5332 Federal Register / Vol. 75, No. 21 / Tuesday, February 2, 2010 / Notices 

Dated: January 27, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–2034 Filed 2–1–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0420] 

Brian Ullom: 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 act) permanently 

debarring Brian Ullom from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. We base this order 

on a finding that Mr. Ullom was 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the act. Mr. Ullom 

was given notice of the proposed 

permanent debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

As of December 2, 2009, Mr. Ullom 

failed to respond. Mr. Ullom’s failure to 

respond constitutes a waiver of his right 

to a hearing concerning this action. 

DATES: This order is effective February 

2, 2010. 

ADDRESSES: Submit applications for 

special 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, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(B) of the act (21 

U.S.C. 335a(a)(2)(B)) requires debarment 

of an individual if FDA finds that the 

individual has been convicted of a 

felony under Federal law for conduct 

otherwise relating to the regulation of 

any drug product under the act. 

On August 17, 2009, the U.S. District 

Court for the Western District of 

Kentucky entered judgment against 

Brian Ullom for one count of 

participation in a scheme to defraud 

health care benefit programs by billing 

patients and patients’ health care benefit 

programs, including Medicare and 

Medicaid, for prescription drug samples 

and for prescriptions that were never 

filled, in violation of 18 U.S.C. 1347; 

and one count of knowingly selling, 

purchasing and trading prescription 

drug samples with the intent to defraud, 

in violation of sections 301(t) and 

503(c)(1) of the act (21 U.S.C. 331(t) and 

353(c)(1)). 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction related to the sale of drug 

samples. The factual basis for this 

conviction is as follows: Beginning in or 

about 2002 and continuing until on or 

about October 12, 2006, Mr. Ullom, with 

the intent to defraud, knowingly sold, 

purchased, and traded prescription drug 

samples. During that time period, Mr. 

Ullom obtained prescription drug 

samples by purchasing the drug samples 

from others, including a local physician 

and a pharmaceutical sales 

representative. After obtaining the 

samples, he removed the drugs from 

their original sample packaging and sold 

them to the public through his 

pharmacy. At the time of sale, he knew 

the drugs were samples, and he resold 

them with the intent to defraud and 

mislead the purchaser by selling the 

sample drugs as drugs properly obtained 

and dispensed. 

As a result of this conviction, FDA 

sent Mr. Ullom by certified mail on 

October 27, 2009, 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 act that Brian Ullom 

was convicted of a felony under Federal 

law for conduct relating to the 

regulation of a drug product under the 

act. In accordance with section 306(i) of 

the act and part 12 (21 CFR part 12), the 

proposal also offered Mr. Ullom 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. 

Accordingly, Mr. Ullom had to request 

a hearing by December 2, 2009. As of 

December 2, 2009, Mr. Ullom had not 

responded to the notice. Mr. Ullom thus 

failed to respond within the timeframe 

prescribed by regulation and as a result 

has waived both his opportunity for a 

hearing and waived any contentions 

concerning his debarment (21 U.S.C. 

335(a)(i); part 12)). 

II. Findings and Order 

Therefore, the Acting Director, Office 

of Enforcement, Office of Regulatory 

Affairs, under section 306(a)(2)(B) of the 

act, under authority delegated to the 

Acting Director (Staff Manual Guide 

1410.35), finds that Brian Ullom has 

been convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

act. 

As a result of the foregoing finding, 

Mr. Ullom is permanently debarred 

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 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)(ii), 

and 201(dd) of the act (21 U.S.C. 

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 Brian Ullom, in any 

capacity, during Mr. Ullom’s debarment, 

will be subject to civil money penalties 

(section 307(a)(6) of the act (21 U.S.C. 

335b(a)(6))). If Mr. Ullom, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, he will be subject to civil 

money penalties (section 307(a)(7) of the 

act. In addition, FDA will not accept or 

review any abbreviated new drug 

applications submitted by or with the 

assistance of Mr. Ullom during his 

period of debarment (section 

306(c)(1)(B) of the act). 

Any application by Mr. Ullom for 

special termination of debarment under 

section 306(d)(4) of the act should be 

identified with Docket No. FDA–2009– 

N–0420 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: January 8, 2010. 

Brenda Holman, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2010–2135 Filed 2–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

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