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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices 12173 

debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred. Mr. 

Bishop provided notice to FDA that he 

acquiesced to the debarment; FDA 

received that notice on January 4, 2022. 

As such, his debarment commenced on 

the date FDA was notified of 

acquiescence. 

DATES: This order is applicable January 

4, 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(b)(1)(D) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(D)) permits 

debarment of an individual from 

importing or offering for import any 

drug into the United States if FDA finds, 

as required by section 306(b)(3)(C) of the 

FD&C Act, that the individual has been 

convicted of a felony for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. On July 9, 2021, Mr. Bishop 

was convicted, as defined in section 

306(l)(1) of FD&C Act, in the U. S. 

District Court for the Northern District 

of Alabama, when the court entered 

judgment against him for the offense of 

conspiracy to commit fraud, in violation 

of 18 U.S.C. 371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: As contained in the plea 

agreement in Mr. Bishop’s case, filed on 

January 7, 2021, in which he pleaded 

guilty, he owned Patrick, LLC and 

employed other individuals. Using the 

business name ‘‘Best Peptide Supply, 

LLC,’’ he ordered PNC–27 from GL 

Biochem (Shanghai), Ltd., a supplier 

based in China, and used the PNC–27 to 

manufacture drug products intended for 

the treatment of cancer in humans. FDA 

has not approved PNC–27 for use in the 

United States as a drug to treat any 

disease, including any form of cancer. 

He obtained PNC–27 under the false 

pretense that he intended to use the 

product solely for laboratory research 

purposes. In fact, he provided invoices 

to GL Biochem that did not use the term 

‘‘PNC–27’’ and included the statement 

‘‘FOR RESEARCH ONLY.’’ He falsely 

certified to GL Biochem that the product 

he was purchasing from GL Biochem 

was ‘‘restricted to laboratory research 

purposes, excluding clinical research on 

[the] human body.’’ 

Mr. Bishop also falsely represented to 

FDA personnel that the product shipped 

from GL Biochem was to be used for 

laboratory testing and scientific 

research. Mr. Bishop directed GL 

Biochem to ship the PNC–27 to his 

residences and other locations in the 

State of Alabama where he used the 

PNC–27 he purchased to manufacture 

drug products intended for human use 

to treat cancer. Specifically, along with 

others, Mr. Bishop knowingly caused 

PNC–27 to be processed into a ‘‘waterbased PNC–27 drug product’’ as well as 

suppositories using methods, controls, 

and facilities that did not conform to 

current good manufacturing practice. 

Mr. Bishop sold and distributed the 

unapproved, misbranded, and 

adulterated PNC–27 drug products he 

manufactured to individuals in other 

States and countries; these drug 

products failed to bear directions for 

use, and some bore no labeling 

whatsoever. To avoid detection by FDA 

and to conceal the nature of these 

unapproved, misbranded, and 

adulterated drug products, Mr. Bishop 

operated under the business name 

‘‘Immuno Cellular Restoration Program, 

Inc. (ICRP)’’ and used the terms, 

‘‘research,’’ ‘‘sample,’’ ‘‘ICRP’’ and 

‘‘ICRPstudy.com’’ on his product labels 

and shipping documentation. Mr. 

Bishop received millions of dollars in 

payments for his unapproved, 

misbranded, and adulterated PNC–27 

drug products. 

As a result of this conviction, FDA 

sent Mr. Bishop, by certified mail, on 

October 18, 2021, a notice proposing to 

debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Bishop’s felony conviction for 

one count of conspiracy to commit fraud 

was for conduct relating to the 

importation into the United States of 

any drug or controlled substance 

because he conspired to illegally import, 

manufacture, and distribute in interstate 

commerce unapproved, misbranded, 

and adulterated drug products while 

concealing this conduct from Federal 

authorities in violation of 18 U.S.C. 371. 

In proposing a debarment period, FDA 

weighed the considerations set forth in 

section 306(c)(3) of the FD&C Act that 

it considered applicable to Mr. Bishop’s 

offense and concluded that the felony 

offense warranted the imposition of a 5- 

year period of debarment. 

The proposal informed Mr. Bishop 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. 

Bishop received the proposal and notice 

of opportunity for a hearing on October 

25, 2021. Mr. Bishop sent a 

memorandum to FDA, dated November 

3, 2021, wherein he stated that he 

acquiesced to the proposed debarment. 

FDA received the memorandum on 

January 4, 2022. In accordance with 

section 306(c)(2)(B) of the FD&C Act, 

Mr. Bishop’s period of debarment shall 

commence on the date FDA received 

notice he acquiesced to the debarment, 

which was January 4, 2022 (21 CFR part 

12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Patrick 

Charles Bishop has been convicted of a 

felony under Federal law for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. FDA finds that the offense 

should be accorded a debarment period 

of 5 years as provided by section 

306(c)(2)(A)(iii) of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Bishop is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective January 4, 2022. Pursuant to 

section 301(cc) of the FD&C Act (21 

U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of any drug or controlled 

substance by, with the assistance of, or 

at the direction of Mr. Bishop is a 

prohibited act. 

