82_FR_49818 82 FR 49612 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

82 FR 49612 - 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 206 (October 26, 2017)

Page Range49612-49632
FR Document2017-23224

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 Thermo Fisher Scientific and The Center for Infection and Immunity, Columbia University. 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 206 (Thursday, October 26, 2017) 
[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49612-49632]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23224]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1486]


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
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 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 Thermo Fisher Scientific and The 
Center for Infection and Immunity, Columbia University. 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 Thermo Fisher Scientific is applicable as 
of August 2, 2017; the Authorization for The Center for Infection and 
Immunity, Columbia University is effective as of August 11, 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 assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for

[[Page 49613]]

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 360(e) 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 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 June 5, 2017, Thermo Fisher Scientific 
requested, and on August 2, 2017, FDA issued, an EUA for the TaqPath 
Zika Virus Kit (ZIKV), subject to the terms of the Authorization. On 
July 31, 2017, The Center for Infection and Immunity, Columbia 
University requested, and on August 11, 2017, FDA issued, an EUA for 
the CII-ArboViroPlex rRT-PCR assay, 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) follows and provides an 
explanation of the reasons for issuance, as required by section 
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 49614]]

[GRAPHIC] [TIFF OMITTED] TN26OC17.000


[[Page 49615]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.001


[[Page 49616]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.002


[[Page 49617]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.003


[[Page 49618]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.004


[[Page 49619]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.005


[[Page 49620]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.006


[[Page 49621]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.007


[[Page 49622]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.008


[[Page 49623]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.009


[[Page 49624]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.010


[[Page 49625]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.011


[[Page 49626]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.012


[[Page 49627]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.013


[[Page 49628]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.014


[[Page 49629]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.015


[[Page 49630]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.016


[[Page 49631]]


[GRAPHIC] [TIFF OMITTED] TN26OC17.017



[[Page 49632]]


    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23224 Filed 10-25-17; 8:45 am]
BILLING CODE 4164-01-C

