Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Antibodies Against SARS-CoV-2, the Virus That Causes Coronavirus Disease 2019 (COVID-19), 62739-62746 [2020-21952]

Download as PDF Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices recommendations and guidance for any public health actions related to COVID– 19, even when outside of U.S. waters for any ships that intend to return to U.S. waters during the period that this Order remains in effect. This Order is effective upon signature and shall remain in effect until the earliest of (1) the expiration of the Secretary of Health and Human Services’ declaration that COVID–19 constitutes a public health emergency; (2) the CDC Director rescinds or modifies the order based on specific public health or other considerations; or (3) October 31, 2020. Authority: The authority for these orders is Sections 361 and 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 71.32(b). Dated: October 1, 2020. Nina B. Witkofsky, Acting Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2020–22030 Filed 10–1–20; 11:15 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1602] Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Antibodies Against SARS-CoV–2, the Virus That Causes Coronavirus Disease 2019 (COVID–19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Autobio Diagnostics Co. Ltd. (‘‘Autobio’’) for the Anti-SARS-CoV–2 Rapid Test (‘‘Autobio’s Test’’) and to Manufacturers and Other Stakeholders (‘‘Stakeholders’’) for certain in vitro diagnostic SARS-CoV–2 Antibody Tests. FDA revoked Autobio’s Authorization on August 6, 2020, and the Stakeholders’ Authorization on July 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: Autobio’s Authorization is revoked as of August 6, 2020. The DATES: VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 Stakeholders’ Authorization is revoked as of July 21, 2020. ADDRESSES: Submit written requests for single copies of the revocations 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 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: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 240–402–8155 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) 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 April 24, 2020, FDA issued an EUA for Autobio’s Anti-SARS-CoV–2 Rapid Test, subject to the terms of the Authorization. On April 28, 2020, FDA issued an EUA to Stakeholders, for certain in vitro diagnostic SARS-CoV–2 Antibody Tests (lateral flow or enzymelinked immunosorbent assay tests to detect IgG only, IgG and IgM, or total antibodies in human plasma and/or serum) for use at laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a, to perform moderate or high complexity tests. Notice of the issuance of the Authorizations was published in the Federal Register on July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the FD&C Act. Subsequent to the issuance of the Authorization for Autobio’s Test, FDA considered new information, including from an independent evaluation of Autobio’s Test from the National Institute of Health’s Frederick National Laboratory for Cancer Research, part of the National Cancer Institute (the ‘‘NCI study’’), demonstrating performance below the performance information submitted in Autobio’s original EUA request and reflected in the authorized labeling for Autobio’s Test. Subsequent PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 62739 to the Stakeholders’ Authorization, FDA considered that no device had been listed under the EUA and that FDA may issue individual EUAs instead. II. EUA Criteria for Issuance No Longer Met and Other Circumstances Make Revocation Appropriate To Protect the Public Health or Safety Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary of HHS 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. On August 6, 2020, FDA revoked the EUA for Autobio’s Test because the criteria for issuance were no longer met and other circumstances make such revocation appropriate to protect the public health or safety. Under section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes that, based on the totality of scientific evidence available, including data from adequate and wellcontrolled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing such disease or condition and that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product. Given the poor device performance observed in the NCI study since the issuance of the Authorization for Autobio’s Test, FDA has concluded it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV–2 or that the known and potential benefits of the device outweigh its known and potential risks. In addition, based on the same information and the risks to public health from false test results, FDA has concluded under