82_FR_30011 82 FR 29886 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

82 FR 29886 - 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 125 (June 30, 2017)

Page Range29886-29906
FR Document2017-13720

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 Nanobiosym Diagnostics, Inc. and DiaSorin Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

Federal Register, Volume 82 Issue 125 (Friday, June 30, 2017) 
[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29886-29906]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) for in vitro diagnostic devices for detection of the 
Zika virus in response to the Zika virus outbreak in the Americas. FDA 
issued these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by Nanobiosym Diagnostics, Inc. and 
DiaSorin Inc. The Authorizations contain, among other things, 
conditions on the emergency use of the authorized in vitro diagnostic 
devices. The Authorizations follow the February 26, 2016, determination 
by the Secretary of Health and Human Services (HHS) that there is a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves Zika virus. 
On the basis of such determination, the Secretary of HHS declared on 
February 26, 2016, that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostic tests for 
detection of Zika virus and/or diagnosis of Zika virus infection, 
subject to the terms of any authorization issued under the FD&C Act. 
The Authorizations, which include an explanation of the reasons for 
issuance, are reprinted in this document.

DATES: The Authorization for Nanobiosym Diagnostics, Inc. is effective 
as of March 20, 2017; the Authorization for DiaSorin Inc. is effective 
as of April 5, 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 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

[[Page 29887]]

intended for use when the Secretary of HHS has declared that 
circumstances exist justifying the authorization of emergency use. 
Products appropriate for emergency use may include products and uses 
that are not approved, cleared, or licensed under sections 505, 510(k), 
or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 
of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after 
consultation with the HHS Assistant Secretary for Preparedness and 
Response, the Director of the National Institutes of Health, and the 
Director of the Centers for Disease Control and Prevention (to the 
extent feasible and appropriate given the applicable circumstances), 
FDA\1\ concludes: (1) That an agent referred to in a declaration of 
emergency or threat can cause a serious or life-threatening disease or 
condition; (2) that, based on the totality of scientific evidence 
available to FDA, including data from adequate and well-controlled 
clinical trials, if available, it is reasonable to believe that: (A) 
The product may be effective in diagnosing, treating, or preventing (i) 
such disease or condition; or (ii) a serious or life-threatening 
disease or condition caused by a product authorized under section 564, 
approved or cleared under the FD&C Act, or licensed under section 351 
of the PHS Act, for diagnosing, treating, or preventing such a disease 
or condition caused by such an agent; and (B) the known and potential 
benefits of the product, when used to diagnose, prevent, or treat such 
disease or condition, outweigh the known and potential risks of the 
product, taking into consideration the material threat posed by the 
agent or agents identified in a declaration under section 564(b)(1)(D) 
of the FD&C Act, if applicable; (3) that there is no adequate, 
approved, and available alternative to the product for diagnosing, 
preventing, or treating such disease or condition; and (4) that such 
other criteria as may be prescribed by regulation are satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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    No other criteria for issuance have been prescribed by regulation 
under 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 February 24, 2017, Nanobiosym 
Diagnostics, Inc. requested, and on March 20, 2017, FDA issued, an EUA 
for the Gene-RADAR[supreg] Zika Virus Test, subject to the terms of the 
Authorization. On March 30, 2017, DiaSorin Inc. requested, and on April 
5, 2017, FDA issued an EUA for the LIAISON[supreg] XL Zika Capture IgM 
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) follow and provide an 
explanation of the reasons for issuance, as required by section 
564(h)(1) of the FD&C Act:

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    Dated: June 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13720 Filed 6-29-17; 8:45 am]
 BILLING CODE 4164-01-P

