Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices 12171 

the estimated burden, ways to enhance 

the quality, utility and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments must be received by 

March 17, 2022. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(see below) and the OMB control 

number (0938–1148). To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: CMS–10398 (#64)/OMB 

control number: 0938–1148, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may access CMS’ 

website at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Following 

is a summary of the use and burden 

associated with the subject information 

collection(s). More detailed information 

can be found in the collection’s 

supporting statement and associated 

materials (see ADDRESSES). 

Generic Information Collection 

1. Title of Information Collection: 

Medicaid Section 1115 Substance Use 

Disorder (SUD) Demonstration: Federal 

Meta-Analysis Support; Type of 

Information Collection Request: 

Revision of a currently approved 

collection; Use: Starting in 2015, in 

response to the opioid epidemic, CMS 

offered states the flexibility to test 

Medicaid coverage of a full substance 

use disorder (SUD) treatment service 

array in the context of overall SUD 

service delivery transformation through 

the authority of section 1115 

demonstrations. In 2017, CMS modified 

the requirements for SUD section 1115 

demonstrations to improve access to 

clinically appropriate treatment for 

OUD and other SUDs, to better support 

the development and expansion of 

comprehensive treatment strategies, and 

to incorporate improved progress and 

outcome monitoring. In 2018, CMS 

awarded the Federal Meta-Analysis 

Support contract to RTI International to 

understand the overall effectiveness of 

the groups of demonstrations with 

similar features and how variations in 

state demonstration features and the 

context in which they are implemented 

contribute to differences in 

effectiveness. The meta-analysis 

includes multiple rounds of qualitative 

data collection. The first round of 

interviews (both, Characteristics 

Interviews and Implementation 

Interviews) have been completed. This 

March 2022 collection of information 

request seeks OMB’s approval for a 

second round (State-level Stakeholder 

Virtual Interviews) of data collection 

activities. The purpose is to learn about 

the perspectives of other types of 

stakeholders important to implementing 

the demonstration. Respondents would 

include stakeholders with differing 

perspectives, including leadership of 

behavioral health service providers and 

leadership of MCOs or third-party 

administrators in states with fee-forservice SUD treatment services. Form 

Number: CMS–10398 (#64) (OMB 

control number: 0938–1148); Frequency: 

Once; Affected Public: State, Local, or 

Tribal Governments, and the Private 

sector; Number of Respondents: 90; 

Total Annual Responses: 90; Total 

Annual Hours: 83. (For policy questions 

regarding this collection contact: 

Danielle Daly at 410–786–0897.) 

Dated: February 28, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–04445 Filed 3–2–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0964] 

Eduardo Navarro: 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 Eduardo 

Navarro 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 Mr. Navarro was convicted 

of a felony under Federal law for 

conduct relating to the development or 

approval, including the process for 

development or approval, of any drug 

product under the FD&C Act. Mr. 

Navarro was given notice of the 

proposed permanent debarment and 

was given an opportunity to request a 

hearing to show why he should not be 

debarred. As of December 24, 2021 (30 

days after receipt of the notice), Mr. 

Navarro had not responded. Mr. 

Navarro’s failure to respond and request 

a hearing within the prescribed 

timeframe constitutes a waiver of his 

right to a hearing concerning this action. 

DATES: This order is applicable March 3, 

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 https://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, Mr. Navarro 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 his 

plea of guilty and entered judgment 

against him 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 his guilty plea, entered 


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12172 Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices 

into the docket on June 8, 2021, both 

from his case, Mr. Navarro was an 

advanced Registered Nurse Practitioner 

employed as a sub-investigator at Tellus 

Clinical Research (Tellus) under the 

direction of a clinical investigator. 

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. The 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 his role as a sub-investigator, Mr. 

Navarro was responsible for conducting 

physical exams on subjects, reviewing 

lab work and electrocardiograms, and 

preparing case histories reflecting the 

participation of subjects in the Study. 

However, Mr. Navarro and his coconspirators engaged in an effort to 

impair, impede, and obstruct FDA’s 

legitimate function of regulating clinical 

trials of drugs in order to obtain money. 

Mr. Navarro and his co-conspirators did 

this by fabricating medical records to 

portray persons as legitimate Study 

subjects when they were not. He and his 

co-conspirators 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, Mr. Navarro 

represented that he had seen a 

purported Study subject and performed 

a physical examination of her when he 

knew she was not a Study subject and 

these representations were false. Mr. 

Navarro also knew that one or more of 

his co-conspirators 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 Mr. Navarro by certified mail on 

November 8, 2021, 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. 

Navarro 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 

approval, of any drug product under the 

FD&C Act. The proposal also offered Mr. 

Navarro 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 

an election not to use the opportunity 

for a hearing and a waiver of any 

contentions concerning this action. Mr. 

Navarro received the proposal on 

November 24, 2021. He did not request 

a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived his opportunity for a 

hearing and any contentions concerning 

his 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 Mr. Navarro 

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, 

Mr. Navarro is permanently debarred 

from providing services in any capacity 

to a person with an approved or 

pending drug product application, 

effective (see DATES) (see section 

306(a)(2)(A) and (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 the services of Mr. 

Navarro in any capacity 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. 

Navarro 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. Navarro during his period of 

debarment, other than in connection 

with an audit under 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, or 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 Mr. Navarro for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2021–N–0964 and sent to the 

Dockets Management Staff (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: February 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04459 Filed 3–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0873] 

Patrick Charles Bishop: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Patrick Charles Bishop for a period of 5 

years from importing or offering for 

import any drug into the United States. 

FDA bases this order on a finding that 

Mr. Bishop was convicted of one felony 

count under Federal law for conspiracy 

to commit fraud. The factual basis 

supporting Mr. Bishop’s conviction, as 

described below, is conduct relating to 

the importation into the United States of 

a drug or controlled substance. Mr. 

Bishop was given notice of the proposed 


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