[Federal Register Volume 67, Number 195 (Tuesday, October 8, 2002)]
[Notices]
[Pages 62729-62730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25641]


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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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