[Federal Register: April 29, 2002 (Volume 67, Number 82)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biological Response Modifiers Advisory Committee; Notice of
AGENCY: Food and Drug Administration, HHS.
SUMMARY: 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 is 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 May 9, 2002, from 8 a.m.
to 6:30 p.m. and on May 10, 2002, from 8 a.m. to 3 p.m.
Location: Hilton Hotel, DC North-Gaithersburg, 620 Perry Pkwy.,
Contact Person: Gail Dapolito, Center for Biologics Evaluation and
Research (HFM-71) 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 May 9, 2002, at 8 a.m., the committee will receive
updates of research programs in the Division of Therapeutic Proteins
and the Division of Monoclonal Antibodies; at 9 a.m., the committee
will discuss issues related to ooplasm transfer in assisted
reproduction. On May 10, 2002, the committee will discuss issues
related to inadvertent germline transmission of gene transfer vectors.
Procedure: On May 9, 2002, from 8 a.m. to 8:45 a.m. and from 9 a.m.
to 6:30 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 May 2, 2002. Oral presentations from the public are
scheduled between approximately 3:35 p.m. and 4:05 p.m. on May 9, 2002,
and from 11:40 a.m. to 12:10 p.m. on May 10, 2002. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 2, 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 May 9, 2002, from 8:45 a.m. to
9:00 a.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
the review of research programs in the Division of Therapeutic Proteins
and Division of Monoclonal Antibodies.
FDA regrets that it was unable to publish this notice 15 days prior
to the May 9 and 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.
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
accommodation due to a disability, please contact Gail Dapolito or
Rosana L. Harvey 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: April 23, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
[FR Doc. 02-10508 Filed 4-24-02; 3:29 pm]
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