81_FR_39770 81 FR 39653 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability

81 FR 39653 - 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 117 (June 17, 2016)

Page Range39653-39672
FR Document2016-14380

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for two in vitro diagnostic devices for detection of 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 Focus Diagnostics, Inc., and altona Diagnostics GmbH. 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 Department of Health and Human Services (HHS) Secretary 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 HHS Secretary 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 explanations of the reasons for issuance, are reprinted in this document.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016) 
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39653-39672]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14380]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) for two in vitro diagnostic devices for detection of 
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 Focus Diagnostics, Inc., and altona 
Diagnostics GmbH. The Authorizations contain,

[[Page 39654]]

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 Department of Health and Human Services 
(HHS) Secretary 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 HHS 
Secretary 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 explanations of the reasons 
for issuance, are reprinted in this document.

DATES: The Authorization for Focus Diagnostics, Inc., is effective as 
of April 28, 2016, and the Authorization for altona Diagnostics GmbH is 
effective as of May 13, 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: 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.

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

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

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

II. EUA Requests for In Vitro Diagnostic Devices for Detection of 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

[[Page 39655]]

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 April 26, 2016, Focus Diagnostics, Inc., requested, and on 
April 28, 2016, FDA issued, an EUA for the Zika Virus RNA Qualitative 
Real-Time RT-PCR test, subject to the terms of the Authorization. On 
May 11, 2016, altona Diagnostics GmbH requested, and on May 13, 2016, 
FDA issued, an EUA for the RealStar[supreg] Zika Virus RT-PCR Kit U.S., 
subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
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) follow and provide 
explanations of the reasons for their issuance, as required by section 
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 39656]]