section 564(g)(2)(C) of the FD&C Act that other circumstances make revocation appropriate to protect the public health or safety. Accordingly, FDA has revoked EUA200349 for Autobio’s Anti-SARS-CoV–2 Rapid Test, pursuant to section 564(g)(2)(B) and (C) of the FD&C Act. On July 21, 2020, FDA revoked the EUA for Stakeholders’ certain in vitro diagnostic SARS-CoV–2 Antibody Tests because other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act), considering that no device has been listed under the EUA, and FDA can issue individual EUAs instead. III. Electronic Access An electronic version of this document and the full text of the revocations are available on the internet E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES at https://www.regulations.gov/, https:// IV. The Revocations www.fda.gov/media/140351/download Having concluded that the criteria for and https://www.fda.gov/media/140908/ revocation of the Authorizations under download. section 564(g) of the FD&C Act are met, FDA has revoked the EUAs for Autobio’s Anti-SARS-CoV–2 Rapid Test VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 and Stakeholders’ certain in vitro diagnostic SARS-CoV–2 Antibody Tests. 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 4164–01–P E:\FR\FM\05OCN1.SGM 05OCN1 EN05OC20.066</GPH> 62740 VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\05OCN1.SGM 05OCN1 62741 EN05OC20.067</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\05OCN1.SGM 05OCN1 EN05OC20.068</GPH> jbell on DSKJLSW7X2PROD with NOTICES 62742 VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\05OCN1.SGM 05OCN1 62743 EN05OC20.069</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices VerDate Sep<11>2014 Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\05OCN1.SGM 05OCN1 EN05OC20.070</GPH> jbell on DSKJLSW7X2PROD with NOTICES 62744 VerDate Sep<11>2014 23:42 Oct 02, 2020 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\05OCN1.SGM 05OCN1 62745 EN05OC20.071</GPH> jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices 62746 Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Notices The meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee was originally announced in the Federal Register of August 20, 2020 (85 FR 51453), and was initially scheduled for October 7, 2020. FDA has decided to postpone this public meeting until further notice. SUPPLEMENTARY INFORMATION: [FR Doc. 2020–21952 Filed 10–2–20; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 29, 2020. Lauren K. Roth, Associate Commissioner for Policy. Food and Drug Administration [Docket No. FDA–2020–N–0008] [FR Doc. 2020–21939 Filed 10–2–20; 8:45 am] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Postponement AGENCY: BILLING CODE 4164–01–P Food and Drug Administration, HHS. Health Resources and Services Administration Notice of meeting; postponement. ACTION: The Food and Drug Administration (FDA) is postponing the meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee scheduled from October 7, 2020, to a later date to be determined. The meeting was announced in the Federal Register of August 20, 2020. A future meeting date will be announced in the Federal Register. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, Aden.Asefa@ fda.hhs.gov, 301–796–0400, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area) and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. VerDate Sep<11>2014 23:42 Oct 02, 2020 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 253001 Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Information Collection Request Title: Application for Deemed Health Center Program Award Recipients To Sponsor Volunteer Health Professionals for Deemed PHS Employment Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 HRSA’s ICR only after the 30 day comment period for this notice has closed. Comments on this ICR must be received no later than November 4, 2020. DATES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Application for Deemed Health Center Program Award Recipients to Sponsor Volunteer Health Professionals for Deemed PHS Employment, OMB No. 0915–0032—Revision. Abstract: Subsection 224(q) to the Public Health Service (PHS) Act (42 U.S.C. 233(q)), extended liability protections for the performance of medical, surgical, dental, and related functions to Volunteer Health Professionals (VHPs) of health centers that have also been deemed as employees of the PHS for this purpose. Through the process established by HRSA, VHPs of deemed health centers may be deemed as PHS employees for ADDRESSES: E:\FR\FM\05OCN1.SGM 05OCN1 EN05OC20.072</GPH> Dated: September 29, 2020. Lauren K. Roth, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62739-62746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1602]


