Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 103 

whom they wrote the additional 

SUBSYS prescriptions did not have 

cancer. Mr. Burlakoff, along with his coconspirators, measured the effect of the 

bribes and kickbacks on each 

practitioner’s prescribing habits and on 

the revenue that each bribed 

practitioner generated. Mr. Burlakoff, 

along with his co-conspirators, reduced 

or eliminated bribes and kickbacks paid 

to those practitioners who failed to meet 

the minimum prescription requirements 

or failed to generate enough revenue to 

justify additional bribes and kickbacks. 

As a result of this conviction, FDA 

sent Mr. Burlakoff 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. 

Burlakoff 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. Burlakoff 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. Burlakoff received the 

proposal on July 25, 2020. 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)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Alec Burlakoff 

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. Burlakoff, 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. Burlakoff, 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. Burlakoff 

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. Burlakoff 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 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. Burlakoff for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1372 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: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29046 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1412] 

Joseph A. Rowan: 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 Joseph A. 

Rowan 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 Joseph A. Rowan 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. Rowan 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 

August 6, 2020 (30 days after receipt of 

the notice), Mr. Rowan had not 

responded. Mr. Rowan’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 January 

4, 2021. 

ADDRESSES: Submit applications for 

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 (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, 240–402–8743, or 

at debarments@fda.hhs.gov. 

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 21, 2020, Mr. Rowan 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, on 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. Rowan held executive 

management positions, including 

Regional Sales Manager and Regional 

Director of the East Region of Insys 

Therapeutics Inc. (Insys), a Delaware 

corporation, with headquarters in 

Chandler, Arizona. 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 

104 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

their underlying persistent cancer pain. 

From May 2012 and continuing until 

December 2015, Mr. Rowan participated 

in a conspiracy whereby employees of 

Insys bribed medical practitioners in 

various States to get those practitioners 

to increase prescribing SUBSYS to their 

patients, many of whom did not have 

cancer. Mr. Rowan, 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. Rowan, 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. Rowan 

was involved in a scheme with his coconspirators 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. Rowan and his coconspirators directed Insys employees 

to mislead insurers to obtain payment 

authorization. 

As a result of this conviction, FDA 

sent Mr. Rowan by certified mail on 

August 3, 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. 

Rowan 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. 

Rowan 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. 

Rowan received the proposal on August 

7, 2020. 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)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Rowan 

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. Rowan 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 306(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. 

Rowan, 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. 

Rowan 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 (21 

U.S.C. 335b(a)(7))). In addition, FDA 

will not accept or review any 

abbreviated new drug application from 

Mr. Rowan 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. Rowan for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1412 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: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29045 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; National 

Agriculture and Food Defense Strategy 

Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 the information 

collection requirements for a voluntary 

survey for the Department of Health and 

Human Services (HHS), the U.S. 

Department of Agriculture (USDA), and 

the Department of Homeland Security 

(DHS), which will inform the FDA Food 

Safety Modernization Act (FSMA), 

National Agriculture and Food Defense 

Strategy (NAFDS) Report to Congress. 

The proposed survey will be used to 

determine what food defense activities, 

if any, State, local, territorial, and/or 

tribal (SLTT) agencies have completed 

to date. The information will be 

compared to the initial baseline data 

collected by State(s) in 2018. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 2021. 

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 March 5, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 5, 2021. 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. 

Electronic Submissions 

Submit electronic comments in the 

following way: