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<<CVM and Animal Cloning

A Risk-Based Approach to Evaluate Animal Clones and Their Progeny - DRAFT

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Animal Cloning: A Draft Risk Assessment

• Animal Cloning: A Draft Risk Assessment (Entire pdf Document) 4.24 MB
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• Addendum to the Draft Risk Assessment: Raw Data from the Viagen Dataset (pdf)

Individual Chapters of the Draft Risk Assessment

• Table of Contents (pdf)
• Preface
• Chapter I: Draft Executive Summary
• Chapter II: Technology Overview
• Chapter III: Developing the Risk Assessment Methodology
• Chapter IV: Epigenetic Reprogramming: Implications for Clones and their Progeny 
• Chapter V: Animal Health Risks 
• Chapter VI: Food Consumption Risks
• Chapter VII: Summary and Conclusions
• Glossary
• References
• Appendix A: Risk and Safety Assessment Primer for Animal Cloning
• Appendix B: Overall Reproductive Efficiency and Health Statistics for US Animal Agriculture
• Appendix C: Comparison of Outcomes Among Assisted Reproductive Technologies (ARTs)  
• Appendix D: Transgenic Clones 
• Appendix E: The Cyagra Dataset
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• Appendix E(b): Addendum to the Cyagra Dataset (pdf) 3.04 MB
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• Appendix F: The Viagen Dataset
• Appendix F(b): Raw Data from the Viagen Dataset (pdf) 17.38 MB
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• Appendix G: Investigation on the Attributes of Cloned Bovine Products
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• Appendix H: The Comprehensive Veterinary Examination

Memoranda and Correspondence Referenced in the Draft Risk Assessment 

• CVM Memorandum I
• CVM Memorandum II

Proposed Risk Management Plan

Draft Guidance for Industry (GFI) 179

Federal Register Notices

• Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability; Extension of Comment Period. Docket No. 2003N-0573, CVM 200726.  Pages 15887-15888 [FR Doc. E7-6170] April 3, 2007 [TXT] [PDF] [PRE-PUB] Comments due May 3, 2007
  

• Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability. Docket No. 2003N-0573, CVM 200346.  Pages 136-137 [FR Doc. 06–9927] January 3, 2007 [TXT] [PDF] [PRE-PUB] Comments due April 3, 2007

Peer Review 

• Charge
• Peer Reviewers Biographies
• Comments from Peer Reviewers on the Draft Risk Assessment
• FDA Response to Comments from Peer Reviewers

Peer Reviewed Articles

• L Rudenko, JC Matheson, SF Sundlof; Animal cloning and the FDA—the risk assessment paradigm under public scrutiny Nature Biotechnology, January 2007; 25(1):39-43 
• Rudenko L, Matheson JC, Adams AL, Dubbin ES, Greenlees KJ; Food consumption risks associated with animal clones: what should be investigated? Cloning Stem Cells, 2004;6(2):79-93
• Rudenko L, Matheson JC; The US FDA and animal cloning: Risk and regulatory approach. Theriogenology, 1 January 2007;67(1):198-206 

Additional Information

• FDA News Release - FDA Issues Draft Documents on the Safety of Animal Clones, December 28, 2006
• Cloning Primer
• FAQs for Consumers
• FAQs for Producers
• Cloning Myths

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