49612 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices the following proposed collection(s) of Dated: October 23, 2017. of Counterterrorism and Emerging information for public comment: William N. Parham, III, Threats, Food and Drug Administration, 1. Type of Information Collection Director, Paperwork Reduction Staff, Office 10903 New Hampshire Ave., Bldg. 1, Request: Extension of a currently of Strategic Operations and Regulatory Rm. 4338, Silver Spring, MD 20993– Affairs. 0002. Send one self-addressed adhesive approved collection; [FR Doc. 2017–23341 Filed 10–25–17; 8:45 am] label to assist that office in processing Title of Information Collection: BILLING CODE 4120–01–P your request or include a fax number to National Provider Identifier (NPI) which the Authorizations may be sent. Application and Update Form and See the SUPPLEMENTARY INFORMATION Supporting Regulations in 45 CFR DEPARTMENT OF HEALTH AND section for electronic access to the 142.408, 45 CFR 162.406, 45 CFR HUMAN SERVICES Authorizations. 162.408; Use: The National Provider FOR FURTHER INFORMATION CONTACT: Identifier Application and Update Form Food and Drug Administration Carmen Maher, Office of is used by health care providers to apply [Docket No. FDA–2016–N–1486] Counterterrorism and Emerging Threats, for NPIs and furnish updates to the Food and Drug Administration, 10903 information they supplied on their Authorizations of Emergency Use of In New Hampshire Ave., Bldg. 1, Rm. initial applications. The form is also Vitro Diagnostic Devices for Detection 4347, Silver Spring, MD 20993–0002, used to deactivate their NPIs if of Zika Virus; Availability 301–796–8510 (this is not a toll free necessary. The original application form number). AGENCY: Food and Drug Administration, was approved in February 2005 and has HHS. SUPPLEMENTARY INFORMATION: been in use since May 23, 2005. The form is available on paper or can be ACTION: Notice. I. Background completed via a web-based process. SUMMARY: The Food and Drug Section 564 of the FD&C Act (21 Health care providers can mail a paper Administration (FDA) is announcing the U.S.C. 360bbb–3) as amended by the application, complete the application issuance of two Emergency Use Project BioShield Act of 2004 (Pub. L. via the web-based process via the Authorizations (EUAs) (the 108–276) and the Pandemic and All- National Plan and Provider Authorizations) for in vitro diagnostic Hazards Preparedness Reauthorization Enumeration System (NPPES), or have a devices for detection of the Zika virus Act of 2013 (Pub. L. 113–5) allows FDA trusted organization submit the in response to the Zika virus outbreak to strengthen the public health application on their behalf via the in the Americas. FDA issued these protections against biological, chemical, Electronic File Interchange (EFI) Authorizations under the Federal Food, nuclear, and radiological agents. Among process. The Enumerator uses the Drug, and Cosmetic Act (the FD&C Act), other things, section 564 of the FD&C NPPES to process the application and as requested by Thermo Fisher Act allows FDA to authorize the use of generate the NPI. NPPES is the Medicare Scientific and The Center for Infection an unapproved medical product or an contractor tasked with issuing NPIs, and and Immunity, Columbia University. unapproved use of an approved medical maintaining and storing NPI data. Form The Authorizations contain, among product in certain situations. With this Number: CMS–10114 (OMB control other things, conditions on the EUA authority, FDA can help assure number: 0938–0931); Frequency: On emergency use of the authorized in vitro that medical countermeasures may be occasion; Affected Public: Business or diagnostic devices. The Authorizations used in emergencies to diagnose, treat, other for-profit, Not-for-profit follow the February 26, 2016, or prevent serious or life-threatening institutions, and Federal government; determination by the Secretary of Health diseases or conditions caused by Number of Respondents: 1,473,185; and Human Services (HHS) that there is biological, chemical, nuclear, or Total Annual Responses: 1,473,185; a significant potential for a public radiological agents when there are no Total Annual Hours: 250,442. (For health emergency that has a significant adequate, approved, and available policy questions regarding this potential to affect national security or alternatives. collection contact Kimberly McPhillips the health and security of U.S. citizens Section 564(b)(1) of the FD&C Act at 410–786–5374). living abroad and that involves Zika provides that, before an EUA may be 2. Type of Information Collection virus. On the basis of such issued, the Secretary of HHS must Request: Reinstatement without change determination, the Secretary of HHS declare that circumstances exist of a previously approved collection; declared on February 26, 2016, that justifying the authorization based on Title of Information Collection: Hospice circumstances exist justifying the one of the following grounds: (1) A Request for Certification and Supporting authorization of emergency use of in determination by the Secretary of Regulations; Use: The Hospice Request vitro diagnostic tests for detection of Homeland Security that there is a for Certification Form is the Zika virus and/or diagnosis of Zika domestic emergency, or a significant identification and screening form used virus infection, subject to the terms of potential for a domestic emergency, to initiate the certification process and any authorization issued under the involving a heightened risk of attack to determine if the provider has FD&C Act. The Authorizations, which with a biological, chemical, radiological, sufficient personnel to participate in the include an explanation of the reasons or nuclear agent or agents; (2) a Medicare program. Form Number: for issuance, are reprinted in this determination by the Secretary of CMS–417 (OMB Control number: 0938– document. Defense that there is a military 0313); Frequency: Annually; Affected DATES: The Authorization for Thermo emergency, or a significant potential for ethrower on DSK3G9T082PROD with NOTICES Public: Private Sector—Business or Fisher Scientific is applicable as of a military emergency, involving a other for-profits; Number of August 2, 2017; the Authorization for heightened risk to U.S. military forces of Respondents: 851; Total Annual The Center for Infection and Immunity, attack with a biological, chemical, Responses: 851; Total Annual Hours: Columbia University is effective as of radiological, or nuclear agent or agents; 213. (For policy questions regarding this August 11, 2017. (3) a determination by the Secretary of collection contact Thomas Pryor at 410– ADDRESSES: Submit written requests for HHS that there is a public health 786–1332.) single copies of the EUAs to the Office emergency, or a significant potential for VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49613 a public health emergency, that affects, FDA 1 concludes: (1) That an agent potential to affect national security or or has a significant potential to affect, referred to in a declaration of emergency the health and security of U.S. citizens national security or the health and or threat can cause a serious or life- living abroad and that involves Zika security of U.S. citizens living abroad, threatening disease or condition; (2) virus. On February 26, 2016, under and that involves a biological, chemical, that, based on the totality of scientific section 564(b)(1) of the FD&C Act, and radiological, or nuclear agent or agents, evidence available to FDA, including on the basis of such determination, the or a disease or condition that may be data from adequate and well-controlled Secretary of HHS declared that attributable to such agent or agents; or clinical trials, if available, it is circumstances exist justifying the (4) the identification of a material threat reasonable to believe that: (A) The authorization of emergency use of in by the Secretary of Homeland Security product may be effective in diagnosing, vitro diagnostic tests for detection of under section 319F–2 of the Public treating, or preventing (i) such disease Zika virus and/or diagnosis of Zika Health Service (PHS) Act (42 U.S.C. or condition; or (ii) a serious or life- virus infection, subject to the terms of 247d–6b) sufficient to affect national threatening disease or condition caused any authorization issued under section security or the health and security of by a product authorized under section 564 of the FD&C Act. Notice of the U.S. citizens living abroad. 564, approved or cleared under the determination and declaration of the FD&C Act, or licensed under section 351 Secretary was published in the Federal Once the Secretary of HHS has of the PHS Act, for diagnosing, treating, Register on March 2, 2016 (81 FR declared that circumstances exist or preventing such a disease or 10878). On June 5, 2017, Thermo Fisher justifying an authorization under condition caused by such an agent; and Scientific requested, and on August 2, section 564 of the FD&C Act, FDA may (B) the known and potential benefits of 2017, FDA issued, an EUA for the authorize the emergency use of a drug, the product, when used to diagnose, TaqPath Zika Virus Kit (ZIKV), subject device, or biological product if the prevent, or treat such disease or to the terms of the Authorization. On Agency concludes that the statutory condition, outweigh the known and July 31, 2017, The Center for Infection criteria are satisfied. Under section potential risks of the product, taking and Immunity, Columbia University 564(h)(1) of the FD&C Act, FDA is into consideration the material threat requested, and on August 11, 2017, FDA required to publish in the Federal posed by the agent or agents identified issued, an EUA for the CII-ArboViroPlex Register a notice of each authorization, in a declaration under section rRT-PCR assay, subject to the terms of and each termination or revocation of an 564(b)(1)(D) of the FD&C Act, if the Authorization. authorization, and an explanation of the applicable; (3) that there is no adequate, reasons for the action. Section 564 of the approved, and available alternative to III. Electronic Access FD&C Act permits FDA to authorize the the product for diagnosing, preventing, introduction into interstate commerce of or treating such disease or condition; An electronic version of this a drug, device, or biological product and (4) that such other criteria as may document and the full text of the intended for use when the Secretary of be prescribed by regulation are satisfied. Authorizations are available on the HHS has declared that circumstances No other criteria for issuance have internet at https://www.regulations.gov. exist justifying the authorization of been prescribed by regulation under IV. The Authorizations emergency use. Products appropriate for section 564(c)(4) of the FD&C Act. emergency use may include products Because the statute is self-executing, Having concluded that the criteria for and uses that are not approved, cleared, regulations or guidance are not required issuance of the Authorizations under or licensed under sections 505, 510(k), for FDA to implement the EUA section 564(c) of the FD&C Act are met, or 515 of the FD&C Act (21 U.S.C. 355, authority. FDA has authorized the emergency use 360(k), and 360(e) or section 351 of the of two in vitro diagnostic devices for II. EUA Requests for In Vitro Diagnostic PHS Act (42 U.S.C. 262). FDA may issue detection of Zika virus subject to the Devices for Detection of the Zika Virus an EUA only if, after consultation with terms of the Authorizations. The the HHS Assistant Secretary for On February 26, 2016, the Secretary of Authorizations in their entirety (not Preparedness and Response, the HHS determined that there is a including the authorized versions of the Director of the National Institutes of significant potential for a public health fact sheets and other written materials) Health, and the Director of the Centers emergency that has a significant follows and provides an explanation of for Disease Control and Prevention (to the reasons for issuance, as required by 1 The Secretary of HHS has delegated the the extent feasible and appropriate authority to issue an EUA under section 564 of the section 564(h)(1) of the FD&C Act. given the applicable circumstances), FD&C Act to the Commissioner of Food and Drugs. BILLING CODE 4164–01–P ethrower on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1

