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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