Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 14539 

Histamine (CPG 7108.24).’’ This draft 

CPG would update and replace existing 

guidance for FDA staff on adulteration 

associated with decomposition and 

histamine identified during surveillance 

sampling and testing of fish and fishery 

products susceptible to histamine 

formation. We gave interested parties 

until February 25, 2022, to submit 

comments before we began work on the 

final guidance. 

FDA has received a request for a 30- 

day extension for this comment period 

to allow additional time for interested 

parties to develop and submit data, 

other information, and comments for 

this draft Compliance Policy Guide 

before we begin work on the final 

version of the guidance. We have 

considered this request and are 

reopening the comment period for 30 

days. FDA believes that this additional 

30 days will allow adequate time for any 

interested parties to submit data, other 

information, and comments before we 

begin work on the final guidance. 

Dated: March 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05476 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0968] 

Nayade Varona: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Nayade 

Varona from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Ms. Varona was convicted 

of a felony under Federal law for 

conduct related to the development or 

approval, including the process for 

development or approval, of any drug 

product under the FD&C Act. Ms. 

Varona was given notice of the proposed 

permanent debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

December 22, 2021 (30 days after receipt 

of the notice), Ms. Varona had not 

responded. Ms. Varona’s failure to 

respond and request a hearing within 

the prescribed timeframe constitutes a 

waiver of her right to a hearing 

concerning this action. 

DATES: This order is applicable March 

15, 2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(A)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual 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 under the FD&C Act. On August 

11, 2021, Ms. Varona was convicted as 

defined in section 306(l)(1) of the FD&C 

Act in the U.S. District Court for the 

Southern District of Florida, Miami 

Division, when the court accepted her 

plea of guilty and entered judgment 

against her for one count of Conspiracy 

to Defraud the United States in violation 

of 18 U.S.C. 371. 

The factual basis for this conviction is 

as follows: As contained in the 

Information, entered into the docket on 

March 16, 2021, and the Factual Proffer 

in Support of Ms. Varona’s guilty plea, 

entered into the docket on June 8, 2021, 

both from her case, Ms. Varona was 

employed as an assistant study 

coordinator at Tellus Clinical Research 

(Tellus). Tellus was a medical clinic 

that conducted clinical trials on behalf 

of pharmaceutical company sponsors. A 

drug manufacturer (Sponsor) initiated a 

clinical trial concerning a new 

investigational drug intended to treat 

patients suffering from irritable bowel 

syndrome (Study or IBS Trial). The 

Sponsor retained a Contract Research 

Organization (CRO) to manage various 

aspects of the IBS Trial. CRO entered 

into a contract with Tellus and Martin 

Valdes, a medical doctor serving as a 

clinical investigator for clinical trials 

conducted at Tellus and as the clinical 

investigator for the IBS Trial. The study 

protocol for the IBS Trial required 

subjects to make periodic scheduled 

visits to the clinical trial site for which 

they were paid $100 per visit. During 

some of these visits, subjects were 

required to provide blood samples for 

pharmacokinetic analysis, receive 

physical exams by clinical trial staff, 

and undergo electrocardiograms. 

Subjects were also required to use an ‘‘ediary’’ system to report their daily 

experience with the Study drugs. They 

would do this by making daily phone 

calls to a number maintained by a third 

party and answering automated 

questions nonverbally by touch-tone 

buttons. 

In her role as an assistant study 

coordinator, Ms. Varona was 

responsible for administering 

procedures to subjects in the Study and 

creating written records reflecting the 

participation in the Study. However, 

Ms. Varona and her co-conspirators 

engaged in an effort to impair, impede, 

and obstruct FDA’s legitimate function 

of regulating clinical trials of drugs in 

order to obtain money. Ms. Varona and 

her co-conspirators did this by 

fabricating medical records to portray 

persons as legitimate Study subjects 

when they were not. She and her coconspirators falsified these records to 

make it appear that the Study subjects 

had consented to participating in the 

Study, satisfied the Study’s eligibility 

criteria, appeared for scheduled visits at 

the Study’s site, taken Study drugs as 

required, and received checks as 

payment for site visits, among other 

things. For example, Ms. Varona 

represented that she had seen a 

purported Study subject, spoken to her 

about her dietary habits, lifestyle, and 

exercise regimen, collected a urine 

sample, taken vital signs, and dispensed 

the Study drug to her when Ms. Varona 

well knew that the individual was not 

a Study subject and that these 

representations were false. Ms. Varona 

also knew that one or more of her coconspirators placed telephone calls to 

the e-diary system for the purposes of 

reporting fabricated data on behalf of 

purportedly legitimate Study subjects. 

As a result of this conviction, FDA 

sent Ms. Varona by certified mail on 

November 8, 2021, a notice proposing to 

permanently debar her 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 Ms. 

Varona was convicted, as set forth in 

section 306(l)(1) of the FD&C Act, of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process of development or 


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14540 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 

approval, of any drug product under the 

FD&C Act. The proposal also offered 

Ms. Varona an opportunity to request a 

hearing, providing her 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her that 

failure to request a hearing constituted 

an election not to use the opportunity 

for a hearing and a waiver of any 

contentions concerning this action. Ms. 

Varona received the proposal on 

November 22, 2021. She did not request 

a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived her opportunity for a 

hearing and any contentions concerning 

her debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(A) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Varona 

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 under the FD&C Act. 

As a result of the foregoing finding, 

Ms. Varona 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, (21 U.S.C. 355a(2)(A) and 

335a(c)(2)(A)(ii))). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses the services of Ms. 

Varona in any capacity during her 

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 Ms. 

Varona provides services in any 

capacity to a person with an approved 

or pending drug product application 

during her period of debarment, she 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 Ms. Varona during her 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))). 

Any application by Ms. Varona for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–0968 and sent to the 

Division of Dockets Management (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: March 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05401 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0375] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Agreement for 

Shipment of Devices for Sterilization 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection requirements relating to 

shipment of nonsterile devices that are 

to be sterilized elsewhere or are shipped 

to other establishments for further 

processing, labeling, or repacking. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 16, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0375 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Agreement for Shipment of Devices for 

Sterilization.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 


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