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Inspection References
Investigations Operations Manual 2004
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Contents

SUBCHAPTER 250 - CENTER FOR VETERINARY MEDICINE (CVM)
250 - OFFICE OF THE CENTER DIRECTOR (HFV-1)
251 - OFFICE OF MANAGEMENT AND COMMUNICATION (HFV-10)
252 - OFFICE OF NEW ANIMAL DRUG EVALUATION (HFV-100)
253 - OFFICE OF SURVEILLANCE AND COMPLIANCE (HFV-200)
254 - OFFICE OF RESEARCH (HFV-500)

SUBCHAPTER 250 - CENTER FOR VETERINARY MEDICINE (CVM)

250 - OFFICE OF THE CENTER DIRECTOR (HFV-1)

Stephen F. Sundlof, DVM, Ph.D., is the Center Director.

George A. Mitchell, DVM, is the Associate Director for Policy and Regulations. The Deputy Center Director is Linda K. Tollefson, DVM,Ph.D.

The Office of the Director is located at: MPN IV, 7519 Standish Place, Rockville, MD 20855 (301-827-2950).

CVM develops and recommends the veterinary medical policy of the Agency with respect to the safety and effectiveness of animal drugs, feeds, feed additives, veterinary medical devices (medical devices for animal use), and other veterinary medical products. CVM also ensures the food from these animals is safe before drugs are approved for marketing.

The Center evaluates, for animal safety and effectiveness, proposed and marketed animal drugs and feed additives and marketed veterinary medical devices. It coordinates, evaluates, and plans Agency inspectional, investigational and surveillance programs.

Additional information on CVM can be found on their website at: www.fda.gov/cvm.

There are four offices within CVM that help to accomplish the mission of the Center. Those offices are as follows:

 

251 - OFFICE OF MANAGEMENT AND COMMUNICATION (HFV-10)

Robert W. Sauer is the Office Director. The Office is located at MPN IV. A contact phone number is 301-827-4410.

This office provides management oversight, administrative program and systems support for CVM. It is the CVM Freedom of Information focal point and provides educational information and material to both the consumer and industry. It also serves as liaison within FDA as well as with other government agencies.

The four staffs within this office are:

  1. Administrative Staff (HFV-15)
    Barbara E. Leach, Director
  2. Communications Staff (HFV-12)
    Jon W. Scheid, Director
  3. Program Planning and Evaluation Staff (HFV-11)
    David L. Lynch, Acting Director
  4. Information Resources Management Staff
    (HFV-16):
    • Information Resources Support: Michele Koff
    • Data Applications: Dr. Jerome J. McDonald

252 - OFFICE OF NEW ANIMAL DRUG EVALUATION (HFV-100)

The Office Director is Dr. Claire M. Lathers. This Office is located at MPN II, 7500 Standish Place, Rockville, MD 20855. A contact phone number is: 301-827-1796.

This office is responsible for evaluating for animal safety and effectiveness new animal drugs in pharmaceutical dosage forms or feed delivered products. It evaluates the safety aspects of drug and food additive residues remaining in food produced for human consumption from animals given drugs or food additives. It also coordinates the development and implementation of regulations and policies pertaining to new drugs intended for animal use.

The five divisions in this office are:

  1. Div. of Therapeutic Drugs for Non-Food Animals
    (HFV-110), Dr. Melanie R. Berson, DVM, Director
  2. Div. of Biometrics & Production Drugs (HFV-120)
    Woodrow M. Knight, Ph.D., Director
  3. Div. of Therapeutic Drugs for Food Animals
    (HFV-130), Steven V. Vaughn, DVM, Director
  4. Div. of Manufacturing Technologies (HFV-140)
    William G. Marnane, Director
  5. Div. of Human Food Safety (HFV-150)
    Dr. Mark Robinson, Ph.D., Director

253 - OFFICE OF SURVEILLANCE AND COMPLIANCE (HFV-200)

The Acting Director for this office is Daniel G. McChesney, Ph.D. This office is located at MPN II. A contact phone number is 301-827-6644.

This office has the responsibility of maintaining the effectiveness of the animal drugs which have been approved and ensuring animals treated with drugs are safe for human consumption. It also maintains the safety and effectiveness of animal feeds, feed additives, veterinary medical devices, and other veterinary medical products.

The four divisions in this office are:

  1. Division of Surveillance (HFV-210)
    William C. Keller, DVM, Director
  2. Division of Animal Feeds (HFV-220)
    George Graber, Ph.D., Director
  3. Division of Compliance (HFV-230)
    Gloria Dunnavan, Director
  4. Division of Epidemiology (HFV-250)
    Charlotte Spires, Director

254 - OFFICE OF RESEARCH (HFV-500)

The Director is Norris E. Alderson, Ph.D. This office is located at MOD II, 8401 Muikirk Road, Laurel, MD. A contact phone number is: 301-827-8010.

This office provides a focal point for all research activities in the Center. It serves as the liaison for intramural and extramural research. It evaluates and interprets results of scientific research, initiates and recommends action as appropriate to implement policy changes.

The three divisions in this office are:

  1. Division of Residue Chemistry (HFV-510)
    Michael H. Thomas, Director
  2. Division of Animal Research (HFV-520)
    Dr. David A. Frobish, Director
  3. Division of Animal and Food Microbiology
    (HFV-530), Robert Walker, Ph.D., Director

 

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