81_FR_93066 81 FR 92822 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

81 FR 92822 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 244 (December 20, 2016)

Page Range92822-92832
FR Document2016-30532

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

Federal Register, Volume 81 Issue 244 (Tuesday, December 20, 2016) 
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92822-92832]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0969]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
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 an Emergency Use Authorization (EUA) (the Authorization) 
for an in vitro diagnostic device for detection of the Zika virus in 
response to the Zika virus outbreak in the Americas. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by Abbott Molecular, Inc. The Authorization 
contains, among other things, conditions on the emergency use of the 
authorized in vitro diagnostic device. The Authorization follows the 
February 26, 2016, determination by the Secretary of Health and Human 
Services (HHS) that there is a significant potential for a public 
health emergency that has a significant potential to affect national 
security or the health and security of U.S. citizens living abroad and 
that involves Zika virus. On the basis of such determination, the 
Secretary of HHS declared on February 26, 2016, that circumstances 
exist justifying the authorization of emergency use of in vitro 
diagnostic tests for detection of Zika virus and/or diagnosis of Zika 
virus infection, subject to the terms of any authorization issued under 
the FD&C Act. The Authorization, which includes an explanation of the 
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of November 21, 2016.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military

[[Page 92823]]

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.
---------------------------------------------------------------------------

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

II. EUA Request for an In Vitro Diagnostic Device for Detection of the 
Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is 
a significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of U.S. citizens living abroad and that involves Zika virus. 
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on 
the basis of such determination, the Secretary of HHS declared that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostic tests for detection of Zika virus and/or diagnosis of 
Zika virus infection, subject to the terms of any authorization issued 
under section 564 of the FD&C Act. Notice of the determination and 
declaration of the Secretary was published in the Federal Register on 
March 2, 2016 (81 FR 10878). On November 9, 2016, Abbott Molecular, 
Inc. requested, and on November 21, 2016, FDA issued, an EUA for the 
Abbott Real Time ZIKA assay, subject to the terms of the Authorization.

III. Electronic Access

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

IV. The Authorization

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

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    Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30532 Filed 12-19-16; 8:45 am]
BILLING CODE 4164-01-C

