[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Page 12971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5309]



[[Page 12971]]

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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.

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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 TRI-toxin 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