[Federal Register: April 29, 2002 (Volume 67, Number 82)]
[Page 20978-20979]
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.


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., 
Gaithersburg, MD.
    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.

[[Page 20979]]

    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]