[Federal Register Volume 61, Number 46 (Thursday, March 7, 1996)]
[Notices]
[Pages 9185-9186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5584]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0200]


Regulatory Approach To Products Comprised of Living Autologous 
Cells Manipulated Ex Vivo and Intended for Structural Repair or 
Reconstruction; FDA Commissioner's Roundtable; Notice of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a FDA 
Commissioner's roundtable public meeting on the regulatory approach to 
products comprised of living autologous cells manipulated ex vivo and 
intended for structural repair or reconstruction. The purpose of this 
meeting is to discuss FDA's current thinking on the regulatory approach 
of these products with respect to clinical and manufacturing issues, 
and to get input on the agency's tentative approach. The comments 
received to the Dockets Management Branch in response to an earlier 
hearing held on November 16 and 17, 1995, will also be discussed.

DATES: The Commissioner's roundtable public meeting will be held on 
Friday, March l5, l996, from 8 a.m. to 5 p.m.

ADDRESSES: The Commissioner's roundtable public meeting will be held at 
the Parklawn Bldg., 5600 Fishers Lane, third floor, conference rooms C 
and D, Rockville, MD.

FOR FURTHER INFORMATION CONTACT: Emma J. Knight, Office of Blood 
Research and Review (HFM-305), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0969. Those persons interested in attending this 
meeting should FAX their registration to Emma J. Knight, 30l-827-2844, 
or Jeanne White, 30l-827-0926, including name(s), affiliation, address, 
telephone and FAX numbers by March l3, 1996. There is no registration 
fee for this public meeting, but advance registration is required. 
Space is limited and all interested parties are encourage to register 
early.

SUPPLEMENTARY INFORMATION: The purpose of this public meeting is to 
interact with interested persons on the good manufacturing practice and 
clinical issues related to products comprised of living autologous 
cells manipulated ex vivo and intended for surgical repair or 
reconstruction, and to discuss FDA's approach to these issues. FDA will 
take this public discussion into consideration in reaching a final 
decision on the approach the agency will take.


[[Page 9186]]


    Dated: February 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5584 Filed 3-5-96; 3:44 pm]
BILLING CODE 4160-01-F