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FR 1. 20. 74)Amendment Effective March 5, 2. Federal Register. September 5, 2. 01. FR 5. 45. 84)Amendment Effective November 6, 2. Federal Register. November 6, 2. 01. FR 6. 67. 51)Amendment Effective April 2. Federal Register, March. FR 1. 53. 15)Amendment Effective April 1. Federal Register, April. FR 2. 22. 86)TABLE OF CONTENTSSECTION I............ SCOPE OF. THE NIH GUIDELINES. Section I- A.......... Section I- B.......... Definition. of Recombinant and Synthetic Nucleic Acid Molecules. Section I- C.......... General. Applicability. Section I- D.......... Compliance. with the NIH Guidelines. Section I- E.......... SECTION II............ SAFETY. CONSIDERATIONS. Section II- A......... Risk. Assessment. Section II- A- 1........ Section II- A- 2........ Criteria. for Risk Groups. Section II- A- 3........ Comprehensive. Risk Assessment. Section II- B......... Containment. 13. SECTION III........... EXPERIMENTS. COVERED BY THE NIH GUIDELINES. Section III- A......... Experiments. that Require Institutional Biosafety Committee Approval, RAC Review, and NIH. Director Approval Before Initiation (See Section IV- C- 1- b- (1), Major Actions). Section III- A- 1........ Major. Actions under the NIH Guidelines. Section III- B......... Experiments. That Require NIH OSP and Institutional Biosafety Committee Approval Before. Initiation. 1. 5Section III- B- 1........ Experiments. Involving the Cloning of Toxin Molecules with LD5. Less than 1. 00. Nanograms per Kilogram Body Weight. Section III- B- 2........ Experiments. that have been Approved (under Section III- A- 1- a) as Major Actions under the NIH. Guidelines. 1. 6Section III- C......... Experiments. that Require Institutional Biosafety Committee and Institutional Review Board. Approvals and RAC Review Before Research Participant Enrollment. Section III- C- 1........ Experiments. Involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid. Molecules, or DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid. Molecules, into One or More Human Research Participants. Section III- D......... Experiments. that Require Institutional Biosafety Committee Approval Before Initiation. Section III- D- 1........ Experiments. Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as. Host- Vector Systems (See Section II- A, Risk Assessment)1. Section III- D- 2........ Experiments. in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted. Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host- Vector. Systems. 1. 8Section III- D- 3........ Experiments. Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA. Viruses in the Presence of Helper Virus in Tissue Culture Systems. Section III- D- 4........ Experiments. Involving Whole Animals. Section III- D- 5........ Experiments. Involving Whole Plants. Section III- D- 6........ Experiments. Involving More than 1. Liters of Culture. Section III- D- 7........ Experiments. Involving Influenza Viruses. Section III- E......... Experiments. that Require Institutional Biosafety Committee Notice Simultaneous with. Initiation. Experiments. Involving the Formation of Recombinant or Synthetic Nucleic Acid Molecules. Containing No More than Two- Thirds of the Genome of any Eukaryotic Virus. Section III- E- 2........ Experiments. Involving Whole Plants. Section III- E- 3........ Experiments. Involving Transgenic Rodents. Section III- F......... SECTION IV........... ROLES. AND RESPONSIBILITIES. Section IV- A......... Section IV- B......... Responsibilities. Institution. 2. 