81_FR_23801 81 FR 23723 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

81 FR 23723 - 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 78 (April 22, 2016)

Page Range23723-23733
FR Document2016-09370

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 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 the U.S. Centers for Disease Control and Prevention (CDC). 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 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 Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016) 
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23723-23733]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09370]


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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 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 the U.S. Centers for Disease Control and 
Prevention (CDC). 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 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 Authorization, which includes an explanation of the reasons for 
issuance, is reprinted in this document.

DATES: The Authorization is effective as of March 17, 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,

[[Page 23724]]

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 360(e)), or section 351 of the PHS Act (42 U.S.C. 262). FDA may 
issue an EUA only if, after consultation with the HHS Assistant 
Secretary for Preparedness and Response, the Director of the National 
Institutes of Health, and the Director of the CDC (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 Request for an In Vitro Diagnostic Device 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 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 March 14, 2016, CDC requested, and on 
March 17, 2016, FDA issued, an EUA for the CDC Trioplex Real-time RT-
PCR Assay (Trioplex rRT-PCR), 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 http://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: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09370 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23723 rubrum and Epidermophyton floccosum determination regarding whether the vitro diagnostic tests for detection of in patients 18 years of age and older. applicant for extension acted with due Zika virus and/or diagnosis of Zika Subsequent to this approval, the USPTO diligence during the regulatory review virus infection subject to the terms of received a patent term restoration period. To meet its burden, the petition any authorization issued under the application for LUZU (U.S. Patent No. must be timely (see DATES) and contain FD&C Act. The Authorization, which 5,900,488) from Nihon Nohyaku Co., sufficient facts to merit an FDA includes an explanation of the reasons Ltd., and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1, for issuance, is reprinted in this assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.) document. eligibility for patent term restoration. In Petitions should be in the format DATES: The Authorization is effective as a letter dated May 11, 2015, FDA specified in 21 CFR 10.30. of March 17, 2016. advised the USPTO that this human Submit petitions electronically to drug product had undergone a ADDRESSES: Submit written requests for http://www.regulations.gov at Docket regulatory review period and that the No. FDA–2013–S–0610. Submit written single copies of the EUA to the Office approval of LUZU represented the first petitions (two copies are required) to the of Counterterrorism and Emerging permitted commercial marketing or use Division of Dockets Management (HFA– Threats, Food and Drug Administration, of the product. Thereafter, the USPTO 305), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, requested that FDA determine the 5630 Fishers Lane, Rm. 1061, Rockville, Rm. 4338, Silver Spring, MD 20993– product’s regulatory review period. MD 20852. 0002. Send one self-addressed adhesive label to assist that office in processing II. Determination of Regulatory Review Dated: April 18, 2016. your request or include a fax number to Period Leslie Kux, which the Authorization may be sent. FDA has determined that the Associate Commissioner for Policy. See the SUPPLEMENTARY INFORMATION applicable regulatory review period for [FR Doc. 2016–09374 Filed 4–21–16; 8:45 am] section for electronic access to the LUZU is 2,242 days. Of this time, 1,903 BILLING CODE 4164–01–P Authorization. days occurred during the testing phase FOR FURTHER INFORMATION CONTACT: of the regulatory review period, while Carmen Maher, Office of 339 days occurred during the approval DEPARTMENT OF HEALTH AND Counterterrorism and Emerging Threats, phase. These periods of time were HUMAN SERVICES Food and Drug Administration, 10903 derived from the following dates: New Hampshire Ave., Bldg. 1, Rm. 1. The date an exemption under Food and Drug Administration 4347, Silver Spring, MD 20993–0002, section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–0969] 301–796–8510 (this is not a toll free and Cosmetic Act (the FD&C Act) (21 number). U.S.C. 355(i)) became effective: Authorization of Emergency Use of an September 27, 2007. FDA has verified In Vitro Diagnostic Device for SUPPLEMENTARY INFORMATION: the Nihon Nohyaku Co., Ltd. claim that Detection of Zika Virus; Availability I. Background September 27, 2007, is the date the investigational new drug application AGENCY: Food and Drug Administration, Section 564 of the FD&C Act (21 (IND) became effective. HHS. U.S.C. 360bbb–3) as amended by the 2. The date the application was ACTION: Notice. Project BioShield Act of 2004 (Pub. L. initially submitted with respect to the 108–276) and the Pandemic and All- human drug product under section SUMMARY: The Food and Drug Hazards Preparedness Reauthorization 505(b) of the FD&C Act: December 11, Administration (FDA) is announcing the Act of 2013 (Pub. L. 113–5) allows FDA 2012. FDA has verified the applicant’s issuance of an Emergency Use to strengthen the public health claim that the new drug application Authorization (EUA) (the Authorization) protections against biological, chemical, (NDA) for LUZU (NDA 204153) was for an in vitro diagnostic device for nuclear, and radiological agents. Among initially submitted on December 11, detection of Zika virus in response to other things, section 564 of the FD&C 2012. the Zika virus outbreak in the Americas. Act allows FDA to authorize the use of 3. The date the application was FDA issued this Authorization under an unapproved medical product or an approved: November 14, 2013. FDA has the Federal Food, Drug, and Cosmetic unapproved use of an approved medical verified the applicant’s claim that NDA Act (the FD&C Act), as requested by the product in certain situations. With this 204153 was approved on November 14, U.S. Centers for Disease Control and EUA authority, FDA can help assure 2013. Prevention (CDC). The Authorization that medical countermeasures may be This determination of the regulatory contains, among other things, used in emergencies to diagnose, treat, review period establishes the maximum conditions on the emergency use of the or prevent serious or life-threatening potential length of a patent extension. authorized in vitro diagnostic device. diseases or conditions caused by However, the USPTO applies several The Authorization follows the February biological, chemical, nuclear, or statutory limitations in its calculations 26, 2016, determination by the radiological agents when there are no of the actual period for patent extension. Department of Health and Human adequate, approved, and available In its application for patent extension, Services (HHS) Secretary that there is a alternatives. this applicant seeks 1,289 days of patent significant potential for a public health Section 564(b)(1) of the FD&C Act term extension. emergency that has a significant provides that, before an EUA may be mstockstill on DSK4VPTVN1PROD with NOTICES potential to affect national security or issued, the Secretary of HHS must III. Petitions the health and security of U.S. citizens declare that circumstances exist Anyone with knowledge that any of living abroad and that involves Zika justifying the authorization based on the dates as published are incorrect may virus. On the basis of such one of the following grounds: (1) A submit either electronic or written determination, the HHS Secretary determination by the Secretary of comments and ask for a redetermination declared on February 26, 2016, that Homeland Security that there is a (see DATES). Furthermore, any interested circumstances exist justifying the domestic emergency, or a significant person may petition FDA for a authorization of emergency use of in potential for a domestic emergency, VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