29886 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Dated: June 21, 2017. explanation of the reasons for issuance, Section 564(b)(1) of the FD&C Act Anna K. Abram, are reprinted in this document. provides that, before an EUA may be Deputy Commissioner for Policy, Planning, DATES: The Authorization for issued, the Secretary of HHS must Legislation, and Analysis. Nanobiosym Diagnostics, Inc. is declare that circumstances exist [FR Doc. 2017–13666 Filed 6–29–17; 8:45 am] effective as of March 20, 2017; the justifying the authorization based on BILLING CODE 4164–01–P Authorization for DiaSorin Inc. is one of the following grounds: (1) A effective as of April 5, 2017. determination by the Secretary of ADDRESSES: Submit written requests for Homeland Security that there is a DEPARTMENT OF HEALTH AND single copies of the EUAs to the Office domestic emergency, or a significant HUMAN SERVICES of Counterterrorism and Emerging potential for a domestic emergency, Threats, Food and Drug Administration, involving a heightened risk of attack Food and Drug Administration with a biological, chemical, radiological, 10903 New Hampshire Ave., Bldg. 1, [Docket No. FDA–2017–N–1486] Rm. 4338, Silver Spring, MD 20993– or nuclear agent or agents; (2) a 0002. Send one self-addressed adhesive determination by the Secretary of Authorizations of Emergency Use of In label to assist that office in processing Defense that there is a military Vitro Diagnostic Devices for Detection your request or include a fax number to emergency, or a significant potential for of Zika Virus; Availability which the Authorizations may be sent. a military emergency, involving a AGENCY: Food and Drug Administration, See the SUPPLEMENTARY INFORMATION heightened risk to U.S. military forces of HHS. section for electronic access to the attack with a biological, chemical, Authorizations. radiological, or nuclear agent or agents; ACTION: Notice. (3) a determination by the Secretary of FOR FURTHER INFORMATION CONTACT: HHS that there is a public health SUMMARY: The Food and Drug Administration (FDA) is announcing the Carmen Maher, Office of emergency, or a significant potential for issuance of two Emergency Use Counterterrorism and Emerging Threats, a public health emergency, that affects, Authorizations (EUAs) (the Food and Drug Administration, 10903 or has a significant potential to affect, Authorizations) for in vitro diagnostic New Hampshire Ave., Bldg. 1, Rm. national security or the health and devices for detection of the Zika virus 4347, Silver Spring, MD 20993–0002, security of U.S. citizens living abroad, in response to the Zika virus outbreak 301–796–8510 (this is not a toll free and that involves a biological, chemical, in the Americas. FDA issued these number). radiological, or nuclear agent or agents, Authorizations under the Federal Food, SUPPLEMENTARY INFORMATION: or a disease or condition that may be Drug, and Cosmetic Act (the FD&C Act), attributable to such agent or agents; or as requested by Nanobiosym I. Background (4) the identification of a material threat Diagnostics, Inc. and DiaSorin Inc. The Section 564 of the FD&C Act (21 by the Secretary of Homeland Security Authorizations contain, among other U.S.C. 360bbb–3) as amended by the under section 319F–2 of the Public things, conditions on the emergency use Project BioShield Act of 2004 (Pub L. Health Service (PHS) Act (42 U.S.C. of the authorized in vitro diagnostic 108–276) and the Pandemic and All- 247d–6b) sufficient to affect national devices. The Authorizations follow the Hazards Preparedness Reauthorization security or the health and security of February 26, 2016, determination by the Act of 2013 (Pub L. 113–5) allows FDA U.S. citizens living abroad. Secretary of Health and Human Services to strengthen the public health Once the Secretary of HHS has (HHS) that there is a significant protections against biological, chemical, declared that circumstances exist potential for a public health emergency nuclear, and radiological agents. Among justifying an authorization under that has a significant potential to affect other things, section 564 of the FD&C section 564 of the FD&C Act, FDA may national security or the health and Act allows FDA to authorize the use of authorize the emergency use of a drug, security of U.S. citizens living abroad an unapproved medical product or an device, or biological product if the and that involves Zika virus. On the unapproved use of an approved medical Agency concludes that the statutory basis of such determination, the product in certain situations. With this criteria are satisfied. Under section Secretary of HHS declared on February EUA authority, FDA can help assure 564(h)(1) of the FD&C Act, FDA is 26, 2016, that circumstances exist that medical countermeasures may be required to publish in the Federal mstockstill on DSK30JT082PROD with NOTICES justifying the authorization of used in emergencies to diagnose, treat, Register a notice of each authorization, emergency use of in vitro diagnostic or prevent serious or life-threatening and each termination or revocation of an tests for detection of Zika virus and/or diseases or conditions caused by authorization, and an explanation of the diagnosis of Zika virus infection, subject biological, chemical, nuclear, or reasons for the action. Section 564 of the to the terms of any authorization issued radiological agents when there are no FD&C Act permits FDA to authorize the under the FD&C Act. The adequate, approved, and available introduction into interstate commerce of Authorizations, which include an alternatives. a drug, device, or biological product EN30JN17.271</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29887 intended for use when the Secretary of condition caused by such an agent; and Zika virus and/or diagnosis of Zika HHS has declared that circumstances (B) the known and potential benefits of virus infection, subject to the terms of exist justifying the authorization of the product, when used to diagnose, any authorization issued under section emergency use. Products appropriate for prevent, or treat such disease or 564 of the FD&C Act. Notice of the emergency use may include