[Federal Register: December 31, 2003 (Volume 68, Number 250)]
[Page 75577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Biological Response Modifiers Advisory Committee; Notice of 

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: Biological Response Modifiers Advisory 
    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 March 18, 2004, from 
approximately 8:30 a.m. and 5 p.m.; and on March 19, 2004, from 
approximately 8:30 a.m. to 3 p.m.
    Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD.
    Contact Person: Gail Dapolito or Rosanna Harvey, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3014, 
e-mail dapolito@cber.fda.gov, 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: On March 18 and 19, 2004, the committee will discuss issues 
related to the design of early phase clinical trials of cellular 
therapies for the treatment of cardiac diseases.
    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 by March 11, 
2004. Oral presentations from the public will be scheduled on March 18, 
2004, between approximately 4:30 p.m. and 5 p.m.; and on March 19, 
2004, between approximately 9:50 a.m. and 10:20 a.m. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 11, 2004, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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: December 22, 2003.
Peter J. Pitts,
Assoicate Commissioner for External Relations.
[FR Doc. 03-32242 Filed 12-30-03; 8:45 am]