18768 Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Notices 

promote actions or documents within 

their own jurisdictions and seek 

convergence of regulatory policies and 

practices. Successful implementation 

will require input from stakeholders. 

The agenda for the public meeting 

will be made available on the Internet 

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

InternationalActivities/Conferences

MeetingsWorkshops/International

CooperationonCosmeticsRegulations

ICCR/default.htm. 

Dated: March 30, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7966 Filed 4–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Cellular, Tissue, and Gene Therapies 

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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Cellular, Tissue, 

and Gene Therapies 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 31, 2011, from 2:30 p.m. 

to 6:15 p.m. 

Location: National Institutes of Health 

(NIH) Campus, 29 Lincoln Dr., Bldg. 

29B, Conference Rooms A and B, 

Bethesda, MD 20892. 

The public is welcome to attend the 

meeting at NIH, Building 29B, 

Conference Rooms A and B, where a 

speakerphone will be provided. Public 

participation in the meeting is limited to 

the use of the speakerphone in the 

conference room. Important information 

about transportation and directions to 

the NIH campus, parking, and security 

procedures is available on the Internet 

at http://www.nih.gov/about/visitor/ 

index.htm. (FDA has verified the Web 

site address, but FDA is not responsible 

for any subsequent changes to the Web 

site after this document publishes in the 

Federal Register.) Visitors must show 

two forms of identification, one of 

which must be a government-issued 

photo identification such as a Federal 

employee badge, driver’s license, 

passport, green card, etc. Detailed 

information about security procedures is 

located at http://www.nih.gov/about/ 

visitorsecurity.htm. Due to the limited 

available parking, visitors are 

encouraged to use public transportation. 

Contact Person: Gail Dapolito or 

Sheryl Clark (HFM–71), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, 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 31, 2011, the 

committee will meet in open session to 

hear brief overviews of research 

programs in the Laboratory of 

Biochemistry, Division of Therapeutic 

Proteins, Center for Drug Evaluation and 

Research; and the Laboratory of Cell 

Biology, the Laboratory of Molecular 

and Developmental Immunology, the 

Laboratory of Molecular Oncology, 

Division of Monoclonal Antibodies, 

Center for Drug Evaluation and 

Research. 

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: On May 31, 2011, from 

2:30 p.m. to approximately 5:15 p.m., 

the meeting is open to the public. 

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 24, 2011. Oral presentations from 

the public will be scheduled between 

approximately 4:15 p.m. and 5:15 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 May 16, 2011. 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 17, 2011. 

Closed Committee Deliberations: On 

May 31, 2011, from 5:15 p.m. to 6:15 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

a report of intramural research programs 

and make recommendations regarding 

personnel staffing decisions. 

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 Gail Dapolito 

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/ 

AdvisoryCommittees/ 

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, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7968 Filed 4–4–11; 8:45 am] 

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