products condition, outweigh the known and determination and declaration of the and uses that are not approved, cleared, potential risks of the product, taking Secretary was published in the Federal or licensed under sections 505, 510(k), into consideration the material threat Register on March 2, 2016 (81 FR or 515 of the FD&C Act (21 U.S.C. 355, posed by the agent or agents identified 10878). On February 24, 2017, 360(k), and 360e) or section 351 of the in a declaration under section Nanobiosym Diagnostics, Inc. requested, PHS Act (42 U.S.C. 262). FDA may issue 564(b)(1)(D) of the FD&C Act, if and on March 20, 2017, FDA issued, an an EUA only if, after consultation with applicable; (3) that there is no adequate, EUA for the Gene-RADAR® Zika Virus the HHS Assistant Secretary for approved, and available alternative to Test, subject to the terms of the Preparedness and Response, the the product for diagnosing, preventing, Authorization. On March 30, 2017, Director of the National Institutes of or treating such disease or condition; DiaSorin Inc. requested, and on April 5, Health, and the Director of the Centers and (4) that such other criteria as may 2017, FDA issued an EUA for the for Disease Control and Prevention (to be prescribed by regulation are satisfied. LIAISON® XL Zika Capture IgM Assay, the extent feasible and appropriate No other criteria for issuance have subject to the terms of the given the applicable circumstances), been prescribed by regulation under Authorization. FDA1 concludes: (1) That an agent section 564(c)(4) of the FD&C Act. III. Electronic Access referred to in a declaration of emergency Because the statute is self-executing, or threat can cause a serious or life- regulations or guidance are not required An electronic version of this threatening disease or condition; (2) for FDA to implement the EUA document and the full text of the that, based on the totality of scientific authority. Authorizations are available on the evidence available to FDA, including Internet at https://www.regulations. II. EUA Requests for In Vitro Diagnostic data from adequate and well-controlled gov/. Devices for Detection of the Zika Virus clinical trials, if available, it is IV. The Authorizations reasonable to believe that: (A) The On February 26, 2016, the Secretary of product may be effective in diagnosing, HHS determined that there is a Having concluded that the criteria for treating, or preventing (i) such disease significant potential for a public health issuance of the Authorizations under or condition; or (ii) a serious or life- emergency that has a significant section 564(c) of the FD&C Act are met, threatening disease or condition caused potential to affect national security or FDA has authorized the emergency use by a product authorized under section the health and security of U.S. citizens of two in vitro diagnostic devices for 564, approved or cleared under the living abroad and that involves Zika detection of Zika virus subject to the FD&C Act, or licensed under section 351 virus. On February 26, 2016, under terms of the Authorizations. The of the PHS Act, for diagnosing, treating, section 564(b)(1) of the FD&C Act, and Authorizations in their entirety (not or preventing such a disease or on the basis of such determination, the including the authorized versions of the Secretary of HHS declared that fact sheets and other written materials) 1 The Secretary of HHS has delegated the circumstances exist justifying the follow and provide an explanation of authority to issue an EUA under section 564 of the authorization of emergency use of in the reasons for issuance, as required by FD&C Act to the Commissioner of Food and Drugs. vitro diagnostic tests for detection of section 564(h)(1) of the FD&C Act: mstockstill on DSK30JT082PROD with NOTICES VerDate Sep<11>2014 18:35 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

29888 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices March 2017 Anita Ph.D. Chainnan and CEO Dear Dr. Goe!: This letter is in response to your request that the Food and issue an t:n1er~ret1cv Use Authorization for emergency use Inc.'s Zika Virus Test for the •m•wnn1eo detection of RNA from Zika to up to 14 Positive results are indicative of cmTent pursuant to section ofthe Act s,,,r<>t,.rv of Health and Human Services "'~'!~"''"""' pote:ntial tor a health emergency that has a '"t::•""'v~"' or the health and of U.S. citizens )ofthcAc.t(21 U.S.C. of reference. this letter will refer to "laboratories in the United States (U.S.) that certi!ied under the uuxmam•ry Improvement Amendments 1988 (CUA). U.S.C. § 263a. to perform high complexity non-U.S. laboratories" as "authorized laboratories." bh·rru'd'''k:r· .hlilll (las! updated on November 16. Preoared""'"" Reauthorization Act, Pub. L. No. 113-5, under section del<"nnina!linn of a public health emergency, significant mstockstill on DSK30JT082PROD with NOTICES EN30JN17.272</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29889 Page 2- Dr. Anita God, Nanobiosym of such detennination, the of HHS then declared that circumstances the authorization of the emergency use of in vitro dia!:;nostic tests for detection of Zika virus and/or of Zika virus infection, subject to the tem1s of any authorization issued under 21 u.s.c. § 4 concluded that the criteria tor issuance of this authorization under section of the Act (21 § 360bbb-3(c)) are met, I am authorizing the