12482 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

M. Ophthalmic 

No new entries at this time. 

N. Orthopedic 

11–368 ................ Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total 

Knee Tibial Components.

ASTM F3334—19. 

11–369 ................ Standard Practice for Inspection of Spinal Implants Undergoing Testing ............... ASTM F3292—19. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–331 ................ Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance 

Imaging Systems.

NEMA Standards Publication MS 14– 

2019. 

12–332 ................ Magnetic resonance equipment for medical imaging—Part 1: Determination of 

essential image quality parameters.

IEC 62464–1 Edition 2.0 2018–12. 

12–333 ................ Guidance on error and warning messages for software used in radiotherapy ....... IEC TR 63183 Edition 1.0 2019–12. 

12–334 ................ Radiation therapy machine characterization ............................................................ AAMI RT3:2020. 

Q. Software/Informatics 

13–115 ................ Software and systems engineering—Software testing—Part 1: Concepts and definitions.ISO/IEC/IEEE 29119–1 First edition 

2013–09–01. 

R. Sterility 

14–549 ................ Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne 

Ultrasound.

ASTM F3004—13e1. 

S. Tissue Engineering 

No new entries at this time. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the current list of FDA 

Recognized Consensus Standards in a 

searchable database that may be 

accessed at https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. Such 

standards are those that FDA has 

recognized by notice published in the 

Federal Register or that FDA has 

decided to recognize but for which 

recognition is pending (because a 

periodic notice has not yet appeared in 

the Federal Register). FDA will 

announce additional modifications and 

revisions to the list of recognized 

consensus standards, as needed, in the 

Federal Register once a year, or more 

often if necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to 

CDRHStandardsStaff@fda.hhs.gov. To 

be considered, such recommendations 

should contain, at a minimum, the 

information listed on FDA’s website, 

which is specifically available at https:// 

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04376 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–1638] 

Lawrence B. Ryan: 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 Lawrence B. 

Ryan 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. Ryan 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. Ryan 

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 

October 18, 2020 (30 days after receipt 

of the notice), Mr. Ryan had not 

responded. Mr. Ryan’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 March 3, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 


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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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