Any application by Mr. Bishop for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2021– 

N–0873 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
12174 Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices 

Dated: February 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04469 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–0665] 

George Kuiper: 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 

George Kuiper 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. 

Kuiper was convicted of multiple felony 

offenses: One count of smuggling, one 

count of conspiracy to smuggle goods 

into the United States and to introduce 

into interstate commerce unapproved 

drugs, and one count of introduction 

into interstate commerce of unapproved 

drugs. The factual basis supporting Mr. 

Kuiper’s convictions, as described 

below, is conduct relating to the 

importation into the United States of a 

drug or controlled substance. Mr. 

Kuiper was given notice of the proposed 

debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

December 8, 2021 (30 days after receipt 

of the notice), Mr. Kuiper had not 

responded. Mr. Kuiper’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

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(b)(1)(D) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(D)) permits 

debarment of an individual from 

importing or offering for import any 

drug into the United States if the FDA 

finds, as required by section 306(b)(3)(C) 

of the FD&C Act, that the individual has 

been convicted of a felony for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. 

On May 26, 2021, Mr. Kuiper was 

convicted, as defined in section 

306(l)(1) of FD&C Act, in the U.S. 

District Court for the District of New 

Hampshire, when the court entered 

judgment against him for one count of 

smuggling in violation of 18 U.S.C. 545; 

one count of conspiracy to smuggle 

goods into the United States and to 

introduce into interstate commerce 

unapproved drugs in violation of 18 

U.S.C. 371 and 545 and sections 301(d) 

and 303(a)(2) of the FD&C Act (21 U.S.C. 

331(d) and 333(a)(2)); and one count of 

introduction into interstate commerce of 

unapproved drugs in violation of 

sections 301(d) and 303(a)(2) of the 

FD&C Act. FDA’s finding that 

debarment is appropriate is based on the 

felony convictions referenced herein. 

The factual basis for these convictions 

is as follows: As contained in the plea 

agreement in Mr. Kuiper’s case, filed on 

December 21, 2020, from as early as 

2006, and until June 2020, Mr. Kuiper 

operated an internet pharmacy through 

several websites which changed over 

the years. Specifically, Mr. Kuiper 

operated the website nubrain.com until 

February 2015, when the registration for 

the website was revoked after FDA 

notified the domain name registrar that 

the website was selling products in 

violation of section 301 of the FD&C 

Act). Mr. Kuiper then immediately reestablished his operations on a new 

website, healthclown.com. On both 

these websites, Mr. Kuiper offered for 

sale over 100 types of products, 

including prescription drugs and 

controlled substances. 

Mr. Kuiper’s best-selling product 

through these websites was modafinil, a 

new prescription drug, and a Schedule 

IV controlled substance. FDA-approved 

modafinil, sold under the trade name 

PROVIGIL, is indicated to improve 

wakefulness in patients with excessive 

daytime sleepiness associated with 

narcolepsy, and it is only available by 

prescription. The version of modafinil 

Mr. Kuiper sold was not approved by 

the FDA, and it is therefore an 

unapproved new drug. FDA’s Office of 

Criminal Investigations (OCI) conducted 

a number of controlled buys of 

unapproved modafinil and other 

unapproved prescription drugs from Mr. 

Kuiper’s websites over approximately 

11 years. On most occasions, the drugs 

were either received by OCI directly 

from shippers in foreign countries or 

had packaging indicating that they were 

manufactured in foreign countries. 

During subsequent interviews, Mr. 

Kuiper admitted to investigators that he 

caused unapproved modafinil to be 

shipped directly to customers from his 

overseas suppliers. OCI’s purchases 

from Mr. Kuiper’s websites never 

required a prescription. 

As a result of his convictions, FDA 

sent Mr. Kuiper, by certified mail on 

October 28, 2021, a notice proposing to 

debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Kuiper’s convictions for three 

felony counts under Federal law, 

specifically for one count of smuggling, 

one count of conspiracy to smuggle 

goods into the United States and to 

introduce into interstate commerce 

unapproved drugs, and one count of 

introduction into interstate commerce of 

unapproved drugs, were for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance, because he knowingly 

conspired to illegally smuggle 

modafinil, an unapproved drug and 

controlled substance, into the United 

States on multiple occasions and then 

caused it to be introduced into interstate 

commerce. 

In proposing a debarment period, 

FDA weighed the considerations set 

forth in section 306(c)(3) of the FD&C 

Act that it considered applicable to Mr. 

Kuiper’s offenses and concluded that 

each felony offense warranted the 

imposition of a 5-year period of 

debarment. However, FDA placed 

significant weight on the cooperation 

Mr. Kuiper provided to law 

enforcement. Specifically, upon the 

execution of a search warrant by FDA’s 

OCI, Mr. Kuiper immediately began to 

cooperate meaningfully with Federal 

agents and ceased his own operations. 

In light of Mr. Kuiper’s assistance, 

FDA determined that the 5-year 

debarment periods for each conviction 

should run concurrently. The proposal 

informed Mr. Kuiper of the proposed 

debarment, 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. Kuiper 


khammond on DSKJM1Z7X2PROD with NOTICES