FDA

1
FDAs 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
FDAs 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

• 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
  Administration5630 Fishers Lane, rm.
  1061Rockville, MD 20852
• Electronic commentshttp//www.fda.gov/dockets/ec
  omments

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