92822 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices Application No. Drug 065102 ....................... Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base. 065109 ....................... Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base. 065113 ....................... Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL. 065115 ....................... Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL. 065118 ....................... Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base. 065132 ....................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ 57 mg base per 5 mL. 065161 ....................... Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg base. 065207 ....................... Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL. 065323 ....................... Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL. 074975 ....................... Acyclovir Capsules USP, 200 mg. 074980 ....................... Acyclovir Tablets USP, 400 mg and 800 mg. 075132 ....................... Ranitidine Tablets USP, EQ 75 mg base. 075439 ....................... Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base. 076041 ....................... Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg. 076285 ....................... Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. 076332 ....................... Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL. 076409 ....................... Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. 076503 ....................... Sotret (isotretinoin) Capsules USP, 30 mg. 076606 ....................... Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg. 076739 ....................... Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg. Therefore, under section 505(e) of the emergency use of the authorized in vitro 4347, Silver Spring, MD 20993–0002, Federal Food, Drug, and Cosmetic Act diagnostic device. The Authorization 301–796–8510 (this is not a toll free (21 U.S.C. 355(e)) and under authority follows the February 26, 2016, number). delegated to the Director, Center for determination by the Secretary of Health SUPPLEMENTARY INFORMATION: Drug Evaluation and Research, by the and Human Services (HHS) that there is Commissioner, approval of the a significant potential for a public I. Background applications listed in the table, and all health emergency that has a significant Section 564 of the FD&C Act (21 amendments and supplements thereto, potential to affect national security or U.S.C. 360bbb–3) as amended by the is hereby withdrawn, effective January the health and security of U.S. citizens Project BioShield Act of 2004 (Pub L. 19, 2017. living abroad and that involves Zika 108–276) and the Pandemic and All- Dated: December 15, 2016. virus. On the basis of such Hazards Preparedness Reauthorization Leslie Kux, determination, the Secretary of HHS Act of 2013 (Pub L. 113–5) allows FDA declared on February 26, 2016, that to strengthen the public health Associate Commissioner for Policy. circumstances exist justifying the protections against biological, chemical, [FR Doc. 2016–30623 Filed 12–19–16; 8:45 am] authorization of emergency use of in nuclear, and radiological agents. Among BILLING CODE 4164–01–P vitro diagnostic tests for detection of other things, section 564 of the FD&C Zika virus and/or diagnosis of Zika Act allows FDA to authorize the use of virus infection, subject to the terms of an unapproved medical product or an DEPARTMENT OF HEALTH AND any authorization issued under the unapproved use of an approved medical HUMAN SERVICES FD&C Act. The Authorization, which product in certain situations. With this Food and Drug Administration includes an explanation of the reasons EUA authority, FDA can help assure for issuance, is reprinted in this that medical countermeasures may be [Docket No. FDA–2016–N–0969] document. used in emergencies to diagnose, treat, Authorization of Emergency Use of an DATES: The Authorization is effective as or prevent serious or life-threatening In Vitro Diagnostic Device for of November 21, 2016. diseases or conditions caused by Detection of Zika Virus; Availability biological, chemical, nuclear, or ADDRESSES: Submit written requests for radiological agents when there are no single copies of the EUA to the Office AGENCY: Food and Drug Administration, adequate, approved, and available of Counterterrorism and Emerging HHS. alternatives. Threats, Food and Drug Administration, Section 564(b)(1) of the FD&C Act ACTION: Notice. 10903 New Hampshire Ave., Bldg. 1, provides that, before an EUA may be SUMMARY: The Food and Drug Rm. 4338, Silver Spring, MD 20993– issued, the Secretary of HHS must Administration (FDA) is announcing the 0002. Send one self-addressed adhesive declare that circumstances exist issuance of an Emergency Use label to assist that office in processing justifying the authorization based on Authorization (EUA) (the Authorization) your request or include a fax number to one of the following grounds: (1) A for an in vitro diagnostic device for which the Authorization may be sent. determination by the Secretary of detection of the Zika virus in response See the SUPPLEMENTARY INFORMATION Homeland Security that there is a mstockstill on DSK3G9T082PROD with NOTICES to the Zika virus outbreak in the section for electronic access to the domestic emergency, or a significant Americas. FDA issued this Authorization. potential for a domestic emergency, Authorization under the Federal Food, FOR FURTHER INFORMATION CONTACT: involving a heightened risk of attack Drug, and Cosmetic Act (the FD&C Act), Carmen Maher, Office of with a biological, chemical, radiological, as requested by Abbott Molecular, Inc. Counterterrorism and Emerging Threats, or nuclear agent or agents; (2) a The Authorization contains, among Food and Drug Administration, 10903 determination by the Secretary of other things, conditions on the New Hampshire Ave., Bldg. 1, Rm. Defense that there is a military VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1

Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92823 emergency, or a significant potential for Preparedness and Response, the II. EUA Request for an In Vitro a military emergency, involving a Director of the National Institutes of Diagnostic Device for Detection of the heightened risk to U.S. military forces of Health, and the Director of the Centers Zika Virus attack with a biological, chemical, for Disease Control and Prevention (to On February 26, 2016, the Secretary of radiological, or nuclear agent or agents; the extent feasible and appropriate HHS determined that there is a (3) a determination by the Secretary of given the applicable circumstances), significant potential for a public health HHS that there is a public health FDA 1 concludes: (1) That an agent emergency that has a significant emergency, or a significant potential for referred to in a declaration of emergency potential to affect national security or a public health emergency, that affects, or threat can cause a serious or life- the health and security of U.S. citizens or has a significant potential to affect, threatening disease or condition; (2) living abroad and that involves Zika national security or the health and that, based on the totality of scientific virus. On February 26, 2016, under security of U.S. citizens living abroad, evidence available to FDA, including section 564(b)(1) of the FD&C Act, and and that involves a biological, chemical, data from adequate and well-controlled on the basis of such determination, the radiological, or nuclear agent or agents, clinical trials, if available, it is Secretary of HHS declared that or a disease or condition that may be reasonable to believe that: (A) The circumstances exist justifying the attributable to such agent or agents; or product may be effective in diagnosing, authorization of emergency use of in (4) the identification of a material threat vitro diagnostic tests for detection of treating, or preventing (i) such disease by the Secretary of Homeland Security Zika virus and/or diagnosis of Zika or condition; or (ii) a serious or life- under section 319F–2 of the Public virus infection, subject to the terms of threatening disease or condition caused Health Service (PHS) Act (42 U.S.C. any authorization issued under section 247d–6b) sufficient to affect national by a product authorized under section 564, approved or cleared under the 564 of the FD&C Act. Notice of the security or the health and security of determination and declaration of the U.S. citizens living abroad. FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, Secretary was published in the Federal Once the Secretary of HHS has Register on March 2, 2016 (81 FR or preventing such a disease or declared that circumstances exist 10878). On November 9, 2016, Abbott condition caused by such an agent; and justifying an authorization under Molecular, Inc. requested, and on (B) the known and potential benefits of section 564 of the FD&C Act, FDA may November 21, 2016, FDA issued, an the product, when used to diagnose, authorize the emergency use of a drug, EUA for the Abbott Real Time ZIKA device, or biological product if the prevent, or treat such disease or condition, outweigh the known and assay, subject to the terms of the Agency concludes that the statutory Authorization. criteria are satisfied. Under section potential risks of the product, taking 564(h)(1) of the FD&C Act, FDA is into consideration the material threat III. Electronic Access required to publish in the Federal posed by the agent or agents identified An electronic version of this Register a notice of each authorization, in a declaration under section document and the full text of the and each termination or revocation of an 564(b)(1)(D) of the FD&C Act, if Authorization are available on the authorization, and an explanation of the applicable; (3) that there is no adequate, Internet at https://www.regulations.gov. reasons for the action. Section 564 of the approved, and available alternative to FD&C Act permits FDA to authorize the the product for diagnosing, preventing, IV. The Authorization introduction into interstate commerce of or treating such disease or condition; Having concluded that the criteria for a drug, device, or biological product and (4) that such other criteria as may issuance of the Authorization under intended for use when the Secretary of be prescribed by regulation are satisfied. section 564(c) of the FD&C Act are met, HHS has declared that circumstances No other criteria for issuance have FDA has authorized the emergency use exist justifying the authorization of been prescribed by regulation under of an in vitro diagnostic device for emergency use. Products appropriate for section 564(c)(4) of the FD&C Act. detection of Zika virus subject to the emergency use may include products Because the statute is self-executing, terms of the Authorization. The and uses that are not approved, cleared, regulations or guidance are not required Authorization in its entirety (not or licensed under sections 505, 510(k), for FDA to implement the EUA including the authorized versions of the or 515 of the FD&C Act (21 U.S.C. 355, authority. fact sheets and other written materials) 360(k), and 360e) or section 351 of the follows and provides an explanation of PHS Act (42 U.S.C. 262). FDA may issue 1 The Secretary of HHS has delegated the the reasons for its issuance, as required an EUA only if, after consultation with authority to issue an EUA under section 564 of the by section 564(h)(1) of the FD&C Act. the HHS Assistant Secretary for FD&C Act to the Commissioner of Food and Drugs. BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1

‘/é' DEFARTMENXT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20998 November 21. 2016 Stacy Ferguson Regulatory Affairs Project Manager Abbotft Molecular Inc. 1300 East Touhy Avenue Des Plaines, IL 60018 Dear Ms. Ferguson: 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 Abbott Molecular Inc.‘s ("Abbott") RealTime ZIKA assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient—matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (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 Cosmeti¢ Aét (the Act) (21 US.C. § 360bbb—3).‘ Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase ofinfection and, according to the updated CDC 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, pursuant to section 564(b)(1}(C) of the Act (21 U.S.C. § 360bbb—3(b)(1)(C)), the Secretary of Health and Human Services (HHS) determined that there is a significant potential for a public health emergencythat has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus." Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances extst justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 TU.S.C. § 360bbb—3(a)." ‘ For ease of reference, this letter will refer to "laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C, § 263a, to perform high complexity tests, or bysimilarly qualified non—U,8. laboratories" as "authorized laboratories." * Available at httpy//wi w.ede.covizika/laboratories/lab—guidance.htrl (fast updated on November 16, 201 6). * As amended by the Pandemic and All Hazards Preparedness Reauthorization Act, Pub,. L. No. 113—3, under section S64(bY1}C) of the Act, the Secretary may make a determination of a public health emergency, or of significant otential for a public health emergency. HHS. Determination and Declaration Regarding Emergency Use ofin Fitro Diagnostic Tests for Detection of Zika

Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92825 Criteria for Issuance of Authorization of Authorization RealTime ZIKA assay mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.005</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

92826 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices other or .. mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.006</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92827 Results ZIKA be mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.007</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

92828 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices Abbott RealTime • this mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.008</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92829 D. Abbott Molecular Inc. L mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.009</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

92830 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices M. P. Authorized Laboratories mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.010</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices 92831 Y. Abbott Molecular and Authorized Conditions Related to mstockstill on DSK3G9T082PROD with NOTICES EN20DE16.011</GPH> VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\20DEN1.SGM 20DEN1

92832 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices Dated: December 14, 2016. redetermination by February 21, 2017. public, submit the comment as a Leslie Kux, Furthermore, any interested person may written/paper submission and in the Associate Commissioner for Policy. petition FDA for a determination manner detailed (see ‘‘Written/Paper [FR Doc. 2016–30532 Filed 12–19–16; 8:45 am] regarding whether the applicant for Submissions’’ and ‘‘Instructions’’). extension acted with due diligence BILLING CODE 4164–01–C Written/Paper Submissions during the regulatory review period by June 19, 2017. See ‘‘Petitions’’ in the Submit written/paper submissions as DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION section for follows: HUMAN SERVICES more information. • Mail/Hand delivery/Courier (for ADDRESSES: You may submit comments written/paper submissions): Division of Food and Drug Administration as follows: Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers [Docket No. FDA–2016–E–0626] Electronic Submissions Lane, Rm. 1061, Rockville, MD 20852. Determination of Regulatory Review Submit electronic comments in the • For written/paper comments Period for Purposes of Patent following way: submitted to the Division of Dockets Extension; COSENTYX • Federal eRulemaking Portal: http:// Management, FDA will post your www.regulations.gov. Follow the comment, as well as any attachments, AGENCY: Food and Drug Administration, instructions for submitting comments. except for information submitted, HHS. Comments submitted electronically, marked and identified, as confidential, ACTION: Notice. including attachments, to http:// if submitted as detailed in www.regulations.gov will be posted to ‘‘Instructions.’’ SUMMARY: The Food and Drug the docket unchanged. Because your Instructions: All submissions received Administration (FDA) has determined comment will be made public, you are must include the Docket No. FDA– the regulatory review period for solely responsible for ensuring that your 2016–E–0626 for ‘‘Determination of COSENTYX and is publishing this comment does not include any Regulatory Review Period for Purposes notice of that determination as required confidential information that you or a of Patent Extension; COSENTYX.’’ by law. FDA has made the third party may not wish to be posted, Received comments will be placed in determination because of the such as medical information, your or the docket and, except for those submission of an application to the anyone else’s Social Security number, or submitted as ‘‘Confidential Director of the U.S. Patent and confidential business information, such Submissions,’’ publicly viewable at Trademark Office (USPTO), Department as a manufacturing process. Please note http://www.regulations.gov or at the of Commerce, for the extension of a that if you include your name, contact Division of Dockets Management mstockstill on DSK3G9T082PROD with NOTICES patent which claims that human information, or other information that between 9 a.m. and 4 p.m., Monday biological product. identifies you in the body of your through Friday. DATES: Anyone with knowledge that any comments, that information will be • Confidential Submissions—To of the dates as published (see the posted on http://www.regulations.gov. submit a comment with confidential SUPPLEMENTARY INFORMATION section) are • If you want to submit a comment information that you do not wish to be incorrect may submit either electronic with confidential information that you made publicly available, submit your EN20DE16.012</GPH> or written comments and ask for a do not wish to be made available to the comments only as a written/paper VerDate Sep<11>2014 19:36 Dec 19, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1


Document Created: 2018-02-14 09:10:25
Document Modified: 2018-02-14 09:10:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of November 21, 2016.
ContactCarmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993- 0002, 301-796-8510 (this is not a toll free number).
FR Citation81 FR 92822 
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