ADDITIONAL INFORMATION FOR POTENTIAL APPLICANTS TO THE HUMAN PANCREATIC ISLET 
CELL RESOURCE CENTER (ICR) COOPERATIVE AGREEMENT

Release Date:  February 5, 2001

NOTICE:  NOT-RR-01-004

National Center for Research Resources
 (http://www.ncrr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)
Juvenile Diabetes Research Foundation International
 (http://www.jdf.org)

This notice is an addendum to RFA-RR-01-002, entitled “HUMAN PANCREATIC 
ISLET CELL RESOURCE CENTER (ICR)”, which was previously published as 
Request for Applications RR-01-002 in the NIH Guide for Grants and 
Contracts (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-01-002.html).

The listing of FDA guidance documents and information relevant to this 
RFA has been expanded to include:

CELL/TISSUE BASED DOCUMENTS

o "Guidance for Industry: Guidance for Human Somatic Cell Therapy and 
Gene Therapy" (1998) available at: 
http://www.fda.gov/cber/gdlns/somgene.pdf 

o "Points to Consider in the Characterization of Cell Lines Used to 
Produce Biologicals" (1993) available at: 
http://www.fda.gov/cber/gdlns/051793.pdf

o "Points to Consider in the Manufacture and Testing of Monoclonal 
Antibody Products for Human Use " (1997) 
available at: http://www.fda.gov/cber/gdlns/ptc_mab.pdf

PROPOSED AND FINAL RULES IMPACTING HUMAN ISLETS

o FEDERAL REGISTER Establishment Registration and Listing for 
Manufacturers of Human Cellular and Tissue-Based Products; Final Rule 
(1/2001) available at: http://www.fda.gov/cber/rules.htm

o FEDERAL REGISTER Current Good Tissue Practice for Manufacturers of 
Human Cellular and Tissue-Based Products; Inspection and Enforcement; 
Proposed Rule (1/2001) available at: http://www.fda.gov/cber/rules.htm 
- gtp

PANCREATIC ISLET SPECIFIC DOCUMENTS

o Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic 
Islets for Transplantation (9/2000) available at:  
http://www.fda.gov/cber/ltr/allpan090800.pdf

o Transcript of discussion of allogeneic pancreatic islets by FDA 
Biologic Response Modifier Advisory Committee (3/20-21/2000) available 
at: http://www.fda.gov/ohrms/dockets/ac/cber00.htm

SUBMISSION OF AN INVESTIGATIONAL NEW DRUG

o Including information on cGMP and GLP for a Biological Product 
available at: http://www.fda.gov/cber/ind/ind.htm 

Please direct programmatic inquiries to:

Richard Knazek, M.D. 
Medical Officer
Clinical Research Area
National Center for Research Resources
One Rockledge Centre, Room 6030
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone: (301) 435-0792
FAX: (301) 480-3661
Email: richardk@ncrr.nih.gov

or 

Joan T. Harmon, Ph.D.
Supervisor, Health Science Administration
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 601, MSC 5460
Bethesda, MD 20892
Phone: (301) 594-8813
FAX: (301) 480-3503
Email: harmonj@ep.niddk.nih.gov

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