Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76583 

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 

June 27, 2017, Mr. Cadden 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, for one count of 

racketeering in violation of 18 U.S.C. 

1962(c), one count of racketeering 

conspiracy in violation of 18 U.S.C. 

1962(d), 52 counts of mail fraud in 

violation of 18 U.S.C. 1341, and three 

counts of introduction of misbranded 

drugs into interstate commerce with the 

intent to defraud and mislead-no 

prescriptions in violation of 21 U.S.C. 

353(b)(1), 331(a), and 333(a)(2). 

As contained in counts 1–2, 4–39, 41– 

56, 95, and 99–100 of the indictment, 

filed on December 16, 2014, Mr. Cadden 

was an owner and director of the New 

England Compounding Center (NECC), 

which held itself out as a compoundingonly pharmacy, and he served as 

NECC’s president, head pharmacist, and 

Manager of Record. In addition, Mr. 

Cadden was an owner and director of 

Medical Sales Management, Inc. (MSM), 

and served as MSM’s Treasurer. MSM 

provided sales and administrative 

services to NECC for which MSM was 

paid a service fee. MSM’s sales 

representatives sold drugs on behalf of 

NECC to customers throughout the 

country. In those capacities, Mr. Cadden 

instructed the MSM sales force to falsely 

represent to customers that NECC was 

providing the highest quality 

compounded medications, when in fact 

Mr. Cadden, among other things, failed 

to properly sterilize drug products 

consistent with applicable U.S. 

Pharmacopeia standards, failed to test 

purportedly sterile drugs, authorized the 

shipping of drugs before test results 

confirming their sterility were returned, 

never notified customers of nonsterile 

results, and compounded drugs with 

expired ingredients. Additionally, Mr. 

Cadden directed and authorized the 

shipping and mailing, in interstate 

commerce, of contaminated 

methylprednisolone acetate to NECC 

customers nationwide. Mr. Cadden also 

caused drugs to be introduced and 

delivered into interstate commerce 

without the valid prescription of a 

practitioner licensed by law to 

administer drugs, which act resulted in 

the drugs being misbranded. Further, 

Mr. Cadden defrauded the United States 

by interfering with and obstructing the 

lawful governmental functions of FDA 

by claiming to be a pharmacy 

dispensing drugs pursuant to valid, 

patient-specific prescriptions. In fact, 

NECC routinely dispensed drugs in bulk 

without valid, patient-specific 

prescriptions. 

As a result of this conviction, FDA 

sent Mr. Cadden, by certified mail on 

June 2, 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. 

Cadden was convicted of felonies under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Mr. 

Cadden 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. 

Cadden received the proposal on June 9, 

2020. Mr. Cadden 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 Barry J. 

Cadden, 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, 

Barry J. Cadden, 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 Barry J. 

Cadden, 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. 

Cadden 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 applications 

from Mr. Cadden 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, 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. Cadden for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2019–N–4248 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 

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. 2020–26255 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–2020–N–1255] 

Tuan Anh Tran: 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 

Tuan Anh Tran 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. 

Tran engaged in a pattern of importing 

or offering for import misbranded drugs 

(i.e., in an amount, frequency, or dosage 

that is inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 


TKELLEY on DSKBCP9HB2PROD with NOTICES
76584 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

regulated by FDA. Mr. Tran was given 

notice of the proposed debarment and 

an opportunity to request a hearing to 

show why he should not be debarred. 

As of September 14, 2020 (30 days after 

receipt of the notice), Mr. Tran had not 

responded. Mr. Trans’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 

November 30, 2020. 

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)(D) of 

the FD&C Act, that the individual has 

engaged in a pattern of importing or 

offering for import misbranded drugs 

(i.e., in an amount, frequency, or dosage 

that is inconsistent with personal or 

household use by the importer), and the 

shipments are not designated in an 

entry in an authorized electronic data 

exchange system as products regulated 

by FDA. 

After an investigation, FDA 

discovered that Mr. Tran has engaged in 

numerous instances of importing or 

offering for import misbranded drugs; 

all the parcels containing the 

misbranded drugs serving as the basis 

for this action were intercepted by FDA 

at the John F. Kennedy International 

Mail Facility and were addressed to Mr. 

