文档介绍：Overview of Registration Interim Final Rule Implementing the Bioterrorism Act
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FDA Lead Personnel
L. Robert Lake – Senior Manager
(301) 436-2379 or Lloyd.******@
Leslye M. Fraser – Lead
(301) 436-2378 or Leslye.******@
HELP DESK
Phone: 800-216-7331 or 301-575-0156
E-mail: ******@
Fax: 301-210-0247
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Background: FDA’s Regulatory Development Timeline
Feb. 3, 2003: FDA and Customs and Border Protection (CBP) published proposed rule with a 60 ment period
FDA received over ments
Oct. 10, 2003: FDA and CBP published interim final rule (registration system operational on Oct. 16, 2003)
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Background: FDA’s Regulatory Development Timeline
Oct. 28, 2003: Public meeting via satellite downlink to domestic and international sites
Transcripts available in English, French & Spanish
Outreach materials will be available on FDA’s website in Arabic , Chinese, French, Hindi, Japanese, Malay, Portuguese, and Spanish:
/bioterrorism/
Dec. 12, 2003: Interim final rule takes effect
Dec. 24, 2003: Comments due on interim final rule (comment period will reopen in March 2004)
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Regulatory Development Timeline (cont.)
FDA also is developing two additional rules:
Section 306: Establishment and Maintenance of Records
Section 303: Administrative Detention
Goal: by December 12, 2003, publish final rules implementing these two provisions and hold satellite downlink meeting shortly after
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What Is An Interim Final Rule (IFR)?
An IFR is a final rule that has the full force and effect of law; thus, affected parties have an obligation ply with its requirements
An IFR allows stakeholders to ments during the ment period on the areas requested in the interim final rule that the agency will consider before deciding whether to issue a revised final rule or confirm the interim final rule as final
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Who Must Register?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food (subje