[GRAPHIC] [TIFF OMITTED] TN17JN16.007


[[Page 39657]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.008


[[Page 39658]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.009


[[Page 39659]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.010


[[Page 39660]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.011


[[Page 39661]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.012


[[Page 39662]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.013


[[Page 39663]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.014


[[Page 39664]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.015


[[Page 39665]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.016


[[Page 39666]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.017


[[Page 39667]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.018


[[Page 39668]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.019


[[Page 39669]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.020


[[Page 39670]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.021


[[Page 39671]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.022


[[Page 39672]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.023


    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14380 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39653 accordance with 21 CFR 10.20 and other ELUTING PERIPHERAL STENT. This determination of the regulatory applicable disclosure law. For more ZILVER PTX DRUG ELUTING review period establishes the maximum information about FDA’s posting of PERIPHERAL STENT is indicated for potential length of a patent extension. comments to public dockets, see 80 FR improving luminal diameter for the However, the USPTO applies several 56469, September 18, 2015, or access treatment of de novo or restenotic statutory limitations in its calculations the information at: http://www.fda.gov/ symptomatic lesions in native vascular of the actual period for patent extension. regulatoryinformation/dockets/ disease of the above-the-knee In its application for patent extension, default.htm. femoropopliteal arteries having this applicant seeks 1,826 days of patent Docket: For access to the docket to reference vessel diameters from 4 term extension. read background documents or the millimeters (mm) to 9 mm and total III. Petitions electronic and written/paper comments lesion lengths up to 140 mm per limb received, go to http:// and 280 mm per patient. Subsequent to Anyone with knowledge that any of www.regulations.gov and insert the this approval, the USPTO received a the dates as published are incorrect may docket number, found in brackets in the patent term restoration application for submit either electronic or written heading of this document, into the ZILVER PTX DRUG ELUTING comments and ask for a redetermination ‘‘Search’’ box and follow the prompts PERIPHERAL STENT (U.S. Patent No. (see DATES). Furthermore, any interested and/or go to the Division of Dockets 6,299,604) from Cook Medical person may petition FDA for a Management, 5630 Fishers Lane, Rm. Technologies, LLC, and the USPTO determination regarding whether the 1061, Rockville, MD 20852. requested FDA’s assistance in applicant for extension acted with due determining this patent’s eligibility for diligence during the regulatory review FOR FURTHER INFORMATION CONTACT: patent term restoration. In a letter dated period. To meet its burden, the petition Beverly Friedman, Office of Regulatory March 25, 2014, FDA advised the must be timely (see DATES) and contain Policy, Food and Drug Administration, USPTO that this medical device had sufficient facts to merit an FDA 10903 New Hampshire Ave., Bldg. 51, investigation. (See H. Rept. 857, part 1, Rm. 6250, Silver Spring, MD 20993, undergone a regulatory review period and that the approval of ZILVER PTX 98th Cong., 2d sess., pp. 41–42, 1984.) 301–796–3600. Petitions should be in the format DRUG ELUTING PERIPHERAL STENT SUPPLEMENTARY INFORMATION: specified in 21 CFR 10.30. represented the first permitted I. Background commercial marketing or use of the Submit petitions electronically to product. Thereafter, the USPTO http://www.regulations.gov at Docket The Drug Price Competition and No. FDA–2013–S–0610. Submit written requested that FDA determine the Patent Term Restoration Act of 1984 petitions (two copies are required) to the product’s regulatory review period. (Pub. L. 98–417) and the Generic Division of Dockets Management (HFA– Animal Drug and Patent Term II. Determination of Regulatory Review 305), Food and Drug Administration, Restoration Act (Pub. L. 100–670) Period 5630 Fishers Lane, Rm. 1061, Rockville, generally provide that a patent may be FDA has determined that the MD 20852. extended for a period of up to 5 years applicable regulatory review period for Dated: June 13, 2016. so long as the patented item (human ZILVER PTX DRUG ELUTING drug product, animal drug product, Leslie Kux, PERIPHERAL STENT is 3,075 days. Of medical device, food additive, or color Associate Commissioner for Policy. this time, 2,180 days occurred during additive) was subject to regulatory [FR Doc. 2016–14356 Filed 6–16–16; 8:45 am] the testing phase of the regulatory review by FDA before the item was review period, while 895 days occurred BILLING CODE 4164–01–P marketed. Under these acts, a product’s during the approval phase. These regulatory review period forms the basis periods of time were derived from the for determining the amount of extension DEPARTMENT OF HEALTH AND following dates: an applicant may receive. 1. The date an exemption under HUMAN SERVICES A regulatory review period consists of section 520(g) of the Federal Food, Drug, Food and Drug Administration two periods of time: A testing phase and and Cosmetic Act (the FD&C Act) (21 an approval phase. For medical devices, U.S.C. 360j(g)) involving this device [Docket No. FDA–2016–N–1486] the testing phase begins with a clinical became effective: June 16, 2004. FDA investigation of the device and runs has verified the applicant’s claim that Authorizations of Emergency Use of In until the approval phase begins. The the date the investigational device Vitro Diagnostic Devices for Detection approval phase starts with the initial exemption (IDE) required under section of Zika Virus; Availability submission of an application to market 520(g) of the FD&C Act for human tests AGENCY: Food and Drug Administration, the device and continues until to begin became effective was June 16, HHS. permission to market the device is 2004. ACTION: Notice. granted. Although only a portion of a 2. The date an application was regulatory review period may count initially submitted with respect to the SUMMARY: The Food and Drug toward the actual amount of extension device under section 515 of the FD&C Administration (FDA) is announcing the that the Director of USPTO may award Act (21 U.S.C. 360e): June 4, 2010. FDA issuance of two Emergency Use (half the testing phase must be has verified the applicant’s claim that Authorizations (EUAs) (the subtracted as well as any time that may the premarket approval application Authorizations) for two in vitro have occurred before the patent was (PMA) for ZILVER PTX DRUG ELUTING diagnostic devices for detection of Zika sradovich on DSK3TPTVN1PROD with NOTICES issued), FDA’s determination of the PERIPHERAL STENT (PMA P100022) virus in response to the Zika virus length of a regulatory review period for was initially submitted June 4, 2010. outbreak in the Americas. FDA issued a medical device will include all of the 3. The date the application was these Authorizations under the Federal testing phase and approval phase as approved: November 14, 2012. FDA has Food, Drug, and Cosmetic Act (the specified in 35 U.S.C. 156(g)(3)(B). verified the applicant’s claim that PMA FD&C Act), as requested by Focus FDA has approved for marketing the P100022 was approved on November Diagnostics, Inc., and altona Diagnostics medical device ZILVER PTX DRUG 14, 2012. GmbH. The Authorizations contain, VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1

