Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 12971 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0441] 

Anastasios Pappas: 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 (the FD&C Act) debarring 

Anastasios Pappas, MD, for 5 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on findings that Dr. Pappas 

was convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

Dr. Pappas was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Dr. 

Pappas failed to respond. Dr. Pappas’ 

failure to respond constitutes a waiver 

of his right to a hearing concerning this 

action. 

DATES: This order is effective March 9, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of drug products under the 

FD&C Act and if FDA finds that the type 

of conduct that served as the basis for 

the conviction undermines the process 

for the regulation of drugs. 

On April 4, 2006, Dr. Pappas pleaded 

guilty to a misdemeanor offense of 

introducing and causing the 

introduction into interstate commerce of 

a misbranded drug in violation of 21 

U.S.C. 352(o), 331(a) and 333(a)(1). On 

August 14, 2006, the U.S. district court 

for the district of South Dakota, 

Southern Division, entered judgment 

against Dr. Pappas for misdemeanor 

misbranding. 

FDA’s finding that debarment is 

appropriate is based on the 

misdemeanor conviction referenced 

herein. The factual basis for the 

conviction is as follows: Dr. Pappas was 

a licensed dermatologist in the state of 

South Dakota and a partner with Dakota 

Dermatology in Sioux Falls, SD. 

Between August and November 2004, in 

the District of South Dakota and 

elsewhere, Dr. Pappas placed three 

orders for a total of six vials of 

botulinum toxin type A (TRI-toxin) from 

Toxin Research International (TRI). 

Between September and November 

2004, Dr. Pappas administered TRItoxin to patients. TRI was not duly 

registered with FDA and, therefore, the 

TRI-toxin is deemed misbranded under 

21 U.S.C. 352(o). 

As a result of his convictions, on 

November 16, 2010, FDA sent Dr. 

Pappas a notice by certified mail 

proposing to debar him for 5 years 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(b)(2)(B)(i)(I) of the FD&C Act, that 

Dr. Pappas was convicted of a 

misdemeanor under Federal law for 

conduct relating to the regulation of 

drug products under the FD&C Act, and 

the conduct that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. The proposal 

also offered Dr. Pappas 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. Dr. Pappas failed 

to respond 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 Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(2)(B)(i)(I) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Anastasios Pappas 

has been convicted of a misdemeanor 

under Federal law for conduct relating 

to the regulation of a drug product 

under the FD&C Act and that the type 

of conduct that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. 

As a result of the foregoing finding, 

Dr. Pappas is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

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), effective (see 

DATES), (see sections 306(c)(1)(B), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 321(dd))). 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 Dr. Pappas, in any capacity 

during Dr. Pappas’ 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 Dr. Pappas 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 applications 

submitted by or with the assistance of 

Dr. Pappas during his period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Dr. Pappas for 

termination of debarment under section 

306(d)(1) of the FD&C Act (21 U.S.C. 

335a(d)(1)) should be identified with 

Docket No. FDA–2010–N–0441 and sent 

to the Division of Dockets Management 

(see ADDRESSES). All such submissions 

are to be filed in four copies. The public 

availability of information in these 

submissions is governed by 21 CFR 

10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 16, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–5309 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0473] 

David E. Berman: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


Emcdonald on DSK2BSOYB1PROD with NOTICES
12972 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

David E. Berman, MD, for 3 years 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 Dr. Berman 

was convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

Dr. Berman was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Dr. 

Berman failed to respond. Dr. Berman’s 

failure to respond constitutes a waiver 

of his right to a hearing concerning this 

action. 

DATES: This order is effective March 9, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of drug products under the 

FD&C Act and if FDA finds that the type 

of conduct that served as the basis for 

the conviction undermines the process 

for the regulation of drugs. 

On October 30, 2007, Dr. Berman 

pleaded guilty to a misdemeanor offense 

of the introduction into interstate 

commerce of a misbranded drug in 

violation of 21 U.S.C 331(a), 333(a)(1), 

and 352(i)(3), and judgment was entered 

against Dr. Berman by the U.S. District 

Court, Eastern District of Virginia. 

FDA’s finding that debarment is 

appropriate is based on the 

misdemeanor conviction referenced 

herein. The factual basis for the 

conviction is as follows: Dr. Berman is 

a medical doctor licensed by the 

Virginia Department of Health 

Professions, specializing in plastic 

surgery with an office in Sterling, VA. 

On or about January 16, 2004, and on or 

about February 16, 2004, Dr. Berman 

caused TRI-toxin, an unapproved 

botulinum toxin type A product, to be 

introduced into interstate commerce by 

causing Toxin Research International, 

Inc., to ship vials of TRI-toxin from 

Arizona to the Eastern District of 

Virginia. TRI-toxin was a misbranded 

drug in that Dr. Berman offered it for 

sale to, and used it on, thirty of his 

patients as BOTOX Cosmetic. Dr. 

Berman did not disclose to his patients 

that he was using a substitute, 

unapproved, unlicensed, and less 

expensive botulinum toxin type A 

product. TRI-toxin was not duly 

registered with the FDA and, therefore, 

the TRI-toxin is deemed misbranded. 

As a result of his convictions, on 

December 17, 2010, FDA sent Dr. 

Berman a notice by certified mail 

proposing to debar him for 3 years 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(b)(2)(B)(i)(I) of the FD&C Act, that 

Dr. Berman was convicted of a 

misdemeanor under Federal law for 

conduct relating to the regulation of 

drug products under the FD&C Act, and 

the conduct that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. The proposal 

also offered Dr. Berman 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. Dr. Berman 

failed to respond 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 Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(2)(B)(i)(I) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that David E. Berman 

has been convicted of a misdemeanor 

under Federal law for conduct relating 

to the regulation of a drug product 

under the FD&C Act and that the type 

of conduct that served as a basis for the 

conviction undermines the process for 

the regulation of drugs. 

As a result of the foregoing finding, 

Dr. Berman is debarred for 3 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

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), effective (see 

DATES), (see sections 306(c)(1)(B), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 321(dd))). 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 Dr. Berman, in any capacity 

during Dr. Berman’s 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 Dr. Berman 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 submitted by or with 

the assistance of Dr. Berman during his 

period of debarment (section 

306(c)(1)(B) of the FD&C Act). 

Any application by Dr. Berman for 

termination of debarment under section 

306(d)(4) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0473 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 16, 2011. 

Howard R. Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–5308 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Joint Meeting of the Nonprescription 

Drugs Advisory Committee and the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 


Emcdonald on DSK2BSOYB1PROD with NOTICES