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
Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices 12175 

received the proposal and notice of 

opportunity for a hearing on November 

8, 2021. Mr. Kuiper 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 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. George 

Kuiper has been convicted of felonies 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offenses 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. Kuiper is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

applicable (see DATES). 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. Kuiper is a 

prohibited act. 

Any application by Mr. Kuiper for 

termination of debarment under section 

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

identified with Docket No. FDA–2021– 

N–0665 and sent to the Dockets 

Management Staff (see ADDRESSSES). 

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. 

Dated: February 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04484 Filed 3–2–22; 8:45 am] 

BILLING CODE 4146–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–N–0918; FDA– 

2018–N–1967; FDA–2009–D–0268; and 

FDA–2019–N–3077] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

publishing a list of information 

collections that have been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Labeling Requirements for Human Prescription Drug and Biological Products ..................................................... 0910–0572 1/31/2025 

Biosimilar User Fee Program .................................................................................................................................. 0910–0718 1/31/2025 

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA ........................................................... 0910–0728 1/31/2025 

Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities ................................................................................................................................................. 0910–0883 2/28/2025 

Dated: February 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04409 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–2022–N–0117] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Authorization for 

Medical Products for Use in 

Emergencies 

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 of 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 associated with FDA 

Authorization for Medical Products for 

Use in Emergencies. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 2, 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 2, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 2, 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. 


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