39654 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices among other things, conditions on the used in emergencies to diagnose, treat, or 515 of the FD&C Act (21 U.S.C. 355, emergency use of the authorized in vitro or prevent serious or life-threatening 360(k), and 360e) or section 351 of the diagnostic devices. The Authorizations diseases or conditions caused by PHS Act (42 U.S.C. 262). FDA may issue follow the February 26, 2016, biological, chemical, nuclear, or an EUA only if, after consultation with determination by the Department of radiological agents when there are no the HHS Assistant Secretary for Health and Human Services (HHS) adequate, approved, and available Preparedness and Response, the Secretary that there is a significant alternatives. Director of the National Institutes of potential for a public health emergency Section 564(b)(1) of the FD&C Act Health, and the Director of the Centers that has a significant potential to affect provides that, before an EUA may be for Disease Control and Prevention (to national security or the health and issued, the Secretary of HHS must the extent feasible and appropriate security of U.S. citizens living abroad declare that circumstances exist given the applicable circumstances), and that involves Zika virus. On the justifying the authorization based on FDA 1 concludes: (1) That an agent basis of such determination, the HHS one of the following grounds: (1) A referred to in a declaration of emergency Secretary declared on February 26, determination by the Secretary of or threat can cause a serious or life- 2016, that circumstances exist justifying Homeland Security that there is a threatening disease or condition; (2) the authorization of emergency use of in domestic emergency, or a significant that, based on the totality of scientific vitro diagnostic tests for detection of potential for a domestic emergency, evidence available to FDA, including Zika virus and/or diagnosis of Zika involving a heightened risk of attack data from adequate and well-controlled virus infection subject to the terms of with a biological, chemical, radiological, clinical trials, if available, it is any authorization issued under the or nuclear agent or agents; (2) a reasonable to believe that: (A) The FD&C Act. The Authorizations, which determination by the Secretary of product may be effective in diagnosing, include explanations of the reasons for Defense that there is a military treating, or preventing (i) such disease issuance, are reprinted in this emergency, or a significant potential for or condition; or (ii) a serious or life- document. a military emergency, involving a threatening disease or condition caused DATES: The Authorization for Focus heightened risk to U.S. military forces of by a product authorized under section Diagnostics, Inc., is effective as of April attack with a biological, chemical, 564, approved or cleared under the 28, 2016, and the Authorization for radiological, or nuclear agent or agents; FD&C Act, or licensed under section 351 altona Diagnostics GmbH is effective as (3) a determination by the Secretary of of the PHS Act, for diagnosing, treating, of May 13, 2016. HHS that there is a public health or preventing such a disease or emergency, or a significant potential for condition caused by such an agent; and ADDRESSES: Submit written requests for a public health emergency, that affects, (B) the known and potential benefits of single copies of the EUAs to the Office or has a significant potential to affect, the product, when used to diagnose, of Counterterrorism and Emerging national security or the health and prevent, or treat such disease or Threats, Food and Drug Administration, security of U.S. citizens living abroad, condition, outweigh the known and 10903 New Hampshire Ave., Bldg. 1, and that involves a biological, chemical, potential risks of the product, taking Rm. 4338, Silver Spring, MD 20993– radiological, or nuclear agent or agents, into consideration the material threat 0002. Send one self-addressed adhesive or a disease or condition that may be posed by the agent or agents identified label to assist that office in processing attributable to such agent or agents; or in a declaration under section your request or include a fax number to (4) the identification of a material threat 564(b)(1)(D) of the FD&C Act, if which the Authorizations may be sent. by the Secretary of Homeland Security applicable; (3) that there is no adequate, See the SUPPLEMENTARY INFORMATION under section 319F–2 of the Public approved, and available alternative to section for electronic access to the Health Service (PHS) Act (42 U.S.C. the product for diagnosing, preventing, Authorizations. 247d–6b) sufficient to affect national or treating such disease or condition; FOR FURTHER INFORMATION CONTACT: security or the health and security of Carmen Maher, Office of and (4) that such other criteria as may U.S. citizens living abroad. be prescribed by regulation are satisfied. Counterterrorism and Emerging Threats, Once the Secretary of HHS has No other criteria for issuance have Food and Drug Administration, 10903 declared that circumstances exist been prescribed by regulation under New Hampshire Ave., Bldg. 1, Rm. justifying an authorization under section 564(c)(4) of the FD&C Act. 4347, Silver Spring, MD 20993–0002, section 564 of the FD&C Act, FDA may Because the statute is self-executing, 301–796–8510. authorize the emergency use of a drug, regulations or guidance are not required SUPPLEMENTARY INFORMATION: device, or biological product if the for FDA to implement the EUA Agency concludes that the statutory I. Background authority. criteria are satisfied. Under section Section 564 of the FD&C Act (21 564(h)(1) of the FD&C Act, FDA is II. EUA Requests for In Vitro Diagnostic U.S.C. 360bbb–3) as amended by the required to publish in the Federal Devices for Detection of Zika Virus Project BioShield Act of 2004 (Pub. L. Register a notice of each authorization, On February 26, 2016, the Secretary of 108–276) and the Pandemic and All- and each termination or revocation of an HHS determined that there is a Hazards Preparedness Reauthorization authorization, and an explanation of the significant potential for a public health Act of 2013 (Pub. L. 113–5) allows FDA reasons for the action. Section 564 of the emergency that has a significant to strengthen the public health FD&C Act permits FDA to authorize the potential to affect national security or protections against biological, chemical, introduction into interstate commerce of the health and security of U.S. citizens nuclear, and radiological agents. Among a drug, device, or biological product sradovich on DSK3TPTVN1PROD with NOTICES living abroad and that involves Zika other things, section 564 of the FD&C intended for use when the Secretary of virus. On February 26, 2016, under Act allows FDA to authorize the use of HHS has declared that circumstances section 564(b)(1) of the FD&C Act, and an unapproved medical product or an exist justifying the authorization of on the basis of such determination, the unapproved use of an approved medical emergency use. Products appropriate for product in certain situations. With this emergency use may include products 1 The Secretary of HHS has delegated the EUA authority, FDA can help assure and uses that are not approved, cleared, authority to issue an EUA under section 564 of the that medical countermeasures may be or licensed under sections 505, 510(k), FD&C Act to the Commissioner of Food and Drugs. VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39655 Secretary of HHS declared that Time RT–PCR test, subject to the terms IV. The Authorizations circumstances exist justifying the of the Authorization. On May 11, 2016, Having concluded that the criteria for authorization of emergency use of in altona Diagnostics GmbH requested, and issuance of the Authorizations under vitro diagnostic tests for detection of on May 13, 2016, FDA issued, an EUA section 564(c) of the FD&C Act are met, Zika virus and/or diagnosis of Zika for the RealStar® Zika Virus RT–PCR Kit FDA has authorized the emergency use virus infection, subject to the terms of U.S., subject to the terms of the of two in vitro diagnostic devices for any authorization issued under section Authorization. detection of Zika virus subject to the 564 of the FD&C Act. Notice of the terms of the Authorizations. The determination and declaration of the III. Electronic Access Authorizations in their entirety (not Secretary was published in the Federal An electronic version of this including the authorized versions of the Register on March 2, 2016 (81 FR document and the full text of the fact sheets and other written materials) 10878). On April 26, 2016, Focus Authorizations are available on the follow and provide explanations of the Diagnostics, Inc., requested, and on Internet at http://www.regulations.gov. reasons for their issuance, as required April 28, 2016, FDA issued, an EUA for by section 564(h)(1) of the FD&C Act. the Zika Virus RNA Qualitative Real- BILLING CODE 4164–01–P sradovich on DSK3TPTVN1PROD with NOTICES VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1

39656 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Dear Mr. sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.007</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39657 I. Criteria for Issuance of Authorization L II. of Authorization sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.008</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Focus Diagnostics, Inc.‘s Zika Virus RNA Qualitative Real—Time RT—PCR is a real—time reverse transcriptase PCR (rRT—PCR) for the in vitro qualitative detection of Zika virus RNA in serum specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). The Zika Virus RNA Qualitative Real—Time RT—PCR can also be used with other authorized specimen types. The test procedure consists of nucleic acid extraction using the Roche MagNA Pure LC Total Nucleic Acid Isolation Large Volume Kit on the Roche MagNA Pure LC System, or other authorized extraction method, followed by rRT— PCR on the Applied Biosystems (ABI) 7500 Real—Time PCR System or other authorized instruments, using the Life Technologies SuperScript" IH Platinum" One—Step Quantitative RT— PCR System, or other authorized PCR enzyme Kits. The Zika Virus RNA Qualitative Real—Time RT—PCR includes primers and dual—labeled hydrolysis (Tagman®) probes targeting two separate nucleotide sequences within the Zika virus genome to be used in the in vitro qualitative detection of Zika virus RNA isolated from human serum and anyother authorized specimens. The purified nuclete acids are first reverse transcribed into cDNAs. In the process, the probes anneal to the specific target sequences located between the respective forward and reverse primers. During the extension phase of the PCR cycle, the 5° nuclease activity of Taq polymerase degrades the probes, causing the reporter dyes to separate from the quencher dyes, generating fluorescent signals. With each cyclie, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. The Zika Virus RNA Qualitative Real—Time RT—PCR kit includes the following materials: e Zika Virus RNA Qualitative Real—Time RT—PCR Primer and Probe sets for the detection of Zika virus and the Internal Control o ZV RTPCR Mix 1 {contains SuperScriptHI reaction buffer, primers, and probes for the "M" region of the Zika virus genome and the Internal Control} o ZV RTPCR Mix 2 (contains SuperScript" III reaction buffer, primers, and probes for the "env‘‘ region of the Zika virus genome and the Internal Control) The Zika Virus RNA Qualitative Real—Time RT—PCR requires the following control materials; all assay controls listed below should be run concurrently with all test samples and must generate expected results in order for a test to be considered valid: a Zika Virus RNA Qualitative Real—Time RT—PCR Negative Control o Normal human serum, no detectable Zika virus RNA o One included in each batch of specimen extraction to monitor Zika virus contamination o Zika Virus RNA Qualitative Real—Time RT—PCR Positive Control o Zika virus strain FLR diluted in normal human serum o One included in each batch ofspecimen extraction to monitor nucleic acid isolation and detection of Zika virus RNA

