13192 Federal Register / Vol. 76, No. 47 / Thursday, March 10, 2011 / Notices 

Catina Conner, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevent. 

[FR Doc. 2011–5460 Filed 3–9–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0479] 

Mark E. Van Wormer: 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) 

permanently debarring Mark E. Van 

Wormer, MD, 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 Dr. Van Wormer was 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the FD&C Act. Dr. 

Van Wormer was given notice of the 

proposed permanent debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

In a January 1, 2011, letter to FDA, Dr. 

Van Wormer notified FDA that he did 

not plan to seek a hearing and therefore 

has waived his right to a hearing 

concerning this action. 

DATES: This order is effective March 10, 

2011. 

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, 301–796–4640. 

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 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 FD&C Act. 

On December 13, 2007, the U.S. 

District Court, District of New Mexico, 

entered judgment against Dr. Van 

Wormer for felony misbranding a drug 

while held for sale in violation of 21 

U.S.C. 333(a)(2), 331(k) and 352(i)(3). 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein for 

conduct relating to the regulation of a 

drug product. The factual basis for the 

conviction is as follows: Dr. Van 

Wormer is a physician licensed by the 

New Mexico State Board of Medicine, 

and he owned and operated the Union 

County Medical Center, also known as 

the Union County Medical, Diagnostic 

Imaging and Laser Surgery Center, PC, 

and the Physicians GreatSkin® Clinic. 

From on or about January 13, 2004, 

through on or about November 9, 2004, 

Dr. Van Wormer advertised the use of 

Allergan’s approved BOTOX for use in 

treatment of forehead wrinkles. 

However, during that time he knowingly 

used TRI-toxin, an unapproved 

botulinum toxin type A product, that he 

purchased from Toxin Research 

International, Inc. (TRI), a company in 

Tucson, AZ. 

Dr. Van Wormer purchased 

approximately 20 vials of the TRI-toxin, 

which he injected into his patients. He 

did not inform his patients that they 

were being injected with an unapproved 

substance, and patients were charged as 

if they were receiving the approved drug 

product. Dr. Van Wormer injected 

approximately 120 patients with the 

unapproved TRI-toxin. 

As a result of his convictions, on 

December 17, 2010, FDA sent Dr. Van 

Wormer a notice by certified mail 

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 Dr. Van Wormer 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 Dr. Van Wormer 

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. 

Van Wormer submitted a letter dated 

January 1, 2011, acknowledging receipt 

of the proposal to debar and noting that 

he did not plan to seek a further hearing 

regarding the matter and thereby has 

waived his opportunity for a hearing 

and 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(a)(2)(B) of the 

FD&C Act, under authority delegated to 

the Director (Staff Manual Guide 

1410.35), finds that Mark E. Van 

Wormer has been convicted of a felony 

under Federal law for conduct relating 

to the regulation of a drug product 

under the FD&C Act. 

As a result of the foregoing finding 

and based on his notification of 

acquiescence, Dr. Van Wormer 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 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 section 

306(c)(1)(B), (c)(2)(A)(ii), (c)(2)(B) of the 

FD&C Act and section 201(dd) of the 

FD&C 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 Dr. Van Wormer, in 

any capacity during Dr. Van Wormer’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. 

Van Wormer 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. Van Wormer during his period of 

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

FD&C Act). 

Any application by Dr. Van Wormer 

for special termination of debarment 

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

should be identified with Docket No. 

FDA–2010–N–0479 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. 2011–5498 Filed 3–9–11; 8:45 am] 

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