[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Page 56193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28671]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biologics License Application for Blood Products, and Reporting
Changes to an Approved Application; Public Workshop
AGENCY: Food and Drug Administration.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Workshop on the Biologics License Application (BLA)
for Blood Products, and Reporting Changes to an Approved Application.''
The topics to be discussed include completing Form FDA 356h; chemistry,
manufacturing, and controls information; establishment information;
changes requiring supplement submission and approval; changes requiring
supplement submission at least 30 days prior to distribution; changes
to be described in an annual report; and comparability protocols.
Date and Time: The workshop will be held on December 2, 1997, 8:30
a.m. to 5 p.m.
Location: The workshop will be held at Jack Masur Auditorium,
National Institutes of Health, 8800 Rockville Pike, Bldg. 10, Bethesda,
MD 20892.
Contact: Joseph Wilczek, Center for Biologics Evaluation and
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-3514, FAX 301-827-2843.
SUPPLEMENTARY INFORMATION: The public workshop is intended for firms
which manufacture or intend to manufacture licensed human blood
products, including products for transfusion and source materials for
further manufacture. The workshop is also intended for firms planning
to supplement their current license for additional products or
modifications to current products.
The goals for the workshop are to provide guidance on the
application procedures, forms, and documentation needed for the single
BLA and guidance on how changes to approved applications are to be
reported to the FDA.
Registration: Early registration is recommended on or before
Friday, November 21, 1997. Mail or fax registration information
(including name, title, firm name, address, telephone, and fax number)
to Michelle Priester Healy, Conference Management Associates, Inc.,
1010 Wayne Ave., suite 450, Silver Spring, MD 20910, 301-585-8203, FAX
301-585-1186, e-mail [email protected]. Registration at the site will
be done on a space available basis on the day of the workshop,
beginning at 7:30 a.m. There is no registration fee for the workshop.
If you need special accommodations due to a disability, please
contact Michelle Priester Healy at least 7 days in advance.
Transcripts: Transcripts of the meeting may be requested in writing
from the Freedom of Information Office (HFI-35), Food and Drug
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
Dated: October 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-28671 Filed 10-28-97; 8:45 am]
BILLING CODE 4160-01-F