u — y sz e Zika Virus RNA Qualitative Real—Time RT—PCR Internal Control o DNA target included in each specimen, Positive Control, and Negative o Consists of a portion of the Arabidopsis thaliana genome, added to the lysis reagent provided in the MagNA Pure LC Total Nucleic Acid Large Volume Isolation Kit 0 Ensures the absence of non—specific PCR inhibition of a sample The above described Zika Virus RNA Qualitative Real—Time RT—PCR, when labeled consistently with the labeling authorized by FDA entitled "Zika Virus RNA Qualitative Real—Time RT—PCR Instructions for Use" (available at http://www. fda. gov/MedicalDevices/%20Safety/EmergencySituations/uem 1 61 496.htm), which may be revised by Focus Diagnostics, Inc. in consultation with FDA, 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 RNA Qualitative Real—Time RT—PCR is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care providers, pregnant women, and other patients: # Fact Sheet for Health Care Providers: Interpreting Zika Virus RNA Qualitative Real— Time RT—PCR Test Results * Fact Sheet for Pregnant Women: Understanding Results from the Zika Virus RNA Qualitative Real—Time RT—PCR Test * Fact Sheet for Patients: Understanding Results from the Zika Virus RNA Qualitative Real—Time RT—PCR Test As described in Section IV below, Focus Diagnostics, Inc. is also authorized to make available additional information relating to the emergency use ofthe authorized Zika Virus RNA Qualitative Real—Time RT—PCR that is consistent with, and does not exceed, the terms of this Ietter 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 of the authorized Zika Virus RNA Qualitative Real—Time RT—PCR 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 11}, outweigh the known and potential risks of such a product. Ihave concluded, pursuant to section 564(d)(3) ofthe Act, based on the totality ofsctentific evidence available to FDA, that it is reasonable to befieve that the authorized Zika Virus RNA Qualitative Real—Time RT—PCR 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. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section | above, and concludes that the authorized Zika Virus RNA Qualitative Real—Time RT—PCR, when used for detection of Zika virus and to diagnose Zika virus infection in the specified population (as described in the Scope of Authorization ofthis letter (Section 11}), meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

