The Food and Drug Administration’s (FDA) Compliance Program Guidance Manual contains a series of documents, commonly called “Compliance Programs,” which are prepared and managed by each of the Centers that constitute the FDA. These documents provide guidance and instructions to FDA personnel for conducting investigations, inspections, sample collections, sample analyses and regulatory activities in specific program areas.
A Compliance Program does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations enforced by the FDA. It is intended for FDA personnel and is available electronically to the public.
The Compliance Programs currently managed by the Center for Veterinary Medicine (CVM) are on the CPG Manuals page. Other Compliance Programs which are managed by other FDA Centers can be found in electronic form on the FDA’s Office of Regulatory Affairs’ (ORA) web page - Compliance Program Guidance Manual for FDA Staff.
Points of Contacts for CVM Compliance Programs
Program Name |
Contact Person |
Good Laboratory Practices (7366.808) |
Vernon Toelle |
Sponsor/Monitor (7366.810) |
Vernon Toelle |
Clinical Investigators (7366.811) |
Vernon Toelle |
Drug Process and New Animal Drug Inspections (7371.001) |
Jorge Christian Sandra Washington |
Illegal Sales (7371.002) |
Mark Hackman |
Illegal Drug Residues in Meat, Poultry, Seafood and Other Animal Derived Foods (7371.006) |
Deborah Cera Frances Pell |
BSE/Ruminant Feed Ban Inspections (7371.009) |
Neal Bataller Shannon Jordre |
NOTE:
Currently, most of CVM’s Compliance Programs in electronic form are only available on PDF format. You will need "Acrobat Reader" to view them. If you do not have it installed on your computer, click here to download a free copy.
As required by Section 508 of the Rehabilitation Act as amended by Congress in 1998, a copy of any of these Compliance Programs will be provided to those individuals with disabilities simply by contacting Deborah A. Cera by telephone at Phone: (240) 276-9209 FAX: (240) 276-9241, or by e-mail at Deborah.Cera@fda.hhs.gov.
Questions regarding CVM’s Compliance Programs should be addressed to:
Division of Compliance (HFV-230) Office of Surveillance and Compliance Center for Veterinary Medicine U.S. Food and Drug Administration MPN IV Bldg., Room 146 7519 Standish Place Rockville, MD 20855-2773 Telephone: (240) 276-9200 FAX: (240) 276-9241
Web Page Updated by - July 14, 2005, 3:10 PM ET
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