[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Page 61142-61143]
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 by teleconference on 
October 10, 2002, 5:30 p.m. to approximately 7:30 p.m.
    Location: National Institutes of Health, Bldg. 29B, conference room 
C, 29 Lincoln Dr., Bethesda, MD. This meeting will be held by a 
telephone conference call. Members of the public attending the meeting 
may participate during the open session of the meeting.
    Contact Person: Gail Dapolito or Rosanna L. 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 10, 2002, the committee will receive an update 
on individual research programs in the Division of Cell and Gene 
Therapies and the Division of Therapeutic Proteins.
    Procedure: On October 10, 2002, from 5:30 p.m. to approximately 7 
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 October 3, 2002. Oral presentations from the public will be 
scheduled between approximately 6 p.m. and 7 p.m. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before October 3, 2002, 
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 10, 2002, from 
approximately 7 p.m. to 7:30 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 reports of a review of individual research programs

[[Page 61143]]

in the 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 10, 2002, Biological Response Modifiers Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring these issues to public discussion and qualified members of the 
Biological Response Modifiers Advisory Committee were available at this 
time, the Commissioner of Food and Drugs concluded that it was in the 
public interest to hold this meeting even if there was not sufficient 
time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 20, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-24605 Filed 9-26-02; 8:45 am]