agents when there are no speak is greater than can be reasonably device. The Authorization follows the adequate, approved, and available accommodated during the scheduled February 26, 2016, determination by the alternatives. open public hearing session, FDA may Secretary of Health and Human Services Section 564(b)(1) of the FD&C Act conduct a lottery to determine the (HHS) that there is a significant provides that, before an EUA may be speakers for the scheduled open public potential for a public health emergency issued, the Secretary of HHS must hearing session. The contact person will that has a significant potential to affect declare that circumstances exist notify interested persons regarding their national security or the health and justifying the authorization based on security of U.S. citizens living abroad one of the following grounds: (1) A sradovich on DSK3GMQ082PROD with NOTICES request to speak by February 2, 2017. Persons attending FDA’s advisory and that involves Zika virus. On the determination by the Secretary of committee meetings are advised that the basis of such determination, the Homeland Security that there is a Agency is not responsible for providing Secretary of HHS declared on February domestic emergency, or a significant access to electrical outlets. 26, 2016, that circumstances exist potential for a domestic emergency, FDA welcomes the attendance of the justifying the authorization of involving a heightened risk of attack public at its advisory committee emergency use of in vitro diagnostic with a biological, chemical, radiological, meetings and will make every effort to tests for detection of Zika virus and/or or nuclear agent or agents; (2) a VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1

2370 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices determination by the Secretary of the HHS Assistant Secretary for II. EUA Request for an In Vitro Defense that there is a military Preparedness and Response, the Diagnostic Device for Detection of the emergency, or a significant potential for Director of the National Institutes of Zika Virus a military emergency, involving a Health, and the Director of the Centers On February 26, 2016, the Secretary of heightened risk to U.S. military forces of for Disease Control and Prevention (to HHS determined that there is a attack with a biological, chemical, the extent feasible and appropriate significant potential for a public health radiological, or nuclear agent or agents; given the applicable circumstances), emergency that has a significant (3) a determination by the Secretary of FDA 1 concludes: (1) That an agent potential to affect national security or HHS that there is a public health referred to in a declaration of emergency the health and security of U.S. citizens emergency, or a significant potential for or threat can cause a serious or life- living abroad and that involves Zika a public health emergency, that affects, threatening disease or condition; (2) virus. On February 26, 2016, under or has a significant potential to affect, that, based on the totality of scientific section 564(b)(1) of the FD&C Act, and national security or the health and evidence available to FDA, including on the basis of such determination, the security of U.S. citizens living abroad, data from adequate and well-controlled Secretary of HHS declared that and that involves a biological, chemical, clinical trials, if available, it is circumstances exist justifying the radiological, or nuclear agent or agents, reasonable to believe that: (A) The authorization of emergency use of in or a disease or condition that may be vitro diagnostic tests for detection of product may be effective in diagnosing, attributable to such agent or agents; or Zika virus and/or diagnosis of Zika treating, or preventing (i) such disease (4) the identification of a material threat virus infection, subject to the terms of or condition; or (ii) a serious or life- by the Secretary of Homeland Security any authorization issued under section under section 319F–2 of the Public threatening disease or condition caused by a product authorized under section 564 of the FD&C Act. Notice of the Health Service (PHS) Act (42 U.S.C. determination and declaration of the 247d–6b) sufficient to affect national 564, approved or cleared under the FD&C Act, or licensed under section 351 Secretary was published in the Federal security or the health and security of Register on March 2, 2016 (81 FR U.S. citizens living abroad. of the PHS Act, for diagnosing, treating, or preventing such a disease or 10878). On November 28, 2016, Once the Secretary of HHS has ELITechGroup Inc. Molecular condition caused by such an agent; and declared that circumstances exist Diagnostics requested, and on December (B) the known and potential benefits of justifying an authorization under 9, 2016, FDA issued, an EUA for the the product, when used to diagnose, section 564 of the FD&C Act, FDA may Zika ELITe MGB® Kit U.S., subject to authorize the emergency use of a drug, prevent, or treat such disease or condition, outweigh the known and the terms of the Authorization. device, or biological product if the Agency concludes that the statutory potential risks of the product, taking III. Electronic Access criteria are satisfied. Under section into consideration the material threat An electronic version of this 564(h)(1) of the FD&C Act, FDA is posed by the agent or agents identified document and the full text of the required to publish in the Federal in a declaration under section Authorization are available on the Register a notice of each authorization, 564(b)(1)(D) of the FD&C Act, if Internet at https://www.regulations.gov/ and each termination or revocation of an applicable; (3) that there is no adequate, . authorization, and an explanation of the approved, and available alternative to reasons for the action. Section 564 of the the product for diagnosing, preventing, IV. The Authorization FD&C Act permits FDA to authorize the or treating such disease or condition; Having concluded that the criteria for introduction into interstate commerce of and (4) that such other criteria as may issuance of the Authorization under a drug, device, or biological product be prescribed by regulation are satisfied. section 564(c) of the FD&C Act are met, intended for use when the Secretary of No other criteria for issuance have FDA has authorized the emergency use HHS has declared that circumstances been prescribed by regulation under of an in vitro diagnostic device for exist justifying the authorization of section 564(c)(4) of the FD&C Act. detection of Zika virus subject to the emergency use. Products appropriate for Because the statute is self-executing, terms of the Authorization. The emergency use may include products regulations or guidance are not required Authorization in its entirety (not and uses that are not approved, cleared, for FDA to implement the EUA including the authorized versions of the or licensed under sections 505, 510(k), authority. fact sheets and other written materials) or 515 of the FD&C Act (21 U.S.C. 355, follows and provides an explanation of 360(k), and 360e) or section 351 of the 1 The Secretary of HHS has delegated the the reasons for its issuance, as required PHS Act (42 U.S.C. 262). FDA may issue authority to issue an EUA under section 564 of the by section 564(h)(1) of the FD&C Act: an EUA only if, after consultation with FD&C Act to the Commissioner of Food and Drugs. BILLING CODE 4164–01–P sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1

