81_FR_76811 81 FR 76598 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

81 FR 76598 - 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 81, Issue 213 (November 3, 2016)

Page Range76598-76618
FR Document2016-26532

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 Vela Diagnostics USA, Inc. and ARUP Laboratories. 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 81 Issue 213 (Thursday, November 3, 2016) 
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76598-76618]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26532]


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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.

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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 Vela Diagnostics USA, Inc. and ARUP 
Laboratories. 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

[[Page 76599]]

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 Vela Diagnostics USA, Inc. is effective as 
of September 23, 2016; the Authorization for ARUP Laboratories is 
effective as of September 28, 2016.

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: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for a public health emergency, that affects, or 
has a significant potential to affect, national security or the health 
and security of U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be attributable to such agent or agents; 
or (4) the identification of a material threat by the Secretary of 
Homeland Security under section 319F-2 of the Public Health Service 
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or 
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue 
an EUA only if, after consultation with the HHS Assistant Secretary for 
Preparedness and Response, the 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

[[Page 76600]]

determination and declaration of the Secretary was published in the 
Federal Register on March 2, 2016 (81 FR 10878). On September 1, 2016, 
Vela Diagnostics USA Inc., requested, and on September 23, 2016, FDA 
issued, an EUA for the Sentosa SA ZIKV RT-PCR Test, subject to the 
terms of the Authorization. On September 26, 2016, ARUP Laboratories 
requested, and on September 28, 2016, FDA issued an EUA for the Zika 
Virus Detection by RT-PCR test, 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 http://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:

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    Dated: October 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26532 Filed 11-2-16; 8:45 am]
BILLING CODE 4164-01-C

76598 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices completion. We estimate that it will take institution. FDA estimates about seven The regulatory provisions in parts 50 an IRB approximately 1 hour to prepare IRBs or institutions will be issued a and 56 currently approved under this a written statement to the study sponsor noncompliance letter annually. We collection of information, OMB control describing each public disclosure, for a estimate that the IRB’s or institution’s number 0910–0755, and for which this total of 2 hours per study. The total response will take about 10 hours to extension is requested, are shown in annual third party disclosure burden for prepare, with an estimated total annual table 1. IRBs to fulfill this requirement related to burden of 70 hours. emergency research under § 50.24 is In 2016, FDA disqualified one IRB In the Federal Register of July 19, estimated at 16 hours (see table 2). under § 56.121. To date, no IRB or 2016 (81 FR 46935), FDA published a When an IRB or institution violates institution has been reinstated or 60-day notice requesting public the regulations, FDA issues to the IRB applied for reinstatement under comment on the proposed collection of or institution a noncompliance letter § 56.123. For this reason, we estimate information. No comments were (see § 56.120(a)). The IRB or institution the annual reporting burden for one received. must respond to the noncompliance respondent only. We estimate a 5-hour FDA estimates the burden of this letter describing the corrective actions burden per response, with an estimated collection of information as follows: that will be taken by the IRB or total annual burden of 5 hours. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Average burden 21 CFR section responses per Total hours respondents responses per response respondent 56.109(d) Written statement about minimal risk re- 2,520 2 5,040 .5 (30 minutes) ..... 2,520 search when documentation of informed consent is waived. 56.109(e) IRB written notification to approve or dis- 2,520 40 100,800 1 ............................ 100,800 approve research; 56.109(f) Continuing review; 50.25 Elements of informed consent; and 50.27 Documentation of informed consent. 50.24 Exception from informed consent requirements 8 3 24 1 ............................ 24 for emergency research. 56.113 Suspension or termination of IRB approval of 2,520 1 2,520 .5 (30 minutes) ..... 1,260 research. 56.120(a) IRB response to lesser administrative ac- 7 1 7 10 .......................... 70 tions for noncompliance. 56.123 Reinstatement of an IRB or an institution ........ 1 1 1 5 ............................ 5 Total ....................................................................... ........................ ........................ ........................ ............................... 104,679 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR section burden per Total hours respondents per disclosures disclosure respondent 56.109(g) IRB written statement about public disclosures to sponsor of emergency research under 50.24 .............. 8 2 16 1 16 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 28, 2016. DEPARTMENT OF HEALTH AND Authorizations) for in vitro diagnostic Leslie Kux, HUMAN SERVICES devices for detection of the Zika virus Associate Commissioner for Policy. in response to the Zika virus outbreak Food and Drug Administration in the Americas. FDA issued these [FR Doc. 2016–26528 Filed 11–2–16; 8:45 am] Authorizations under the Federal Food, BILLING CODE 4164–01–P [Docket No. FDA–2016–N–1486] Drug, and Cosmetic Act (the FD&C Act), as requested by Vela Diagnostics USA, Authorizations of Emergency Use of In Inc. and ARUP Laboratories. The Vitro Diagnostic Devices for Detection Authorizations contain, among other of Zika Virus; Availability things, conditions on the emergency use Food and Drug Administration, of the authorized in vitro diagnostic mstockstill on DSK3G9T082PROD with NOTICES AGENCY: HHS. devices. The Authorizations follow the ACTION: Notice. February 26, 2016, determination by the Secretary of Health and Human Services SUMMARY: The Food and Drug (HHS) that there is a significant Administration (FDA) is announcing the potential for a public health emergency issuance of two Emergency Use that has a significant potential to affect Authorizations (EUAs) (the national security or the health and VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1

Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices 76599 security of U.S. citizens living abroad issued, the Secretary of HHS must for Disease Control and Prevention (to and that involves Zika virus. On the declare that circumstances exist the extent feasible and appropriate basis of such determination, the justifying the authorization based on given the applicable circumstances), Secretary of HHS declared on February one of the following grounds: (1) A FDA 1 concludes: (1) That an agent 26, 2016, that circumstances exist determination by the Secretary of referred to in a declaration of emergency justifying the authorization of Homeland Security that there is a or threat can cause a serious or life- emergency use of in vitro diagnostic domestic emergency, or a significant threatening disease or condition; (2) tests for detection of Zika virus and/or potential for a domestic emergency, that, based on the totality of scientific diagnosis of Zika virus infection, subject involving a heightened risk of attack evidence available to FDA, including to the terms of any authorization issued with a biological, chemical, radiological, data from adequate and well-controlled under the FD&C Act. The or nuclear agent or agents; (2) a clinical trials, if available, it is Authorizations, which include an determination by the Secretary of reasonable to believe that: (A) The explanation of the reasons for issuance, Defense that there is a military product may be effective in diagnosing, are reprinted in this document. emergency, or a significant potential for treating, or preventing (i) such disease DATES: The Authorization for Vela a military emergency, involving a or condition; or (ii) a serious or life- Diagnostics USA, Inc. is effective as of heightened risk to U.S. military forces of threatening disease or condition caused September 23, 2016; the Authorization attack with a biological, chemical, by a product authorized under section for ARUP Laboratories is effective as of radiological, or nuclear agent or agents; 564, approved or cleared under the September 28, 2016. (3) a determination by the Secretary of FD&C Act, or licensed under section 351 ADDRESSES: Submit written requests for HHS that there is a public health of the PHS Act, for diagnosing, treating, single copies of the EUAs to the Office emergency, or a significant potential for or preventing such a disease or of Counterterrorism and Emerging a public health emergency, that affects, condition caused by such an agent; and Threats, Food and Drug Administration, or has a significant potential to affect, (B) the known and potential benefits of 10903 New Hampshire Ave., Bldg. 1, national security or the health and the product, when used to diagnose, Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad, prevent, or treat such disease or 0002. Send one self-addressed adhesive and that involves a biological, chemical, condition, outweigh the known and label to assist that office in processing radiological, or nuclear agent or agents, potential risks of the product, taking your request or include a fax number to or a disease or condition that may be into consideration the material threat which the Authorizations may be sent. attributable to such agent or agents; or posed by the agent or agents identified See the SUPPLEMENTARY INFORMATION (4) the identification of a material threat in a declaration under section section for electronic access to the by the Secretary of Homeland Security 564(b)(1)(D) of the FD&C Act, if Authorizations. under section 319F–2 of the Public applicable; (3) that there is no adequate, FOR FURTHER INFORMATION CONTACT: Health Service (PHS) Act (42 U.S.C. approved, and available alternative to Michael Mair, Office of 247d–6b) sufficient to affect national the product for diagnosing, preventing, Counterterrorism and Emerging Threats, security or the health and security of or treating such disease or condition; Food and Drug Administration, 10903 U.S. citizens living abroad. and (4) that such other criteria as may New Hampshire Ave., Bldg. 1, Rm. Once the Secretary of HHS has be prescribed by regulation are satisfied. 