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
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20643 

June 1, 2012. 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 June 4, 2012. 

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 Ann Marie 

Williams, at 

AnnMarie.Williams@fda.hhs.gov or 

301–796–5966, 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 30, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8166 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] 

Blood Products 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: Blood Products 

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 May 15, 2012, from 8:30 a.m. to 

5 p.m. and May 16, 2012 from 8 a.m. to 

4 p.m. 

Location: Hilton Washington DC/ 

North Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877, 301–977–8900. 

For those unable to attend in person, the 

meeting will also be Web cast. The Web 

cast will be available at the following 

links. 

Blood Products Advisory Committee 

Web Cast Link 

May 15 

http://fda.yorkcast.com/webcast/

Viewer/?peid=ba104b31fe4c4c0995

68bacda9a4e5401d. 

May 16 

http://fda.yorkcast.com/webcast/ 

Viewer/?peid=19caf3c8c1624acdaab

205ddde9c48581d. 

Contact Person: Bryan Emery or 

Rosanna Harvey, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–1297, 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 15, 2012, the 

committee will discuss as a device 

panel the evaluation of the safety and 

effectiveness of the OraQuick In-Home 

HIV Test. On May 16, 2012, the 

committee will discuss the evaluation of 

possible new plasma products frozen 

following in-process storage at room 

temperature for up to 24 hours, namely 

plasma for transfusion prepared from 

Whole Blood held at room temperature 

for up to 24 hours prior to separation 

and freezing, or from apheresis plasma 

held at room temperature for up to 24 

hours before freezing. In the afternoon, 

the committee will hear update 

presentations on the following topics: 

HHS activities related to the evaluation 

of the donor deferral policy for men 

who have had sex with other men; a 

summary of the November 8–9, 2011, 

public workshop on hemoglobin 

standards and maintaining an adequate 

blood supply; and a summary of the 

November 29, 2011, public workshop on 

data and data needs to advance risk 

assessment for emerging infectious 

diseases for blood and blood products. 

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 May 8, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. and 3:15 p.m. on May 15, 2012, 

and between approximately 11:30 a.m. 

and 12:45 p.m. on May 16, 2012. 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 30, 2012. 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 May 1, 2012. 

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 Bryan Emery, 

301–827–1277, or Rosanna Harvey, 301– 

827–1297, 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


Tkelley on DSK3SPTVN1PROD with NOTICES