Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 48169 

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 April 2, 2007, Dr. Choi pleaded 

guilty to one count of receipt in 

interstate commerce of a misbranded 

drug and delivery thereof in violation of 

sections 301(c), 303(c), and 502(f) of the 

FD&C Act (21 U.S.C. 331(c), 333(a)(1), 

and 352(f)). On August 11, 2008, the 

U.S. District Court for the Central 

District of California entered judgment 

against Dr. Choi for the misdemeanor 

offense of receipt in interstate commerce 

of a misbranded drug and delivery 

thereof. 

FDA’s finding that debarment is 

appropriate is based on the 

misdemeanor conviction referenced 

herein. The factual basis for the 

conviction is as follows: Dr. Choi was a 

licensed physician in the State of 

California. Prior to November 13, 2003, 

Dr. Choi injected patients with Botox®, 

an FDA-approved Botulinum Toxin 

Type A drug product manufactured by 

Allergan, Inc. In 2003, Dr. Choi began 

ordering an unapproved drug purported 

to be Botulinum Toxin Type A (TRI– 

Toxin) manufactured by Toxin Research 

International, Inc. (TRI), located in 

Tucson, Arizona, instead of the 

approved Botox®. From on or about 

November 13, 2003, and continuing 

until about August 3, 2004, Dr. Choi 

placed 14 orders for a total of 28 vials 

of TRI–Toxin, which he had shipped to 

his office in the Central District of 

California. The TRI–Toxin did not come 

with labeling or directions on how to 

dilute the product for injection. The 

TRI–Toxin label stated ‘‘for research 

purposes only’’ and ‘‘not for human 

use,’’ as did the TRI–Toxin invoices. Dr. 

Choi admitted to injecting the TRI– 

Toxin into his employees and patients. 

Between on or about November 13, 

2003, and continuing until on or about 

August 3, 2004, Dr. Choi received and 

delivered the TRI–Toxin when he 

administered it to other persons, all in 

violation of sections 301(c), 303(c), and 

502(f) of the FD&C Act. 

As a result of his conviction, on April 

22, 2011, FDA sent Dr. Choi a notice by 

certified mail proposing to debar him 

for 4 years from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application. FDA subsequently 

confirmed on May 9, 2011, that Dr. Choi 

personally received the notice. The 

proposal was based on a finding, under 

section 306(b)(2)(B)(i)(I) of the FD&C 

Act that Dr. Choi 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 Dr. Choi 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. 

Choi failed to respond within the 

timeframe prescribed by regulation and 

has therefore, waived his opportunity 

for a hearing and waived 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(b)(2)(B)(i)(I) 

of the FD&C Act under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Andrew K. Choi 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, 

Dr. Choi is debarred for 4 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. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 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. Choi, in any capacity 

during Dr. Choi’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. Choi 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. Choi during his 

period of debarment (section 

306(c)(1)(B) of the FD&C Act). 

Any application by Dr. Choi for 

termination of debarment under section 

306(d)(1) of the FD&C Act (21 U.S.C. 

335a(d)(1)) should be identified with 

Docket No. FDA–2011–N–0126 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: July 27, 2011. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2011–19976 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0557] 

Advancing Regulatory Science for 

Highly Multiplexed Microbiology/ 

Medical Countermeasure Devices; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the following 

public meeting: ‘‘Advancing Regulatory 

Science for Highly Multiplexed 

Microbiology/Medical Countermeasure 

Devices.’’ The purpose of the public 

meeting is to discuss performance 

evaluation of highly multiplexed 

microbiology/medical countermeasure 

(MCM) devices, their clinical 

application and public health/clinical 

needs, and quality criteria for 

establishing the accuracy of reference 

databases. These considerations are 

essential to establish the safety and 

effectiveness of highly multiplexed 

devices when used for the clinical 

diagnosis of infectious diseases from a 

human specimen. 

Date and Time: The public meeting 

will be held on October 13, 2011, from 

8 a.m. to 6 p.m. 

