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Authorizing Legislation

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FDA Authorizing Legislation


FDA is requesting the authorization of two new user fees.  The first will authorize FDA to collect user fees for Export Certificates for foods and animal feeds.  The second user fee is for re-inspections and follow-up work when a regulated firm fails to meet good manufacturing practices or other regulatory requirements. 

 

1.  Authorize the Collection of User Fees for Export Certificates for Foods and Animal Feed

Current Law:  FDA collects user fees of up to $175 per certificate issued for export certificates for drugs, animal drugs and devices as authorized by Section 801 (e)(4)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).  However, there is no similar authority for collecting user fees for export certificates for foods and animal feed.

Proposal:  Amend the Act to authorize the Secretary to recover costs of food and animal feed export certificate-related activities through user fees and to use the fees to hire staff (above normal FTE ceiling) for these activities.  The Administration proposes the following legislative language:  Amend Section 801(e)(4)(A) by inserting "food and animal feed", before each appearance of the words "drug, animal drug, or device."

 

Estimated User Fee Collections for Food and Animal Feed Export Certificates
Program FY 2006 FY 2007
  FTE $ FTE $
Foods 0 $0 6 $906,000
Foods Field 0 $0 17 $2,567,000
Center for Veterinary Medicine 0 $0 0 $63,000
Total 0 $0 23 $3,536,000

 

2.  Authorization of User Fees for re-inspections and follow-up work due to failure to meet Good Manufacturing Practice regulations and other requirements

Current Law:  Reinspections of FDA-regulated firms are currently funded from appropriations. 

Proposal: Amend the Act to permit FDA to collect and retain fees to recover from the inspected firm the full cost of reinspections that FDA performs to ensure that their products and facilities comply with current FDA regulations.  FDA conducts follow-up inspection to verify that a firm implements action to correct violations discovered during an inspection or when we issue a warning letter.  When FDA finds violations during an inspection, the agency conducts a follow-up inspection to ensure the firm has corrected the violation.  When FDA issues warning letters, the agency usually conducts follow-up inspections within 90 days. 

 

Estimated User Fee Collections for Re-Inspections and Follow-Up Work
Program FY 2006 FY 2007
  FTE $ FTE $
Foods Field 0 $0 44 $5,215,000
Human Drugs Field 0 $0 16 $2,009,000
Biologics Field 0 $0 3 $410,000
Animal Drugs and Feeds Field 0 $0 17 $2,050,000
Devices and Radiological Health Field 0 $0 22 $2,616,000
Office of the Commissioner 0 $0 10 $2,000,000
Office of Management 0 $0 6 $5,100,000
GSA Rent and Other Rent Related 0 $0 0 $2,600,000
Total 0 $0 118 $22,000,000

 

<< Return to FY 2007 Budget Summary