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        PART VI - REFERENCES AND CONTACTS

      1. References
        1. FFDCA - Sections 501(i), 505(i) and 505(k)(2)
        2. Regulations in 21 CFR Parts 11, 50, 56, 312, 314, 511, 514, 809, 812, and 814.
        3. SPECIFIC FORMS
          1. FDA Form 1571 - Investigational New Drug Application (See 21 CFR 312.40)
          2. FDA Form 1572 - Statement of Investigator, (See 21 CFR 312.53(c))
          3. Notice of claimed investigational exemption for a new animal drug, (See 21 CFR 511.1(b)(4)).
        4. ICH Good Clinical Practice Consolidated Guideline, May 1997.
        5. Guideline for the Monitoring of Clinical Investigations, January 1988.
        6. Good Target Animal Study Practices: Clinical Investigators and Monitors, May 1997.
      2. Program Contacts

        3. When technical questions arise on a specific assignment, or when additional information or guidance is required, contact the assigning Center. Operational questions should be addressed to HFC-130.

        1. Office of the Associate Commissioner for Regulatory Affairs
          1. Office of Enforcement, Division of Compliance Policy: Dr. James F. McCormack, HFC-230, 301-827-0425, FAX 301-827-0482.
          2. Office of Regional Operations, Division of Emergency and Investigational Operations: Dr. Thaddeus Sze, HFC-130, 301-827-5649, FAX 301-443-6919.
        2. Center for Drug Evaluation and Research (CDER), Division of Scientific Investigations:
          1. Good Clinical Practice Branch I – Dr. John Martin, HFD-46, 301-594-1032, FAX 301-827-5290.
          2. Good Clinical Practice Branch II – Dr. Antoine El Hage, HFD-47, 301-594-1032, FAX 301-827-5290.
        3. Center for Biologics Evaluation and Research (CBER)

          4. Division of Inspections and Surviellance – Mr. Joseph Salewski, HFM- 664, 301-827-6221, FAX 301-827-6748.

        4. Center for Veterinary Medicine (CVM)

          5. Bioresearch Monitoring Staff: Ms. Dorothy Pocurull, HFV-234, 301-827-6664, FAX 301-827-1498.

        5. Center for Devices and Radiological Health (CDRH)

          6. Division of Bioresearch Monitoring: Ms. Barbara Crowl, HFZ-311, 301-594-4720, FAX 301-594-4731.

        6. Center for Food Safety and Applied Nutrition (CFSAN)
          Division of Product Policy: Dr. John Welsh, HFS-207, 202-418-3057, FAX 202-418-3126.

         
Hypertext updated April 5, 2001 tmc