Inspections, Compliance, Enforcement, and Criminal Investigations
PART VI - REFERENCES AND CONTACTS
- Guide for the Care and Use of Laboratory Animals, DHHS Publication No. (NIH) 96-23
- The Animal Welfare Act, 9 CFR Parts 1, 2, 3
- 21 CFR 11 - Electronic Records. Electronic Signatures Regulation effective August 1997.
- 21 CFR 58.1 - 58.219 Good Laboratory Practice Regulations effective June 1979, and amended effective October 1987
- Good Laboratory Practice Regulations, Management Briefings, Post Conference Report, August 1979
- Good Laboratory Practice Regulations, Questions and Answers, June 1981
- "Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives used in Food," FDA, Bureau of Foods
- "Guide to Inspection of Computerized Systems in Drug Processing," February 1983
- "Software Development Activities, Technical Report" July 1987
- "Guide For Detecting Fraud in Bioresearch Monitoring Inspections," April 1993
- Copies of the listed references may be obtained from HFC-130.
- Program Contacts
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.
- 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.