4336, Silver Spring, MD 20993–0002, declared that circumstances exist No other criteria for issuance have 301–796–8510 (this is not a toll free justifying an authorization under been prescribed by regulation under number). section 564 of the FD&C Act, FDA may section 564(c)(4) of the FD&C Act. authorize the emergency use of a drug, Because the statute is self-executing, SUPPLEMENTARY INFORMATION: regulations or guidance are not required device, or biological product if the I. Background Agency concludes that the statutory for FDA to implement the EUA criteria are satisfied. Under section authority. Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the 564(h)(1) of the FD&C Act, FDA is II. EUA Requests for In Vitro Diagnostic Project BioShield Act of 2004 (Pub. L. required to publish in the Federal Devices for Detection of the Zika Virus 108–276) and the Pandemic and All- Register a notice of each authorization, On February 26, 2016, the Secretary of Hazards Preparedness Reauthorization and each termination or revocation of an HHS determined that there is a Act of 2013 (Pub. L. 113–5) allows FDA authorization, and an explanation of the significant potential for a public health to strengthen the public health reasons for the action. Section 564 of the emergency that has a significant protections against biological, chemical, FD&C Act permits FDA to authorize the potential to affect national security or nuclear, and radiological agents. Among introduction into interstate commerce of the health and security of U.S. citizens other things, section 564 of the FD&C a drug, device, or biological product living abroad and that involves Zika Act allows FDA to authorize the use of intended for use when the Secretary of virus. On February 26, 2016, under an unapproved medical product or an HHS has declared that circumstances section 564(b)(1) of the FD&C Act, and unapproved use of an approved medical exist justifying the authorization of on the basis of such determination, the product in certain situations. With this emergency use. Products appropriate for Secretary of HHS declared that EUA authority, FDA can help assure emergency use may include products circumstances exist justifying the that medical countermeasures may be and uses that are not approved, cleared, authorization of emergency use of in used in emergencies to diagnose, treat, or licensed under sections 505, 510(k), vitro diagnostic tests for detection of or prevent serious or life-threatening or 515 of the FD&C Act (21 U.S.C. 355, mstockstill on DSK3G9T082PROD with NOTICES Zika virus and/or diagnosis of Zika diseases or conditions caused by 360(k), and 360e) or section 351 of the virus infection, subject to the terms of biological, chemical, nuclear, or PHS Act (42 U.S.C. 262). FDA may issue any authorization issued under section radiological agents when there are no an EUA only if, after consultation with 564 of the FD&C Act. Notice of the adequate, approved, and available the HHS Assistant Secretary for alternatives. Preparedness and Response, the 1 The Secretary of HHS has delegated the Section 564(b)(1) of the FD&C Act Director of the National Institutes of authority to issue an EUA under section 564 of the provides that, before an EUA may be Health, and the Director of the Centers FD&C Act to the Commissioner of Food and Drugs. VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1