emergency usc ofthc Gene- Zika Virus Test described in the of Authorization section of this letter H)) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical and symptoms associated with Zika virus infection) and/or CDC Zika vims criteria of residence in or travel to a region with active Zika transmission at the time or other critetia for which Zika vims may be indicated) (as desctibed in the of Authorization section ofthis letter H)) for the detection of Zika virus infection by authotized subject to the tenns ofthis authotization. I. Criteria for Issuance of Authorization I have concluded that the emergency use ofthe Gene-RADAR'' Zika Virus Test 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: I. The Zika virus can cause Zika virus infection, a serious or lite-threatening disease or condition to humans infected with the virus; 2. evidence available to FDA, it is reasonable to believe Zika Virus Test, when used with the specified instrument(s) and in accordance with the Scope of Authorization, may be etTective in Zika virus and Zika virus infection, and that the known and of the Zika Virus Test for Zika virus and u'"'""'"'""~ infection outweigh the known and potential risks of such product; and 3. There is no ade9,uate, approved, and available alternative to the emer£,>ency use ofthe Gene-RADAR" Zika Vims Test for Zika virus and diagnosing Zika vims infection. 5 U. Scope of Authorization I have concluded, pursuant to section 564(d)( I) ofthe Act, that the scope of this authorization is limited to the use of the authorized Zika Vims Test by authorized laboratories autgnosJ:s of Zika virus infection in individuals ""'"'"""'CDC Zika virus clinical criteria and associated with Zika and/or CDC Zika virus emaeJ:nHllOJI!;JC,at of residence in or 4 HHS. Determination and Declaration Regarding Use of in Vitro l(cstsfor Detection <~IZika Virus and/or Diagnosis of'Zika Virus b1fixtion, 8! Fed, 10878 {March 2, 5 No other criteria of issuance have been prescribed by regulation under sec !ion 564( c)(4) ofthe Act mstockstill on DSK30JT082PROD with NOTICES EN30JN17.273</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29890 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices with active Zika transmission at the time of travel, or other for which Zika virus may be mdiJca,tcdl). The Authorized Zika Vi.rus Test The poJyrrlen1se chain in human serum materials or other authorized and reaction Zika Virus and controls. The the use of additional and cmnn1or11y used in clinical laboratories and are n:strut:utm~ for Use. Zika Virus Test or other authorized control materials; all controls listed below must .,,,,,.,,t, "'""l·'"''-'tcu considered valid, as outlined in the vcm::··I\.t'uJtu\. • Zika Virus Positive Control: Zika RNA target sequence that can be and detected run with batch "'. ··~"~-• SP<~ci1mens. Monitors for failures ofrRT-PCR reagents and reaction conditions. "' Control: DNase and RNase-free water··· nm with each batch sp•ectmens. Monitors for reagent and system contamination. "' Zika Virus !ntemal Process Control: inactivated and stabilized extraction added to each and control The MS2 RNA is co-extracted and with the target monitors for of the kit reagents, function and inhibitors in the the fact that it does not meet certain Zika Virus Test is authorized to be acc:on1panie:d the mstockstill on DSK30JT082PROD with NOTICES EN30JN17.274</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29891 Page 4 Dr. Anita following information n"'rtllinirl<> to the emergency use, which is authorized to be made available to healthcarc pregnant women: • Fact Sheet for Healthcare Providers: Interpreting Gene-RADAR*"' Zika Virus Test Results "' Fact Sheet for Patients: Understanding Results fmm the Zika Virus Test Nanobiosym and its authorized distributors are also additional infom1ation relating to the emergency use of the authorized Zika Virus Test that is consistent with, and does not exceed, the tenus of this letter of authorization. I have pursuant to section 564(d)(2) ofthe Act, that it is reasonable to believe that the known and potential benefits of the authotized Gene-RADAR':R: Zika Virus Test in the specified population, when used for detection of Zika virus and to Zika virus infection and used consistently with the of Authorization of this letter II), the known and pv•"~"'"""'' risks of such a product. I 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 '-'"""-,"-r'u'"''' Zika Virus Test may be effective in the detection ofZika virus and ofZika virus int:<,dinn when used with the of Authorization of this letter (Section II), pursuant to section 564{c)(2)(A) ofthe Act. FDA has reviewed the scientific infonnation available to FDA, including the information ~nr>n<)rtit''" the conclusions described in Section I above, and concludes that the authorized Gcne- Zika Vin1s Test, when used for detection of Zika vims and to Zika virus infection in the population (as described in the of Authorization ofthis letter meets the ctitcria set forth in section 564(c) ofthe Act and pu•,~.:wmu effectiveness, The emergency use of the authmized Zika Virus Test under this EUA must be consistent with, and may not the terms of this letter, of Authorization (Section II) and the Conditions of Authorization tenus of this EUA and under the circumstances set forth in the ofHHS's detcnnination described above and the ofHHS's declaration under section564(b)(l ), the Zika Virus Test