39660 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices am the PCR IV. Conditions of Authorization Focus Dililltll:oslics, Inc. sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.011</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39661 D. CFR Part H. L sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.012</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

39662 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Authorized Laboratories RT- Conditions Related to sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.013</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39663 V. Duration or Authorization sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.014</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

39664 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Dear Dr. sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.015</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39665 I. Criteria for Issuance of Authorization 11. of Authorization sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.016</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

39666 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Zika Virus RT-PCR Kit sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.017</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register/Vol. 81, No. 117 /Friday, June 17, 2016 /Notices 39667 Page 4 — Dr. Cramer, altona Diagnostics GmBH monitor nucleic acid tsolation and detection of Zika virus RNA s RealStar® Zika Virus RT—PCR Kit U.S. Internal Control o RNA target included in each specimen, Positive Control, and Negative Control o Consists of an artificial RNA molecule with no homologies to any other known sequences, added to the nuclei¢e acid extraction procedure o Ensures the absence of non—specific PCR inhibition ofa sample The above described RealStar® Zika Virus RT—PCR Kit U.S., when labeled consistently with the labeling authorized by FDA entitled "RealStar" Zika Virus RT—PCR Kit U.S. Instructions for Use" (available at http:/www,fda.gov/MedicalDevices/%20Safety/EmergencySituationsy/uem 161496 .htm), which may be revised by altona Diagnostics GimbH in consultation with FDA, 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 RealStar® Zika Virus RT—PCR Kit U.S. is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care providers, pregnant women, and other patients: e Fact Sheet for Health Care Providers: Interpreting RealStar® Zika Virus RT—PCR Kit U.S. Test Results e Fact Sheet for Pregnant Women: Understanding Results from the RealStar® Zika Virus RT—PCR Kit U.S. e Fact Sheet for Patients: Understanding Results from the RealStar®" Zika Virus RT— PCR Kit ULS. As described in Section TV below, altona Diagnostics GinbH is also authorized to make available additional information relating to the emergency use of the authorized RealStar® Zika Virus RT— PCR Kit U.S. that is consistent with, and does not exceed, the terms of this letter 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 of the authorized RealStar® Zika Virus RT—PCR Kit U.S. 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 I1), outweigh the known and potential 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 RealStar®" Zika Virus RT—PCR Kit U.S. 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) ofthe Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section 1 above, and concludes that the authorized RealStar® Zika Virus RT—PCR Kit U.8., 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

39668 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices III. Waiver of Certain .. IV. Conditions of Authorization altona sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.019</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39669 D. E. G. I. sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.020</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

39670 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices L. 0. P. and under I CFR Authorized Laboratories sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.021</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39671 and Authorized l,aboratorics Conditions Related to X. • test • • • sradovich on DSK3TPTVN1PROD with NOTICES EN17JN16.022</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1