'l’uffr;’w je* "% %, L oecin, BEFARTMENT OF HEALTH AND HUMAN SERVICES "Shig Food and Drug Administralion Siver Spang. MD 200903 August 2, 2017 Faith Du Regulatory Analyst Thermo Fisher Scientific 6055 Sunol Blvd. Pleasanton, CA 94566 Dear Ms. Du: This letteris in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of Therms Figher Scientific‘s ("Thermo Fisher") TagPath Zika Viros Kit (ZIK V) for the qualitative detection of LNA from Zika virus in human serum and urine (collected alongside a patient—matched serum specimen} from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection} and/or CDC Zika virus epidemiological criteria (ecg., history ofresidence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiotogical criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S;) that are certified under the Climical Laboratory Improverment 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 KNA is generally detectable in serum during the acute phase of infection and, according to the updated CDC Guidance for U.$. Laboratories Testing for Zika Virus Infection," up to 14 days in serum and urine (possibly longer in urine}, following onset of symptoms; if present,. Positive results are indicative of current infection. On February 26, 2016, pursuant to section 564(b)(1 YC) of the Act{21 U.S.C. $360bbb6— 3HbY1}(C)), the Secretary of Health—and Human Services (MHHS) determined that there is a significant potential for a public health emergency that has a significant potential to affect national sgcurity or the health and security of U.S. citizens living abroad and that involves Zika virus." Pursuantto section $64(b)(1} of the Act(21 U.S.C. § 360bbb—3(b)(1)), and on the basis ‘Forease of reference, this letter will refer to "Taboratories in the United States (U—S.) that are certified under the Clinical Laboratory Improvernent Amendments of 1988 (CLIA), 42 U.S.C.§ 263a, to perform high complexity testsor...snmflarly qualihied non—Ll .S. faboratories" as "authorized laboratories:" * Available at hi wvecde roviet bbomries ht—euilance hmd (ber updated on July 24, 2017), * as amended by the Pandemic and All—Hazards Preparedness Reauthorization Act, Pub. L. No. 113—5, under section