Location: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

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48170 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 

rm. 1503 (the Great Room), Silver 

Spring, MD 20993–0002. For parking 

and security information, please visit 

the following Web site: http:// 

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. The public meeting 

will also be available to be viewed 

online via webcast. 

Contact Person: Raquel Peat, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

5561, Silver Spring, MD 20993–0002, 

301–796–6218, e-mail: 

raquel.peat@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: If you wish to attend or 

view the webcast of the public meeting, 

you must register online at http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select the appropriate 

meeting from the list). 

Provide complete contact information 

for each attendee, including name, title, 

affiliation, email, and telephone 

number. Registration requests should be 

received by September 13, 2011. 

If you wish to make an oral 

presentation during the open comment 

session at the meeting, you must 

indicate this at the time of registration. 

FDA has included general discussion 

topics for comment in section III of this 

document, Topics for Input. You should 

also identify which discussion topic you 

wish to address in your presentation. 

FDA will do its best to accommodate 

requests to speak. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. If the number of registrants 

requesting to speak is greater than what 

can be reasonably accommodated 

during the scheduled open public 

hearing session, FDA may conduct a 

lottery to determine the speakers for the 

scheduled open comment session. 

Registration is free and will be on a 

first-come, first-served basis. Early 

registration is recommended because 

seating is limited. FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once their registration has been 

accepted. Onsite registration on the day 

of the public meeting will be provided 

on a space-available basis beginning at 

7 a.m. Non-U.S. citizens are subject to 

additional security screening, and they 

should register as soon as possible. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4321, Silver Spring, 

MD 20993–0002, 301–796–5661, e-mail: 

susan.monahan@fda.hhs.gov at least 7 

days in advance of the meeting. 

Streaming Webcast of the Public 

Meeting: There will be a registration 

process for the webcast, and it will be 

on a first-come, first-served basis 

(maximum capacity: 900). If you have 

never attended a Connect Pro meeting 

before, test your connection at: https:// 

collaboration.fda.gov/common/help/en/ 

support/meeting_test.htm. To get a 

quick overview of the Connect Pro 

program, visit: http://www.adobe.com/ 

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Comments: In advance of the meeting, 

FDA will place its proposed evaluation 

approach to assess the performance of 

highly multiplexed microbiology/MCM 

devices on file in the public docket 

(docket number found in brackets in the 

heading of this document) and will post 

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

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm. 

The deadline for submitting comments 

to be presented at this public meeting is 

September 13, 2011 (see section III of 

this document.) 

Regardless of attendance at the public 

meeting, interested persons may submit 

either electronic or written comments 

on any discussion topic(s) to the open 

docket. The deadline for submitting 

comments to the docket is September 

13, 2011. Submit electronic comments 

to http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. It 

is only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

if responding to specific topics as 

outlined in section III of this document, 

please identify the topic you are 

addressing. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Highly multiplexed devices for the 

diagnosis of infectious diseases, 

including those caused by MCM-related 

pathogens, are a new generation of 

diagnostic products designed to 

simultaneously identify and 

differentiate a large number of 

pathogens from a single clinical 

specimen. This involves the testing of 

multiple targets through a common 

process of sample preparation, 

amplification and/or detection, and 

result interpretation. The identification 

of the organism is often based on 

sequence information compared to 

reference databases created either by the 

device manufacturer or otherwise 

publicly available. 

These diagnostic devices present 

several advantages, such as identifying 

potential disease etiology in situations 

where many different pathogens share a 

common clinical manifestation and the 

simultaneous detection of co-infections. 

However, establishing and validating 

the performance of these devices to 

make informed clinical and public 

health decisions poses significant 

scientific challenges. This public 

meeting is to discuss the performance 

evaluation of highly multiplexed 

microbiology/MCM device, their 

clinical application and public health/ 

clinical needs and quality criteria for 

establishing the accuracy of reference 

databases. These considerations are 

essential to establish the safety and 

effectiveness of highly multiplexed 

devices when used for the clinical 

diagnosis of infectious diseases from a 

human specimen. 

FDA is holding this public meeting to 

obtain input from academia, 

government, industry, clinical 

laboratories, and other stakeholders on 

the performance evaluation approach to 

be proposed by FDA, which includes 

validation methods, reference panels, 

and bioinformatic concepts needed to 

address the clinical and analytical 

performance requirements for highly 

multiplexed microbiology/MCM 

devices. The ultimate goal is to advance 

regulatory science for highly 

multiplexed devices used in pathogen 

detection in order to ensure their safety 

and effectiveness and thereby provide 

potential clinical and public health 

benefits. 

II. Meeting Overview 

The public meeting will consist of 

presentations providing background on 

current and anticipated uses for highly 

multiplexed microbiology devices that 

may contain MCM analytes, the 

performance evaluation approach 

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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 48171 

proposed by FDA, and information on 

reference databases; an open public 

comment session; and an open 

discussion on selected topics raised by 

the presentations (see section III of this 

document.) During the discussions, the 

participants will not be asked to 

develop consensus opinions but rather 

to provide their individual perspectives. 

Additional information, including a 

meeting agenda, will be available on the 

Internet, immediately after publication 

of this document in the Federal 

Register. The evaluation approach 

proposed by FDA is expected to be 

available at a later date. This 

information will be placed on file in the 

public docket (docket number found in 

brackets in the heading of this 

document), which is available at 

http://www.regulations.gov. This 

information will also be available at 

http://www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select the appropriate 

meeting from the list). 

III. Topics for Input 

FDA will seek input on its proposed 

performance evaluation approach, 

which will include the following topics: 

1. Clinical Application of Highly 

Multiplexed Microbiology Devices: Their 

clinical application and public health/ 

clinical needs; inclusion of MCMrelated pathogens that are expected to 

be rarely present in the tested 

specimens; the composition of clinically 

relevant panels of pathogens; the 

interpretation of the test results taking 

into consideration the possible 

detection of microorganisms that are not 

clinically relevant, and what is known 

and unknown about co-infections. 

2. Device Evaluation: How to evaluate 

the analytical and clinical performance 

of highly multiplexed microbiology 

devices; approaches to device validation 

when positive specimens are not easily 

available, which is the case for many 

MCM pathogens; sufficiency, feasibility, 

and practicality of the proposed FDA 

evaluation approach to establish device 

performance. 

3. Reference Databases: Quality 

criteria for establishing the accuracy of 

reference databases; methods for 

curating, maintaining, and updating 

these databases; what is the current 

practice for creating and maintaining 

reference databases. 

IV. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., rm. 1050, 

Rockville, MD 20857. 

Dated: August 2, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19996 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency; (b) the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: National Health 

Service Corps Site Application (OMB 

No. 0915–0230)—Revision 

The National Health Service Corps 

(NHSC) of the Bureau of Clinician 

Recruitment and Service (BCRS), Health 

Resources and Services Administration, 

is committed to improving the health of 

the Nation’s underserved by uniting 

communities in need with caring health 

professionals, and by supporting their 

efforts to build better systems of care. 

The NHSC Site Application, which 

renames and revises the previous 

Recruitment and Retention Assistance 

Application, requests information on 

the clinical service site, sponsoring 

agency, recruitment contact, staffing 

levels, service users, charges for 

services, employment policies, and 

fiscal management capabilities. 

Assistance in completing the 

application may be obtained through the 

appropriate State Primary Care Offices, 

State Primary Care Associations and the 

NHSC. The information on the 

application is used for determining the 

eligibility of sites for assignment of 

NHSC-obligated health professionals 

and to verify the need for NHSC 

clinicians. Approval as an NHSC service 

site is good for 3 years; sites wishing to 

remain eligible for assignment of NHSC 

providers must submit a new Site 

Application every 3 years. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

NHSC Site Application ......................................................... 3000 1 3000 0.5 1500 

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