76600 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices determination and declaration of the RT–PCR test, subject to the terms of the section 564(c) of the FD&C Act are met, Secretary was published in the Federal Authorization. FDA has authorized the emergency use Register on March 2, 2016 (81 FR of two in vitro diagnostic devices for III. Electronic Access 10878). On September 1, 2016, Vela detection of Zika virus subject to the Diagnostics USA Inc., requested, and on An electronic version of this terms of the Authorizations. The September 23, 2016, FDA issued, an document and the full text of the Authorizations in their entirety (not EUA for the Sentosa SA ZIKV RT–PCR Authorizations are available on the including the authorized versions of the Test, subject to the terms of the Internet at http://www.regulations.gov. fact sheets and other written materials) Authorization. On September 26, 2016, follows and provides an explanation of IV. The Authorizations the reasons for issuance, as required by ARUP Laboratories requested, and on September 28, 2016, FDA issued an Having concluded that the criteria for section 564(h)(1) of the FD&C Act: EUA for the Zika Virus Detection by issuance of the Authorizations under BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1

4 eie ; 00 h¥iine, C DEPARTMENT OF HEALTH AND HUMAN SERYVICES af % Ti Food anil Drug Administration: Siver Spriag. MD 20093 September 23, 2016 Donald Henton Director Regulatory Affairs North America Vela Diagnostics USA, Inc. 353C US Route 46 West, Suite 250 Fairfield, NJ 07004 Dear Mr. Henton: This letter is in response to your request that the Food and Drug Administration {FDA) tssue an Emergency Use Authorization (EUA) for emergency use of Vela Diagnostics USA, Inc.‘s ("Vela")‘ Sentosa" SA ZIKY RT—PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasmas, and urine (collected alongside a patient—matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CHC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zike virus infection} and/or CDC Zika virus epidemiological ¢riteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiclogical criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S—C. §263a, to perform high complexity tests, or by similarly qualified non—U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act)} (21 U.S.C. § 360bbb—3) Test results are for the identificition of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDHC Guidance for U.S. Laboratories Testing for Zika Virus infecti-tmf" 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 (C) of the Act (21 U.S.C. § 360bbb— MbY1NC]), the Secretary of Health and Human Services (HHS) determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus." Porsuant to section 564(b)(1) of the Act (21 USXC. § 360bbb—3(b)(1)), and on the basis ‘ At the time of suthorization, Vela, as the EUA holder, is responsible for satisfying the Conditions of Authorization fm the Sentosq® SA ZIKNV RT—PCR Test, which is manufactured by Vela Operations (Singapore). * For ease ofreference, this letter will refer to "laboratories in the United States (T.8.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 {CLIA), 42 U.S,.C. § 2632, to perform high complexity :cst*-. or by similarly qualified non—L.S. laboratories" as *authmized laboratortes." Awdable at hitp : vlaboratorics Iah guidancefitm! (Jast updated on ?epteml:ver 1, 2016). * As amended by the Pandemic and All Hazards Prepamdmw Reautimmalmn Act, Pub. L. No. 112—5, under section 5§4(bNIXC) of the Act, the Secretary may make a determination of a public health emergency, or of significant potential fora public health emergency.

76602 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices Criteria for Issuance of Authorization II. of Authorization mstockstill on DSK3G9T082PROD with NOTICES EN03NO16.002</GPH> VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\03NON1.SGM 03NON1

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u& + &9 Page 4 — Mr, Henton, Vela Diagnostics USA, Inc. To produce a valid run the test controls must meet the performance specifications outlined in the Instructions for Use. The Sentosa® SA FIKY RT—PCR Test also requires the use of additional materials and ancillary. reagents commonly used in clinical laboratories and that are described in the authorized Sentosq*" SA ZIKV RT—PCR Test Instractions for Use. The above described Sentosa® SA ZIKV RT—PCR Test, when labeled consistently with the labeting authorized by FDA entitled "Instructions for Use: Sentosa®"SA ZIKV RT—PCR Test and the Product Insert {available at htipo wwIda goviMedicalDevices Saterv EmerpencySttuations uem161496.htm}, which may bhe revised by Vela in consultation with the Division of Microbiclogy Devices (DMDYOfFfice of In Vitro Diagnostics and Radiological Health (OlRY/Center for Devices and Radiolagical Health (CDRH), is authorized to be distributed to and used by authorized laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described Senfosa® SA ZIKYV RT—PCR Test is authorized 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 Sentrosa® SA ZIKV RT—PCR Test Results e Fact Sheet for Patients: Understanding Results from the Sentosa" SA ZIKYV RT— PCR Test As described in Section V below, Vela and its authorized distributors are also authorized to make available additional information relating to the emergency use of the authorized Sentosa®" SA ZIKV RT—PCR Test that is consistent with, and does not exceed, the terms of this fetter of authorization. I have concluded, pursuant to section 564(d){2} of the Act, that it is reasonable to believe that the known and potential benefits ofthe anthorized Sentosa" SA ZIKY RT—PCR Test 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 of this letter (Section H}), outweigh the known and potential risks ofsuch a product. 1 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 Serrosa" SA ZIKY RT—PCR Test may be effective in the detection of Zika virus and diagnosis of Zika virus infection, when used consistently with the Scope of Authorization of this letter (Section H}, pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that the authorized Sentosa" SA ZIKV RT—PCR Test, 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 11)), meets the criteria set forth in section §64(c) ofthe Act concerning safety and potential effectiveness.

