Cellular, Tissue and Gene Therapies Advisory Committee (formerly Biological Response Modifiers Advisory Committee); Notice of Meeting, 38689 [05-13122]

Download as PDF Federal Register / Vol. 70, No. 127 / Tuesday, July 5, 2005 / Notices both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 28, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–13131 Filed 7–1–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Prospective Grant of Exclusive License: Diagnostics of Fungal Infections; Correction In the notice document appearing on page 33905 in the Federal Register issued on Friday, June 10, 2005, Vol. 70, No. 111, make the following correction: On page 33905 under Centers for Disease Control and Prevention, change the title ‘‘Prospective Grant of Exclusive License: Diagnostics of Fungal Infections’’ to ‘‘Prospective Grant of Exclusive License: System and Methods for Aerosolized Delivery of Vaccines’’ (remove previous title ‘‘Diagnostics of Fungal Infections’’). All other information in the document remains unchanged. Dated: June 24, 2005. James D. Seligman, Associate Director for Program Services, Centers for Disease Control and Prevention. [FR Doc. 05–13132 Filed 7–1–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee (formerly Biological Response Modifiers 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 VerDate jul<14>2003 18:41 Jul 01, 2005 Jkt 205001 recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held, via teleconference, on July 29, 2005, from 12:30 p.m. to 2:30 p.m. Location: National Institutes of Health, Bldg. 29B, conference room C, 8800 Rockville Pike, Rockville, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the previously mentioned location. A speakerphone will be provided at the specified location for public participation in the meeting. Contact Person: Gail Dapolito, 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), code 3014512389. Please call the Information Line for up-to-date information on this meeting. Agenda: In open session, the committee will hear brief opening remarks and allow time for public participation and comments related to individual FDA research programs during the open public hearing. The committee will not hear presentations or discuss individual research programs in the open session (see Closed Committee Deliberations below). Procedure: On July 29, 2005, from 12:30 p.m. to 1:30 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 by July 21, 2005. Oral presentations from the public will be scheduled between approximately 12:30 p.m. to 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 21, 2005, 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. Closed Committee Deliberations: On July 29, 2005, from approximately 1:30 p.m. to 2:30 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 review of individual FDA research programs. Persons attending FDA’s advisory committee meetings are advised that the PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 38689 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. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 23, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–13122 Filed 7–1–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D–0333] Draft Guidance; Emergency Use Authorization of Medical Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft guidance entitled ‘‘Emergency Use Authorization of Medical Products.’’ The draft guidance explains FDA’s policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. The draft guidance is not final and is not in effect at this time. FDA also is announcing an opportunity for public comment on the proposed collection of information related to emergency use authorizations by the agency. DATES: Submit written or electronic comments on the draft guidance and the proposed collection of information by September 6, 2005. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Counterterrorism Policy and Planning (HF–29), Food and Drug Administration, 5600 Fishers Lane, rm. 14C–26, Rockville, MD 20857. Send a self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–827–5671. Submit written comments on the draft guidance and the proposed collection of information to the Division of Dockets E:\FR\FM\05JYN1.SGM 05JYN1

Agencies

[Federal Register Volume 70, Number 127 (Tuesday, July 5, 2005)]
[Notices]
[Page 38689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cellular, Tissue and Gene Therapies Advisory Committee (formerly 
Biological Response Modifiers 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, via teleconference, on 
July 29, 2005, from 12:30 p.m. to 2:30 p.m.
    Location: National Institutes of Health, Bldg. 29B, conference room 
C, 8800 Rockville Pike, Rockville, MD. This meeting will be held by 
teleconference. The public is welcome to attend the meeting at the 
previously mentioned location. A speakerphone will be provided at the 
specified location for public participation in the meeting.
    Contact Person: Gail Dapolito, 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), code 
3014512389. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: In open session, the committee will hear brief opening 
remarks and allow time for public participation and comments related to 
individual FDA research programs during the open public hearing. The 
committee will not hear presentations or discuss individual research 
programs in the open session (see Closed Committee Deliberations 
below).
    Procedure: On July 29, 2005, from 12:30 p.m. to 1:30 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 by 
July 21, 2005. Oral presentations from the public will be scheduled 
between approximately 12:30 p.m. to 1:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 21, 2005, 
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.
    Closed Committee Deliberations: On July 29, 2005, from 
approximately 1:30 p.m. to 2:30 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 review of individual FDA research programs.
    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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13122 Filed 7-1-05; 8:45 am]
BILLING CODE 4160-01-S

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