[Federal Register Volume 60, Number 73 (Monday, April 17, 1995)]
[Notices]
[Pages 19266-19267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9411]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Regulatory Concerns in Biopharmaceutical Manufacturing; Notice of 
Public Workshops

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) (Office of Regulatory 
Affairs, Office of the Pacific Region, Office of the Southwest Region, 
Center for Biologics Evaluation and Research, Center for Drug 
Evaluation and Research, and Office of External Affairs) is announcing 
a series of three free public workshops to assist small companies that 
are developing and producing biopharmaceutical and biologic therapeutic 
products for clinical trials and product marketing approval. The 
workshops will address regulatory policy, licensing requirements, 
cooperative manufacturing arrangements, multi-product facilities, 
clinical trial design, and manufacturing requirements for clinical 
material.

DATES: The public workshops are scheduled as follows:
1. Monday, May 22, 1995, 8:30 a.m. to 5 p.m., Houston, TX.
2. Wednesday, May 24, 1995, 8:30 a.m. to 5 p.m., San Diego, CA.
3. Friday, May 26, 1995, 8:30 a.m. to 5 p.m., San Francisco, CA.

ADDRESSES: The public workshops will be held at the following 
locations:
1. Houston--Rice University, Sewall Hall, rm. 301, Houston, TX.
2. San Diego--Pan Pacific Hotel, 400 West Broadway, San Diego, CA.
3. San Francisco--Holiday Inn Golden Gateway, 1500 West Van Ness Ave., 
San Francisco, CA.
FOR FURTHER INFORMATION CONTACT:
Regarding registration for the Houston TX, public workshop: Marie T. 
Falcone, Small Business Representative Southwest Region, Food and Drug 
Administration, 7920 Elmbrook Dr., suite 102, Dallas, TX 75247, 214-
655-8100, ext. 128 or FAX 214-655-8130.
Regarding registration for the San Diego and San Francisco workshops: 
Mark S. Roh, Small Business Representative Pacific Region, Food and 
Drug Administration, Federal Office Bldg., 50 United Nations Plaza, San 
Francisco, CA 94102, 415-556-2263 or FAX 415-556-2822.
SUPPLEMENTARY INFORMATION: The public workshops are free of charge, 
however registration is required. Due to space limitations, early 
registration is recommended. To register please submit your name(s), 
affiliation, address, phone and fax numbers and any specific questions 
you want addressed at the workshop, to the contact person listed above.
    The workshops are to further assist small companies that are 
developing and producing biopharmaceutical and biologic therapeutic 
products in better understanding current regulatory policy; licensing 
requirements for products and establishments and cooperative 
manufacturing arrangements; multiproduct facilities design and 
operation; clinical trial design and monitoring; points to consider 
during processing, cell culture, fermentation, harvest, recovery, 
purification and [[Page 19267]] ascites production; and current good 
manufacturing practice requirements in the production of clinical 
material, including recordkeeping, processing changes, and 
environmental monitoring.

    Dated: April 12, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-9411 Filed 4-14-95; 8:45 am]
BILLING CODE 4160-01-F