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Page 6 — Mr. Henton, Vela Diagnostics USA, Inc. authorized the Serfosa®" SAZIKV RT—PCR Test Fact Sheet for Healthcare Providers and the authorized Sentosa" SA ZIKY RT—PCR Test Fact Sheet for Patients. C. Vela and its authorized distributor(s) will make available on their websites the guthorized Sentosa® SA ZIKV RT—PCR Test Fact Sheet for Healthcare Providers and the authorized Sentosa® SA HKV RT—PCR Test Fact Sheet for Patients. 1. Vela and its authorized distributor(s) will inform authorized laboratories and relevant public health anthority(ies) of this EUA, including the terms and conditions herein. E. Yela and its authorized distributor(s) will ensure that the authorized Iaboratories using the authorized Senfrosa® SA ZIKV RT—PCR Test have a process in place for reporting test results to bealthcare providers and relevant public health authorities, as appropriate." F. Through a process of inventory control, Vela and its authorized distributor(s) will maintain records ofdevice usage. . Vela and its authorized distributor(s) will collect information on the performance of the test. Vela 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 of which Vela becomes aware. H. Vela and its authorized distributor(s) are authorized to make available additional information relating to the emergency use of the authorized Sentosa" SA ZIKYV RT— PCR Test that is consistent with, and does not exceed, the terms of this letter of authorization. Yela Diagnostics USA, Inc. L. Vela will notify FDA ofany authorized distributor(s) of the Sentosa®" SA ZIKY RT— PCR Test, including the name, address, and phone number of any, authorized distributor(s). J. Vela will provide its authorized distributor(s) with a copy ofthis 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. Vela may request changes to the authorized Sentosa® SA ZIKV RT—PCR Test Fact Sheet for Healthcare Providers and the authorized Sentosa®" SA ZIKY RT—PCR Test Fact Sheet for Patients. Such requests will be made by Vela in consultation with, and require concurrence of, DMD/OIR/CDRH. ‘For questions related to reporting Zika test results to relevant public health authorities, it is recommended that Vela, other authorized distributor(s), and authorized laboratories consult with the applicable country, state or territory health department(s).. According to CDC, Zike virus—discase is a nationally notifiable condition (see hitp wowencdegion ke‘).

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Page 8 — Mr. Henton, Vela Diagnostics USA, Inc, V. Authorized faboratories will perform the Sentosa® SA ZIKYRT—PCR Test using the Sentosa® SX Virus Total Nucleic Acid Kit v2.0 for nucteic acid extraction, or with other authorized extraction methods. W. Authorized laboratories will perform the Sentosa" SA ZIKYV RT—PCR Test on human serum, EDTA plasma, or urine {collected alongside a patient—matched serum or plasma specimen} or with other authorized specimen types, X. Authorized laboratories will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." Y. Authorized Iaboratories will collect information on the performance of the test and report to Vela any suspected occurrence of false positive or false negative results of which they become aware. 7. All laboratory personnel using the test should be appropriately trained in RT—PCR techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use the test in accordance with the authorized labeling. Vela Diagnostics USA, Inc., Its Authorized Distributor(s} and Authorized Laboratories AA. Vele, its authorized distributor(s), and authorized laboratories, will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. Conditions Related to Advertising and Promotion BB, All advertising and promotional descriptive printed matter relating to the use of the authorized Sentosa® SA ZIKV RT—PCR Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations. CC. All advertising and promotional descriptive printed matter relating to the use ofthe authorized Sentosa® SA ZIKV RT—PCR Test 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 of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and ° For questions related to reporting Zika test results to relevant public health authorities, it is recommended that Vela, other authorized distributor(s}, and authorized laboratories comsult with the applicable country, state or territory health department(s). According to CDC, Zika virus disease is a nationally noflfighle condition. |i ki