described above is authorized to detect Zika virus and dla.gn•Dse Zika vints infection in individuals CDC' Zika vims clinical criteria and associated with Zika virus infection) and/or CDC' Zika virus epidemiological criteria history of residence in or travel to a with active Zika virus transmissions at the time or other epidemiological criteria tor which Zika vims may be indicated). This EUA will cease to be effective when the HHS declaration that circumstances exist to justify the EUA is terminated under section 564(b)(2) ofthe Act or when the EllA is revoked under section 564(g) ofthe Act. mstockstill on DSK30JT082PROD with NOTICES EN30JN17.275</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29892 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Page 5 Dr. Anita Goel, Nanobiosym Inc. I am the Zika Virus Test during the duration ofthis EUA: rtorn._,IHS InClUding the quality system "'"'rn<•n:t~ under 21 CFR Part 820 respect to the manufacture, pa,ck!tgurrg, labeling, storage, and distribution ofthe Gene-RADAR:sJ Zika Virus Test • for cleared, approved, or including labeling requirements under 21 CFR 809.10 and 21 CFR 809.30, except for the intended use statement CFR 809.10(a)(2), (b)(2)), directions tor use (2 J U.S.C. CFR 809.1 O(b)(5), (7), and (8)), any appropriate limitations on the use of the device infonnation required under 21 CFR 809.1 O(a)(4), and any available infbrmation pertbnnance of the including rc<juircmcnts under 21 CFR 809.10(b)(12). IV. Conditions of Authorization Pursuant to section 564 ofthe Act, 1 am establishing the following conditions on this authorization: Nanobiosym and Us Authorized Distributor(s) A. Nanobiosym and its authorized distributor(s) will distribute the authorized Gene- RADAR'!t Zika Virus Test with the authmized labeling to authorized laboratories. to the authorized labeling may be made by Nanobiosym in consultation concurrence ot: DMD/OIR/CDRR B. Nanobiosym and its authorized distributor(s) will to authorized laboratories the authorized Gene-RADAR'K' Virus Test Fact Sheet for Healthcare Providers and the authorized Zika Virus Test Fact Sheet for Patients. c. "~'""''""''tin and its authorized distributor(s) will make available on their websites the Virus Test Fact Sheet for Healthcarc Providers and Zika Virus Test Fact Sheet tor Patients. D. Nanobiosym and its authorized will inform authorized laboratories and relevant public health authority(ies) of this EUA, including the tenns and conditions herein. E. and its authorized distributor(s) will ensure that the authmizt-'d laboratories using the authorized Gene-RADAR:t Zika Virus Test have a in fur reporting test results to healthcare and relevant public mstockstill on DSK30JT082PROD with NOTICES EN30JN17.276</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29893 F. a process control, records of device usage. G. H. and its authorized are authorized to make available additional information to the emergency use of the authorized '-'"'H""'''d''·-n. Zika Vims Test that is consistent and does not exceed, the terms ofthis letter of authorization. flf"'r>htf\~'nm will Zika Virus Test, mcmnmg l will <ltstnlmt,or(s) with a copy ofthis EUA. and communicate to its authorized sur>sequ•em amendments that be made to this EUA and its authorized ac<:on1pany1m Fact Instmctions for Use). K. may request to the authorized '"'"'"-•~ruH"''' Fact Sheet tl)r Healthcare Providers and the authorized '"''"'""-'''".""" Test Fact Sheet for Patients. Such requests \'l'ill be made in consultation and concurrence of, DMD/OIR!CDRH. L may request the addition of other instruments tor use with the authorized Zika Virus Test Such requests will be made in consultation with, and concurrence DMD/OlR/CDRR M. addition of other extraction methods for use with the Zika Virus Test. Such requests will be made concurrence DMD/OIR/CDRH. N. addition of other t_ypes for use with the Zika Virus Test Such requests will be made concurrence ot~ DMD/OlR/CDRH. related to reponing Zika test results to relevant public health authorities, is recommended that Na1mhios~rm. other authorized distributor(s). and authorized laburatories consult with the coumry, state or department(s). According CDC Zika virus disease is a nationally condition (see mstockstill on DSK30JT082PROD with NOTICES EN30JN17.277</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29894 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 7 Dr. Anita Goel, Inc. 0. may request the addition substitution of other control materials for usc with the authorized Zika Vims Test. Such requests will be made in consultation with, and concurrence DMD/OIR/CDRH. P. may request the addition and/or sutlstltut1on reagents and materials use with the authorized u"n"""'"r"uru" Such requests will be made concurrence of, DMD/OIR/CDRH. ""''"'"'"'""will assess of the Zika Virus Test with FDA- recommended reference After submission to FDA and DMD/OIR/CDRH's review of and eoncu!Tcnce with the data, will its to reflect the additional R. Authorized Laboratories S. Authorized laboratories will include with of the results ofthe uvuv·,v·u/n Zika Vims Test the authorized Fact Sheet Healthcare Providers and the authorized Fact Sheet for Patients. Under cireurnstan(;es, other methods for these Fact Sheets may be used, which may include mass media. T. Authorized laboratories will Zika Virus Test the Viral RNA Mini Kit or with other authorized extraction methods. Authorized