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FDA’s Regulatory Development Timeline

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.

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FDA’s Regulatory Development Timeline

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  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 • 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 comments: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

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