[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19373-19374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0443]


Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia): 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

[[Page 19374]]

Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) 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 
Ms. Chatman 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. Ms. Chatman was given notice of 
the proposed debarment and an opportunity to request a hearing within 
the timeframe prescribed by regulation. Ms. Chatman failed to respond. 
Ms. Chatman's failure to respond constitutes a waiver of her right to a 
hearing concerning this action.

DATES: This order is effective April 7, 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 March 14, 2006, Cathryn Lyn Chatman (also known as Cathryn Lyn 
Garcia) pleaded guilty to a misdemeanor offense of misbranding a drug. 
On August 14, 2006, the United States District Court for the District 
of Oregon entered judgment against Ms. Chatman for misdemeanor 
misbranding a drug, in violation of 21 U.S.C. 331(k) and 333(a)(1).
    FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for the 
conviction is as follows: Ms. Chatman was a registered nurse licensed 
by the Oregon Board of Nursing. Throughout 2004, she assisted a 
codefendant in operating two clinics that offered treatments they 
claimed could combat the effects of aging, including injection with 
BOTOX. From August 2004 through December 2004, Ms. Chatman offered a 
botulinum toxin called ``Refinex'' for sale for injection to patients 
under the name of another drug, BOTOX. Refinex is manufactured by the 
Shandong Bioresearch Institute in the People's Republic of China and 
has never been approved or licensed by FDA for any use. Ms. Chatman 
misbranded a drug, namely botulinum toxin type A manufactured by 
Shandong Bioresearch Institute and known as Refinex, while it was held 
for sale and after shipment in interstate commerce, in that she offered 
Refinex for sale by injection to patients under the name of another 
drug that is approved, namely BOTOX, all in violation of 21 U.S.C. 
331(k) and 333(a)(1).
    As a result of her conviction, on January 5, 2011, FDA sent Ms. 
Chatman a notice by certified mail proposing to debar her 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 Ms. 
Chatman was convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the conduct that served as a basis for the conviction undermines 
the process for the regulation of drugs. The proposal also offered Ms. 
Chatman an opportunity to request a hearing, providing her 30 days from 
the date of receipt of the letter in which to file the request, and 
advised her that failure to request a hearing constituted a waiver of 
the opportunity for a hearing and of any contentions concerning this 
action. Ms. Chatman failed to respond within the timeframe prescribed 
by regulation and has, therefore, waived her opportunity for a hearing 
and waived any contentions concerning her 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 Cathryn Lyn Chatman 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, Ms. Chatman 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. 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 Ms. 
Chatman, in any capacity during Ms. Chatman'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 Ms. Chatman provides services in any capacity 
to a person with an approved or pending drug product application during 
her period of debarment she 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 Ms. Chatman during her period of debarment (section 
306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B)). Any application 
by Ms. Chatman for termination of debarment under section 306(d)(1) of 
the FD&C Act should be identified with Docket No. FDA-2010-N-0443 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: March 22, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-8218 Filed 4-6-11; 8:45 am]
BILLING CODE 4160-01-P