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: 

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