Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 91760-91763 [2024-27094]

Download as PDF khammond on DSK9W7S144PROD with NOTICES 91760 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices the persons as legitimate subjects in the CDAD clinical trial, when in fact they were not. Mr. Montalvo Villa was primarily responsible for completing the patients’ informed consent form and falsifying their signatures to make it appear as though the patients consented to participate in the clinical trial when they had not. In addition, Mr. Montalvo Villa along with his co-conspirators submitted his own stool and blood samples to make it appear as if they came from study participants. Furthermore, Mr. Montalvo Villa was one of only two individuals who inputted CDAD clinical trial data in the Almac Clinical Technology Integrated Response Technology database (Almac database). The information in the Almac database was the foundation for all subsequent subject CDAD clinical trial data. Mr. Montalvo Villa repeatedly entered false and fabricated subject screening and randomization information in the Almac database. After an on-site audit by the Sponsor of AMB, the Sponsor notified the FDA in writing of potential scientific misconduct by AMB. Mr. Montalvo Villa wrote AMB’s response letter, which contained false information, for the Principal Investigator’s signature. Mr. Montalvo Villa told the Principal Investigator that she would lose her medical license if she did not sign the letter. In addition, an FDA regulatory investigator conducted an official onsite inspection of AMB for the CDAD clinical trial that began on February 20, 2018. On the first day of the inspection, Mr. Montalvo Villa told the FDA investigator that during the CDAD clinical trial he was present when his co-conspirator, the Principal Investigator, had obtained all the informed consents from the trial subjects. Mr. Montalvo Villa also told the regulatory investigator that copies of the informed consent were given to the subjects and that he was the most responsible person at AMB. Mr. Montalvo Villa received $100,634.84 in proceeds for the CDAD clinical trial. AMB received over $277,000 for the CDAD clinical trial. FDA sent Mr. Montalvo Villa, by certified mail, on August 12, 2024, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) of the FD&C Act, that Mr. Montalvo Villa was convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product. The proposal VerDate Sep<11>2014 18:39 Nov 19, 2024 Jkt 265001 informed Mr. Montalvo Villa of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Montalvo Villa received the proposal and notice of opportunity for a hearing on August 20, 2024. Mr. Montalvo Villa failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(a)(2)(A) of the FD&C Act, under authority delegated to the Division of Field Enforcement Director, finds that Mr. Miguel Angel Montalvo Villa has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product. As a result of the foregoing finding, Mr. Montalvo Villa is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see DATES) (see sections 306(a)(2)(A) and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses in any capacity the services of Mr. Montalvo Villa during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Montalvo Villa provides services in any capacity to a person with an approved or pending drug product application during his period of debarment, he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug application from Mr. Montalvo Villa during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306 and 307 of the FD&C Act, a ‘‘drug product’’ is defined as a ‘‘drug subject to regulation under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262)’’ (section PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Dated: November 7, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–27093 Filed 11–19–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–0150] Revocation of Two 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 Cue Health, Inc., for the Cue COVID–19 Test, and Cue COVID–19 Test for Home and Over The Counter (OTC) Use. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the 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 Authorizations for the Cue Health, Inc.’s Cue COVID–19 Test, and Cue COVID–19 Test for Home and Over The Counter (OTC) Use are effective as of October 9, 2024. 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, Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). SUMMARY: E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices SUPPLEMENTARY INFORMATION: I. Background khammond on DSK9W7S144PROD with NOTICES 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 June 10, 2020, FDA issued the Authorization to Cue Health, Inc., for the Cue COVID–19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. On March 5, 2021, FDA issued the Authorization to Cue Health, Inc., for the Cue COVID–19 Test for Home and Over The Counter (OTC) Use, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on VerDate Sep<11>2014 18:39 Nov 19, 2024 Jkt 265001 July 23, 2021 (86 FR 39040), 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. Authorizations Revocation Requests In a request received by FDA on September 9, 2024, Cue Health, Inc., requested the revocation of, and on October 9, 2024, FDA revoked, the Authorization for the Cue Health, Inc.’s Cue COVID–19 Test. Because Cue Health, Inc., notified FDA that they ceased manufacturing, shipping, and distributing the Cue COVID–19 Test and requested FDA revoke the Cue 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 September 9, 2024, Cue Health, Inc., requested the revocation of, and on PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 91761 October 9, 2024, FDA revoked, the Authorization for Cue Health, Inc.’s Cue COVID–19 Test for Home and Over The Counter (OTC) Use. Because Cue Health, Inc., notified FDA that they have ceased manufacturing, shipping, and distributing the Cue COVID–19 Test for Home and Over The Counter (OTC) Use and requested FDA revoke the Cue COVID–19 Test for Home and Over The Counter (OTC) Use, 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 EUAs of Cue Health, Inc.’s Cue COVID–19 Test, and Cue COVID–19 Test for Home and Over The Counter (OTC) Use. The revocations in their entirety follow and provide an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P E:\FR\FM\20NON1.SGM 20NON1 VerDate Sep<11>2014 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 18:39 Nov 19, 2024 Jkt 265001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4725 E:\FR\FM\20NON1.SGM 20NON1 EN20NO24.071</GPH> khammond on DSK9W7S144PROD with NOTICES 91762 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2024–27094 Filed 11–19–24; 8:45 am] [Docket No. FDA–2007–D–0369] khammond on DSK9W7S144PROD with NOTICES BILLING CODE 4164–01–C Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 18:39 Nov 19, 2024 Jkt 265001 PO 00000 Notice of availability. Frm 00092 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific SUMMARY: E:\FR\FM\20NON1.SGM 20NON1 EN20NO24.072</GPH> Dated: November 14, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. 91763

