Section 105 Reporting

1. Section 105 Reporting Elizabeth Anne Grove, M.S., Microbiologist Jinhee J. Lee, Pharm.D., Senior Regulatory Review Officer Office of Surveillance and Compliance (OSC) CVM/FDA January 13, 2011

2. Outline • New Requirements – Why? • New Requirements for Antimicrobial Animal Drug Distribution Data • Voluntary Form FDA 3744 • Section 105 results • Lessons learned • Questions

3. New Requirements – Why? • This legislation was enacted to address the problem of antimicrobial resistance, and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. (154 Congressional Record H7534).

4. New Requirements for Antimicrobial Animal Drug Distribution Data • Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, &Cosmetic Act. • Section 105 of ADUFA requires: • Sponsors of new animal drugs that contain an antimicrobial active ingredient to submit data on Voluntary Form FDA 3744 or a sponsor generated form.

5. New Requirements for Antimicrobial Animal Drug Distribution Data (cont) • May submit data on Voluntary Form FDA 3744 or a sponsor generated form • Each report shall – • Be submitted not later than March 31 each year; • Cover the period of the preceding calendar year; and • Include separate information for each month of such calendar year

6. New Requirements for Antimicrobial Animal Drug Distribution Data (cont) • Each report must specify the amount of each antimicrobial active ingredient by – • Container size, strength, and dosage form; • Quantities distributed domestically and quantities exported; and • Dosage form, including, for each such dosage form, a listing of target animals, indications, and production classes that are specified on the approved label of the product.

7. Form FDA 3744 • Firm and Application Information (i.e. Application type, Application number, Firm name, Date Submitted) • Food Animal Dosage Form Information (i.e. Dosage form(s), Animal Species Category, Target Food Animal(s), Production Class(es), Indication(s)

8. Form FDA 3744 (cont) • Total of All Quantities Sold or Distributed (Domestic and Export) • Domestic Quantities Sold/Distributed by Month • Export Quantities Sold/Distributed by Month

9. Form FDA 3744 (cont) • Individual Product Information (i.e. Dosage form, Container size, Active ingredient, etc) • Quantities of Individual Product Sold or Distributed by Month (Domestic and Export)

10. Section 105 Results • Sponsors sent in data using different formats • Product distribution data for approved antimicrobial drugs used in food-producing animals during 2009 were summarized • Only active applications were included in the summary

11. Section 105 Results • The drugs are classified in fifteen classes: aminocoumarins, aminoglycosides, amphenicols, cephalosporins, diaminopyrimidines, fluoroquinolones, glycolipids, lincosamides, macrolides, penicillins, pleuromutilins, polypeptides, streptogramins, sulfas, and tetracyclines.

12. Section 105 Results

13. Section 105 Results • Data grouped according to antimicrobial class for those classes that represent 3 or more sponsors • Quantities of these drugs are expressed in kilograms (kg) • Classes with less than 3 sponsors are called either NIR or NIRE

14. Section 105 Results • Due to the sensitivity of the information, the data represents a collective summary of the activity in the antimicrobial class, and individual sponsor data for a respective application has not been identified. In all groups, the kilogram activity was summed together in classes.

15. Section 105 Results

16. Lessons Learned • Most of the sponsors did not use the Voluntary FDA Form 3744. • Follow-up was needed regarding some of the sales and distribution data received.

17. Questions? • Should you have additional questions, please do not hesitate to e-mail us at elizabeth.grove@fda.hhs.gov or jinhee.lee@fda.hhs.gov.