Document ID: FDA-2016-N-0969-0004
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus
Posted Date: 2017-06-30T04:00Z

[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]

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

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