laboratories will the Zika Virus Test on the Gene- Platform, or other authorized instmments. V. Authorized laboratories will the Zika Virus Test on human serum or other authorized """'''"''""" W. Authorized laboratories will have a process in for healthcare and relevant X. Authorized laboratories will collect intlmnation on the ""'·ttu'Wl<> of the test and report to DMD/OIRICDRH (via email and Nanotnos:ym any occurrence of false aware. FDA ·recQtnmended reference materiaL laboratories consult with "Pf"'~''m"country, state According to CDC, Zika virus disease a""'''""''""' condition. mstockstill on DSK30JT082PROD with NOTICES EN30JN17.278</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29895 Page 8 Dr. Anita Nanobiosym agntost1cs, Inc. Y. All laboratory personnel the test should be trained in RT-PCR techniques and use appropriate laboratory and personal protective when handling this kit, and use the test in accordance with the Z. Nanobiosym, its authmized distributor(s), and authorized will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. "r"""''h"'""l r~,..~,,rintiunprinted matter to the use of the Zika Virus Test shall be consistent with the Fact Sheets and as well as the tenns set forth in this EUA and the applicable in the Act and FDA BB. All and promotional descriptive printed matter relating to the use of the authorized Gene-RADAR"" Zika Virus Test shall and conspicuously state that: • This test has been authorized by FDA under an EUA for use authorized • This test has been authorizt-'d only for the detection of RNA from Zika virus and of Zika virus not for any other viruses or pathogens: and • This test is only authorized for the duration of the declaration that circumstances exist the authorization of the emergency use of in vitro tests fi)r detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)( l) of the Act, 21 U.S.C. § 360hhb-3(b)(l ), unless the authorization is tenninatcd or revoked sooner. No advertising or promotional printed matter to the use of the authmized Gene-RADAR'"' Zika Virus Test may represent or suggest that test is safe or eticctive for the of Zika virus infection. The emergency use of the authmized Zika Virus Test as described in this letter of authorization must comply with the conditions and all other terms of this authorization. mstockstill on DSK30JT082PROD with NOTICES EN30JN17.279</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29896 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 9 Dr. Anita God, Nanobiosym lJt;fHlllOS;tlcs. Inc. V. Duration of Authorization This EUA will be effective until the declaration that circumstances the authorization of the emergency use of in vitro diagnostic tests for detection ofZika virus and/or diagnosis of Zika virus infection is terminated under section of the Act or the EUA is revoked under section 564(g) ofthc Act. Acting Commissioner of Food and Enclosures mstockstill on DSK30JT082PROD with NOTICES EN30JN17.280</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29897 2017 North America 1951 Northwestern A venue ""'"""""''· MN 55082 Dear Ms. 360bbb- detennined that there is a ::.1 ~.::mlll'-'<uu notential to a.ffect national abroad and that involves Zika and on the basis of such rloi>-"'··~•;iftn the authorization of the emergency use of in vitro dilltllnostic ofrefttence, !his letter will the Clinical '-'"AI"""'', bmnro·venl!!:lll Amendments complexity qualified the Pandemic amiii!!,H~·,.,w,rt< Prepare•:lness R.tlltlithoriza:tioll the Secretary may public health emerge.ncy. mstockstill on DSK30JT082PROD with NOTICES EN30JN17.281</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29898 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices DiaS~lrin Inc. to the tenns authorization issued under 21 U.S.C. concluded that the criteria fbr issuance ofthis authorization undt~r section are met, l am the emergency use ofthe '-'H""f'>v• (as described in the of Authorization section letter \""'''"""·m "''""''<~""'"'"''""'""CDC Zika virus clinical cliteria (e.g., a 11f clinical arid ""'''n·t"t~"' int~x!ion) andlor CDC Zika virus cD!,::Ien:uollo~:tcal of residence in or travel to a with active Zikn tmnsmission at the time or other criteria for which Zika virus (as described in the Qm:tlit:athre detection authorized authorization. I. Criteria for Issuance of Authorization XL Zika detection virus antibodies in the meets the criteria for issuance ofan authorization under section of the Act, because I have c.1ncluded that: 1. TI1e Zika virus can cause Zika virus tnl·ecltioJn, a serious or condition to hu.mans infected with the 2. of scientific evidence available to FDA. it is reasonable to believe that XL Zika recent Zika XLZika ofthc u. of Authorization ofthe Act, that the scope oflhis authorization is XL Zika authorized CDC Ztka virus clinical. criteria (e.g., a with Zika virus and/or CDC Zika virus "~"''·"'"'''"""~'.~'>"·''" with active Zika ttatlSmissioll at the time ~·· ...h""'' mstockstill on DSK30JT082PROD with NOTICES EN30JN17.282</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29899 3 Meyer, DiaSorin In<:. <:tmsidered. virus infection. The automated assay uses two separate reagent which contain beads coated either a monoclonal or a sera or controls are then incubated T'\W\N>,{m•,c> and in the authorized includes the or other authorized The '"''"""""''-'' materials: mstockstill on DSK30JT082PROD with NOTICES EN30JN17.283</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29900 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Page 4- !VIs. Meyer, DiaSorin lt1c. 0 " ZIKV-C Re1~ge1~t 0 coated with a mouse monoclonal anllbCidyto human 0 0 "' Additional components not on the Reaa•ent ...t ......,.