Federal Register/Vol. 82, No. 206 /Thursday, October 26, 2017 /Notices 49615 Page 2 — Faith Du, Thermo Fisher Scientific of such determination, the Secretary of HHS then declared that cireumstances exist fustifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms ofany authorization issued under 21 U.S.C. § 360bbb—3(@).° Having concluded that the criteria for issuance ofthis authorization under section 564(c) of the Act{2] LL.S.C.—§ 360bbb—3(c)) are met, 1 am authorizing the emergency use ofthe TagPath Zika YVirus Kit (ZIKYV) (as described in the Scape of Authorization section afthis letter {Section f!}) in individuals meeting CDC Zika virus clinical critena (e:g., climeal 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 geographicregion with active Zika transmission at the fime of travel, or other epidemiological criteria for which Zika virus testing may be indicated) (as described in the Scope of Authorization section of this letter (Section [F}) for the detection of Zika virus infection by authorized laboratories, subject to the terms of this authorization. L. Criteria for Issuance of Authorization [ have concluded that the emergency use of the TagPath Zika Virus Kit (ZIKY) for the detection of Zika 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 1 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; Based on the totality of scientific evidence available to FDA, it is reasonable to believe t3 that the TagPath Zika Virus Kit (ZIKV), 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 TagPath Zika Virus Kit (ZIKYV) for detecting Zika virus and diagnosing Zika virus infection outweigh the known and potential risks ofsuch product; and 3. There is no adequate, approved. and available alternative to the emergency use of the TagPath Zika Virus Kit (ZIKY) for detecting Zika virus and diagnosing Zika virus infection." 1L. Scope of Authorization 1 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 TagPath Zika Virus Kit (ZIKY) by authorized laboratories for the detection of LNA from Zika virus and diagnosis of Zika virus infection in individuals Shd4(b)(T)(C) of the Act, the Secretary may make a determination of a public healthemergency, or of a significant g:mcnrial for a public health emergency. HHS.Determination and Declaration Regarding Emergency Use of in Vitro Miagnostic Tests for Detection ofZika Firus andior Magnosis of Zike Virus Infection, 81 Fed: Reg. 10878 (March 2, 201 6). * No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act

49616 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices • ethrower on DSK3G9T082PROD with NOTICES EN26OC17.002</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Page 4— Faith Du, Thermo Fisher Scientific distributed to and used by authorized faboratories under this ELA, despite the fact that it does not meet certain requirements otherwise required by federal law, Theabove described TagPath Zika Virus Kit (ZIKY) is authonzed to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients, including pregnant women: * Fact Sheet for Healthcare Providers: Interpreting TagPath Zika YViros Kit (ZIKY) Test Results a Fact Sheet for Patients: Understanding Results from the TagPath Zika Virus Kit (ZIKYV) As described in Section TV below, Thermo Fisher and its authorized distributors are also authorized to make available additional information relating to the emergency use of the authorized TagPath Zika Virus Kit (ZIKV) that is consistent with, and does not exceed, the terms of this lefter ofauthorization, t have concluded, pursuant to section 564(d)}(2) of the Act, that it is reasonable to befieve that the known and potential benefits of the authorized TagPath Zika Virus Kit {ZIKY) in the specified population, when used for detection of Zika virus and to diagnose Zika virus infection and used consistently with the Scope of Authorization ofthis letter:(Section IT), outweigh the known and potential risks of such a product. T have concluded, pursuant to section 564(d)(3) of the Act. based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized TagPath Zika Virus Kit (ZIKY) may be effective in the detection of Zika virus and diagnosis of Zika virus infection, whenmused consistently with the Seope of Authorization of this letter (Section IT}, pursuant to section S64(cY2)(A) of the Act. FDA has reviewed the scientific information available to FDA, imcluding the information supporting the conclusions described in Section | above, and concludes that the authorized TagPath Zika Virus Kit (ZIKV), when used for detection of Zika virus and to diagnose Zika virus infection in the specified population {as described in the Scope of Authorization ofthis letter (Section H}), meets the critena set forth in section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of the authorized TagPath Zika Virus Kit (ZIKYV) under this EUA must be consistent with, and may not exceed. the terms of this letter, including the Scope of Authorization (Section IT) and the Conditions of Authorization (Section IV).. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHMS‘s determinatton described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the TagPath Zika Virus Kit (ZIKY) described above is authorized to detect Zika virus and diagnose Zika virus infection in individuals meeting CDC Zika virus clinical criteria (eg.. clinmical signs and symptoms associated with Zika virus infection} and/or CDC Zika virus épidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika viros transmissions at the time oftravel, or other epidemiological criteria for which Zika virus testing may be indicated}.

49618 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices Ill. Conditions of Authorization of the the Thenno ethrower on DSK3G9T082PROD with NOTICES EN26OC17.004</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Page 6 — Faith Du, Thermo Fisher Scientific laboratories using the authorized TagPath Zika Virus Kit (ZIKY) have a process in place for reporting test results to healthcare providers and relevant public health avthorities, as appropriate." F. Through a process of inventory control, Thermo Fisher and its authorized distributor(s) will maintain records of device usage. 3. Thermo Fisher and its authorized distributor(s) will collect information on the performance of the test. Thermo— Fisher will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the test ofwhich Thermo Figher becomes aware. H. Thermo Fisher and its authorized distributor(s) are authorized to make available additional information relating to the emergency use of the authorized TagPath Zika Virus Kit (ZIKYV) that is consistent with, and does not exceed, the terms of this letter of authorization. Thermo Fisher L. Thermo Fisher will notify FDA of any authorized distributor(s) of the TagPath Zika Virus Kit{(ZIKV), including the name, address, and phone mumber of any authorized distributor(s). 1. Thermo Fisher 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 itsauthorized accompanying materials (e—g., Fact Sheets, Instractions for Usey. K.. Thermo Fisher may request changes to the authorized TagPath Zika Virns Kit (ZIKV) Fact Sheet for Healthcare Providers and the authorized TagPath Zika Virus Kit (ZIKYV) Fact Sheet for Patrents. Such requests will be made by Thermo Figher in consultation with, and require concurrence of, DMDY/OIR/CORHL L. Thermo Fisher may request the addition of other instruments for use with the authorized TagPath Zika Virus Kit (ZIKV). Such requests will be made by Thermo Figher in consultation with, and require concurrence of, DMD/OIR/CORH. M. Thermo Fisher may request the addition of other extraction methods for use with the authorized TagPath Zika Viros Kit (ZIKV). Such requests will be made by Thermo Fisher in consultation with, and require concurrence of, DMD/OIR/CDORH, ®For questions related to reporting Zika teat results to relevant public health authoritics; it is recommended that Thermo Fisher, other authorized distnbutor(s}, and authorized laboratories consult with the applicable country, «tate or territory health department(s). According to CDC, Zika virus disease is a nationally notthable condition (see hitps naseedogcy sihe‘y.

