Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 30135-30139 [2023-09879]

Download as PDF Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: December 21, 2017. The applicant claims November 28, 2017, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 21, 2017, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: January 3, 2020. FDA has verified the applicant’s claim that the new drug application (NDA) for Detectnet (NDA 213227) was initially submitted on January 3, 2020. 3. The date the application was approved: September 3, 2020. FDA has verified the applicant’s claim that NDA 213227 was approved on September 3, 2020. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 312 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 30135 Dated: May 4, 2023. Lauren K. Roth, Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). [FR Doc. 2023–09891 Filed 5–9–23; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0973] Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability AGENCY: 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 Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA Test; Detect, Inc., for the Detect Covid–19 Test; and Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV. 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 Authorization for the Thermo Fisher Scientific Inc.’s OmniPATH COVID–19 Total Antibody ELISA Test is revoked as of April 13, 2023. The Authorization for the Detect, Inc.’s Detect Covid–19 Test is revoked as of April 14, 2023. The Authorization for the Cepheid’s Xpert Xpress SARS– CoV–2/Flu/RSV is revoked as of April 17, 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 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, SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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, radiological, or nuclear agent or 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 2, 2020, FDA issued the Authorization to Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. On October 28, 2021, FDA issued the Authorization to Detect, Inc., for the Detect Covid–19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on March 22, 2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act. On September 24, 2020, FDA issued the Authorization to Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21751), 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 April 10, 2023, Thermo Fisher Scientific Inc., requested the withdrawal of, and on April 13, 2023, FDA revoked, the Authorization for the Thermo Fisher Scientific Inc.’s OmniPATH COVID–19 E:\FR\FM\10MYN1.SGM 10MYN1 30136 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 Total Antibody ELISA Test. Because Thermo Fisher Scientific Inc., notified FDA that it is no longer manufacturing or producing the OmniPATH COVID–19 Total Antibody ELISA Test and requested FDA withdraw the Thermo Fisher Scientific Inc.’s, OmniPATH COVID–19 Total Antibody ELISA Test, 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 March 16, 2023, Detect, Inc., requested revocation of, and on April 14, 2023, FDA revoked, the Authorization for the Detect, Inc.’s Detect Covid–19 Test. Because Detect, Inc., indicated to FDA that as of February 1, 2023, there are no viable/nonexpired Detect Covid–19 Tests in distribution in the United States and requested FDA revoke the VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 Authorization for the Detect Covid–19 Test, 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 March 7, 2023, Cepheid, requested revocation of, and on April 17, 2023, FDA revoked, the Authorization for the Cepheid’s Xpert Xpress SARS–CoV–2/ Flu/RSV. Because Cepheid, indicated to FDA that they have stopped sales of the authorized product and requested FDA revoke the Authorization for the Cepheid’s Xpert Xpress SARS–CoV–2/ Flu/RSV, 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 revocations are available on the internet at https://www.regulations.gov/. 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 Thermo Fisher Scientific Inc.’s OmniPATH COVID–19 Total Antibody ELISA Test; Detect, Inc’s Detect Covid– 19 Test; and of Cepheid’s Xpert Xpress SARS–CoV–2/Flu/RSV. 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 E:\FR\FM\10MYN1.SGM 10MYN1 VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\10MYN1.SGM 10MYN1 30137 EN10MY23.000</GPH> lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices VerDate Sep<11>2014 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices 17:49 May 09, 2023 Jkt 259001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\10MYN1.SGM 10MYN1 EN10MY23.001</GPH> lotter on DSK11XQN23PROD with NOTICES1 30138 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices [FR Doc. 2023–09879 Filed 5–9–23; 8:45 am] Food and Drug Administration [Docket No. FDA–2023–D–1573] BILLING CODE 4161–01–C lotter on DSK11XQN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 PO 00000 Notice of availability. Frm 00070 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ‘‘Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.’’ This guidance provides updated recommendations on testing and other activities that will help pharmaceutical manufacturers, repackers, other suppliers, and compounders prevent the use of highrisk drug components, including SUMMARY: E:\FR\FM\10MYN1.SGM 10MYN1 EN10MY23.002</GPH> Dated: May 4, 2023. Lauren K. Roth, Associate Commissioner for Policy. 30139

