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

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19375 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: Cardiovascular 

and Renal Drugs Advisory Committee 

and the Drug Safety and Risk 

Management Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 2, 2011, from 8 a.m. to 4 

p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center, rm. 1503, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking and 

transportation may be accessed at: http: 

//www.fda.gov/AdvisoryCommittees/ 

default.htm; under the heading 

‘‘Resources for You’’, click on ‘‘White 

Oak Conference Center Parking and 

Transportation Information for FDA 

Advisory Committee Meetings’’. Please 

note that visitors to the White Oak 

Campus must enter through Building 1. 

Contact Person: Nicole Vesely, 

Pharm.D., Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, WO31–2417, Silver Spring, MD 

20993–0002, 301–796–9001, Fax: 301– 

847–8533, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On May 2, 2011, the 

committees will discuss safety 

considerations of ultrasound contrast 

agents (materials intended to improve 

the clarity of ultrasound imaging), 

particularly related to new information 

and developments since the prior 

Advisory Committee meeting on the 

same topic on June 24, 2008. The 

discussion will include the results of 

required postmarketing safety studies 

and data from postmarketing 

surveillance. Specific drugs to be 

discussed include: (1) New drug 

application (NDA) 21–064, perflutren 

lipid microsphere injectable suspension, 

Lantheus Medical Imaging, Inc.; (2) 

NDA 20–899, perflutren protein-type A 

microspheres injectable suspension, GE 

Healthcare; and (3) the investigational 

new drug (IND) application for sulfur 

hexafluoride microbubble injection, 

Bracco Diagnostics, Inc. Perflutren lipid 

microsphere injectable suspension and 

perflutren protein-type A microspheres 

injectable suspension are indicated for 

use in patients with suboptimal 

echocardiograms to opacify the left 

ventricular chamber and to improve the 

delineation of the left ventricular 

endocardial border (improve the clarity 

of imaging of specific areas of the left 

lower side of the heart). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. Written 

submissions may be made to the contact 

person on or before April 18, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 8, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 11, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 

Vesely at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated March 22, 2011. 

Leslie Kux, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2011–8284 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] 

Safety and Efficacy of Hypnotic Drugs; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting to 

discuss the safety and efficacy of drugs 

for the treatment of insomnia. The 

Division of Neurology Products (DNP) 

in FDA’s Center for Drug Evaluation and 

Research and the Pharmaceutical 

Education and Research Institute (PERI) 

are cosponsoring the 2-day meeting, 

with the first day centered on issues of 

efficacy and the second day on safety. 

Date and Time: The public meeting 

will be held on Tuesday, May 10, and 

Wednesday, May 11, 2011, from 8 a.m. 

to 5 p.m. 

Location: The public meeting will be 

held at the Bethesda Marriott, 5151 

Pooks Hill Rd., Bethesda, MD 20814. 

Contact: Margaret Bogie, 703–276– 

0178, ext. 115, Fax: 703–276–0069; or 

Cathleen Michaloski, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4342, 

Silver Spring, MD 20993, 301–796– 

1123, e-mail: 

Cathleen.michaloski@fda.hhs.gov. 

Accommodations: Attendees are 

responsible for their own 

accommodations. Reservations can be 

mstockstill on DSKH9S0YB1PROD with NOTICES