14538 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 

party. Medicare beneficiaries can submit 

the Medicare Authorization to Disclose 

Personal Health Information 

electronically at Medicare.gov. 

Beneficiaries may also submit the 

Medicare Authorization to Disclose 

Personal Health Information by mailing 

a complete and valid authorization form 

to Medicare. Beneficiaries can submit 

the Medicare Authorization to Disclose 

Personal Health Information verbally 

over the phone by calling Medicare. 

Form Number: CMS–10106 (OMB 

control number: 0938–0930); Frequency: 

Occasionally; Affected Public: 

Individuals or households; Number of 

Respondents: 1,000,000; Total Annual 

Responses: 1,000,000; Total Annual 

Hours: 250,000. (For policy questions 

regarding this collection contact Sam 

Jenkins at 410–786–3261.) 

Dated: March 9, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–05360 Filed 3–14–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0367] 

Compliance Policy Guide Sec. 540.525 

Scombrotoxin (Histamine)-Forming 

Fish and Fishery Products— 

Decomposition and Histamine; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; reopening 

of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

reopening the comment period for the 

draft Compliance Policy Guide entitled 

‘‘Compliance Policy Guide Sec. 540.525 

Scombrotoxin (Histamine)-forming Fish 

and Fishery Products—Decomposition 

and Histamine’’ that published in the 

Federal Register of December 27, 2021. 

We are taking this action in response to 

a request from stakeholders to extend 

the comment period to allow additional 

time for interested parties to develop 

and submit data, other information, and 

comments before FDA begins work on 

the final guidance. 

DATES: FDA is reopening the comment 

period for the draft Compliance Policy 

Guide announced in the Federal 

Register on December 27, 2021 (86 FR 

73295). Submit either electronic or 

written comments on the draft guidance 

by April 14, 2022, to ensure that we 

consider your comments before we 

begin work on the final guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows. 

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– 

2021–D–0367 for ‘‘Compliance Policy 

Guide Sec. 540.525 Scombrotoxin 

(Histamine)-forming Fish and Fishery 

Products—Decomposition and 

Histamine.’’ Received comments 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 between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Steven Bloodgood, Division of Seafood 

Safety (HFS–325), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–5316, 

email: Steven.Bloodgood@fda.hhs.gov; 

or Jessica Larkin, Center for Food Safety 

and Applied Nutrition, Office of 

Regulations and Policy (HFS–024), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2378. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 27, 2021 

(86 FR 73295), we published a notice 

announcing the availability of a draft 

Compliance Policy Guide (CPG) entitled 

‘‘Sec. 540.525 Scombrotoxin 

(Histamine)-forming Fish and Fishery 

Products—Decomposition and 


khammond on DSKJM1Z7X2PROD with NOTICES
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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