~~ o ZIKV-M derivative recombinant Zika virus "'llrnnr•ll1te<1 to an isoluminol derivative Calibrator 1· Human. senm;idefiblinated virus ZIKV-C Calibrator 2- Human serum/defibrinated virus The XLZika the control nu1terials or other nr<>VHII"'I with the test XL Zika 1c. . . . . . . . . .. , Control Set: The control aids in of the kit. Controls listed above must be ,,,.t'"""''>t·l or ,.,.,,,.,,.rl,,.,,. requlremten•ts oflocal,c~,;.umuu••" Controls must ,,.,,,.,,.,,""' "'~l"""·•cu results in order li)r also !he use of additional mate1ials and laboratories and that are described in the authorized Instructions for Use. authorized to be distributed to and used tact that it does not meet certain may be revised MlCf(lfli<Cll(llgv Devices ""'""'u•-.A;;,,m,, fhr De·viees and Radl(!I!Ol~IC;al mstockstill on DSK30JT082PROD with NOTICES EN30JN17.284</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29901 Page Ms ..Meyer, DiaSorin Inc. The above described • ·"''' """ authorized to the information ""'""'"'''"' available to healthcare •v""''""r<• • Fact Sheet for Healthcare Providers: XL Zi.ka Results Other Fact Sheets DiaSorin in c.onsultation and witl1 concurrence the Office of Counterterrorism and Threats <lfthe Chief Scientist of the Commissioner DMD/OlR/CDRH may be authorized to aec:onma.nv the above described XL Zika and be made ""'""'""'"'tO healthcarc ~r•m·i.•b•·" described in Section IV information to the ""''"'r''"'W"'" that is C01tlSl:StC1:1t antibodies the I have conclud~.'d. pursuam to section of the Act,. based on the evidence available to it is reasonable to believe that the authorized L"'"""'u"' Zika of recent Zika vims int<:ction, when nursuant !o section FDA bas reviewed the scientific infbnnation available to FDi".., the information conclusions described in Section I and concludes that the authorized XL Zika when used lo Zika virus infection in the nmmhitic1n (as described in the of Authorization ofthis letter meets criteria set fbrth in section of the Acl and Authorization to the tem1s of this EUA and under the circumstances set forth in the ofHHS's detennination descrihe.d of HHS's declaration under stx:liou the de:>cribed above is authorized to .c~;"'""''"~D infection in individuals CDC Zika virus clinical cliteria a and symptoms associated with Zika virus CDC Zika virus CO!tdemiokt~ti<::a of residence in or travel to v.··ith active Zika transmission at the time of travel. or other Zika virus may be i11nli••"t''rl mstockstill on DSK30JT082PROD with NOTICES EN30JN17.285</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29902 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Page 6 EUA will cease to be effective when tht\ HHS declatationlhai. circumstances is terminated under section ofthe Act or when the EUA is revoked under of the Act the XLZika duration of this EUA: IV. Conditions of Authorization Pursuant to section 564 ofthe Act, l am ».tuhlich,ino the conditions on this authorization: A. D.iaSorin and its authorized will distribute the authorized t~u'\t.::!vJ XL Zib with the authorized to the authorized and B. to authorized laboratories the authorized Fact Sheet for Bcalthcare Providers Fact Sheet and Fact Sheets for Healthcare Providers and Patients that OCET/OCS/OC and DMD/OIRICDRH may authorize. C. will make available on their websites the Fact Sheet Ibr Healthcarc Providers Fact Sheet tr1r Patients, and any additional XL Zika Fact Sheets for Hcalthcare Providers and Patients that OCET/OCS/OC and DTvfD/OIR/CDRH may authorize, D. DiaSori11 and its authorized mstockstill on DSK30JT082PROD with NOTICES EN30JN17.286</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29903 l)iaSor!n Inc. "'"""~"''·'""and its aui:lloltiz(:d aum·lt>Ittol·ts will ensure that authorized laboratori.es the authorized L'."'''·:nJ''' have for results to healthcare nr;~'.·tdl"l'>t as process DiaSorin and its !mthorized will maintain records of d~:wice usage. G. DiaSorin and lts authorized will cQUec! intormation ()!l !he "'""''r...,.,.,.,,•., the assay. DiaSorin will rep<>rt to FDA any false results and deviations the established "A,.+;-, ...,.,.~"''a characteristics of the assay of which DiaSorin becomes aware. H. DiaSorin and its authorized are authorized to make additional information to the en:ten~eltcv of the aulhorized XL Zika that not the tenns ofthis letter of DlaSorin I. XL Zika authorized J. DiaSorin will utw·>h,,.,.,..,,, witl1 a copy of this EUA, and communicate to its authorized distrii)Ut•or(:sl amendments that be made to this EUA and its Fact Instructions tor K. DiaSorin may request Fact Sheet for Healtheare l'rn,vt(lte~ Sheet for Patients, DiaSorin n1ay also Fact Sheets for Healthcare Providers and ~·u•cuu~o;:~ to Sheets. All such requests listed in this rm·u1iti!nn made DiaSorin in consultation and concurrence Ot'::ETIOCS!OC and DMD/OIRJCDRH, request the addition of other instruments for use with the authorized XL Zika Such requests will he made DiaSorin in consultation DMD/OlR/CDRH. M. request the addition of other reagents for use with the authorized Zika Such requests will be made DiaSorin in mstockstill on DSK30JT082PROD with NOTICES EN30JN17.287</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29904 