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  4. FDA Bioresearch Monitoring Information
  1. FDA Bioresearch Monitoring Information


  1. References
    1. Guide for the Care and Use of Laboratory Animals, DHHS Publication No. (NIH) 96-23
    2. The Animal Welfare Act, 9 CFR Parts 1, 2, 3
    3. 21 CFR 11 - Electronic Records. Electronic Signatures Regulation effective August 1997.
    4. 21 CFR 58.1 - 58.219 Good Laboratory Practice Regulations effective June 1979, and amended effective October 1987
    5. Good Laboratory Practice Regulations, Management Briefings, Post Conference Report, August 1979
    6. Good Laboratory Practice Regulations, Questions and Answers, June 1981
    7. "Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives used in Food," FDA, Bureau of Foods
    8. "Guide to Inspection of Computerized Systems in Drug Processing," February 1983
    9. "Software Development Activities, Technical Report" July 1987
    10. "Guide For Detecting Fraud in Bioresearch Monitoring Inspections," April 1993

    Copies of the listed references may be obtained from HFC-130.

  2. Program Contacts
  3. Questions regarding the interpretation of the regulations or agency policy should be addressed to the Bioresearch Monitoring Program Coordinator (HFC-230). When technical questions arise on a specific assignment, or when additional information or guidance is required, contact the assigning Center.

    1. Specific Contacts

    Office of the Associate Commissioner for Regulatory Affairs

    Office of Enforcement, Division of Compliance Policy: Dr. James F. McCormack, HFC-230, 301-827-0425, FAX 301-827-0482.

    Office of Regional Operations, Division of Emergency and Investigational Operations: Dr. Thaddeus Sze, HFC-130, 301-827-5649, FAX 301-827-6685.

    Center for Drug Evaluation and Research (CDER)

    Division of Scientific Investigations: Mr. Ty Fujiwara, HFD-48, 301-827-7287, FAX 301-594-1204.

    Center for Biologics Evaluation and Research (CBER)

    Bioresearch Monitoring Staff: Dr. Patricia Hasemann, HFM-664, 301-594-1077, FAX 301-827-6221.

    Center for Veterinary Medicine (CVM)

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

    Center for Devices and Radiological Health (CDRH)

    Division of Bioresearch Monitoring: Mr. Rodney Allnutt, HFZ-311, 301-594-4723, FAX 301-594-4731.

    Center for Food Safety and Applied Nutrition (CFSAN)

    Division of Product Policy: Dr. John Welsh, HFS-207, 202-418-3057, FAX 202-418-3126.

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