Revocation of Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection of Antibodies Against SARS-CoV-2, the 
Virus That Causes Coronavirus Disease 2019 (COVID-19)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocations of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Autobio Diagnostics Co. Ltd. (``Autobio'') 
for the Anti-SARS-CoV-2 Rapid Test (``Autobio's Test'') and to 
Manufacturers and Other Stakeholders (``Stakeholders'') for certain in 
vitro diagnostic SARS-CoV-2 Antibody Tests. FDA revoked Autobio's 
Authorization on August 6, 2020, and the Stakeholders' Authorization on 
July 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act). The revocations, which include an explanation of the reasons for 
each revocation, are reprinted in this document.

DATES: Autobio's Authorization is revoked as of August 6, 2020. The 
Stakeholders' Authorization is revoked as of July 21, 2020.

ADDRESSES: Submit written requests for single copies of the revocations 
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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) 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 April 24, 2020, FDA issued an EUA for Autobio's Anti-
SARS-CoV-2 Rapid Test, subject to the terms of the Authorization. On 
April 28, 2020, FDA issued an EUA to Stakeholders, for certain in vitro 
diagnostic SARS-CoV-2 Antibody Tests (lateral flow or enzyme-linked 
immunosorbent assay tests to detect IgG only, IgG and IgM, or total 
antibodies in human plasma and/or serum) for use at laboratories 
certified under the Clinical Laboratory Improvement Amendments of 1988, 
42 U.S.C. 263a, to perform moderate or high complexity tests. Notice of 
the issuance of the Authorizations was published in the Federal 
Register on July 14, 2020 (85 FR 42407), as required by section 
564(h)(1) of the FD&C Act. Subsequent to the issuance of the 
Authorization for Autobio's Test, FDA considered new information, 
including from an independent evaluation of Autobio's Test from the 
National Institute of Health's Frederick National Laboratory for Cancer 
Research, part of the National Cancer Institute (the ``NCI study''), 
demonstrating performance below the performance information submitted 
in Autobio's original EUA request and reflected in the authorized 
labeling for Autobio's Test. Subsequent to the Stakeholders' 
Authorization, FDA considered that no device had been listed under the 
EUA and that FDA may issue individual EUAs instead.

II. EUA Criteria for Issuance No Longer Met and Other Circumstances 
Make Revocation Appropriate To Protect the Public Health or Safety

    Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary 
of HHS 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. On August 6, 2020, 
FDA revoked the EUA for Autobio's Test because the criteria for 
issuance were no longer met and other circumstances make such 
revocation appropriate to protect the public health or safety. Under 
section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA 
concludes that, based on the totality of scientific evidence available, 
including data from adequate and well-controlled clinical trials, if 
available, it is reasonable to believe that the product may be 
effective in diagnosing, treating, or preventing such disease or 
condition and that the known and potential benefits of the product, 
when used to diagnose, prevent, or treat such disease or condition, 
outweigh the known and potential risks of the product.
    Given the poor device performance observed in the NCI study since 
the issuance of the Authorization for Autobio's Test, FDA has concluded 
it is not reasonable to believe the product may be effective in 
detecting antibodies against SARS-CoV-2 or that the known and potential 
benefits of the device outweigh its known and potential risks. In 
addition, based on the same information and the risks to public health 
from false test results, FDA has concluded under section 564(g)(2)(C) 
of the FD&C Act that other circumstances make revocation appropriate to 
protect the public health or safety. Accordingly, FDA has revoked 
EUA200349 for Autobio's Anti-SARS-CoV-2 Rapid Test, pursuant to section 
564(g)(2)(B) and (C) of the FD&C Act. On July 21, 2020, FDA revoked the 
EUA for Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody 
Tests because other circumstances make such revocation appropriate to 
protect the public health or safety (section 564(g)(2)(C) of the FD&C 
Act), considering that no device has been listed under the EUA, and FDA 
can issue individual EUAs instead.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocations are available on the internet

[[Page 62740]]

at https://www.regulations.gov/, https://www.fda.gov/media/140351/download and https://www.fda.gov/media/140908/download.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUAs for Autobio's Anti-SARS-CoV-2 Rapid Test and 
Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody Tests. 
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 4164-01-P
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    Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21952 Filed 10-2-20; 8:45 am]
BILLING CODE 4164-01-C
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