4Section IV- B- 1....... Section IV- B- 2....... Institutional. Biosafety Committee (IBC)2. Section IV- B- 2- a...... Membership. and Procedures. Section IV- B- 2- b...... Section IV- B- 3....... Biological. Safety Officer (BSO)2. Section IV- B- 4....... Plant. Plant Pathogen, or Plant Pest Containment Expert. Section IV- B- 5....... Animal. Containment Expert. Section IV- B- 6....... Human. Gene Therapy Expertise. Section IV- B- 7....... Principal. Investigator (PI)2. Section IV- B- 7- a...... General. Responsibilities. Section IV- B- 7- b...... Information. to Be Submitted by the Principal Investigator to NIH OSP. Section IV- B- 7- c...... Submissions. by the Principal Investigator to the Institutional Biosafety Committee. Section IV- B- 7- d...... Responsibilities. Principal Investigator Prior to Initiating Research. Section IV- B- 7- e...... Responsibilities. Principal Investigator During the Conduct of the Research. Section IV- C......... Responsibilities. National Institutes of Health (NIH)3. Section IV- C- 1....... NIH. Director. 31. Section IV- C- 1- a...... General. Responsibilities. Section IV- C- 1- b...... Specific. Responsibilities. Section IV- C- 1- b- (1)... Section IV- C- 1- b- (2)... Section IV- C- 2....... Recombinant. DNA Advisory Committee (RAC)3. Section IV- C- 3....... Office. of Science Policy (OSP)3. Section IV- C- 4....... Other. NIH Components. Section IV- D......... Voluntary. Compliance. Section IV- D- 1....... Basic. Policy - Voluntary Compliance. Section IV- D- 2....... Institutional. Biosafety Committee Approval - Voluntary Compliance. Section IV- D- 3....... Certification. of Host- Vector Systems - Voluntary Compliance. Section IV- D- 4....... Requests. for Exemptions and Approvals - Voluntary Compliance. Section IV- D- 5....... Protection. of Proprietary Data - Voluntary Compliance. Section IV- D- 5- a...... General. 35. Section IV- D- 5- b...... Pre- submission. Review. SECTION V........... FOOTNOTES. AND REFERENCES OF SECTIONS I THROUGH IV. APPENDIX A.......... EXEMPTIONS. UNDER SECTION III- F- 6- -SUBLISTS OF NATURAL EXCHANGERS. Appendix A- I........ Appendix A- II........ Appendix A- III........ Appendix A- IV....... Appendix A- V........ Appendix A- VI....... APPENDIX B.......... CLASSIFICATION. OF HUMAN ETIOLOGIC AGENTS ON THE BASIS OF HAZARD. Appendix B- I........ Risk. Group 1 (RG1) Agents. Appendix B- II........ Risk. Group 2 (RG2) Agents. Appendix B- II- A...... Risk. Group 2 (RG2) - Bacterial Agents Including Chlamydia. Appendix B- II- B...... Risk. Group 2 (RG2) - Fungal Agents. Appendix B- II- C...... Risk. Group 2 (RG2) - Parasitic Agents. Appendix B- II- D...... Risk. Group 2 (RG2) - Viruses. Appendix B- III........ Risk. Group 3 (RG3) Agents. Appendix B- III- A...... Risk. Group 3 (RG3) - Bacterial Agents Including Rickettsia. Appendix B- III- B...... Risk. Group 3 (RG3) - Fungal Agents. Appendix B- III- C...... Risk. Group 3 (RG3) - Parasitic Agents. Appendix B- III- D...... Risk. Group 3 (RG3) - Viruses and Prions. Appendix B- IV....... Risk. Group 4 (RG4) Agents. Appendix B- IV- A...... Risk. Group 4 (RG4) - Bacterial Agents. Appendix B- IV- B...... Risk. Group 4 (RG4) - Fungal Agents. Appendix B- IV- C...... Risk. Group 4 (RG4) - Parasitic Agents. Appendix B- IV- D..... Risk. Group 4 (RG4) - Viral Agents. Appendix B- V........ Animal. Viral Etiologic Agents in Common Use. Appendix B- V- 1...... Murine. Retroviral Vectors. APPENDIX C.......... EXEMPTIONS. UNDER SECTION III- F- 8. Appendix C- I........ Recombinant. or Synthetic Nucleic Acid Molecules in Tissue Culture. Appendix C- I- A....... Appendix C- II........ Escherichia. coli K- 1. Host- Vector Systems. Appendix C- II- A...... Appendix C- III........ Saccharomyces. Host- Vector Systems. Appendix C- III- A...... Appendix C- IV....... Kluyveromyces. Host- Vector Systems. Appendix C- IV- A...... Appendix C- V........ Online data backup for any business or industry. From law firms to medical practices, major sports teams and dog trainers, thousands of businesses across the country trust Carbonite as their backup solution. 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