Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability (Federal Register, November 20, 2024)
Summary
A Food and Drug Administration (FDA) notice in the Federal Register, Vol. 89, No. 224, Wednesday, November 20, 2024, Docket No. FDA–2022–N–0150, announcing the revocation of two Emergency Use Authorizations (EUAs) issued to Cue Health, Inc. for the Cue COVID–19 Test and the 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, effective as of October 9, 2024, and the revocations with reasons are reprinted at the end of the document. The page shown also carries the end of a preceding FDA debarment order against Miguel Angel Montalvo Villa over falsified clinical trial data.
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91760 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
the persons as legitimate subjects in the informed Mr. Montalvo Villa of the 201(dd) of the FD&C Act (21 U.S.C.
CDAD clinical trial, when in fact they proposed debarment and offered him an 321(dd))).
were not. Mr. Montalvo Villa was opportunity to request a hearing, Dated: November 7, 2024.
primarily responsible for completing the providing him 30 days from the date of Kimberlee Trzeciak,
patients’ informed consent form and receipt of the letter in which to file the
Deputy Commissioner for Policy, Legislation,
falsifying their signatures to make it request, and advised him that failure to and International Affairs.
appear as though the patients consented request a hearing constituted a waiver of
[FR Doc. 2024–27093 Filed 11–19–24; 8:45 am]
to participate in the clinical trial when the opportunity for a hearing and of any
BILLING CODE 4164–01–P
they had not. In addition, Mr. Montalvo contentions concerning this action. Mr.
Villa along with his co-conspirators Montalvo Villa received the proposal
submitted his own stool and blood and notice of opportunity for a hearing DEPARTMENT OF HEALTH AND
samples to make it appear as if they on August 20, 2024. Mr. Montalvo Villa HUMAN SERVICES
came from study participants. failed to request a hearing within the
Furthermore, Mr. Montalvo Villa was timeframe prescribed by regulation and Food and Drug Administration
one of only two individuals who has, therefore, waived his opportunity
inputted CDAD clinical trial data in the for a hearing and waived any [Docket No. FDA–2022–N–0150]
Almac Clinical Technology Integrated contentions concerning his debarment
Response Technology database (Almac Revocation of Two Authorizations of
(21 CFR part 12).
database). The information in the Almac Emergency Use of In Vitro Diagnostic
database was the foundation for all II. Findings and Order Devices for Detection and/or Diagnosis
subsequent subject CDAD clinical trial of COVID–19; Availability
Therefore, the Division of Field
data. Mr. Montalvo Villa repeatedly Enforcement Director, Office of AGENCY: Food and Drug Administration,
entered false and fabricated subject Inspections and Investigations, under HHS.
screening and randomization section 306(a)(2)(A) of the FD&C Act, ACTION: Notice.
information in the Almac database. under authority delegated to the
After an on-site audit by the Sponsor Division of Field Enforcement Director, SUMMARY: The Food and Drug
of AMB, the Sponsor notified the FDA finds that Mr. Miguel Angel Montalvo Administration (FDA) is announcing the
in writing of potential scientific revocation of the Emergency Use
Villa has been convicted of a felony
misconduct by AMB. Mr. Montalvo Authorizations (EUAs) (the
under Federal law for conduct relating
Villa wrote AMB’s response letter, Authorizations) issued to Cue Health,
to the development or approval,
which contained false information, for Inc., for the Cue COVID–19 Test, and
including the process of development or
the Principal Investigator’s signature. Cue COVID–19 Test for Home and Over
approval, of any drug product.
Mr. Montalvo Villa told the Principal The Counter (OTC) Use. FDA revoked
Investigator that she would lose her As a result of the foregoing finding,
Mr. Montalvo Villa is permanently the Authorizations under the Federal
medical license if she did not sign the Food, Drug, and Cosmetic Act (FD&C
letter. In addition, an FDA regulatory debarred from providing services in any
capacity to a person with an approved Act) as requested by the Authorization
investigator conducted an official on- holder. The revocations, which include
site inspection of AMB for the CDAD or pending drug product application,
effective (see DATES) (see sections an explanation of the reasons for each
clinical trial that began on February 20, revocation, are reprinted at the end of
2018. On the first day of the inspection, 306(a)(2)(A) and 306(c)(2)(A)(ii) of the
FD&C Act). Any person with an this document.
Mr. Montalvo Villa told the FDA
approved or pending drug product DATES: The revocation of the
investigator that during the CDAD
application who knowingly employs or Authorizations for the Cue Health, Inc.’s
clinical trial he was present when his
retains as a consultant or contractor, or Cue COVID–19 Test, and Cue COVID–19
co-conspirator, the Principal
otherwise uses in any capacity the Test for Home and Over The Counter
Investigator, had obtained all the
services of Mr. Montalvo Villa during (OTC) Use are effective as of October 9,
informed consents from the trial
his debarment, will be subject to civil 2024.
subjects. Mr. Montalvo Villa also told
the regulatory investigator that copies of money penalties (section 307(a)(6) of the ADDRESSES: Submit written requests for
the informed consent were given to the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. a single copy of the revocations to the
subjects and that he was the most Montalvo Villa provides services in any Office of Policy, Center for Devices and
responsible person at AMB. capacity to a person with an approved Radiological Health, Food and Drug
Mr. Montalvo Villa received or pending drug product application Administration, 10903 New Hampshire
$100,634.84 in proceeds for the CDAD during his period of debarment, he will Ave., Bldg. 66, Rm. 5431, Silver Spring,
clinical trial. AMB received over be subject to civil money penalties MD 20993–0002. Send one self-
$277,000 for the CDAD clinical trial. (section 307(a)(7) of the FD&C Act). In addressed adhesive label to assist that
FDA sent Mr. Montalvo Villa, by addition, FDA will not accept or review office in processing your request or
certified mail, on August 12, 2024, a any abbreviated new drug application include a fax number to which the
notice proposing to permanently debar from Mr. Montalvo Villa during his revocations may be sent. See the
him from providing services in any period of debarment, other than in SUPPLEMENTARY INFORMATION section for
capacity to a person that has an connection with an audit under section electronic access to the revocations.
