19100 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

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Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–8164 Filed 4–5–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0450] 

Maria Carmen Palazzo: 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) 

permanently debarring Maria Carmen 

Palazzo, M.D. from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application. We base this order on a 

finding that Dr. Palazzo was convicted 

of felonies 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 any drug product under 

the FD&C Act. Dr. Palazzo was given 

notice of the proposed permanent 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. Dr. Palazzo 

failed to respond. Dr. Palazzo’s failure to 

respond constitutes a waiver of her right 

to a hearing concerning this action. 

DATES: This order is effective April 6, 

2011. 

ADDRESSES: Submit applications for 

special 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(a)(2)(A) and (B) of the 

FD&C Act (21 U.S.C. 335a(a)(2)(A) and 

(B)) require debarment of an individual 

if FDA finds that the individual has 

been convicted of 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 any drug product 

under the FD&C Act. 

On August 19, 2010, the United States 

District Court for the Eastern District of 

Louisiana accepted Dr. Palazzo’s plea of 

guilty, and entered judgment against her 

for 15 counts of failure to prepare and 

maintain records with intent to defraud 

or mislead in violation of 21 U.S.C. 

331(e), 333(a)(2), and 18 U.S.C. 2. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein for 

conduct relating to the development or 

approval, including the process for 

development or approval, of any drug 

product and otherwise relating to the 

regulation of any drug product under 

the FD&C Act. The factual basis for 

those convictions is as follows: Dr. 

Palazzo was a licensed medical doctor 

with offices located in New Orleans, 

Louisiana. SmithKline Beecham, 

Corporation, d.b.a. GlaxoSmithKline 

(SKB) was a pharmaceutical company 

engaged in developing, testing, and 

marketing pharmaceutical products 

including Paroxetine, also known as 

‘‘Paxil.’’ Under the FD&C Act and its 

implementing regulations, SKB had to 

apply to FDA for approval to market 

Paxil. SKB was required to demonstrate, 

through clinical investigations in which 

Paxil was given to human subjects, the 

safety and effectiveness of the drug in 

order to receive approval from FDA. 

SKB hired Dr. Palazzo to be a clinical 

investigator for the Paxil study. As a 

participating investigator, Dr. Palazzo 

signed, on multiple occasions, an FDA 

Form 1572 committing to conduct the 

study in accordance with the study 

protocol, to personally conduct or 

supervise the investigation, and to 

comply with FDA regulations. Dr. 

Palazzo agreed to conduct the study in 

strict compliance with the criteria set 

forth in the study protocol, to personally 

review all Case Report Forms, and, in 

return, SKB agreed to pay for each 

subject who completed the study. 

FDA regulations require that a clinical 

investigator on a drug study prepare and 

maintain adequate and accurate case 

histories that record all observations 

and other data pertinent to the 

investigation on each study subject and 

provide that information to the drug 

sponsor. From on or about October 23, 

2000, through May 24, 2001, Dr. 

Palazzo, with intent to defraud and 

mislead, failed to prepare and maintain 

records required under 21 U.S.C. 355(i) 

and 21 CFR 312.62(b), all in violation of 

21 U.S.C. 331(e), 333(a)(2), and 18 

U.S.C. 2. 

As a result of her convictions, on 

January 11, 2011, FDA sent Dr. Palazzo 

a notice by certified mail proposing to 

permanently debar her 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(a)(2)(A) and (B) of the FD&C Act, 

that Dr. Palazzo was convicted of 

felonies under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product and 

otherwise relating to the regulation of 

any drug product under the FD&C Act. 

The proposal also offered Dr. Palazzo 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. Dr. 

Palazzo 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(a)(2)(A) 

and(B) of the FD&C Act, under authority 

delegated to the Acting Director (Staff 

Manual Guide 1410.35), finds that Maria 

Carmen Palazzo has been convicted of 

felonies under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product and 

otherwise relating to the regulation of 

any drug product under the FD&C Act. 

As a result of the foregoing finding, 

Dr. Palazzo is permanently debarred 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices 19101 

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)(ii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), 

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. 

Palazzo, in any capacity during Dr. 

Palazzo’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. Palazzo 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 

Dr. Palazzo during her period of 

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

FD&C Act. 

Any application by Dr. Palazzo for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2010–N–0450 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 28, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–8152 Filed 4–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Request for Notification From Industry 

Organizations Interested in 

Participating in the Selection Process 

for a Nonvoting Industry 

Representative and Request for 

Nominations for a Nonvoting Industry 

Representative on an FDA Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of a 

nonvoting industry representative to 

serve on its Allergenic Products 

Advisory Committee notify FDA in 

writing. A nominee may either be selfnominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nomination 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating the interest to 

FDA by May 6, 2011 for vacancies listed 

in the notice. Concurrently, nomination 

material for prospective candidates 

should be sent to FDA by May 6, 2011. 

ADDRESSES: All letters of interest and 

nominations should be submitted in 

writing to Gail Dapolito (see FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: Gail 

Dapolito, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike, Rockville, MD 20852–1448, 301– 

827–1289, FAX: 301–827–0294, e-mail: 

gail.dapolito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Agency requests nominations for 

a nonvoting industry representative on 

the Allergenic Products Advisory 

Committee. The Allergenic Products 

Advisory Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to the regulation of allergenic 

products. This Committee has nine 

voting members. Members are asked to 

provide their expert scientific and 

technical advice to FDA to help make 

sound decisions on the safety, 

effectiveness, appropriate use, and 

labeling of allergenic biological 

products. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document. Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the Allergenic Products 

Advisory Committee. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner of Food and Drugs 

will select the nonvoting member to 

represent industry interests. 

III. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. A current 

curriculum vitae and the name of the 

committee of interest should be sent to 

the FDA contact person within the 30 

days following nomination. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees 

and, therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. Specifically, in this 

document, nominations for nonvoting 

representatives of industry interests are 

encouraged from the allergenic product 

manufacturing industry. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: March 31, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8125 Filed 4–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

mstockstill on DSKH9S0YB1PROD with NOTICES