Tran at one of two addresses connected 

to him. 

On or about April 12, 2019, Mr. Tran 

offered for import three parcels. The 

product contained in the first parcel was 

210 packets (pieces) of Kamagra 

Sildenafil Oral Jelly and was a 

misbranded drug because the product 

was a prescription drug product that 

failed to contain the ‘‘Rx-only’’ symbol 

on its label. The product was refused 

entry on May 17, 2019. The product 

contained in the second parcel was 245 

packets (pieces) of Kamagra Sildenafil 

Oral Jelly and was a misbranded drug 

because the product was a prescription 

drug product that failed to contain the 

‘‘Rx-only’’ symbol on its label. The 

product was refused entry on May 17, 

2019. The product contained in the 

third parcel was 245 packets (pieces) of 

Kamagra Sildenafil Oral Jelly and was a 

misbranded drug because the product 

was a prescription drug product that 

failed to contain the ‘‘Rx-only’’ symbol 

on its label. The product was refused 

entry on May 17, 2019. 

On or about September 13, 2019, Mr. 

Tran offered for import four parcels. The 

product contained in the first parcel was 

312 Kamagra Sildenafil Citrate 

Chewable Tablets and was a misbranded 

drug because it was a prescription drug 

product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product 

was refused entry on October 22, 2019. 

The product contained in the second 

parcel was 312 Kamagra Sildenafil 

Citrate Chewable Tablets and was a 

misbranded drug because it was a 

prescription drug product that failed to 

contain the ‘‘Rx-only’’ symbol on its 

label. The product was refused entry on 

October 22, 2019. The product 

contained in the third parcel was 196 

packets (pieces) of Kamagra Sildenafil 

Citrate Jelly and was a misbranded drug 

because it was a prescription drug 

product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product 

was refused entry on October 22, 2019. 

The product contained in the fourth 

parcel was 231 packets (pieces) of 

Kamagra Sildenafil Citrate Jelly and was 

a misbranded drug because it was a 

prescription drug product that failed to 

contain the ‘‘Rx-only’’ symbol on its 

label. The product was refused entry on 

October 22, 2019. 

On or about September 26, 2019, Mr. 

Tran offered for import a parcel that was 

intercepted and processed by FDA. The 

product contained in the parcel was 196 

packets (pieces) of Kamagra Sildenafil 

Oral Jelly and was a misbranded drug 

because it was a prescription drug 

product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product 

was refused entry on October 29, 2019. 

Because of this pattern of importing or 

offering for import misbranded drugs 

(i.e., in an amount, frequency, or dosage 

that is inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 

regulated by FDA, in accordance with 

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

FDA sent Mr. Tran, by certified mail on 

August 7, 2020, a notice proposing to 

debar him for 5 years from importing or 

offering for import any drug into the 

United States. 

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. 

Tran’s pattern of conduct and 

concluded that his conduct warranted 

the imposition of a 5-year period of 

debarment. 

The proposal informed Mr. Tran 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. 

Tran received the proposal and notice of 

opportunity for a hearing on August 15, 

2020. Mr. Tran failed to request a 

hearing within the timeframe prescribed 

by regulation and, therefore, has 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)(D) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Tuan Anh 

Tran has engaged in a pattern of 

importing or offering for import 

misbranded drugs (i.e., in an amount, 

frequency, or dosage that is inconsistent 

with his personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. FDA finds 

that this pattern of conduct should be 

accorded a debarment 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. Tran is debarred for 5 years from 

importing or offering for import any 

drug into the United States, effective 

(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. Tran is a 

prohibited act. 

