[Federal Register: October 8, 2002 (Volume 67, Number 195)]
[Notices]
[Page 62729-62730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc02-102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biological Response Modifiers Advisory Committee; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Biological Response Modifiers
Advisory Committee. This meeting was originally announced in the
Federal Register of September 27, 2002 (67 FR 61142). The amendment is
being made to reflect a change in the Date and Time, Agenda, Procedure,
Location, and Closed Committee Deliberations portions of the meeting.
The meeting was originally scheduled as a teleconference on October 10,
2002, from 5:30 p.m. to 7:30 p.m. at the National Institutes of Health,
Bldg. 29C, 29 Lincoln Dr., Bethesda, MD. FDA added a discussion topic
related to
[[Page 62730]]
retrovirus vectors in gene therapies for the treatment of patients with
severe combined immune deficiency disease to the meeting and the
meeting will be held on October 10 at the Hilton DC North--
Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD from 8 a.m. to 5 p.m.
FOR FURTHER INFORMATION CONTACT: 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 call the 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 27,
2002 (67 FR 61142), FDA announced that a meeting of the Biological
Response Modifiers Advisory Committee would be held on October 10,
2002. This amendment is to update information provided earlier
pertaining to the meeting. On page 61142, beginning in the last column,
the Date and Time, Location, Agenda, Procedure, and Closed Committee
Deliberations portions of the meeting are amended to read as follows:
Date and Time: The meeting will be held on October 10, 2002, from 8
a.m. to approximately 5:30 p.m.
Location: Hilton DC North--Gaithersburg, Grand Ballrooms A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD.
Agenda: On October 10, 2002, the committee will discuss safety
issues recently identified related to retrovirus vectors in gene
therapies for the treatment of patients with severe combined immune
deficiency disease and receive updates on individual research programs
in the Division of Cell and Gene Therapies and the Division of
Therapeutic Proteins.
Procedure: On October 10, 2002, from 8 a.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 by
October 9. Oral presentations from the public will be scheduled between
approximately 11:30 a.m. to 12:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 9, 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 Deliberatons: On October 10, 2002, between
approximately 5 p.m. and 5:30 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 individual research programs in the
Center for Biologics Evaluation and Research.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 2, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-25641 Filed 10-3-02; 3:17 pm]
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