This PDF is the current document as it appeared on Public Inspection on 06/29/2017 at 08:45 am.
Food and Drug Administration, HHS.
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.
The Authorization is revoked as of March 13, 2017.
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.Start Further Info
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).End Further Info End Preamble Start Supplemental Information
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® 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 Start Printed Page 29884longer 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® 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® 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.Start Printed Page 29885 Start Printed Page 29886 Start Signature
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]
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