23724 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices involving a heightened risk of attack 360(k), and 360(e)), or section 351 of the II. EUA Request for an In Vitro with a biological, chemical, radiological, PHS Act (42 U.S.C. 262). FDA may issue Diagnostic Device for Detection of Zika or nuclear agent or agents; (2) a an EUA only if, after consultation with Virus determination by the Secretary of the HHS Assistant Secretary for Defense that there is a military Preparedness and Response, the On February 26, 2016, the Secretary of emergency, or a significant potential for Director of the National Institutes of HHS determined that there is a a military emergency, involving a Health, and the Director of the CDC (to significant potential for a public health heightened risk to U.S. military forces of the extent feasible and appropriate emergency that has a significant attack with a biological, chemical, given the applicable circumstances), potential to affect national security or radiological, or nuclear agent or agents; FDA 1 concludes: (1) That an agent the health and security of U.S. citizens (3) a determination by the Secretary of referred to in a declaration of emergency living abroad and that involves Zika HHS that there is a public health or threat can cause a serious or life- virus. On February 26, 2016, under emergency, or a significant potential for threatening disease or condition; (2) section 564(b)(1) of the FD&C Act, and a public health emergency, that affects, that, based on the totality of scientific on the basis of such determination, the or has a significant potential to affect, evidence available to FDA, including Secretary of HHS declared that national security or the health and data from adequate and well-controlled circumstances exist justifying the security of U.S. citizens living abroad, clinical trials, if available, it is authorization of emergency use of in and that involves a biological, chemical, reasonable to believe that: (A) The vitro diagnostic tests for detection of radiological, or nuclear agent or agents, product may be effective in diagnosing, Zika virus and/or diagnosis of Zika or a disease or condition that may be treating, or preventing (i) such disease virus infection, subject to the terms of attributable to such agent or agents; or or condition; or (ii) a serious or life- any authorization issued under section (4) the identification of a material threat threatening disease or condition caused 564 of the FD&C Act. Notice of the by the Secretary of Homeland Security by a product authorized under section determination and declaration of the under section 319F–2 of the Public 564, approved or cleared under the Secretary was published in the Federal Health Service (PHS) Act (42 U.S.C. FD&C Act, or licensed under section 351 Register on March 2, 2016 (81 FR 247d–6b) sufficient to affect national of the PHS Act, for diagnosing, treating, 10878). On March 14, 2016, CDC security or the health and security of or preventing such a disease or requested, and on March 17, 2016, FDA U.S. citizens living abroad. condition caused by such an agent; and issued, an EUA for the CDC Trioplex Once the Secretary of HHS has (B) the known and potential benefits of Real-time RT-PCR Assay (Trioplex rRT- declared that circumstances exist the product, when used to diagnose, PCR), subject to the terms of the justifying an authorization under prevent, or treat such disease or Authorization. section 564 of the FD&C Act, FDA may condition, outweigh the known and III. Electronic Access authorize the emergency use of a drug, potential risks of the product, taking device, or biological product if the into consideration the material threat An electronic version of this Agency concludes that the statutory posed by the agent or agents identified document and the full text of the criteria are satisfied. Under section in a declaration under section Authorization are available on the 564(h)(1) of the FD&C Act, FDA is 564(b)(1)(D) of the FD&C Act, if Internet at http://www.regulations.gov. required to publish in the Federal applicable; (3) that there is no adequate, IV. The Authorization Register a notice of each authorization, approved, and available alternative to and each termination or revocation of an the product for diagnosing, preventing, Having concluded that the criteria for authorization, and an explanation of the or treating such disease or condition; issuance of the Authorization under reasons for the action. Section 564 of the and (4) that such other criteria as may section 564(c) of the FD&C Act are met, FD&C Act permits FDA to authorize the be prescribed by regulation are satisfied. FDA has authorized the emergency use introduction into interstate commerce of No other criteria for issuance have of an in vitro diagnostic device for a drug, device, or biological product been prescribed by regulation under detection of Zika virus subject to the intended for use when the Secretary of section 564(c)(4) of the FD&C Act. terms of the Authorization. The HHS has declared that circumstances Because the statute is self-executing, Authorization in its entirety (not exist justifying the authorization of regulations or guidance are not required including the authorized versions of the emergency use. Products appropriate for for FDA to implement the EUA fact sheets and other written materials) authority. follows and provides an explanation of emergency use may include products and uses that are not approved, cleared, the reasons for its issuance, as required 1 The Secretary of HHS has delegated the or licensed under sections 505, 510(k), authority to issue an EUA under section 564 of the by section 564(h)(1) of the FD&C Act. or 515 of the FD&C Act (21 U.S.C. 355, FD&C Act to the Commissioner of Food and Drugs. BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

—/é DEPARTMENT OP HEALTH & HUMAN SERVICES Foad and Drug Administration Siiver Spring, MDO 20093 March 17, 2016 Thomas R. Frieden, MD, MPH Director Centers for Disease Control and Prevention 1600 Clifton Rd, MS D—14 Atlanta, GA 30333 Dear Dr. Frieden:; This letter is in response to your request that the Food and Drug Administration (FDA ) issue an Emergency Use Authorization (EUA) for emergency use ofthe Centers for Disease Control and Prevention‘s (CDC) Trioplex Real—time RTPCR Assay (Trioplex rRT—PCR) for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, and chikunguniya virus in hauman sera or cerebrospinal fluid {collected alongside a patient—matched serum specimen}, and for the qualitative detection of Zika virus RNA in urineand amniotic fluid (each collected alongside a patient—matched serum specimen), pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Actf(21 US.C. §360bbb—3). The assay is intended for use with 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 epidemioclogical criteria (e.g., history ofresidence in or travel to a geographic region with active Zika transmission af the time oftravel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation), by qualified laboratories designated by CDC and, in the United States, certthied underthe Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.! Assay results are for the identification of Zika, dengue, and chikungunya viral RNA . Viral RNA is generally detectable in serum during the acute phase ofinfection {approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. On February 26, 2016, pursuant to section 564(b)¥1 NC) of the Aet (21 U.S.C, §360bbh— HMbWIYXC), 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 United States citizens living abroad and that involves Zika virus." Pursuant to section 564(b)(T) ofthe Act (21 U.S.C, § 360bbb—3(b)(1 )), and on the basis of such determination, the Secretary of HHS then declared that circumstances ‘ For ease of reference, this letter will refer to "qualified laboratorfes designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 US.C. $2632, to perform high complexiry tests" as "authorized laboratories." * As amended by the Pandemic and All Hazards Preparedness Reauthorization Act, Pub, L. No. 113—5, under section 564(BNTYC) of the Act, the Secretary may make a determination ofa public health emergency, or of a significant potential for a public health emergeney.

23726 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices Centers for Disease Control and Pn;:vention tor detectton authorization I. Criteria for lssulmt·e of Authorizntion concluded that the emergency use lilld VlfiJS or /',ika infection in thll M>!Ol:llHCU issuance an authorization under section L The virus can caus..:: Zika virus or condition to humans infected with the 2. or scientific evidence availahlll to FDA> it reasonable to bulicvc when used with the instrument and risk.'! of such 3. and available altemative to the emergency use '""'&''""''"& Zika virus infection. u. of Authorization mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.049</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23727 Centers for Disease Control and Pn;:vention The Authmized I'RT-PCR • mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.050</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

23728 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices and P and Rand R a:nd P • and • • Posith·e controls for a!!en:t-snocnitc sets Inactivated Inactivated cn:tKlitng:un.ya lnadivaled Zika virus • IU+lase P Primer and Probe Set pmcess . • mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.051</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23729 Centers for Disease Control and Pn;:vention prcg)lilllt women, • R!!al- RT-PCR • ,.,,,,"'""'"' Real- • Time FDA has reviewed the scientific information available to infonnation when the mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.052</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

23730 Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices Page 6 — Dr. Frieden, Centers for Discase Control and Prevention under section 564(g) ofthe Act. L Waiver of Certain Requirements Lam waiving the following requirements for the Trioplex rRT—PCR during the duration of this ELULA: Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manafacture, packaging, labeling, storage, and distributionmofthe Trioplex rRT—PCR, Labeling requirements for cleared, approved, or investigational deviees, imcluding labeling requirements under 21 CFR 809. 10 and 21 CFR 809:30; except for the intended use statement (21 CFR 809.10(a)(2). (b)y(2)), adequate directions for use (21 U.8.C. 352(fy), (21 CFR 809.10(b)(5), (7), and (8)), any appropriate limitations on the use ofthe device including information required under 21 CFR £09.10(a)(4), and any available information regarding performance ofthe device, including requirements under 21 CFR 809.10(b)(12). IV. Conditions of Authorization Pursuant to section 564 of the Act, L am establishing the following conditions on this authorization: Centers for Disease Control and Prevention (CDC) A. CDC will distribute the authorized Trioplex rRT—PCR with the authorized labeling, as may be revised by CDC in consultation with FDA, only to authorized laboratories. CDC will provide to authorized laboratories the authorized Trioplex rRT—PCR Fact Sheet for Health Care Providers, the authorized Trioplex rRT—PCR Fact Sheet for Pregnant Women;, and the authorized Trioplex rRT—PCR Fact Sheet for Patients. CDC will make available on its website the authoried Trioplex rRT—PCR Fact Shoet for Health Care Providers, the authorized Trioplex rRT—PCR Fact Sheet for Pregnant Women, and the authorized Trioplex rRT—PCR Fact Sheet for Patients. CDC will inform authorized laboratories and relevant public health authortyv(ics) of this EUA, including the terms and conditions herein. . CDC will ensure that authorized laboratories using the authorized Trioplex rRT—PCR have a process in place for reporting test results to health care providers and relevant public health authorities, as appropriate. CDC will track adverse events and report to FDA under 21 CFR Part 803.

Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices 23731 Page 7 — Dr. Frieden, Centers for Discase Control and Prevention . Through a process of inventory control, CDC will mamntain records of device usage. H. CDC will collect information on the performance ofthe assay. CDC will report to FDA any suspected occurrence offalse positive and false negative results and significant deviations fromthe established performance characteristics ofthe assay of which CDC becomes aware. L._ CDCis authorized to make available additional information relating to the emergency use ofthe authorized Trioplex rRT—PCR that is consistent with, and does not exceed, the terms ofthis letter of authorization. 1. CDC may request changes to the authorized Trioplex rRT—PCR Fact Sheet for Health Care Providers, the authorized Trioplex rRT—PCR Fact Sheet for Pregnant Women, and the authorized Trioplex rRT—PCR Fact Sheet for Patients. Suchrequests will be made by CDC in consultation with FDA, and require concurrence of, FDA. CDBC may request the addition ofother real—time PCR instruments for use with the authorized 71 Trioplex rRT—PCR, Such requests will be made by CDC in consultation with, and require concurrence of, FDA. L. CBC may request the addition of other extraction methods for use with the authorized Trioplex rRT—PCR, Such requests will be made by CDC in consultation with, and require concurrence of, FDA, M. CDC may request the addition of other specimen types for use with the authorized Trioplex rRT—PCR, Such requests will be made by CDC in consultation with, and require: concurrence of, FDA. N. CDC will assess tmceabilitys ofthe Troplex rRT—PCR with the interim WHO Zika reference standard when the reference material becomes available. After submission to FDA and FDA‘s review of and concurrence with the data, CDC will update their labeling to reflect the additional testing. Authorized Laboratories 0. Authorized laboratories will include with reports of the results of the Trioplex rRT—PCR, the authorized Fact Sheet for Health Care Providers, the authorized Fact Sheet for Pregnant Women, and the authorized Fact Sheet for Patients. Underexigent Circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which mayinclude mass media. P. Authorized laboratories will perform the Trioplex fRT—PCR on the Applied Biosystems (ABI) 7500 Fast Dx Real—Time PCR Instrument or other authorized instruments. * Traceability refers to tracing analytical sensitivity/reactivity back to the interim WHO Zika reference material.