Page 7 =Faith Du, Thermo Fisher Scientific N. Thermo Fishker may request the addifion of other specimen types for use with the authorized TagPath Zika Virus Kit (ZIKY). Such requests will be made by Thermo Fisher in consultation with, and require concurrence of, DMD/OIR/CDRH. Thermo Fisher may request the addition and/or substitution of other control materials for use with the authorized TagPath Zika Virus Kit (ZIKYV). Such requests will be made by Thermo Fisher in consultation with, and require concurrence of, DMD/OIRCDRH. Thermeo Fisher may request the addition and/or substitution of other ancillary reagents and matertals for use with the authorized TagPath Zika Virus Ki (ZIKY). Such requests will be made by Thermo Fisher in consultation with, and require concurrence of. DMD/OIR/CDORH, ; Thermo Fisher will assess traceability" of the TagPath Zika Virus Kit (ZIKY) with FDA—recommended reference material(s). A ftersubmission to FDA and DMD/OMR/CDORH‘s review of and concurrence with the data, Thermo Figher will update its labeling to reflect the additional testing. K. Therme Fisher will track adverse events and report to FDA under 21 CFR Part 803. Authorized Laboratories §. Authorized laboratories will include with reports of the results of the TagPath Zika Yirus Kit (ZIKYV) the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients. Under exigent circumstances, other appropriate methods for dissernmating these Fact Sheets may be used, which may include mass media. & Authorized laboratortes will perform the TagPath Zike Virus Kit (ZIKYV) using the KingFisher Flex Purification System (KingFisher) and MagMAX Pathogen RNA/DNA Kit or with other authorized extraction methods. L. Authorized laboratories will perform the TagPath Zika Virus Kit (ZIKYV) on the Applted Biogsystems QuantStudio Dx Real—time PCR instrument, or other authorized instruments. . Authorized laboratories will perform the TagPath Zika Virus Kin(ZIKYV) on huroan serum, or urine (collected with a patient—matched serum specimen}, or other authorized specimen types. . Authorized laboratories will have a process in place for reporting test resgults to healthcare providers and relevant public health authorities, as appropriate." * Tyaceability refers to fracing analytical sensitivity/reactivity back 16 a FDA—recommended reference material. *For questions related to reporting Zika test reaults to relovant public health authorities, it is recommended that Therme Fisher, other authorized distributor(s}, and authorized laboratories consult with the applicable country, state of territory health department(s}.. According to CDC, Zika virus disease is a nationally notifiable condifion. ht womw cdegovw ale.

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49621 Promotion • ethrower on DSK3G9T082PROD with NOTICES EN26OC17.007</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Page 9 =Faith Du, Thermo Fisher Scientific The emergency use of the authorized TagPath Zika Virus Kit (ZIK V) as described in this letter of authorization must comply with the conditions and all other terms of this authorization. ¥. Daration of Authorization This EUA will beceffective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zike virug and/or dagnosis of Zika virus infection is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act. Sincerely, s Jal W Seott Gottli¢h, M.D. Commisstoner of Food and Drugs Enclogsures

ywersis, % \_/g',i ie U.S, FOOD & DORUG Larere, A D M LNE TRATO N August 11, 2017 W. lan Lipkin, MD Phrector The Center for Infection and Immunity Columbia University 722 West 168th— St., 17Floor New York, NY 10032 Dear Dr. Lipkin: This letter is in response to your request that the Food and Drug Administration (FDA}Y issue an Emergency Use Authorization (EUAY for emergency use of The Center for Infection and Immunity, Columbia University‘s ("Coltumbia University") Cll—ArboViroPlex rRT—PCR assay for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, chilkungunya virus, and West Nile virus in serum, and for the qualitative detection of Zika virus RNA in urine (collected alongside a patient—matchéed serum speceimen). The assay is intended for use with specimens collected from individuals meeting Centers for Disease Control and Prevention {CDC) Zika virus clinical eritena (e.g., clinical signs and symptoms associated with Zika virus infection} and/or CDC Zika virus epidemiclogical eriteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (L—S.) that arecertified under the Clinieal Laboratory Improvement Amendments of 1988 {CLIA), 42 U.K.C. § 2639, to perform high complexity tests, or by similarly qualified non—U.S. laboratories, g:-ursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act] (31 U.S.C. § 360bbb—3),‘ Assay results are for the identification of Zika, dengue, chikungunya, and West Nile viral RNA. Viral RNA is generally detectable in serum during the acute phase of infection and, according to the updated CDC—Guidance for U.S. Laboratories Testing for Zika Yirus Infection." up to 14 days in sérum and urine (possibly longer in urine}, following onset of symptors, if present. Positive results are indicative ofcurrent infection, On February 26, 201 6, pursuant to section 564(b)(1)(C) of the Act (31.U.8.C. § 360bbb— 3{(b)(TYNC]), the Secretary of Health and Human Services (MHS) determined that there is a significant potential for a public health emergency that has a significant potential to alfeet natmnal 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 ! For ease of reference, this letter will refer to "laboratories in the United States (U.8;) that ure certified under the Clinical Laboratory !mpmxsumm Amendments of 1988 (CLIA}, 42 U.S.C. § 263a, to perform high complexity t6sts, or.. Aimilarly qualified non—LL.S. i’lhm“’lmflex as *‘mthmmd laboratories." Eflmll.:‘.b'sat hopowiaecdegoy ance.him} last updated r::»nluky 24. 2017). * Ar amended by the Pandemic and All Hazards Pre;mredm: Reauthorization: Act, Pub, L. No. t13—5, under section

49624 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices Page 2- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University of such determination, the Secretary of HHS then declared that circumstances exist justifYing the authorization of the 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 21 U.S.C. § 360bbb-3(a). 4 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, I am authorizing the emergency use of the CII- ArboViroPlex rRT-PCR assay (as described in the Scope of Authorization section ofthis letter {Section II)) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical 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 of travel, or other epidemiological criteria for which Zika virus testing may be indicated) {as described in the Scope of Authorization section ofthis letter (Section II)) for the detection of Zika virus infection by authorized laboratories, subject to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of the Cli-ArboViroPlex rRT-PCR assay for the detection of Zika 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 I have concluded that: l. 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 totality of scientific evidence available to FDA, it is reasonable to believe that the CII-ArboViroPlex rRT-PCR assay, 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 CII-ArboViroPlex rRT-PCR assay 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 CII-ArboViroPlex rRT-PCR assay for detecting Zika virus and diagnosing Zika virus infection. s II. Seope of Authorization I have concluded, pursuant to section 564(d)(l) of the Act, that the scope of this authorization is limited to the use of the authorized CH-ArboViroPlex rRT-PCR assay by authorized laboratories for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, 564(b){I )(C) of lhe Act, the Secretary may make a determination of a public health emergency, or of a significant f?tential for a public health emergency. HHS. Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests far Detection afZika Virus and/or DiagnosisofZika Virus Infection. 81 Fed. Reg. 10878 (Maroh2, 2016). 5 No other criteria of issuance have been prescribed by regulation under section .564(c)(4) of the Act. ethrower on DSK3G9T082PROD with NOTICES EN26OC17.010</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49625 Page 3- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Colwnbia University chikungunya virus, and West Nile virus in serwn, and for the qualitative detection of Zika virus RNA in urine (collected alongside a patient-matched serwn specimen) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical 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 of travel, or other epidemiological criteria for which Zika virus testing may be indicated). The Authorized CII-ArboViroPiex rRT-PCR assay The CII-ArboViroPlex rRT-PCR assay is a multiplex one-step real-time reverse transcription polymerase chain reaction (rRT-PCR) assay for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and other authorized specimen types. The CII-ArboViroPiex rRT-PCR assay can also be used for the qualitative detection of Zika virus RNA in urine when collected alongside a patient-matched serum specimen and other authorized whole blood derived specimen types. To perfonn the CII-ArboViroPlex rRT-PCR assay, the RNA is first extracted and purified from the patient specimen. The RNA is then reverse transcribed into eDNA which is amplified using the primer set and detected using the specific probe. The rRT-PCR is performed on the CFX96 Real-Time PCR Detection System (Bio-Rad), or other authorized instruments. The CII-ArboViroPlex rRT-PCR assay includes the following materials or other authorized materials: • ZIKV-MIX, DENV-MIX, CHIKV-MIX, WNV-MIX and RP-MIX vials containing primers and probes for the assay targets and internal contrul • ZPC, DPC, CP, WPC, HSC, eHSC, NTC vials containing the positive and negative controls used in the assay • Diluent vial used to reconstitute dried vials The CII-ArboViroPlex rRT-PCR assay also requires the use of additional materials and ancillary reagents that are not included with the test but are commonly used in clinical laboratories and are described in the authorized CII-ArboViroPlex rRT-PCR assay Instructions for Use. The CII-ArboViroPiex rRT-PCR assay requires the following contrul materials, or other authorized control materials; all controls listed below must generate expected results in order for a test to be considered valid, as outlined in the CII-ArboViroPlex rRT-PCR assay Instructions for Use: • Human Specimen Control: A hwnan cell culture preparation used as an extraction control and positive control for the RNase P primer and probe set that is extracted and tested concurrently with the test specimens. • Extracted Hwnan Specimen Control (eHSC): Extracted total nucleic acid from a hwnan cell culture preparation known to contain RNase P (eHSC), but negative for viral targets, is used as a control for perfonnance ofRNase P primer/probe set and PCR reagent function. • Positive Controls for viruses: Run with each batch of patient specimens. Monitors for failures ofrRT-PCR reagents and reaction conditions. o ZIKV Positive Control (ZPC), synthetic in vitro transcribed RNA ethrower on DSK3G9T082PROD with NOTICES EN26OC17.011</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