_ -'/é DEFARTMENT OF HEALTH & HUMAN SERVICES Faod and Drug Administration: Silver Spring, MD 20993 Decemmber 9, 2016 Terry Trimingham Senior Regulatory Affairs Specialist ELITechGroup Inc. Molecular Diagnostics 21720 23" Drive SE, Suite 150 Bothell, WA 98021 Dear Mr. Trimingham: This letter is in response to your request that the Food and Drug Administration (FDA) isste an Emergency Use Authorization (EUA) for emergency use of ELITechGroup Inc. Molecular Diagnostics® ("EGI MDx") Zika ELITe MGB® Kit U.S. for the qualitative detection of RNA from Zika virus in human serum and EDTA plasma from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical eriteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemtological criteria {e.g., history of residence in or travel to a geographic region with active Zika transmission at the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high 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—33.‘ Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection," up to 14 days in serum, following onset of symptoms, if present. Positive results are indicative of current infection. On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb— 3(b)(1)(C)), the Secretary of Health and Human Services (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." Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that cireumstances exist justifying the authorization of the emergency use of in vitro dagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 U.S.C. §360bbb—3(a)." \ For ease of reference, this letter will refer to "laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S,C. § 263a, to perform high complexity tests, or by similarly qualified non—U.S. taboratories" as "authorized laboratories." * Available at hrtpr//wwiw.¢de. gov/zika/laboratories/lab—seidance.html {last updated on November 16, 2016). * As amended by the Pandemic and All Hazards Preparedness Reauthorization Act, Pub. L. No. 113—5, under section 564(BX1YC) of the Act, the Secretary may make a determination of a public health emergency, or of significant potential for a public heatth emergency, * HHS. Determination and Declaration Regarding Emergency Use ofin Vitro Diagnostic Tesis for Detection ofZika Firus and/or Diagnosis ofZika Virus Infection. 81 Fed. Reg. 10878 (March 2, 2016).

Page 2—Mr. Terry Trimingham, EL[TechGroup Inc. Molecular Diagnostics, USA Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb—3(c)) are met, 1 am suthorizing the emergency use ofthe Zika ELITe MGB® Kit U.S. (as described in the Scope of Authorization section of this letter (Section H)) in individuals meeting CDC Zika virus clinical eriteria (e.g., clinical signs and symptoms associated with Zika virus infection} and/or CDC Zika virus epidemiclogical criteria (e.g., history of residence in or travel to & geographic region with active Zika transmission at the time of travel, or other epidemiclogical criteria for which Zika virus testing may be indicated) (as described in the Scope of Authorization section of this letter (Section 11)) for the detection of Zika virus infection by authorized laboratories, subject to the terms of this authorization. L. Criteria for Issuance of Authorization T have concluded that the emergency use of the Zika ELITé MGB®" Kit U.S. for the detection ofZika virus and diagnosis of Zika virus infection in the specified population meets the criteria for issuance of an authorization under section §564(c) of the Act, because I1 have concluded that: 1. The Zika virus can cause Zika virys infection, a serious or life—threatening disease or condition to humans infected with the virus; : Based on the totality of stientific evidence available to FDA, it is reasonable to believe ba that the Zika ELITe MOB® Kit U.S., when used with the specified instrument(s) and in accordance with the Scope of Authorization, may be effective in detecting Zika virus and diagnosing Zika virus infection, and that the known and potential benefits of the Zika ELITe MGB® Kit U.S; for detecting Zika virus and diagnosing Zika virus infection outweigh the known and potential risks of such product; and 3. There is no adequate, approved, and available alternative to the emergency use of the Zika EL{Te MGB*" Kit U.S. for detecting Zika virus and diagnosing Zika virus infection." 1L Scope of Authorization | have concluded, pursuant to section §564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized Zika EL1Te MGB® Kit U.S. by authorized laboratories for the detection of RNA from Zika virus and diagnosis of Zika virus infection in individuals meeting CDC Zika virus clinical criteria (e.g., clinical gigns and symptoms associated with Zika virus infection} and/or CDC Zika virus epidemiological criteria (e—g., history of residence in or travel to a geographic region with active Zika transmission at the time oftravel, or other epidemmiological criteria for which Zika virus testing maybe indicated). The Authorized Zike ELITe MGB® Kit U.S. The Zika ELITe MGB® Kit U.S, is a real—time reverse franscription polymerase chain reaction (rRT—PCR) assay for the qualitative detection of RNA from Zika virus in human serum, EDTA "No other criteria of issuance have been prescribed by regulation under section §64{c){4) of the Act.

Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2373 .. .. .. .. sradovich on DSK3GMQ082PROD with NOTICES EN09JA17.079</GPH> VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1

2374 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices UI. sradovich on DSK3GMQ082PROD with NOTICES EN09JA17.080</GPH> VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1

Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2375 Conditions of Authorization B. E. sradovich on DSK3GMQ082PROD with NOTICES EN09JA17.081</GPH> VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1

u — y sz & Page 6 —Mr: Terry Trimingham, EL{TechGroup Inc. Molecular Diagnostics, USA G. EGEI MDx and its authorized distributor(s) will collect information on the performance of the test. EGI MDx will report to FDA any suspected occurrence offalse positive and false negative results and significant deviations from the established performance characteristics of the test of which EGI MDx becomes aware: . EGT MDx and its authorized distributor(s} are authorized to make available addifional information relating to the emergency use of the authorized Zika ELITe MGB" Kit U.S. thatis consistent with. and does not exceed, the terms of this letter of authorization. ELI[TechGroup Inc. Molecular Diagnostics 1. EGI MDx will notify FDA ofany authorized distributor(s) ofthe Zika ELITe MGB" Kit U.S,, including the name, address, and phone number of any authorized distributor(s}. EGL MDx will provide its authorized distributor(s) with a copy of this EUA, and communicate to its authorized distributor(s} any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets, Instructions for Use). . EGI MDx may request changes to the authorized Zika ELITe MGB" Kit U.S. Fact Sheet for Healthecare Providers and the authorized Zika ELITe MGB® Kit U.S. Fact Sheet for Patients. Such requests will be made by EGI MDx in consultation with, and require concurrence of, DMDY/OIR/CDRH, EGI MDx may request the addition ofother instruments for use with the authorized Zika ELITe MGB" Kit US. Such requests will be made by EGI MDx in consultation with, and require concurrence of, DMDY/OIR/CDRH. . EGL MDx may request the addition of other extraction methods for use with the authorized Zika ELITe MGB" Kit U.S.. Such requests will be made by EGE MDx in consultation with, and require concurrence of, DMD/OIR/CDORH. N. EGI MDx may request the addition of other specimen types for use with the authorized Zika ELITe MGB" Kit U.S. Such requests will be made by EGH MDx in consultation with, and require concurrence of, DMD/OIR/CDRH, . EGI MDx may request the—addition and/or substitution of other control materials for use with the authorized Zika ELITe MGB" Kit U.S. Such requests will be made by EG] MDx in consultation with, and require concurrence of, DMD/OIR/CDORH. EGI MDx may request the addition and/or substitution of other ancillary reagents and materials for use with the authorized Zika ELITe MGB® Kit U.S. Such requests will be made by EGI MDx in consultation with, and require concurrence of, DMD/OIR/CDORH, 0. EGI MDx will assess traceability" of the Zika ELITeMGB® Kit U.S. with FDA— \ {raceabilityrefors to tracing analytical sensifivityreactivity back to a FDA recommended reférence material.

Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2377 Mr. R. MDx and CFR Part Authorized Laboratories Kit Kit v. sradovich on DSK3GMQ082PROD with NOTICES EN09JA17.083</GPH> VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\09JAN1.SGM 09JAN1

2378 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices Dated: January 3, 2017. DEPARTMENT OF HEALTH AND notice of that determination as required Leslie Kux, HUMAN SERVICES by law. FDA has made the Associate Commissioner for Policy. determination because of the Food and Drug Administration submission of an application to the [FR Doc. 2017–00084 Filed 1–6–17; 8:45 am] Director of the U.S. Patent and BILLING CODE 4164–01–C [Docket Nos. FDA–2016–E–1196 and FDA– 2016–E–1197] Trademark Office (USPTO), Department of Commerce, for the extension of a Determination of Regulatory Review patent which claims that human Period for Purposes of Patent biological product. Extension; ADYNOVATE DATES: Anyone with knowledge that any of the dates as published (see the sradovich on DSK3GMQ082PROD with NOTICES AGENCY: Food and Drug Administration, HHS. SUPPLEMENTARY INFORMATION section) are ACTION: Notice. incorrect may submit either electronic or written comments and ask for a SUMMARY: The Food and Drug redetermination by March 10, 2017. Administration (FDA) has determined Furthermore, any interested person may the regulatory review period for petition FDA for a determination ADYNOVATE and is publishing this regarding whether the applicant for EN09JA17.084</GPH> VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1


Document Created: 2018-10-24 11:10:25
Document Modified: 2018-10-24 11:10:25
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 December 9, 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 Citation82 FR 2369 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR