Federal Register / Vol. 75, No. 208 / Thursday, October 28, 2010 / Notices 66381 

various voting machines to allow for 

equal opportunity for access and 

participation in the voting process. 

FOR FURTHER INFORMATION CONTACT: 

Ophelia McLain, Supervisory Program 

Specialist, Administration on 

Developmental Disabilities, 370 

L’Enfant Promenade, SW., Mail Stop: 

HHH–405D, Washington, DC 20447. 

Telephone: 202–690–7025. E-mail: 

ophelia.mclain@acf.hhs.gov. 

Dated: October 21, 2010. 

Sharon Lewis, 

Commissioner, Administration on 

Developmental Disabilities. 

[FR Doc. 2010–27234 Filed 10–27–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

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). The meeting will be open 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 November 19, 2010, from 8:30 

a.m. to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Gail Dapolito or 

Sheryl Clark, Center for Biologics 

Evaluation and Research (HFM–71), 

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), code 

3014512389. 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 November 19, 2010, the 

Committee will discuss current FDA 

recommendations for Testing of 

Replication Competent Retrovirus 

(RCR)/Lentivirus (RCL) in Retroviral 

and Lentiviral Vector Based Gene 

Therapy 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 November 12, 2010. 

Oral presentations from the public will 

be scheduled between approximately 2 

p.m. to 3 p.m. Those desiring to make 

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 November 4, 2010. 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 

November 5, 2010. 

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: October 22, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–27229 Filed 10–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0553] 

Pediatric 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: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

DATES: The meeting will be held on 

December 6, 2010, from 8 a.m. to 6 p.m. 

FDA is opening a docket to allow for 

additional public comments to be 

submitted to the Agency on the issues 

before the Pediatric Advisory 

Committee. Submit either electronic or 

written comments by January 6, 2011. 

ADDRESSES: The meeting will be held at 

the Bethesda Marriott, 5151 Pooks Hill 

Rd., Bethesda, MD 20814. 

Submit electronic comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Contact Person: Walter Ellenberg, 

Office of Pediatric Therapeutics, Office 

of Special Medical Programs, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5154, Silver Spring, 

MD 20993, 301–796–0885, or FDA 


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