approved or pending drug product 306 of the FD&C Act (section FOR FURTHER INFORMATION CONTACT: Kim
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application. The proposal was based on 306(c)(1)(B) of the FD&C Act). Note that, Sapsford-Medintz, Office of Product
a finding, under section 306(a)(2)(A) of for purposes of sections 306 and 307 of Evaluation and Quality, Center for
the FD&C Act, that Mr. Montalvo Villa the FD&C Act, a ‘‘drug product’’ is Devices and Radiological Health, Food
was convicted of a felony under Federal defined as a ‘‘drug subject to regulation and Drug Administration, 10903 New
law for conduct relating to the under section 505, 512, or 802 of the Hampshire Ave., Bldg. 66, Rm. 3216,
development or approval, including the FD&C Act (21 U.S.C. 355, 360b, 382) or Silver Spring, MD 20993–0002, 301–
process of development or approval, of under section 351 of the Public Health 796–0311 (this is not a toll-free
any drug product. The proposal Service Act (42 U.S.C. 262)’’ (section number).
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91761
SUPPLEMENTARY INFORMATION: July 23, 2021 (86 FR 39040), as required October 9, 2024, FDA revoked, the
by section 564(h)(1) of the FD&C Act. Authorization for Cue Health, Inc.’s Cue
I. Background
Subsequent updates to the COVID–19 Test for Home and Over The
Section 564 of the FD&C Act (21 Authorizations were made available on Counter (OTC) Use. Because Cue Health,
U.S.C. 360bbb–3) as amended by the FDA’s website. The authorization of a Inc., notified FDA that they have ceased
Project BioShield Act of 2004 (Pub. L. device for emergency use under section manufacturing, shipping, and
108–276) and the Pandemic and All- 564 of the FD&C Act may, pursuant to distributing the Cue COVID–19 Test for
Hazards Preparedness Reauthorization section 564(g)(2) of the FD&C Act, be Home and Over The Counter (OTC) Use
Act of 2013 (Pub. L. 113–5) allows FDA revoked when the criteria under section and requested FDA revoke the Cue
to strengthen the public health 564(c) of the FD&C Act for issuance of COVID–19 Test for Home and Over The
protections against biological, chemical, such authorization are no longer met Counter (OTC) Use, FDA has
radiological, or nuclear agent or agents. (section 564(g)(2)(B) of the FD&C Act), determined that it is appropriate to
Among other things, section 564 of the or other circumstances make such protect the public health or safety to
FD&C Act allows FDA to authorize the revocation appropriate to protect the revoke this Authorization.
use of an unapproved medical product public health or safety (section
III. Electronic Access
or an unapproved use of an approved 564(g)(2)(C) of the FD&C Act).
medical product in certain situations. An electronic version of this
II. Authorizations Revocation Requests document and the full text of the
On June 10, 2020, FDA issued the In a request received by FDA on revocations are available on the internet
Authorization to Cue Health, Inc., for September 9, 2024, Cue Health, Inc., at https://www.regulations.gov/.
the Cue COVID–19 Test, subject to the requested the revocation of, and on
terms of the Authorization. Notice of the October 9, 2024, FDA revoked, the IV. The Revocations
issuance of this Authorization was Authorization for the Cue Health, Inc.’s Having concluded that the criteria for
published in the Federal Register on Cue COVID–19 Test. Because Cue revocation of the Authorizations under
November 20, 2020 (85 FR 74346), as Health, Inc., notified FDA that they section 564(g)(2)(C) of the FD&C Act are
required by section 564(h)(1) of the ceased manufacturing, shipping, and met, FDA has revoked the EUAs of Cue
FD&C Act. distributing the Cue COVID–19 Test and Health, Inc.’s Cue COVID–19 Test, and
On March 5, 2021, FDA issued the requested FDA revoke the Cue COVID– Cue COVID–19 Test for Home and Over
Authorization to Cue Health, Inc., for 19 Test, FDA has determined that it is The Counter (OTC) Use. The revocations
the Cue COVID–19 Test for Home and appropriate to protect the public health in their entirety follow and provide an
Over The Counter (OTC) Use, subject to or safety to revoke this Authorization. explanation of the reasons for
the terms of the Authorization. Notice of In a request received by FDA on revocation, as required by section
the issuance of this Authorization was September 9, 2024, Cue Health, Inc., 564(h)(1) of the FD&C Act.
published in the Federal Register on requested the revocation of, and on BILLING CODE 4164–01–P
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91762 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91763
Dated: November 14, 2024. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Kimberlee Trzeciak, HUMAN SERVICES Administration (FDA or Agency) is
Deputy Commissioner for Policy, Legislation, announcing the availability of
and International Affairs. Food and Drug Administration additional draft and revised draft
[FR Doc. 2024–27094 Filed 11–19–24; 8:45 am] product-specific guidances. The draft
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[Docket No. FDA–2007–D–0369] guidances provide product-specific
recommendations on, among other
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Product-Specific Guidances; Draft and things, the design of bioequivalence
Revised Draft Guidances for Industry; (BE) studies to support abbreviated new
Availability drug applications (ANDAs). In the
AGENCY: Food and Drug Administration, Federal Register of June 11, 2010, FDA
HHS. announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
ACTION: Notice of availability.
EN20NO24.072</GPH>
Recommendations for Specific
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