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 

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 

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. 

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 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). 


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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 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 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 

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 


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91762 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 


khammond on DSK9W7S144PROD with NOTICESEN20NO24.071</GPH>
Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91763 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: 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 


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