Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 65640-65641 [2010-27063]

Download as PDF 65640 Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; U.S.-Bilateral Collaborative Research Partnerships (CRP) on the Prevention of HIV/AIDS and Co-morbidities (R21). Date: December 1–2, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Regency, Rockville, MD 20852. Contact Person: Eugene R. Baizman, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–402– 1464, eb237e@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 20, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–27055 Filed 10–25–10; 8:45 am] BILLING CODE 4140–01–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. emcdonald on DSK2BSOYB1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming teleconference 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. VerDate Mar<15>2010 18:09 Oct 25, 2010 Jkt 223001 Date and Time: The teleconference meeting will be held on December 14, 2010, from 3 p.m. to 6 p.m. EST. Location: National Institutes of Health (NIH). Bldg. 29B, Conference Room C. The public is welcome to attend the meeting at the specified location 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 https://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 https://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, 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 December 14, 2010, the committee will meet in open session to hear updates of the research programs in the Tumor Vaccines and Biotechnology Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA. 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: On December 14, 2010, from 3 p.m. to 5 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 December 7, 2010. Oral presentations from the public will be scheduled between approximately 4 p.m. and 5 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 29, 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 30, 2010. Closed Committee Deliberations: On December 14, 2010, from 5 p.m. to 6 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 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. E:\FR\FM\26OCN1.SGM 26OCN1 Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 21, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. [FR Doc. 2010–27063 Filed 10–25–10; 8:45 am] Dated: October 21, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160–01–P [FR Doc. 2010–27060 Filed 10–25–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2010–N–0001] [Docket No. FDA–2010–N–0001] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. emcdonald on DSK2BSOYB1PROD with NOTICES ACTION: ACTION: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register of September 20, 2010 (75 FR 57279). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, Office of Policy, Planning and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3278, Silver Spring, MD 20993, 301–796–9151, FAX: 301– 847–8611, e-mail: RCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 8732112560. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of September 20, 2010, FDA announced that a meeting of the Risk Communication Advisory Committee would be held on November 8 and 9, 2010. On page 57280, in the first column, the Agenda portion of the document is changed to read as follows: Agenda: On November 8 and 9, 2010, the Committee will hear and discuss developments in FDA’s ongoing communications programs, such as FDA’s Strategic Plan for Risk Communication, FDA’s Transparency Initiative, foodborne outbreaks and related recall communications, and the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when a patient is prescribed a medical device for home use. 18:09 Oct 25, 2010 AGENCY: Food and Drug Administration, HHS. Notice. VerDate Mar<15>2010 Tobacco Products Scientific Advisory Committee; Notice of Meeting Jkt 223001 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: Tobacco Products Scientific 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 18, 2010, from 1 p.m. until 5 p.m. Location: FDA White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You’’ click on ‘‘White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.’’ Contact Person: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373 (choose Option 4), e-mail: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 8732110002. 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 65641 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 18, 2010, the committee will (1) Receive an update on the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee. 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 November 9, 2010. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 p.m. on November 18, 2010. 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 1, 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 2, 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 Caryn Cohen E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65640-65641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27063]


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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 teleconference 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 teleconference meeting will be held on December 
14, 2010, from 3 p.m. to 6 p.m. EST.
    Location: National Institutes of Health (NIH). Bldg. 29B, 
Conference Room C. The public is welcome to attend the meeting at the 
specified location 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 https://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 https://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, 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 December 14, 2010, the committee will meet in open 
session to hear updates of the research programs in the Tumor Vaccines 
and Biotechnology Branch, Office of Cellular, Tissue and Gene 
Therapies, Center for Biologics Evaluation and Research, FDA.
    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: On December 14, 2010, from 3 p.m. to 5 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 December 7, 2010. Oral presentations from the public will be 
scheduled between approximately 4 p.m. and 5 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 29, 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 30, 2010.
    Closed Committee Deliberations: On December 14, 2010, from 5 p.m. 
to 6 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.

[[Page 65641]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27063 Filed 10-25-10; 8:45 am]
BILLING CODE 4160-01-P

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