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Ms. DiaSorin lnc. consultati<m vvith, and concurrence ot: DMD/OIR/CDRR .tbr usc with the authorized will be made DiaSorin in 0. request the addition c1f other ccmtro! materials use the authorized XL Zika Stlch will be made DiaSorin in Dl\1D/OlRlCDRH, P. DiaSorin may request substitution for or to the authmiztxl materials ustxl in the detection process of the human anti~Zika and human anti~Zika in the"'"',.""'"" Such requests will be made DiaSorin in consultation with, and concurrence ot~ DMD/OIR/CDRR DiaSorin will track adverse events and R. DiaSorin will evaluate the"'"''"""'""''" \Vttb and with any FDA-recommended reference After submission to FDA and DMD/OIR/CDRII' s review of and concurrence with the its H«''-'""15 1<1 reflect the additional XL Zika and report to DMD/OIR/CDRH on a semi-annual basis. Authorized Laboratories Autborizt~ laboratories \Viii include with of the results XL Zika the authmized Fact Sheet for Providers and tl1e authorized Fact Sheet for and additional XL Zika Fact Sheets for Hcalthcarc Providers and Patients that OCET/OCS/OC and DMD/OIR/CDRH may authorize. Under other methods for ul~il;<;;JtnuJ<ump: these Fact Sheets may be used, whidl may include mass V. XLZika on serum W. AntJ,<..,,r;._,,.~ laboratories will the XL Zika on the XL or on other authorized instruments. mstockstill on DSK30JT082PROD with NOTICES EN30JN17.288</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29905 fvts. tvleyer, DlaSorin .Inc. territories, authorized labomtorit."S will report all recent Zika to l)iaSorin. Z. Authorized laboratories will have a process in test results to healthcarc ·~""""''l"'r~ and relevant health AA. Authorized laboratories will collect information on the ,.,.,,f}v~·"''"''~ to DMDiOIR/CDRH BB. and Authorized Laboratol'ies CC. its authorized and authorized laboratories will ensure that any records associated with this EUA arc maintained until notified FDA. Such records will be made available to FDA upon Conditions Related to DD, All '"iv•••1i•<inn ofthe authori.zed Fact Sheets and authorized '"u,cuug, and the app,licatbie reu\lir,em<)nts set forth the use ofthe COtlSPJCil!OU'SlY state This test has been authorized FDA under an EUA fbr use authorized mstockstill on DSK30JT082PROD with NOTICES EN30JN17.289</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1

29906 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Dated: June 26, 2017. and personal information concerning Time: 9:00 a.m. to 5:00 p.m. Anna K. Abram, individuals associated with the grant Agenda: To review and evaluate grant Deputy Commissioner for Policy, Planning, applications, the disclosure of which applications. Legislation, and Analysis. would constitute a clearly unwarranted Place: National Institutes of Health, [FR Doc. 2017–13720 Filed 6–29–17; 8:45 am] invasion of personal privacy. Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone BILLING CODE 4164–01–P Name of Committee: National Institute on Conference Call). Drug Abuse Special Emphasis Panel; Mechanism for Time-Sensitive Drug Abuse Contact Person: Hiromi Ono, Ph.D., DEPARTMENT OF HEALTH AND Research (R21). Scientific Review Officer, Office of HUMAN SERVICES Date: July 17, 2017. Extramural Policy and Review, National Time: 1:00 p.m. 2:00 p.m. Institute on Drug Abuse, National Institutes National Institutes of Health Agenda: To review and evaluate grant of Health, DHHS, 6001 Executive Boulevard, applications. Room 4238, MSC 9550, Bethesda, MD 20892, National Institute on Drug Abuse; Place: National Institutes of Health, 301–827–5820, hiromi.ono@nih.gov. Notice of Closed Meetings Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone (Catalogue of Federal Domestic Assistance Pursuant to section 10(d) of the Conference Call). Program Nos.: 93.279, Drug Abuse and Federal Advisory Committee Act, as Contact Person: Ivan K. Navarro, Ph.D., Addiction Research Programs, National amended (5 U.S.C. App), notice is Scientific Review Officer, Office of Institutes of Health, HHS) hereby given of the following meetings. Extramural Policy and Review, Division of Dated: June 26, 2017. Extramural Research, National Institute on The meetings will be closed to the Natasha M. Copeland, mstockstill on DSK30JT082PROD with NOTICES Drug Abuse, NIH, DHHS, 6001 Executive public in accordance with the Boulevard, Room 4242, MSC 9550, Bethesda, Program Analyst, Office of Federal Advisory provisions set forth in sections MD 20892, 301–827–5833, ivan.navarro@ Committee Policy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., nih.gov. [FR Doc. 2017–13696 Filed 6–29–17; 8:45 am] as amended. The grant applications and Name of Committee: National Institute on BILLING CODE 4140–01–P the discussions could disclose Drug Abuse Special Emphasis Panel; SEP II: confidential trade secrets or commercial Multi-site Clinical Trials. property such as patentable material, EN30JN17.290</GPH> Date: July 27, 2017. VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 9990 E:\FR\FM\30JNN1.SGM 30JNN1


Document Created: 2017-06-30 06:01:51
Document Modified: 2017-06-30 06:01:51
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 Nanobiosym Diagnostics, Inc. is effective as of March 20, 2017; the Authorization for DiaSorin Inc. is effective as of April 5, 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 29886 
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