Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12483 

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 

June 18, 2020, Mr. Ryan 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 Eastern District of Virginia, Norfolk 

Division, after his plea of guilty to one 

count of conspiracy to defraud the 

United States in violation of 18 U.S.C. 

371. 

The factual basis for this conviction is 

as follows: As contained in the 

Statement of Facts in Mr. Ryan’s case, 

filed on January 8, 2020, from October 

2007, and continuing through 

September 2010, Mr. Ryan, a physician, 

authorized drug orders for RX Limited 

(also known as RX Partners), an internet 

pharmacy organization that facilitated 

the unlawful distribution of prescription 

drugs to consumers throughout the 

United States. RX Limited had a 

business model whereby it allowed 

consumers to fill out a brief medical 

questionnaire, select the type of drugs 

the consumer desired, the desired drug 

strength, and the desired drug quantity 

and pay by credit card. RX Limited then 

forwarded the order to a participating 

physician for ‘‘approval.’’ The drugs 

sold by RX Limited were dispensed 

without a valid prescription because 

there was no valid doctor-patient 

relationship established between the 

authorizing physicians and the 

customers. Customers had no face-toface contact with the participating 

physician and were not subject to any 

mental or physical examinations. 

The physicians authorizing the orders 

for prescription drugs sold by RX 

Limited did not take patient histories or 

perform any diagnostic or laboratory 

testing, did not check the accuracy of 

the information customers provided 

(including their identities, ages, and 

qualifying medical conditions), and did 

not monitor, or provide any means to 

monitor, medication response. After the 

participating physician authorized the 

prescription, RX Limited sent the order 

to a fulfillment pharmacy, which 

fulfilled the order and mailed the drugs 

to the customer. 

As a participating physician, Mr. 

Ryan authorized more than 158,000 

drug orders for well over 10 individual 

RX Limited customers. Prescription 

drugs distributed pursuant to these 

orders included, FIORICET (and its 

generic equivalents), Carisoprodol 

(SOMA), Tramadol (ULTRAM), 

VIAGRA, CIALIS, and XENICAL. RX 

Limited paid Mr. Ryan $2.00 per drug 

order he authorized. From October 2007 

through September 2010, RX Limited 

paid Mr. Ryan at least $316,153 for the 

orders he authorized. 

As a result of this conviction, FDA 

sent Mr. Ryan by certified mail on 

September 11, 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. 

Ryan 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. 

Ryan 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. 

Ryan received the proposal on 

September 18, 2020. Mr. Ryan 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. Ryan, 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. Ryan, 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. Ryan, 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. Ryan 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. Ryan 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)). 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. Ryan for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1638 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, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04375 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 


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12484 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

forthcoming public advisory committee 

meeting of the Circulatory System 

Devices Panel of the Medical Devices 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. 

DATES: The meeting will take place 

virtually on April 6, 2021, from 9 a.m. 

Eastern Time to 6 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, aden.asefa@

fda.hhs.gov, 301–796–0400, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On April 6, 

2021, the committee will discuss, make 

recommendations, and vote on 

information regarding the premarket 

approval application for the 

TransMedics Organ Care System (OCS) 

Heart, by TransMedics, Inc. The 

proposed Indication for Use for the 

TransMedics OCS Heart, is as follows: 

The TransMedics Organ Care System 

(OCS) Heart System is a portable 

extracorporeal heart perfusion and 

monitoring system indicated for the 

resuscitation, preservation, and 

assessment of donor hearts in a nearphysiologic, normothermic, and beating 

state intended for a potential transplant 

recipient. 

OCS Heart is indicated for donor 

hearts with one or more of the following 

characteristics: 

• Expected cross-clamp or ischemic 

time ≥4 hours due to donor or 

recipient characteristics (e.g., 

donor- recipient geographical 

distance, expected recipient 

surgical time); or 

• Expected total cross-clamp time of 

≥2 hours PLUS one of the following risk 

factors: 

• Donor Age ≥55 years; or 

• Donors with history of cardiac 

arrest and downtime ≥20 minutes; or 

• Donor history of alcoholism; or 

• Donor history of diabetes; or 

• Donor Left Ventricular Ejection 

Fraction ≤50 percent but ≥40 percent; or 

• Donor history of Left Ventricular 

Hypertrophy (septal or posterior wall 

thickness of >12 and ≤16 mm); or 

• Donor angiogram with luminal 

irregularities but no significant coronary 

artery disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/circulatory-systemdevices-panel/2021-meeting-materialscirculatory-system-devices-panel. Select 

the link for the 2021 Meeting Materials. 

The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 30, 2021. 

Oral presentations from the public will 

be scheduled on April 6, 2021, between 

approximately 1 p.m. Eastern Time and 

2 p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before March 22, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 23, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallet 

at Artair.Mallet@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04371 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1411] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for Data To Support Cross-Center 

Collaboration for Social Behavioral 

Sciences Associated With Disease 

Prevention, Treatment, and the Safety, 

Efficacy, and Usage of Food and Drug 

Administration Regulated Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a proposed collection 


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