Page 9 — Mr. Henton, Vela Diagnostics USA, Inc. — This test is only authorized for the duration ofthe declaration that cireumstances exist fustifying the authorization ofthe emergency use ofin virre diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) ofthe Act, 21 TLS.C. § 360bbb—3(b)(1), unless the authorization is terminated or revoked sooner. No advertising or promotional descriptive printed matterrelating to the use of the authorized Sentosa" SA ZIKNVRT—PCR Test may represent or suggest that this test is safe or effective for the diagnosis of Zika virus infection. The emergency use of the authorized Sentfosa" SA ZIKV RT—PCR Test as described in this letter of authorization must comply with the conditions and all other terms of this authorization. Y. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization ofthe emergency use ofin vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection is terminated under section 564(b)(2) ofthe Act or the EUA is revoked under section 564(g) of the Act. Sincerely, 3 Robert M. Califf, M.D. Commissioner of Food and Drugs Enclosures

Po 4 # x,II'I'l.l-m_t _/ DEPARTMENT OF HEALTH AND HEOMAN SEKERVICES "*‘w Food and Drug Administration Sllver Spring, MD 709093 September 28, 2016 Dr. Jerry Hussong Chief Medical Officer, Director of Labs ARUP Laboratories Mail Code 209—D02 500 Chipeta Way Salt Lake City, UT 84108 Dear Dr. Hussong: This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the ARUP Laboratories® Zika Virus Detection by RT—PCR test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine {collected alongside a patient—matched serum or EDTA plasma specimen} from individuals meeting Centers for Discase Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection} and/or CDC Zika virus epidemiclogical criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time oftravel, or other epidemiological criterig for which Zika virus testing may be indicated). Testing is limited to laboratories designated by ARUP Laboratories‘ that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.8.C. §263a, to perform high complexity tests, pursuant to section 564 ofthe Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 36fibbb~3}.2 Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, acmrdmg to the updated CDX Guidance for U.S, 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 (C) of the Act (21 US.C. § 360bbb— 3bTHC)), the Secretary of Health and Human Services (HHS) determined that there is a significant potential for a public health emergency that has a significant potential to affect naitr:mal security or the health and security of U.S, citizens Hying abroad and that involves Zika virus." Pursuant to section 564(b)(1) of the Act (21 US.C. $ 360bbb—3(b)y(1y), and on the basis ! At the time of authorization, ARUP Laboratories in Salt Lake City, Utah is the only designated Iaboratory. * For ease of reference, this letter will refer to "Iaboratories designated by ARUP Laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. $263a, to performhigh mm;:ievmae tests," as "guthorized ]aimmwm». s‘%m: able at fittpy on ede ooy elkea laboritories Iab—gurdance bir (last updated on &eptember 1, 2016). * As amended by the Pandemic and All Hazards Preparedness Reauthorization Act, Pub. L. No: 113—5, under section §64(bi( 1)(C) ofthe Act, the Secretary may make a determination of a public health emergency, or of a significant potential for a public health emergency.

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76612 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices Detection by RT-PCR test • • • mstockstill on DSK3G9T082PROD with NOTICES EN03NO16.012</GPH> VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\03NON1.SGM 03NON1

Page 4 — Dr. Hussong, ARUP Laboratories o RNase, DNase—free water, o A no template control is included in each RT—PCR run of specimen extractions to monitor for Zika virus conftamination. a Zika Virus Negative Extraction Control 6 Known negative sample. o A negative extraction control is included in each run of specimen extractions to monitor for Zika virus contamination. + Zika Virus Positive Extraction Control o Live Zika whole virus. o A positive control is included in each run of specimen extractions to monitor nucleic acid fsolation and detection of Zika virus RNA. The above described Zika Virus Detection by RT—PCR test, when labeled consistently with the labeting authorized by FDA entitled "Zika Virus Detection by RT—PCR, ARUP Laboratories, Instructions for Use" (available at Hitp ww Idagouv Medica] DevieesSatety ErmergeneySituations/zem 164| 4096 htm}, which may be revised by ARUP Laboratories in consultation with the Division of Microbiology Devices {DMDYyYOffice of In Vitro Disgnostics and Radiological Health (OIRYCenter for Devices and Radiological Health (CDRH), is authorized to be distributed to and used by authorized laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described Zika Virus Detection by RT—PCR test is authorized to be accompanied by the following information pertaining to the emergeney use, which is authorized to be made available to healthcare providers and patients, including pregnant women: *# Fact Sheet for Healthcare Providers: Interpreting Zika Virus Detection by RT—PCR Test Results e Fact Sheet for Patients: Understanding Results from the Zika Virus Detection by RT—PCR Test As described in Section IV below, ARLUP Laboratories, and other authorized distributer(s}, are also authorized to make available additional information relating to the emergency use of the authorized Zika Virus Detection by RT—PCR test that is consistent with, and does nat exceed, the terms of this letter ofauthorization. 1 have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Zika Virus Detection by RT—PCR test 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 H#}, outweigh the known and potential risks ofsuch 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 Zika Virus Detection by RT—PCR test may be effective in the detection of Zika virus and diagnosis of Zika virus infection, when used consistently with the Scope of Authorization of this letter (Section 11}, pursuant to section 564(c){2}(A) of the Act.

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Page 6 — Dr. Hossong, ARUP Laboratories ARUP Laboratories and other authorized distributor(s) will distribute the authorized Zika Virus Detection by RT—PCR test with the authorized labeling only to authorized laboratories. Changes to the authorized labeling may be made by ARUP Laboratories in consultation with, and require concurrence of, DMD/OIR/CDRH. ARUP Laboratories and other authorized distributor(s) will provide to authorized laboratories the authorized Zika Virus Detection by RT—PCR test Fact Sheet for Healthcare Providers and the authorized Zika Virus Detection by RT—PCR test Fact Sheet for Patients. C. ARUP Laboratories and other authorized distributor(s) will make available on their websites the authorized Zika Virus Detection by RT—PCR test Fact Sheet for Healthcare Providers and the authorized Zika Virus Detection by RT—PCR test Fact Sheet for Patients, ARUP Laboratories and other authorized distributor(s) will inform authorized laboratories and relevant public health authority(ies} of this EUA, including the terms and conditions herein. ARUP Laboratories and other authorized distrbutor(s) will ensure that the authorized laboratories using the authorized Zika Virus Detection by RT—PCR test have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." Through a process of inventory control, ARUP Laboratories and other authorized distributor(s) will maintain records of device usage. ARUP Laboratories and other authorized distributor(s) will collect information on the performance of the test. ARUP Laboratories will report to FDA any suspected cccurrence of false positive and false negative results and significant deviations from the established performance characteristics ofthe test of which ARUP Laboratories becomes aware. ARUP Laboratories and other authorized distributor(s) are authorized to make available additional information relating to the emergency use of the authorized Zika Virus Detection by RT—PCR test that is consistent with, and does not exceed, the terms of this letter of authorization. ARUP Laboratories ARUP Laboratories will notify FDA of any authorized distributor(s} of the Zika Virus Detection by RT—PCR test, including the name, address, and phone number of any authorized distributor(s}. J. ARUP Laboratories will provide other authorized distributor(s) with a copy of this ‘ For questions related to reporting Zika test results to relevant public health authoritics, it is recommended that ARUP Laboratories, authorized distributors, and authorized Iaboratories consult with the applicable country, state or territory health department(s}, According to CDC, Zika virus disease is a nationally nottfiable condition. hieo wy ym ode ow alkns.