49626 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices II . .. ethrower on DSK3G9T082PROD with NOTICES EN26OC17.012</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49627 Page 5- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University ArboViroPlex rRT-PCR assay, when used for detection of Zika virus and to diagnose Zika virus infection in the specified population (as described in the Scope of Authorization of this letter (Section II)}, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of the authorized CII-ArboViroPlex rRT-PCR assay under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination described above and the Secretary of HHS' s corresponding declaration under section 564(b)(1 ), the CII-ArboViroPlex rRT-PCR assay described above is authorized to detect Zika virus and 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 Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmissions at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). This EUA will cease to be effective when the HHS declaration that circumstances exist to justizy the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act. 10. Waiver of Certain Requirements I am waiving the following requirements for the CII-ArboViroPlex rRT-PCR assay during the duration of this EUA: • Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution oftheCII-ArboViroPlex rRT-PCR assay. • Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under21 CFR 809.10 and 21 CFR 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use (21 U.S.C. 352(:1)), (21 CFR 809JO(b)(5), (7), and (8)}; any appropriate limitations on the use of the device including information required under 21 CFR 809.1 O(a)(4); and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12). IV. Conditions of Authorization Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: ethrower on DSK3G9T082PROD with NOTICES EN26OC17.013</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

49628 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices Columbia Columbia ethrower on DSK3G9T082PROD with NOTICES EN26OC17.014</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register/Vol. 82, No. 206 /Thursday, October 26, 2017 /Notices 49629 Page 7 — Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University ArboViroPlex rRT—PCR assay, including the name, address, and phone number of any authorized distributor(s). J. Columbia University 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). K. Columbia University may request changes to the authorized CII—ArboViroPlex rRT— PCR assay Fact Sheet for Healthcare Providers and the authorized CII—ArboViroPlex rRT—PCR assay Fact Sheet for Patients. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH. L. Columbia University may request the addition of other instruments for use with the authorized CHl—ArboViroPlex rRT—PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH, M. Columbia University may request the addition of other extraction methods for use with the authorized CII—ArboViroPlex rRT—PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH. N. Columbia University may request the addition of other specimen types for use with the authorized CII—ArboViroPlex rRT—PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMLD/OIR/CDRH. 0. Columbia University may request the addition and/or substitution ofother control materials for use with the authorized ClI—ArboViroPlex rRT—PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH. P. Columbia University may request the addition and/or substituation of other ancillary reagents and materials for use with the authorized Cll—ArboViroPlex rRT—PCR assay. Such requests will be made by Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH. Q. Columbia University will assess traceability‘ of the Cll—ArboViroPlex rRT—PCR assay with FDA—recommended reference material(s). After submission to FDA and DMD/OIR/CDRH‘s review of and concurrence with the data, Columbia University will update its labeling to reflect the additional testing. R. Columbia University will track adverse events and report to FDA under 21 CFR Part 803. Authorized Laboratories 7 Traceability refers to tracing analytical sensitivity/reactivity back to a FDA—recommended reference material.

49630 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices Columbia and Authorized Conditions ethrower on DSK3G9T082PROD with NOTICES EN26OC17.016</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49631 9- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University authorized CII-ArboViroPlex rRT-PCR assay shall be consistent with the Fact Sheets and authorized labeling, !IS well as the terms set forth in this EUA and the 11pplicable requirements set forth in the Act and FDA regulations. CC. All advertising and promotional descriptive printed matter relating to the use of the authorized CII-ArboViroPlex rRT-PCR assay shall clearly and conspicuously state that: • This test has not been FDA cleared or approved; • This test has been authorized by FDA under an EUA for use by authorized laboratories; • This test has been authorized only for the detection and differentiation of RNA :from Zika virus, dengue virus, chik:ungunya virus, and West Nile virus, not for any other viruses or pathogens; and • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests fur detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(I) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner. No advertising or promotional descriptive printed matter relating to the nse of the authorized CII•ArboViroPlex rRT-PCR assay may represent or suggest that this test is safe or effective for the diagnosis ofZika virus infection. The emergency use of the authorized CII-ArboViroPiex rRT-PCR assay as described in this letter of authorization must comply with the conditions and all other terms of this authorization. V. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests fur detection of Zika virus and/or diagnosis of Zika virus infection is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act. Sincerely, Enclosures ethrower on DSK3G9T082PROD with NOTICES EN26OC17.017</GPH> VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\26OCN1.SGM 26OCN1