Agencies

[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91760-91763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27094]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Two 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 Cue Health, Inc., for the Cue COVID-19 Test, 
and Cue COVID-19 Test for Home and Over The Counter (OTC) Use. FDA 
revoked the Authorizations under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) as requested by the 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 Authorizations for the Cue Health, Inc.'s 
Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over The Counter 
(OTC) Use are effective as of October 9, 2024.

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).

[[Page 91761]]


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 June 10, 2020, FDA issued the Authorization to Cue Health, Inc., 
for the Cue COVID-19 Test, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on November 20, 2020 (85 FR 74346), as required by 
section 564(h)(1) of the FD&C Act.
    On March 5, 2021, FDA issued the Authorization to Cue Health, Inc., 
for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, 
subject to the terms of the Authorization. Notice of the issuance of 
this Authorization was published in the Federal Register on July 23, 
2021 (86 FR 39040), 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. Authorizations Revocation Requests

    In a request received by FDA on September 9, 2024, Cue Health, 
Inc., requested the revocation of, and on October 9, 2024, FDA revoked, 
the Authorization for the Cue Health, Inc.'s Cue COVID-19 Test. Because 
Cue Health, Inc., notified FDA that they ceased manufacturing, 
shipping, and distributing the Cue COVID-19 Test and requested FDA 
revoke the Cue 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 September 9, 2024, Cue Health, 
Inc., requested the revocation of, and on October 9, 2024, FDA revoked, 
the Authorization for Cue Health, Inc.'s Cue COVID-19 Test for Home and 
Over The Counter (OTC) Use. Because Cue Health, Inc., notified FDA that 
they have ceased manufacturing, shipping, and distributing the Cue 
COVID-19 Test for Home and Over The Counter (OTC) Use and requested FDA 
revoke the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, 
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 EUAs of Cue Health, Inc.'s Cue COVID-19 Test, and Cue 
COVID-19 Test for Home and Over The Counter (OTC) Use. The revocations 
in their entirety follow and provide an explanation of the reasons for 
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 91762]]

[GRAPHIC] [TIFF OMITTED] TN20NO24.071


[[Page 91763]]


[GRAPHIC] [TIFF OMITTED] TN20NO24.072


    Dated: November 14, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27094 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-C

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.