23732 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices Centers for Disease Control and Pn;:vention health CDC and authorized IU!llll114UilCU Until the use ofthe 'Ihis lest ha<: been authorized FDA under an for authorized This for the detection and ditlerentiation from other tenninated or revoked sooner. mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.055</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23733 Dated: April 18, 2016. produce grown in fields or other manner detailed (see ‘‘Written/Paper Leslie Kux, growing areas amended with untreated Submissions’’ and ‘‘Instructions’’). Associate Commissioner for Policy. biological soil amendments of animal Written/Paper Submissions [FR Doc. 2016–09370 Filed 4–21–16; 8:45 am] origin (including raw manure). We are BILLING CODE 4164–01–C taking this action for an extension to Submit written/paper submissions as allow interested persons additional time follows: to submit comments. • Mail/Hand delivery/Courier (for DEPARTMENT OF HEALTH AND DATES: Submit either electronic or written/paper submissions): Division of HUMAN SERVICES written comments by July 5, 2016. Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Food and Drug Administration ADDRESSES: You may submit comments Lane, Rm. 1061, Rockville, MD 20852. as follows: • For written/paper comments [Docket No. FDA–2016–N–0321] Electronic Submissions submitted to the Division of Dockets Risk Assessment of Foodborne Illness Management, FDA will post your Associated With Pathogens From Submit electronic comments in the comment, as well as any attachments, Produce Grown in Fields Amended following way: except for information submitted, With Untreated Biological Soil • Federal eRulemaking Portal: http:// marked and identified, as confidential, Amendments of Animal Origin; www.regulations.gov. Follow the if submitted as detailed in Request for Scientific Data, instructions for submitting comments. ‘‘Instructions.’’ Information, and Comments; Extension Comments submitted electronically, Instructions: All submissions received of Comment Period including attachments, to http:// must include the Docket No. FDA– www.regulations.gov will be posted to 2016–N–0321 for ‘‘Risk Assessment of AGENCY: Food and Drug Administration, the docket unchanged. Because your HHS. Foodborne Illness Associated With comment will be made public, you are Pathogens From Produce Grown in ACTION: Notice; request for comments solely responsible for ensuring that your Fields Amended With Untreated and for scientific data and information; comment does not include any Biological Soil Amendments of Animal extension of comment period. confidential information that you or a Origin; Request for Scientific Data, SUMMARY: The Food and Drug third party may not wish to be posted, Information, and Comments.’’ Received Administration (FDA or we) is such as medical information, your or comments will be placed in the docket extending the comment period for the anyone else’s Social Security number, or and, except for those submitted as notice entitled ‘‘Risk Assessment of confidential business information, such ‘‘Confidential Submissions,’’ publicly Foodborne Illness Associated With as a manufacturing process. Please note viewable at http://www.regulations.gov Pathogens From Produce Grown in that if you include your name, contact or at the Division of Dockets Fields Amended With Untreated information, or other information that Management between 9 a.m. and 4 p.m., identifies you in the body of your mstockstill on DSK4VPTVN1PROD with NOTICES Biological Soil Amendments of Animal Monday through Friday. Origin; Request for Scientific Data, comments, that information will be • Confidential Submissions—To Information, and Comments’’ that posted on http://www.regulations.gov. submit a comment with confidential appeared in the Federal Register of • If you want to submit a comment information that you do not wish to be March 4, 2016. The notice requested with confidential information that you made publicly available, submit your scientific data, information, and do not wish to be made available to the comments only as a written/paper comments that would assist in the public, submit the comment as a submission. You should submit two EN22AP16.056</GPH> development of a risk assessment for written/paper submission and in the copies total. One copy will include the VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1


Document Created: 2017-08-22 23:37:00
Document Modified: 2017-08-22 23:37:00
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 March 17, 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 23723 
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