[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37813-37816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16537]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0126]
Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection of Ebola Virus
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA
revoked this Authorization on May 18, 2018, under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by
letter dated March 1, 2018. The revocation, which includes an
explanation of the reasons for revocation, is reprinted in this
document.
DATES: The Authorization is revoked as of May 18, 2018.
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: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4336, 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 February 24, 2015, FDA issued
an EUA to Corgenix, Inc. for the ReEBOV Antigen Rapid Test, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on June 5, 2015 (80
FR 32140), as required by section 564(h)(1) of the FD&C Act. In
response to requests from Zalgen Labs, LLC and Corgenix, Inc. to
transfer ownership of the EUA for the ReEBOV Antigen Rapid Test from
Corgenix, Inc. to Zalgen Labs, LLC, FDA amended and reissued the EUA to
Zalgen Labs, LLC
[[Page 37814]]
in its entirety on November 3, 2016. 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 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 Ebola Virus
Pursuant to a request from Zalgen Labs, LLC on March 1, 2018, FDA
revoked the EUA for the ReEBOV Antigen Rapid Test on May 18, 2018,
because the criteria for issuance were no longer met and these
circumstances made such revocation appropriate to protect the public
health or safety.
III. 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.
IV. 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 Zalgen Labs, LLC's ReEBOV Antigen Rapid 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.
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Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16537 Filed 8-1-18; 8:45 am]
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