Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability, 24425-24427 [2023-08281]

Download as PDF Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices respondents will be identified for each unique rapid response survey. 24425 FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity FDA Rapid Response Surveys ................................... 1 There Dated: April 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–08297 Filed 4–19–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1378] Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to BioFire Defense, LLC, for the FilmArray NGDS BT-E Assay, and Biocartis NV, for the Idylla Rapid Ebola Virus Triage Test. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document. DATES: The revocation of the Authorization for the BioFire Defense, LLC’s FilmArray NGDS BT-E Assay is effective as of March 8, 2023. The revocation of the Authorization for the Biocartis NV’s Idylla Rapid Ebola Virus SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 10,000 Total annual responses 1 10,000 Average burden per response 0.5 (30 minutes) ..... Total hours 5,000 are no capital costs or operating and maintenance costs associated with this collection of information. We estimate that each rapid response survey will take no more than 30 minutes to complete. Based on a review of the information collection since our last request, we have adjusted our burden estimate which has resulted in a decrease to the currently approved burden. We now estimate one response per respondent which results in a decrease in overall burden of 25,000 hours. AGENCY: Number of responses per respondent VerDate Sep<11>2014 20:01 Apr 19, 2023 Jkt 259001 Triage Test is effective as of March 9, 2023. Submit written requests for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request or include a Fax number to which the revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations. FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). ADDRESSES: 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. On October 25, 2014, FDA issued the Authorization to BioFire Defense, LLC, for the FilmArray NGDS BT-E Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on February 9, 2015 (80 FR 6972), as required by section 564(h)(1) of the FD&C Act. On May 26, 2016, FDA issued the Authorization to Biocartis NV, for the Idylla Rapid Ebola Virus Triage Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 published in the Federal Register on July 8, 2016 (81 FR 44616), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorizations were made available on FDA’s website. The authorization of a device for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act). II. Authorization Revocation Requests In a request received by FDA on February 24, 2023, BioFire Defense, LLC, requested the revocation of, and on March 8, 2023, FDA revoked, the Authorization for the BioFire Defense, LLC’s FilmArray NGDS BT-E Assay. Because BioFire Defense, LLC, notified FDA that it is obsolescing the FilmArray NGDS BT-E Assay and requested FDA withdraw the BioFire Defense, LLC’s, FilmArray NGDS BT-E Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on November 23, 2022, Biocartis US, Inc., on behalf of Biocartis NV, requested rescission of, and on March 9, 2023, FDA revoked, the Authorization for the Idylla Rapid Ebola Virus Triage Test. Because Biocartis US, Inc., on behalf of Biocartis NV, notified FDA that it has discontinued the production of Idylla Rapid Ebola Virus Triage Test and requested FDA rescind the Authorization for the Idylla Rapid Ebola Virus Triage Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. III. Electronic Access An electronic version of this document and the full text of the revocations are available on the internet at https://www.regulations.gov/. E:\FR\FM\20APN1.SGM 20APN1 24426 Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are VerDate Sep<11>2014 20:01 Apr 19, 2023 Jkt 259001 met, FDA has revoked the EUA of BioFire Defense, LLC’s FilmArray NGDS BT-E Assay and of Biocartis NV’s Idylla Rapid Ebola Virus Triage Test. The revocations in their entirety follow and PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4161–01–P E:\FR\FM\20APN1.SGM 20APN1 EN20AP23.004</GPH> IV. The Revocations Dated: April 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–08281 Filed 4–19–23; 8:45 am] Food and Drug Administration [Docket No. FDA–2023–D–1146] BILLING CODE 4161–01–C ddrumheller on DSK120RN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: VerDate Sep<11>2014 20:01 Apr 19, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 24427 announcing the availability of a draft guidance for industry entitled ‘‘Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.’’ The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under E:\FR\FM\20APN1.SGM 20APN1 EN20AP23.005</GPH> Federal Register / Vol. 88, No. 76 / Thursday, April 20, 2023 / Notices

Agencies

[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24425-24427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08281]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1378]


Revocation of Two Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection and/or Diagnosis of Ebola; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to BioFire Defense, LLC, for the FilmArray NGDS 
BT-E Assay, and Biocartis NV, for the Idylla Rapid Ebola Virus Triage 
Test. FDA revoked these Authorizations under the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) as requested by each Authorization holder. 
The revocations, which include an explanation of the reasons for each 
revocation, are reprinted at the end of this document.

DATES: The revocation of the Authorization for the BioFire Defense, 
LLC's FilmArray NGDS BT-E Assay is effective as of March 8, 2023. The 
revocation of the Authorization for the Biocartis NV's Idylla Rapid 
Ebola Virus Triage Test is effective as of March 9, 2023.

ADDRESSES: Submit written requests for a single copy of the revocations 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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 revocations may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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 October 25, 2014, FDA issued 
the Authorization to BioFire Defense, LLC, for the FilmArray NGDS BT-E 
Assay, subject to the terms of the Authorization. Notice of the 
issuance of this Authorization was published in the Federal Register on 
February 9, 2015 (80 FR 6972), as required by section 564(h)(1) of the 
FD&C Act. On May 26, 2016, FDA issued the Authorization to Biocartis 
NV, for the Idylla Rapid Ebola Virus Triage Test, subject to the terms 
of the Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on July 8, 2016 (81 FR 44616), as 
required by section 564(h)(1) of the FD&C Act. Subsequent updates to 
the Authorizations were made available on FDA's website. The 
authorization of a device for emergency use under section 564 of the 
FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked 
when the criteria under section 564(c) of the FD&C Act for issuance of 
such authorization are no longer met (section 564(g)(2)(B) of the FD&C 
Act), or other circumstances make such revocation appropriate to 
protect the public health or safety (section 564(g)(2)(C) of the FD&C 
Act).

II. Authorization Revocation Requests

    In a request received by FDA on February 24, 2023, BioFire Defense, 
LLC, requested the revocation of, and on March 8, 2023, FDA revoked, 
the Authorization for the BioFire Defense, LLC's FilmArray NGDS BT-E 
Assay. Because BioFire Defense, LLC, notified FDA that it is 
obsolescing the FilmArray NGDS BT-E Assay and requested FDA withdraw 
the BioFire Defense, LLC's, FilmArray NGDS BT-E Assay, FDA has 
determined that it is appropriate to protect the public health or 
safety to revoke this Authorization.
    In a request received by FDA on November 23, 2022, Biocartis US, 
Inc., on behalf of Biocartis NV, requested rescission of, and on March 
9, 2023, FDA revoked, the Authorization for the Idylla Rapid Ebola 
Virus Triage Test. Because Biocartis US, Inc., on behalf of Biocartis 
NV, notified FDA that it has discontinued the production of Idylla 
Rapid Ebola Virus Triage Test and requested FDA rescind the 
Authorization for the Idylla Rapid Ebola Virus Triage Test, FDA has 
determined that it is appropriate to protect the public health or 
safety to revoke this Authorization.

III. Electronic Access

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

[[Page 24426]]

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of BioFire Defense, LLC's FilmArray NGDS BT-E Assay 
and of Biocartis NV's Idylla Rapid Ebola Virus Triage Test. The 
revocations in their entirety follow and provide an explanation of the 
reasons for each revocation, as required by section 564(h)(1) of the 
FD&C Act.
BILLING CODE 4161-01-P
[GRAPHIC] [TIFF OMITTED] TN20AP23.004


[[Page 24427]]


[GRAPHIC] [TIFF OMITTED] TN20AP23.005


    Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08281 Filed 4-19-23; 8:45 am]
BILLING CODE 4161-01-C

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