Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76581 

Programs, and (2) Performance Progress 

Report for RF Programs; and 

• Quarterly Performance Report 

(QPR), with two versions: (1) Quarterly 

Performance Progress Report for HM 

Programs, and (2) Quarterly 

Performance Progress Report for RF 

Programs. 

Grantees in the new cohort will also 

be required to engage in continuous 

quality improvement (CQI) planning 

and implementation using a proposed 

CQI plan template developed by ACF. 

The estimated burden for completing 

and updating this template is included 

in the table below. 

Respondents: Respondents include 

HM and RF grantee staff and program 

applicants and participants (participants 

are called ‘‘clients’’). 

ANNUAL BURDEN ESTIMATES

Instrument Respondent 

Number of 

respondents 

(total over 

request 

period) 

Annual 

number of 

respondents 

Number of 

responses 

per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Annual 

burden 

(in hours) 

1: Applicant Characteristics ............... Program applicants ........................... 273,839 91,280 1 0.25 68,460 22,820 

Program staff .................................... 408 408 224 0.10 27,384 9,128 

2: Program Operations ...................... Program staff .................................... 136 136 12 0.32 526.32 175.44 

3: Service Delivery Data .................... Program staff .................................... 2,040 2,040 126 0.50 128,706 42,902 

4: Entrance and Exit Surveys ............ Program clients (entrance) ............... 257,409 85,803 1 0.42 108,111.78 36,037.26 

Program clients (exit) ........................ 169,965 56,655 1 0.42 71,385 23,795 

Program staff (entrance and exit on 

paper).

32 32 1,169 0.10 11,220 3,740 

5: Semi-annual Performance 

Progress Report (PPR).

Program staff .................................... 136 136 6 3 2,448 816 

6: Quarterly Performance Report 

(QPR).

Program staff .................................... 136 136 6 1 816 272 

7: CQI Plan ........................................ Program staff .................................... 136 136 3 4 1,632 544 

Estimated Total Annual Burden 

Hours: 140,230. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Sec. 403. [42 U.S.C. 603]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–26266 Filed 11–27–20; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1337] 

John Kapoor: 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 John 

Kapoor 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 John Kapoor was convicted 

of a felony under Federal law for 

conduct that relates to the regulation of 

a drug product under the FD&C Act. 

John Kapoor was given notice of the 

proposed permanent debarment and an 

opportunity to request a hearing to show 

why he should not be debarred. Mr. 

Kapoor, through counsel, submitted a 

letter to FDA, which commented on 

some of the factual circumstances 

surrounding the case. In the letter, he 

also stated that he did not intend to 

request a hearing nor, however, would 

he acquiesce to debarment. As of August 

26, 2020 (30 days after receipt of the 

notice), Mr. Kapoor has not requested a 

hearing. His failure to request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is applicable 

November 30, 2020. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500, or https://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, (ELEM–4029) Division 

of Enforcement, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, debarments@

fda.hhs.gov, 240–402–8743. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

(21 U.S.C. 335a(a)(2)(B)) 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 regulation of any 

drug product under the FD&C Act. On 

January 23, 2020, Mr. Kapoor was 

convicted as defined in section 306(l)(1) 

of the FD&C Act when judgment was 

entered against him in the U.S. District 

Court for the District of Massachusetts, 

after a jury verdict, to one count of 

Racketeering Conspiracy in violation of 

18 U.S.C. 1962(d). The pattern of 

racketeering activity he was convicted 

of included engaging in multiple acts of 

mail fraud (18 U.S.C. 1341) and wire 

fraud (18 U.S.C. 1343). 

The factual basis for this conviction is 

as follows: Mr. Kapoor was the founder 

and majority owner of Insys 

Therapeutics Inc. (Insys), a Delaware 

Corporation, with headquarters in 

Chandler, Arizona. In addition, he held 

executive management positions at 

Insys, including Executive Chairman of 

the Board of Directors and, for a time, 


TKELLEY on DSKBCP9HB2PROD with NOTICES
76582 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

Chief Executive Officer (CEO). Insys 

developed and owned a drug called 

SUBSYS, a liquid formulation of 

fentanyl to be applied under the tongue. 

FDA approved SUBSYS for the 

management of breakthrough pain in 

adult cancer patients who are already 

receiving and are already tolerant to 

opioid therapy for their underlying 

persistent cancer pain. From 2012 and 

continuing through 2015, Mr. Kapoor 

oversaw a conspiracy whereby 

employees of Insys bribed medical 

practitioners in various states to get 

those practitioners to increase 

prescribing SUBSYS to their patients. 

Mr. Kapoor, along with his coconspirators, measured the effect of 

these bribes on each practitioner’s 

prescribing habits and on the revenue 

that each bribed practitioner generated 

for Insys. Mr. Kapoor, along with his coconspirators, reduced or eliminated 

bribes paid to those practitioners who 

failed to meet the minimum 

prescription requirements or failed to 

generate enough revenue to justify 

additional bribes. 

To further this conspiracy, Mr. 

Kapoor oversaw a scheme whereby 

Insys executives conspired to mislead 

and defraud health insurance providers 

to ensure those providers approved 

payment for SUBSYS. Insys achieved 

this goal by establishing the ‘‘Insys 

Reimbursement Center,’’ which was 

designed to shift the burden of seeking 

prior authorization for SUBSYS from 

practitioners to Insys. This allowed 

Insys to determine what medical 

information was presented to insurers. 

Mr. Kapoor and his co-conspirators 

directed Insys employees to mislead 

insurers to obtain payment 

authorization. 

As a result of this conviction, FDA 

sent Mr. Kapoor by certified mail on 

July 16, 2020, 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)(B) of the FD&C Act, that Mr. 

Kapoor was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Mr. 

Kapoor 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. 

Kapoor received the proposal on July 

27, 2020. Mr. Kapoor, through counsel, 

submitted a letter to FDA dated August 

12, 2020, which commented on some of 

the factual circumstances surrounding 

the case. In the letter, he also stated that 

he did not intend to request a hearing 

nor, however, would he acquiesce to 

debarment. Since he did not request a 

hearing within the timeframe prescribed 

by regulation, Mr. Kapoor has 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)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Kapoor 

has been convicted of a felony under 

Federal law for conduct otherwise 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing finding, 

Mr. Kapoor, 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)(B) 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. Kapoor, 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. Kapoor 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. Kapoor 

during his 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 section 306 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) (see section 201(dd) 

of the FD&C Act (21 U.S.C. 321(dd))). 

Any application by Mr. Kapoor for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1337 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: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26262 Filed 11–27–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4248] 

Barry J. Cadden: 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 Barry J. 

Cadden 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. Cadden was convicted 

of a felony under Federal law for 

conduct that relates to the regulation of 

a drug product under the FD&C Act. Mr. 

Cadden was given notice of the 

proposed permanent debarment and an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

July 9, 2020 (30 days after receipt of the 

notice), Mr. Cadden had not responded. 

Mr. Cadden’s failure to respond and 

request a hearing constitutes a waiver of 

his right to a hearing concerning this 

action. 

DATES: This order is applicable 

November 30, 2020. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Dockets Management Staff (HFA–305), 

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, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, debarments@

fda.hhs.gov, or at 240–402–8743. 

SUPPLEMENTARY INFORMATION: 


TKELLEY on DSKBCP9HB2PROD with NOTICES