49632 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices Dated: October 20, 2017. November 17, 2017. Comments received the docket and, except for those Leslie Kux, by mail/hand delivery/courier (for submitted as ‘‘Confidential Associate Commissioner for Policy. written/paper submissions) will be Submissions,’’ publicly viewable at [FR Doc. 2017–23224 Filed 10–25–17; 8:45 am] considered timely if they are https://www.regulations.gov or at the BILLING CODE 4164–01–C postmarked or the delivery service Dockets Management Staff between 9 acceptance receipt is on or before that a.m. and 4 p.m., Monday through date. Friday. DEPARTMENT OF HEALTH AND Comments received on or before • Confidential Submissions—To HUMAN SERVICES November 3, 2017, will be provided to submit a comment with confidential the committee. Comments received after information that you do not wish to be Food and Drug Administration that date will be taken into made publicly available, submit your consideration by the Agency. comments only as a written/paper [Docket No. FDA–2017–N–5818] You may submit comments as submission. You should submit two Pharmacy Compounding Advisory follows: copies total. One copy will include the Committee; Notice of Meeting; Electronic Submissions information you claim to be confidential Establishment of a Public Docket; with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Request for Comments following way: CONFIDENTIAL INFORMATION.’’ The AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: Agency will review this copy, including HHS. https://www.regulations.gov. Follow the the claimed confidential information, in instructions for submitting comments. its consideration of comments. The ACTION: Notice; establishment of a Comments submitted electronically, second copy, which will have the public docket; request for comments. including attachments, to https:// claimed confidential information SUMMARY: The Food and Drug www.regulations.gov will be posted to redacted/blacked out, will be available Administration (FDA) announces a the docket unchanged. Because your for public viewing and posted on forthcoming public advisory committee comment will be made public, you are https://www.regulations.gov. Submit meeting of the Pharmacy Compounding solely responsible for ensuring that your both copies to the Dockets Management Advisory Committee (PCAC). The comment does not include any Staff. If you do not wish your name and general function of the committee is to confidential information that you or a contact information to be made publicly provide advice on scientific, technical, third party may not wish to be posted, available, you can provide this and medical issues concerning drug such as medical information, your or information on the cover sheet and not compounding under the Federal Food, anyone else’s Social Security number, or in the body of your comments and you Drug, and Cosmetic Act (the FD&C Act), confidential business information, such must identify this information as and, as required, any other product for as a manufacturing process. Please note ‘‘confidential.’’ Any information marked which FDA has regulatory that if you include your name, contact as ‘‘confidential’’ will not be disclosed responsibility, and to make appropriate information, or other information that except in accordance with 21 CFR 10.20 recommendations to the Agency. The identifies you in the body of your and other applicable disclosure law. For meeting will be open to the public. comments, that information will be more information about FDA’s posting DATES: The meeting will be held on posted on https://www.regulations.gov. of comments to public dockets, see 80 • If you want to submit a comment FR 56469, September 18, 2015, or access November 20, 2017, from 8:30 a.m. to 5 with confidential information that you the information at: https://www.gpo.gov/ p.m. and November 21, 2017, from 8:30 do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- a.m. to 11:30 a.m. public, submit the comment as a 23389.pdf. ADDRESSES: FDA White Oak Campus, written/paper submission and in the 10903 New Hampshire Ave., Bldg. 31 Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’). 1503), Silver Spring, MD 20993–0002. electronic and written/paper comments Answers to commonly asked questions, Written/Paper Submissions received, go to https:// including information regarding special Submit written/paper submissions as www.regulations.gov and insert the accommodations due to a disability, follows: docket number, found in brackets in the visitor parking, and transportation may • Mail/Hand delivery/Courier (for heading of this document, into the be accessed at: https://www.fda.gov/ written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts AdvisoryCommittees/ Management Staff (HFA–305), Food and and/or go to the Dockets Management AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. FDA is establishing a docket for • For written/paper comments FOR FURTHER INFORMATION CONTACT: public comment on this meeting. The submitted to the Dockets Management Cindy Chee, Center for Drug Evaluation docket number is FDA–2017–N–5818. Staff, FDA will post your comment, as and Research, Food and Drug The docket will close on November 17, well as any attachments, except for Administration, 10903 New Hampshire 2017. Submit either electronic or information submitted, marked and Ave., Bldg. 31, Rm. 2417, Silver Spring, written comments on this public identified, as confidential, if submitted MD 20993–0002, 301–796–9001, Fax: meeting by November 17, 2017. Please as detailed in ‘‘Instructions.’’ 301–847–8533, email: PCAC@ ethrower on DSK3G9T082PROD with NOTICES note that late, untimely filed comments Instructions: All submissions received fda.hhs.gov, or FDA Advisory will not be considered. Electronic must include the Docket No. FDA– Committee Information Line, 1–800– comments must be submitted on or 2017–N–5818 for ‘‘Pharmacy 741–8138 (301–443–0572 in the before November 17, 2017. The https:// Compounding Advisory Committee; Washington, DC area). A notice in the www.regulations.gov electronic filing Notice of Meeting; Establishment of a Federal Register about last minute system will accept comments until Public Docket; Request for Comments.’’ modifications that impact a previously midnight Eastern Time at the end of Received comments will be placed in announced advisory committee meeting VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1


Document Created: 2018-10-25 10:12:31
Document Modified: 2018-10-25 10:12:31
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 Thermo Fisher Scientific is applicable as of August 2, 2017; the Authorization for The Center for Infection and Immunity, Columbia University is effective as of August 11, 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 49612 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR