Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 22405 

B. Length of Support 

The scope of the proposed project will 

determine the project period. The 

maximum period is 5 years. 

III. Electronic Application, 

Registration, and Submission 

Only electronic applications will be 

accepted. To submit an electronic 

application in response to this FOA, 

applicants should first review the full 

announcement located at http:// 

grants.nih.gov/grants/guide/ (select the 

‘‘Request for Applications’’ link), 

http://www.grants.gov/ (see ‘‘For 

Applicants’’ section) and http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

PublicPrivatePartnershipProgram/ 

ucm166082.htm. (FDA has verified the 

Web site addresses throughout this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) For all 

electronically submitted applications, 

the following steps are required. 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number. 

• Step 2: Register With Central 

Contractor Registration. 

• Step 3: Obtain Username & 

Password. 

• Step 4: Authorized Organization 

Representative (AOR) Authorization. 

• Step 5: Track AOR Status. 

• Step 6: Register With Electronic 

Research Administration (eRA) 

Commons. 

Steps 1 through 5, in detail, can be 

found at http://www07.grants.gov/ 

applicants/organization_registration.jsp. 

Step 6, in detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit electronic applications to: 

http://www.grants.gov. 

Dated: April 13, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9650 Filed 4–20–11; 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). 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 June 29, 2011, from 8 a.m. to 

5 p.m. 

Location: Crowne Plaza Hotel, 8777 

Georgia Ave., Silver Spring, MD 20910. 

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), 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 29, 2011, the 

committee will discuss cellular and 

gene therapy products for the treatment 

of retinal disorders. Topics to be 

considered include the following: 

(1) Efficacy endpoints in pediatric and 

adult populations, (2) potential safety 

issues related to repeat administration 

or second eye administration, and 

(3) evaluation of product delivery into 

target site. 

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 22, 2011. Oral 

presentations from the public will be 

scheduled between approximately 

11:30 a.m. and 12:30 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 June 14, 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 June 15, 2011. 

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: April 13, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9653 Filed 4–20–11; 8:45 am] 

BILLING CODE 4160–01–P 


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