[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]
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