39672 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Dated: June 13, 2016. guidance before it begins work on the and Drug Administration, 5630 Fishers Leslie Kux, final version of the guidance, submit Lane, Rm. 1061, Rockville, MD 20852. Associate Commissioner for Policy. either electronic or written comments • For written/paper comments [FR Doc. 2016–14380 Filed 6–16–16; 8:45 am] on the draft guidance by August 16, submitted to the Division of Dockets BILLING CODE 4164–01–C 2016. Management, FDA will post your comment, as well as any attachments, ADDRESSES: You may submit comments except for information submitted, as follows: marked and identified, as confidential, DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions if submitted as detailed in ‘‘Instructions.’’ Food and Drug Administration Submit electronic comments in the Instructions: All submissions received following way: must include the Docket No. FDA– [Docket No. FDA–2007–D–0369] • Federal eRulemaking Portal: http:// 2007–D–0369 for ‘‘Product-Specific www.regulations.gov. Follow the Bioequivalence Recommendations; Draft Product-Specific Bioequivalence instructions for submitting comments. Recommendations; Draft and Revised and Revised Draft Guidances for Comments submitted electronically, Industry.’’ Received comments will be Draft Guidances for Industry; including attachments, to http:// Availability placed in the docket and, except for www.regulations.gov will be posted to those submitted as ‘‘Confidential AGENCY: Food and Drug Administration, the docket unchanged. Because your Submissions,’’ publicly viewable at HHS. comment will be made public, you are http://www.regulations.gov or at the ACTION: Notice of availability. solely responsible for ensuring that your Division of Dockets Management comment does not include any between 9 a.m. and 4 p.m., Monday SUMMARY: The Food and Drug confidential information that you or a through Friday. Administration (FDA or Agency) is third party may not wish to be posted, • Confidential Submissions—To announcing the availability of such as medical information, your or submit a comment with confidential additional draft and revised draft anyone else’s Social Security number, or information that you do not wish to be product-specific bioequivalence (BE) confidential business information, such made publicly available, submit your recommendations. The as a manufacturing process. Please note comments only as a written/paper recommendations provide product- that if you include your name, contact submission. You should submit two specific guidance on the design of BE information, or other information that copies total. One copy will include the studies to support abbreviated new drug identifies you in the body of your information you claim to be confidential applications (ANDAs). In the Federal comments, that information will be with a heading or cover note that states Register of June 11, 2010, FDA posted on http://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS announced the availability of a guidance • If you want to submit a comment CONFIDENTIAL INFORMATION.’’ The for industry entitled ‘‘Bioequivalence with confidential information that you Agency will review this copy, including Recommendations for Specific do not wish to be made available to the the claimed confidential information, in Products’’ that explained the process public, submit the comment as a its consideration of comments. The that would be used to make product- written/paper submission and in the second copy, which will have the specific BE recommendations available manner detailed (see ‘‘Written/Paper claimed confidential information to the public on FDA’s Web site. The BE Submissions’’ and ‘‘Instructions’’). redacted/blacked out, will be available sradovich on DSK3TPTVN1PROD with NOTICES recommendations identified in this for public viewing and posted on http:// notice were developed using the process Written/Paper Submissions www.regulations.gov. Submit both described in that guidance. Submit written/paper submissions as copies to the Division of Dockets DATES: Although you can comment on follows: Management. If you do not wish your any guidance at any time (see 21 CFR • Mail/Hand delivery/Courier (for name and contact information to be 10.115(g)(5)), to ensure that the Agency written/paper submissions): Division of made publicly available, you can considers your comment on this draft Dockets Management (HFA–305), Food provide this information on the cover EN17JN16.023</GPH> VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1


Document Created: 2016-06-17 01:05:13
Document Modified: 2016-06-17 01:05:13
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 Focus Diagnostics, Inc., is effective as of April 28, 2016, and the Authorization for altona Diagnostics GmbH is effective as of May 13, 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.
FR Citation81 FR 39653 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR