1. FDA’s Regulatory Development Timeline Until Aug. 30, 2002: Will seek input on stakeholder concerns and suggested options to consider in developing the notice of proposed rulemaking (NPRM) Dec. 2002 - Anticipated: Issue NPRMs for all four regulations with public comment period

2. FDA’s Regulatory Development Timeline After NPRM published: Receive/review public comments; we also anticipate holding several public meetings to explain NPRM and seek feedback No later than Nov. 12, 2003: Issue final rules* *APA requires 30 days notice before effective date

3. Some Key Personnel in BT Regulatory Development Effort Some Key Personnel in BT Regulatory Development Effort CFSAN Decision Maker: L. Robert Lake CFSAN Overall Lead: Leslye M. Fraser Outreach: Linda A. Skladany, OC, External Affairs

4. CFSAN Day-to-Day Workgroup Leads Administrative Detention – Marquita Steadman Registration – Leslye M. Fraser Records (Traceback) – Nega Beru Prior Notice – Mary Ayling

5. Where to Send Your Comments Written comments: – Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Electronic comments: http://www.fda.gov/dockets/ecomments http://www.fda.gov/dockets/ecomments

6. Where to Send Your Comments (cont) Please include applicable docket number: – Sec. 303 (Detention): Docket 02N-0275 – Sec. 305 (Registration): Docket 02N-0276 – Sec. 306 (Recordkeeping): Docket 02N-0277 – Sec. 307 (Prior Notice): Docket 02N-0278