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Page & — Dr. Hussonig, ARUP Laboratories Authorized Iaboratories will perform the Zika Virus Detection by RT—PCR test on the sed t QuantStudio 12K Flex real—time PCR instrument (Thermo Fisher), or other authorized instruments, U. Authorized laboratories will perform the Zika Virus Detection by RT—PCR test using the chemagic MSM T extraction platform (Perkin Elmer) with the protocal for total nucleic acid extraction, or with other authorized extraction methods. V. Authorized laboratories will perform the Zika Virus Detection by RT—PCR test on human serum, EDTA plasma, or urine (collected with a patient—matched serum or EDTA plasma specimen} or with other authorized specimen types. W. Authorized laboratories will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." X. Authorized laboratories will collect information on the performance of the test and report to ARUP Laboratories, anysuspected occurrence offalse positive or false negative results of which they become aware. Y. All laboratory personnel using the test should be appropriately trained in RT—PCR techniques and use appropriate laboratory and personal protective equipment when bhandling this kit, and use the test in accordance with the authorized labeling. ARUP Laboratories, Other Authorized Distributor(s) and Authorized Laboratories Z. ARUP Laboratories, other authorized distributor(s) and authorized laboratories, will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. Conditions Related to Advertising and Promotion AA. All advertising and promotional descriptive printed matter relating to the use of the authorized Zika Virus Detection by RT—PCR test shall be consistent with the Fact Sheets and authorized labeling, as well as the terrms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations. BB. All advertising and promotional descriptive printed matter relating to the use of the authorized Zika Virus Detection by RT—PCR test shall clearly and conspicuously state that: a This test has not been FDA cleared or approved; * This test has been authorized by FDA under an EUA for use by authorized laboratories; * For questions related to reporting Zika test results to relevant public health authorities, it is recommended that ARUP Laborstories, authorized distributors, and authorized laboratories consult with the applicable country; state or territory health department(s}. According to CDC, Zika virus discase is a nationally notiflable condition. hi oemederen en

76618 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices Dated: October 28, 2016. Federal Register concerning each anyone else’s Social Security number, or Leslie Kux, proposed collection of information, confidential business information, such Associate Commissioner for Policy. including each proposed extension of an as a manufacturing process. Please note [FR Doc. 2016–26532 Filed 11–2–16; 8:45 am] existing collection of information, and that if you include your name, contact BILLING CODE 4164–01–C to allow 60 days for public comment in information, or other information that response to the notice. This notice identifies you in the body of your solicits comments on the information comments, that information will be DEPARTMENT OF HEALTH AND collection in the guidance on planning posted on http://www.regulations.gov. HUMAN SERVICES for the effects of high absenteeism to • If you want to submit a comment ensure availability of medically with confidential information that you Food and Drug Administration necessary drug products. do not wish to be made available to the DATES: Submit either electronic or public, submit the comment as a [Docket No. FDA–2013–N–0719] written comments on the collection of written/paper submission and in the Agency Information Collection information by January 3, 2017. manner detailed (see ‘‘Written/Paper Activities: Proposed Collection; ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’). Comment Request; Guidance for as follows: Written/Paper Submissions Industry on Planning for the Effects of Electronic Submissions High Absenteeism To Ensure Submit written/paper submissions as Availability of Medically Necessary Submit electronic comments in the follows: following way: Drug Products • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for AGENCY: Food and Drug Administration, www.regulations.gov. Follow the written/paper submissions): Division of HHS. instructions for submitting comments. Dockets Management (HFA–305), Food Comments submitted electronically, and Drug Administration, 5630 Fishers ACTION: Notice. Lane, Rm. 1061, Rockville, MD 20852. including attachments, to http:// SUMMARY: The Food and Drug www.regulations.gov will be posted to • For written/paper comments mstockstill on DSK3G9T082PROD with NOTICES Administration (FDA or we) is the docket unchanged. Because your submitted to the Division of Dockets announcing an opportunity for public comment will be made public, you are Management, FDA will post your comment on the proposed collection of solely responsible for ensuring that your comment, as well as any attachments, certain information by the Agency. comment does not include any except for information submitted, Under the Paperwork Reduction Act of confidential information that you or a marked and identified, as confidential, 1995 (the PRA), Federal Agencies are third party may not wish to be posted, if submitted as detailed in EN03NO16.018</GPH> required to publish notice in the such as medical information, your or ‘‘Instructions.’’ VerDate Sep<11>2014 17:54 Nov 02, 2016 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1


Document Created: 2016-11-03 03:24:06
Document Modified: 2016-11-03 03:24:06
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 Vela Diagnostics USA, Inc. is effective as of September 23, 2016; the Authorization for ARUP Laboratories is effective as of September 28, 2016.
ContactMichael Mair, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993- 0002, 301-796-8510 (this is not a toll free number).
FR Citation81 FR 76598 
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