[Federal Register: September 18, 2003 (Volume 68, Number 181)]
[Page 54733-54734]
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). At least one 
portion of the meeting will be closed 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 October 9, 2003, from 8 
a.m. to 6 p.m.; and on October 10, 2003, from 8 a.m. to 2 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
Gaithersburg, 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, 301-827-0314, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12389. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On October 9 and 10, 2003, the committee will discuss the 
following topics: (1) Issues related to manufacturing data and clinical 
evidence to be provided in a biologics license application (BLA) for 
marketing approval of allogeneic islet transplantation to treat type 1 
diabetes mellitus, (2) hear updates of individual research programs in 
the Office of Cellular, Tissue and Gene Therapies, and (3) reports of 
internal research programs in the Office of Cellular, Tissue and Gene 
    Procedure: On October 9, 2003, from 8 a.m. to approximately 5:15 
p.m.; and on October 10, 2003, from 8 a.m. to approximately 2 p.m., the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending

[[Page 54734]]

before the committee. Written submissions may be made to the contact 
person by October 2, 2003. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 1:30 p.m. on October 9 and 
between approximately 10:30 a.m. and 11 a.m. on October 10. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 2, 2003, 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 October 9, 2003, from 
approximately 5:15 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 a review of internal 
research programs in the Office of Cellular, Tissue and Gene Therapies, 
Center for Biologics Evaluation and Research.
    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: September 9, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23780 Filed 9-17-03; 8:45 am]