Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19373 

TABLE 9B.—HOSPITAL RECLASSIFICATIONS AND REDESIGNATIONS BY INDIVIDUAL HOSPITAL UNDER SECTION 508 OF

PUBLIC LAW 108–173—FY 2011—Continued 

CCN Note Geographic 

CBSA 

Wage index 

CBSA section 

508 reclassification 

Own wage 

index 

330106 ............................................................................................................. ........................ 35004 ........................ 1.4341 

330126 ............................................................................................................. ........................ 35644 1.2867 ........................

330135 ............................................................................................................. ........................ 35644 1.2867 ........................

330205 ............................................................................................................. ........................ 35644 1.2867 ........................

330264 ............................................................................................................. ........................ 35004 1.2529 ........................

340002 ............................................................................................................. ........................ 16740 0.9087 ........................

390001 ............................................................................................................. ........................ 10900 0.9370 ........................

390003 ............................................................................................................. ........................ 10900 0.9370 ........................

390045 ............................................................................................................. ** 10900 0.9370 ........................

390072 ............................................................................................................. ........................ 10900 0.9370 ........................

390095 ............................................................................................................. ........................ 10900 0.9370 ........................

390119 ............................................................................................................. ........................ 10900 0.9370 ........................

390137 ............................................................................................................. ........................ 10900 0.9370 ........................

390169 ............................................................................................................. ........................ 10900 0.9370 ........................

390185 ............................................................................................................. ........................ 29540 0.9852 ........................

390192 ............................................................................................................. ........................ 10900 0.9370 ........................

390237 ............................................................................................................. ........................ 10900 0.9370 ........................

390270 ............................................................................................................. ........................ 29540 0.9852 ........................

430005 ............................................................................................................. ........................ 39660 1.0934 ........................

470003 ............................................................................................................. ........................ 14484 1.1629 ........................

490001 ............................................................................................................. ........................ 31340 0.8514 ........................

530015 ............................................................................................................. ........................ 53 ........................ 1.0577 

* These hospitals are assigned a wage index value under a special exceptions policy (see FY 2005 IPPS final rule, 69 FR 49105). 

** This hospital has been assigned a wage index under a special exceptions policy (see FY 2007 IPPS final rule, 71 FR 48070). 

[FR Doc. 2011–8209 Filed 4–6–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

The 14th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference in Irvine, California: New 

Regulatory Challenges 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 14th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics, and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the centers and District Offices, as well 

as from other industry experts. The 

main focus of this interactive conference 

will be product approval, compliance, 

and risk management in the three 

medical product areas. Industry 

speakers, interactive Q & A, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 8 and 9, 2011, from 7:30 

a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott Hotel, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Office of 

Regulatory Affairs, Food and Drug 

Administration, 19701 Fairchild, Irvine, 

CA 92612, Voice: 949–608–4413, Fax: 

949–608–4417; or Orange County 

Regulatory Affairs Discussion Group, 

Attention to Detail, 5319 University Dr., 

suite 641, Irvine, CA 92612, Voice: 949– 

387–9046, Fax: 949–387–9047, Web site: 

http://www.ocra-dg.org. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Registration and Meeting Information: 

See OCRA’s Web site at http:// 

www.ocra-dg.org. Contact Attention to 

Detail at 949–387–9046. 

Before May 1, 2011, registrations fees 

are as follows: $675.00 for members, 

$725.00 for non-members and $475.00 

for FDA/Government/Students.* After 

May 1, 2011, $725.00 for members, 

$775.00 for non-members, and $475.00 

for FDA/Government/Students.* 

* OCRA student rate applies to those 

individuals enrolled in a regulatory or 

quality-related academic program at an 

accredited institution. Proof of 

enrollment required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley (see Contact) at least 10 days in 

advance. 

Transcripts: Transcripts will not be 

available for the conference. 

Dated: April 1, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8283 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

mstockstill on DSKH9S0YB1PROD with NOTICES

19374 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Joint Meeting of the Cardiovascular 

and Renal Drugs Advisory Committee 

and the Drug Safety and Risk 

Management Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

mstockstill on DSKH9S0YB1PROD with NOTICES