Any application by Mr. Tran for 

termination of debarment under section 

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

identified with Docket No. FDA–2020– 

N–1255 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 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76585 

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. 2020–26250 Filed 11–27–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Recharter for the National Advisory 

Council on Nurse Education and 

Practice 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, HHS 

is hereby giving notice that the National 

Advisory Council on Nurse Education 

and Practice (NACNEP) has been 

rechartered. The effective date of the 

recharter is November 30, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Camillus Ezeike, Ph.D., JD, LLM, RN, 

PMP, Designated Federal Officer, 

Bureau of Health Workforce, Division of 

Nursing and Public Health, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; 301–443–2866; or 

BHWNACNEP@hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACNEP 

provides advice and recommendations 

to the Secretary of HHS (‘‘Secretary’’) 

and Congress on policy matters and the 

preparation of general regulations 

concerning activities under Title VIII of 

the Public Health Service (PHS) Act, 

including the range of issues relating to 

the nurse workforce, education, and 

practice improvement. NACNEP also 

prepares and submits an annual report 

to the Secretary and Congress describing 

its activities, including NACNEP’s 

findings and recommendations 

concerning activities under Title VIII, as 

required by the PHS Act. 

The recharter of NACNEP was 

approved on November 30, 2020, which 

will also stand as the filing date. The 

recharter of NACNEP gives 

authorization for the Council to operate 

until November 30, 2022. 

A copy of the NACNEP charter is 

available on the NACNEP website at 

https://www.hrsa.gov/advisorycommittees/nursing/about.html. A copy 

of the charter can also be obtained by 

accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

website address for the FACA database 

is http://www.facadatabase.gov/. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2020–26247 Filed 11–27–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Rural Health 

Care Coordination Program OMB No. 

0906–0024—Reinstate With Changes 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on the proposed data 

collection projects of the Paperwork 

Reduction Act of 1995, HRSA 

announces plans to submit an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB). Prior 

to submitting the ICR to OMB, HRSA 

seeks comments from the public 

regarding the burden estimate, below, or 

any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than January 29, 2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Rural Health Care Coordination Program 

OMB No. 0906–0024—Reinstate with 

Changes. 

Abstract: The Rural Health Care 

Coordination Program (Care 

Coordination Program) is authorized 

under Section 330A(e) of the Public 

Health Service Act (42 U.S.C. 254(e)), as 

amended, to ‘‘improve access and 

quality of care through the application 

of care coordination strategies with the 

focus areas of collaboration, leadership 

and workforce, improved outcomes, and 

sustainability in rural communities.’’ 

This authority permits HRSA’s Federal 

Office of Rural Health Policy to support 

rural health consortiums/networks 

aiming to achieve the overall goals of 

improving access, delivery, and quality 

of care through the application of care 

coordination strategies in rural 

communities. 

This ICR was discontinued in January 

2020. HRSA is requesting a 

reinstatement with changes as it was 

decided to re-compete this pilot 

program. 

The proposed Rural Health Care 

Coordination Program draft measures 

for information collection reflect 

changes to the Clinical Measures 

section, which was previously in 

section eight and now currently in 

section six. The Clinical Measures 

Section now expands previous project 

focus from three chronic diseases (i.e. 

Type 2 diabetes, Congestive Heart 

Failure, and Chronic Obstructive 

Pulmonary Disease) to an inclusive list 

of clinical measures in order to reflect 

a patient’s overall health and well-being 

as well as the organization’s overall 

improved outcomes for the project. 

Proposed revisions also include 

measures to examine key elements cited 

for a successful rural care coordination 

program: (1) Collaboration, (2) 

leadership and workforce, (3) improved 

outcomes, and (4) sustainability. 

1. Collaboration—Utilizing a 

collaborative approach to coordinate 

and deliver health care services through 

a consortium, in which member 

organizations actively engage in 

integrated, coordinated, patientcentered delivery of health care 

services. 

2. Leadership and Workforce— 

Developing and strengthening a highly 

skilled care coordination workforce to 

respond to vulnerable populations’ 

unmet needs within the rural 

communities. 

3. Improved Outcomes—Expanding 

access and improving care quality and 

delivery, and health outcomes through 

evidence-based model and/or promising 

practices tailored to meet the local 

populations’ needs. 

4. Sustainability—Developing and 

strengthening care coordination 

program’s financial sustainability by 

establishing effective revenue sources 

such as expanded service 

reimbursement, resource sharing, and/or 

contributions from partners at the 


TKELLEY on DSKBCP9HB2PROD with NOTICES