Agencies

[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30135-30139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]


Revocation of Three Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection and/or Diagnosis of COVID-19; 
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 Thermo Fisher Scientific Inc., for the 
OmniPATH COVID-19 Total Antibody ELISA Test; Detect, Inc., for the 
Detect Covid-19 Test; and Cepheid, for the Xpert Xpress SARS-CoV-2/Flu/
RSV. 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 Authorization for the Thermo Fisher Scientific Inc.'s 
OmniPATH COVID-19 Total Antibody ELISA Test is revoked as of April 13, 
2023. The Authorization for the Detect, Inc.'s Detect Covid-19 Test is 
revoked as of April 14, 2023. The Authorization for the Cepheid's Xpert 
Xpress SARS-CoV-2/Flu/RSV is revoked as of April 17, 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, radiological, or nuclear agent or 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 2, 2020, FDA 
issued the Authorization to Thermo Fisher Scientific Inc., for the 
OmniPATH COVID-19 Total Antibody ELISA Test, subject to the terms of 
the Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on April 23, 2021 (86 FR 21749), as 
required by section 564(h)(1) of the FD&C Act. On October 28, 2021, FDA 
issued the Authorization to Detect, Inc., for the Detect Covid-19 Test, 
subject to the terms of the Authorization. Notice of the issuance of 
this Authorization was published in the Federal Register on March 22, 
2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act. 
On September 24, 2020, FDA issued the Authorization to Cepheid, for the 
Xpert Xpress SARS-CoV-2/Flu/RSV, subject to the terms of the 
Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on April 23, 2021 (86 FR 21751), 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 April 10, 2023, Thermo Fisher 
Scientific Inc., requested the withdrawal of, and on April 13, 2023, 
FDA revoked, the Authorization for the Thermo Fisher Scientific Inc.'s 
OmniPATH COVID-19

[[Page 30136]]

Total Antibody ELISA Test. Because Thermo Fisher Scientific Inc., 
notified FDA that it is no longer manufacturing or producing the 
OmniPATH COVID-19 Total Antibody ELISA Test and requested FDA withdraw 
the Thermo Fisher Scientific Inc.'s, OmniPATH COVID-19 Total Antibody 
ELISA Test, 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 March 16, 2023, Detect, Inc., 
requested revocation of, and on April 14, 2023, FDA revoked, the 
Authorization for the Detect, Inc.'s Detect Covid-19 Test. Because 
Detect, Inc., indicated to FDA that as of February 1, 2023, there are 
no viable/nonexpired Detect Covid-19 Tests in distribution in the 
United States and requested FDA revoke the Authorization for the Detect 
Covid-19 Test, 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 March 7, 2023, Cepheid, requested 
revocation of, and on April 17, 2023, FDA revoked, the Authorization 
for the Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV. Because Cepheid, 
indicated to FDA that they have stopped sales of the authorized product 
and requested FDA revoke the Authorization for the Cepheid's Xpert 
Xpress SARS-CoV-2/Flu/RSV, 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/.

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 Thermo Fisher Scientific Inc.'s OmniPATH COVID-
19 Total Antibody ELISA Test; Detect, Inc's Detect Covid-19 Test; and 
of Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV. 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

[[Page 30137]]

[GRAPHIC] [TIFF OMITTED] TN10MY23.000


[[Page 30138]]


[GRAPHIC] [TIFF OMITTED] TN10MY23.001


[[Page 30139]]


[GRAPHIC] [TIFF OMITTED] TN10MY23.002


    Dated: May 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09879 Filed 5-9-23; 8:45 am]
BILLING CODE 4161-01-C

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