Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20641 

with an approved or pending drug 

product application who knowingly 

employs or retains as a consultant or 

contractor, or otherwise uses the 

services of Mr. Shah, in any capacity 

during Mr. Shah’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 Mr. Shah 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 (21 U.S.C. 335b(a)(7))). In 

addition, FDA will not accept or review 

any abbreviated new drug applications 

submitted by or with the assistance of 

Mr. Shah during his period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Mr. Shah for 

termination of debarment under section 

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

355a(d)(1)) should be identified with 

Docket No. FDA–2011–N–0659 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 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8229 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0331] 

Jose Concepcion: 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 

Jose Concepcion 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 Mr. 

Concepcion was convicted of 

conspiracy to commit an offense against 

the United States, that the conduct that 

served as the basis for the felony 

conspiracy conviction relates to the 

development or approval, including the 

process for development or approval, of 

any drug product and relates to the 

regulation of drug products under the 

FD&C Act, and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

Mr. Concepcion was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Mr. 

Concepcion failed to request a hearing. 

Mr. Concepcion’s failure to request a 

hearing constitutes a waiver of his right 

to a hearing concerning this action. 

DATES: This order is effective April 5, 

2012. 

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, Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., rm. 

4144, Rockville, MD 20857, 301–796– 

4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(II) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(II)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a conspiracy to commit a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product or 

otherwise relating to the regulation of a 

drug product under the FD&C Act, 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 December 1, 2010, based upon a 

plea of guilty to one count of conspiracy 

to commit an offense against the United 

States, in violation of 18 U.S.C. 371, 

judgment was entered against Mr. 

Concepcion in the U.S. District Court for 

the District of New Jersey. 

FDA’s finding that debarment is 

appropriate is based on the conspiracy 

conviction referenced herein. The 

factual basis for the conviction is as 

follows: Mr. Concepcion was employed 

at Able Laboratories, Inc. (Able) from 

mid-1998 until January 2005. Able 

developed, manufactured, and sold 

several generic drug products, including 

products for cardiac and psychiatric 

conditions and prescription pain 

relievers. Mr. Concepcion was 

employed as a chemist in the Quality 

Control Department performing 

analytical tests on Able products to 

ensure product safety and effectiveness 

from in or around mid-1998 to around 

January 2001. In or around January 

2001, Mr. Concepcion was promoted to 

group leader and around April 2002, he 

was promoted to supervisor in the 

Quality Control Department. 

As group leader and supervisor in the 

Quality Control Department, Mr. 

Concepcion’s responsibilities included 

supervising numerous chemists and 

technicians who performed analytical 

quality control tests on Able’s generic 

drug products to ensure product safety 

and effectiveness; monitoring the 

chemists’ compliance with current Good 

Manufacturing Practices, as required by 

the FD&C Act and FDA regulations; and 

ensuring compliance with Able’s 

standard operating procedures (SOPs). 

From in or around 1999 through 

January, 2005, Mr. Concepcion 

conspired to cause the introduction and 

delivery for introduction into interstate 

commerce of a drug that was adulterated 

and misbranded, with an intent to 

defraud and mislead, contrary to 18 

U.S.C. 371 and 21 U.S.C. 331(a) and 

333(a)(2). 

Mr. Concepcion and his coconspirators impaired, impeded, 

defeated, and obstructed FDA’s lawful 

government function to approve the 

manufacture and distribution of generic 

drug products by violating Good 

Manufacturing Practices; violating SOPs 

by failing to properly investigate, log, 

and archive questionable, aberrant, and 

unacceptable laboratory results so that 

Able could conceal improprieties and 

continue to distribute and sell its drug 

products; manipulating and falsifying 

testing data and information to conceal 

from FDA failing laboratory results 

relating to Able’s generic drug products; 

creating and maintaining false, 

fraudulent, and inaccurate test results to 

make it appear that drug products had 

the requisite identity, strength, quality, 

and purity characteristics so the drug 

products could be distributed and sold 

to increase Able’s sales and profit; and 

creating and maintaining false, 

fraudulent, and inaccurate data and 

records to obtain FDA approval to 

market new product lines. 

In furtherance of the conspiracy, in or 

around December 2001, Mr. Concepcion 

and his co-conspirators falsified and 

manipulated testing data relating to 

stability tests for propoxphene napsylate 

and acetaminophen. 

As a result of his conviction, on 

January 6, 2012, FDA sent Mr. 

Concepcion a notice by certified mail 

proposing to debar him for 5 years from 

providing services in any capacity to a 


Tkelley on DSK3SPTVN1PROD with NOTICES
20642 Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 

person that has an approved or pending 

drug product application. The proposal 

was based on a finding, under section 

306(b)(2)(B)(i)(II) of the FD&C Act, that 

Mr. Concepcion was convicted of 

conspiracy to commit an offense against 

the United States, that the conduct that 

served as the basis for the felony 

conspiracy conviction relates to the 

development or approval, including the 

process for development or approval, of 

any drug product and relates 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 Mr. Concepcion 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. Mr. Concepcion 

failed to request a hearing 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)(II) 

of the FD&C Act under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Jose Concepcion has 

been convicted of a felony 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, 

Mr. Concepcion 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 section 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 Mr. Concepcion, in any 

capacity during Mr. Concepcion’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 Mr. 

Concepcion 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 

Mr. Concepcion during his period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Mr. Concepcion 

for termination of debarment under 

section 306(d)(1) of the FD&C Act (21 

U.S.C. 355a(d)(1)) should be identified 

with Docket No. FDA–2009–N–0331 

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 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8249 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: General and 

Plastic Surgery Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 21, 2012, from 8 a.m. to 6 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, salons A, B, C, and 

D, 620 Perry Pkwy., Gaithersburg, MD 

20877. The hotel telephone number is 

301–977–8900. 

Contact Person: Avena Russell, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

1535, Silver Spring, MD 20993–0002, 

Avena.Russell@fda.hhs.gov, 301–796– 

3805, 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 June 21, 2012, the 

committee will discuss, make 

recommendations, and vote on 

information related to the premarket 

approval application, sponsored by 

Dune Medical Devices, Inc., for the 

MarginProbe System, that utilizes 

electromagnetic waves to characterize 

human tissue in real time and provides 

intraoperative information on the 

malignancy of the surface of the ex vivo 

lumpectomy specimen. 

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 committee. Written 

submissions may be made to the contact 

person on or before June 11, 2012. 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 


Tkelley on DSK3SPTVN1PROD with NOTICES