April 24, 2001
FDA/CVM-Related Increases in the President’s FY 2002 Budget
The President’s FY 2002 budget request for the Food and Drug Administration (FDA) includes significant increases related to the animal drugs and feeds program. The FY 2002 budget request of $81.81 Million (M) for the animal drugs and feeds program includes an $18M increase. Of this increase, $17.3M would come from appropriated funds, and $.7M from new user fees tied to import activities. These increases would be spent in the following main areas:
Current Services -- $2.354 Million
The requested funds will cover pay increases. This increase is necessary to ensure the integrity of the Agency’s work in the field labor force for inspections, compliance, and for FDA's Center for Veterinary Medicine (CVM) to sustain recent progress made toward meeting the core statutory requirements of the program. Specifically it will help CVM to sustain progress in the review of new animal drug applications and abbreviated new animal drug applications reviewed and acted on within 180 days.
Bovine Spongiform Encephalopathy (BSE) -- $13.1 Million.
FDA (via FDA personnel and State contracts) will conduct targeted BSE inspections of all renderers and licensed and non-FDA licensed feed mills handling material prohibited for use in ruminants on a yearly basis. In addition FDA will:
provide intensive line entry and label review (when necessary) of import line entries by expanding import staff by 17 FTEs.
develop a domestic sampling plan to collect and analyze 600 domestic feed and feed component samples and 600 import samples for BSE-related contaminants. These sampling plans will ensure proper labeling of animal feeds and feed components.
develop and validate detection methods for BSE by collaborating with experts and foreign scientists.
Food Safety -- $1.5 Million
Antimicrobial Resistance -- FDA will conduct research to identify food animal species causing human drug resistance; and develop educational devices to describe the issue of antimicrobial resistance and government and industry efforts.
Hazard Analysis and Critical Control Point (HACCP) -- FDA will propose HACCP regulations for the animal and vegetable rendering (processing) industry and organize a pilot program with one or two manufacturing plants. Also, the Agency will develop training programs for Federal and State inspectors to conduct HACCP audit inspections and cosponsor workshops with the FDA's field offices to gather information and support from the feed industry.
Aquaculture -- FDA will compile a list of animal drugs that are used in foreign aquaculture and develop risk assessment priorities by importance to human health.
Biotechnology -- FDA will prepare guidances for the industry explaining that animal biotechnology products are subject to pre-market approval as new animal drugs and informing them about the information required to show safety and effectiveness for this class of products. Also, FDA will develop an inventory of firms that are developing products derived from bioengineered animals.
Imports and Inspections -- $1.0M ($700,000 of which will be from user fees)
FDA will conduct 30 additional inspections for illegal residues and contaminants in domestic animal feed and take appropriate regulatory action when necessary.
User Fee Portion of the increase:
FDA proposes to collect $700,000 in additive import user fees to enable FDA to modernize OASIS to allow import reviewers to have rapid and direct access to information necessary for entry decisions; and, increase data audits, import filer training, and liaison activities to ensure the integrity of import data submitted by import filers.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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