Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus, 29883-29886 [2017-13666]

Download as PDF Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Dated: June 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–13664 Filed 6–29–17; 8:45 am] [Docket No. FDA–2016–N–0969] Food and Drug Administration BILLING CODE 4164–01–P Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus AGENCY: Food and Drug Administration ACTION: [Docket No. FDA–2013–N–0523] Correction In notice document 2017–10818 appearing on pages 24351 through 24356 in the issue of Friday, May 26, make the following correction: On page 24351, in the third column, under the DATES heading, in the third line ‘‘June 26, 2017’’ should read ‘‘July 25, 2017’’. mstockstill on DSK30JT082PROD with NOTICES [FR Doc. C1–2017–10818 Filed 6–29–17; 8:45 am] VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 SUPPLEMENTARY INFORMATION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix® Zika rRT–PCR Test. FDA revoked this Authorization on March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated March 10, 2017. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. SUMMARY: Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug BILLING CODE 1505–01–D Food and Drug Administration, HHS. The Authorization is revoked as of March 13, 2017. ADDRESSES: Submit written requests for single copies of the revocation 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 selfaddressed adhesive label to assist that office in processing your request or DATES: PO 00000 Frm 00063 Fmt 4703 include a fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation. 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). Sfmt 4703 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 AllHazards 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. On August 26, 2016, FDA issued an EUA to Roche Molecular Systems, Inc. for the LightMix® Zika rRT–PCR Test, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on October 28, 2016 (81 FR 75092), as required by section 564(h)(1) of the FD&C Act. Under section 564(g)(2), the Secretary of Health and Human Services may revoke an EUA if, among other things, the criteria for issuance are no E:\FR\FM\30JNN1.SGM 30JNN1 EN30JN17.269</GPH> DEPARTMENT OF HEALTH AND HUMAN SERVICES 29883 29884 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices longer met or other circumstances make such revocation appropriate to protect the public health or safety. II. EUA Revocation Request for an In Vitro Diagnostic Device for Detection of the Zika Virus mstockstill on DSK30JT082PROD with NOTICES On March 10, 2017, Roche Molecular Systems, Inc. requested, and on March 13, 2017, FDA revoked, the EUA for the LightMix® Zika rRT–PCR Test because VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 the criteria for issuance were no longer met and other circumstances made such revocation appropriate to protect the public health or safety. II. Electronic Access An electronic version of this document and the full text of the revocation are available on the Internet at https://www.regulations.gov. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 III. The Revocation Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for Roche Molecular Systems, Inc.’s LightMix® Zika rRT–PCR Test. The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. E:\FR\FM\30JNN1.SGM 30JNN1 VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\30JNN1.SGM 30JNN1 29885 EN30JN17.270</GPH> mstockstill on DSK30JT082PROD with NOTICES Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29886 Dated: June 21, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–13666 Filed 6–29–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–1486] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Nanobiosym Diagnostics, Inc. and DiaSorin Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 explanation of the reasons for issuance, are reprinted in this document. DATES: The Authorization for Nanobiosym Diagnostics, Inc. is effective as of March 20, 2017; the Authorization for DiaSorin Inc. is effective as of April 5, 2017. ADDRESSES: Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorizations. FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub L. 108–276) and the Pandemic and AllHazards 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 E:\FR\FM\30JNN1.SGM 30JNN1 EN30JN17.271</GPH> Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices

Agencies

[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29883-29886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device for Detection of Zika Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika 
rRT-PCR Test. FDA revoked this Authorization on March 13, 2017, under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested 
by Roche Molecular Systems, Inc. by letter dated March 10, 2017. The 
revocation, which includes an explanation of the reasons for 
revocation, is reprinted in this document.

DATES: The Authorization is revoked as of March 13, 2017.

ADDRESSES: Submit written requests for single copies of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

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. On August 26, 2016, FDA issued 
an EUA to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika 
rRT-PCR Test, subject to the terms of the Authorization. Notice of the 
issuance of the Authorization was published in the Federal Register on 
October 28, 2016 (81 FR 75092), as required by section 564(h)(1) of the 
FD&C Act. Under section 564(g)(2), the Secretary of Health and Human 
Services may revoke an EUA if, among other things, the criteria for 
issuance are no

[[Page 29884]]

longer met or other circumstances make such revocation appropriate to 
protect the public health or safety.

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

    On March 10, 2017, Roche Molecular Systems, Inc. requested, and on 
March 13, 2017, FDA revoked, the EUA for the LightMix[supreg] Zika rRT-
PCR Test because the criteria for issuance were no longer met and other 
circumstances made such revocation appropriate to protect the public 
health or safety.

II. Electronic Access

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

III. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUA for Roche Molecular Systems, Inc.'s LightMix[supreg] 
Zika rRT-PCR Test. The revocation in its entirety follows and provides 
an explanation of the reasons for revocation, as required by section 
564(h)(1) of the FD&C Act.

[[Page 29885]]

[GRAPHIC] [TIFF OMITTED] TN30JN17.270


[[Page 29886]]


[GRAPHIC] [TIFF OMITTED] TN30JN17.271


    Dated: June 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13666 Filed 6-29-17; 8:45 am]
 BILLING CODE 4164-01-P

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