Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 22405 [2011-9653]

Download as PDF Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices B. Length of Support ACTION: Notice. emcdonald on DSK2BSOYB1PROD with NOTICES The scope of the proposed project will determine the project period. The maximum period is 5 years. 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 III. Electronic Application, public. Registration, and Submission Name of Committee: Cellular, Tissue Only electronic applications will be and Gene Therapies Advisory accepted. To submit an electronic Committee. application in response to this FOA, General Function of the Committee: applicants should first review the full To provide advice and announcement located at https:// recommendations to the Agency on grants.nih.gov/grants/guide/ (select the FDA’s regulatory issues. ‘‘Request for Applications’’ link), Date and Time: The meeting will be https://www.grants.gov/ (see ‘‘For held on June 29, 2011, from 8 a.m. to Applicants’’ section) and https:// 5 p.m. www.fda.gov/AboutFDA/ PartnershipsCollaborations/ Location: Crowne Plaza Hotel, 8777 PublicPrivatePartnershipProgram/ Georgia Ave., Silver Spring, MD 20910. ucm166082.htm. (FDA has verified the Contact Person: Gail Dapolito or Web site addresses throughout this Sheryl Clark, Center for Biologics document, but FDA is not responsible Evaluation and Research (HFM–71), for any subsequent changes to the Web Food and Drug Administration, 1401 sites after this document publishes in Rockville Pike, Rockville, MD 20852, the Federal Register.) For all 301–827–0314, or FDA Advisory electronically submitted applications, Committee Information Line, 1–800– the following steps are required. 741–8138 (301–443–0572 in the • Step 1: Obtain a Dun and Bradstreet Washington, DC area), and follow the (DUNS) Number. prompts to the desired center or product • Step 2: Register With Central area. Please call the Information Line for Contractor Registration. up-to-date information on this meeting. • Step 3: Obtain Username & A notice in the Federal Register about Password. last minute modifications that impact a • Step 4: Authorized Organization previously announced advisory Representative (AOR) Authorization. committee meeting cannot always be • Step 5: Track AOR Status. published quickly enough to provide • Step 6: Register With Electronic timely notice. Therefore, you should Research Administration (eRA) always check the Agency’s Web site and Commons. call the appropriate advisory committee Steps 1 through 5, in detail, can be hot line/phone line to learn about found at https://www07.grants.gov/ possible modifications before coming to applicants/organization_registration.jsp. the meeting. Step 6, in detail, can be found at https:// Agenda: On June 29, 2011, the commons.era.nih.gov/commons/ committee will discuss cellular and registration/registrationInstructions.jsp. gene therapy products for the treatment After you have followed these steps, of retinal disorders. Topics to be submit electronic applications to: considered include the following: https://www.grants.gov. (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety Dated: April 13, 2011. issues related to repeat administration Leslie Kux, or second eye administration, and Acting Assistant Commissioner for Policy. (3) evaluation of product delivery into [FR Doc. 2011–9650 Filed 4–20–11; 8:45 am] target site. BILLING CODE 4160–01–P FDA intends to make background material available to the public no later than 2 business days before the meeting. DEPARTMENT OF HEALTH AND If FDA is unable to post the background HUMAN SERVICES material on its Web site prior to the meeting, the background material will Food and Drug Administration be made publicly available at the [Docket No. FDA–2011–N–0002] location of the advisory committee meeting, and the background material Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting will be posted on FDA’s Web site after the meeting. Background material is AGENCY: Food and Drug Administration, available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ HHS. VerDate Mar<15>2010 16:37 Apr 20, 2011 Jkt 223001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 22405 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 https://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 E:\FR\FM\21APN1.SGM 21APN1

Agencies

[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Page 22405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9653]


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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 https://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 https://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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