Federal Register Notices

Notices of Meetings   Notices of Proposed Actions   Notices of Actions

Notices of Meetings

• 2002
  • Notice of Meeting for the March 7-8, 2002, Recombinant DNA Advisory Committee, published in the Federal Register  February 13, 2002.
• 2001
  • Notice of Meeting and Safety Symposium for the March 7-8, 2001, Recombinant DNA Advisory Committee, published in the Federal Register February 23, 2001.
  • Notice of Meeting for the June 14-15, 2001, Recombinant DNA Advisory Committee, published in the Federal Register May 24, 2001.
  • Notice of Meeting for the September 6-7, 2001, Recombinant DNA Advisory Committee, published in the Federal Register August 14, 2002.
• 2000
  • Notice of Meeting and Safety Symposium for the December 13-15, 2000, Recombinant DNA Advisory Committee, published in the Federal Register November 30, 2000.
  • Notice of Meeting for the September 25-26, 2000, Recombinant DNA Advisory Committee, published in the Federal Register August 22, 2000.
  • Notice of Meeting for the June 28-29, 2000, Recombinant DNA Advisory Committee, published in the Federal Register June 7, 2000.
  • Notice of Meeting for the March 8-10, 2000, Recombinant DNA Advisory Committee. An additional notice was published regarding an additional agenda item. Both were published on February 18, 2000.
• 1999
  • Amended Notice of Meeting for the December 8-10, 1999, Recombinant DNA Advisory Committee, published in the Federal Register on December 7, 1999.
  • Notice of a Recombinant DNA Advisory Committee Meeting on December 8-10, 1999, published in the Federal Register on November 18, 1999.
  • Notice of a Recombinant DNA Advisory Committee Meeting on September 2-3, 1999, published in the Federal Register on August 11, 1999.
  • Notice of a Recombinant DNA Advisory Committee Meeting on June 14, 1999, published in the Federal Register on May 28, 1999.
  • Notice of a Recombinant DNA Advisory Committee Meeting on March 11-12, 1999 , published in the Federal Register on February 17, 1999.
• 1998
  • Notice of a Gene Therapy Policy Conference on January 7-8, 1999 , published in the Federal Register on December 22, 1998.
  • Notice of a Recombinant DNA Advisory Committee Meeting on September 24-25, 1998, published in the Federal Register on September 1, 1998.
  • Notice of a Recombinant DNA Advisory Committee Meeting on June 18-19, 1998, published in the Federal Register on May 4, 1998.
  • Notice of a Gene Therapy Policy Conference on March 9, 1998 , published in the Federal Register on February 11, 1998. The NIH published a Notice of Conference and agenda items to be discussed at the March 9, 1998, Gene Therapy Policy Conference.
  • Notice of a Recombinant DNA Advisory Committee Meeting on March 10, 1998, published in the Federal Register on February 11, 1998. The NIH published a Notice of Meeting and agenda items to be discussed at the March 10, 1998, Recombinant DNA Advisory Committee meeting.
• 1997
  • Notice of a Recombinant DNA Advisory Committee Meeting on December 15-16, 1997, published in the Federal Register on October 16, 1997. The NIH published a Notice of Meeting and agenda items to be discussed at the December 15-16, 1997, Recombinant DNA Advisory Committee meeting.
  • Notice of Recombinant DNA Advisory Committee Meeting on September 12, 1997, published in the Federal Register on August 20, 1997.
  • Notice of Recombinant DNA Advisory Committee meeting on June 12-13, 1997, published in Federal Register on May 22, 1997.

Notices of Proposed Actions

• 2007
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register May 9, 2007
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register July 24, 2007
    
    
• 2001 
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register December 11, 2001
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register November 19, 2001
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register September 7, 2001
  • Notice of Proposed Actions under the NIH Guidelines Published in the Federal Register August 24, 2001
  • Notice of Proposed Actions under the NIH Guidelines, published in the Federal Register August 13, 2001

• 2000
  • Notice of Proposed Actions under the NIH Guidelines, published in the Federal Register December 12, 2000
• 1999
  • Notice of Proposed Actions Under the NIH Guidelines, published in the Federal Register on November 22, 1999. These Proposed Actions will be discussed at the December 8-10, 1999, Recombinant DNA Advisory Committee meeting.
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on August 11, 1999. These Proposed Actions will be discussed at the Recombinant DNA Advisory Committee on September 2-3, 1999.
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on February 17, 1999. The NIH published for public comment the Proposed Actions for the March 11-12, 1999, Recombinant DNA Advisory Committee meeting.
• 1998
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on February 11, 1998. The NIH published for public comment the Proposed Actions for the March 10, 1998, Recombinant DNA Advisory Committee meeting.
• 1997
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules , published in the Federal Register on October 16, 1997. The NIH published for public comment the Proposed Actions for the December 15-16, 1997, Recombinant DNA Advisory Committee meeting. Second Notice of Proposed Actions Under the NIH Guidelines, published in the Federal Register on November 19, 1997.
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules , published in the Federal Register on August 20, 1997.
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on February 14, 1997.
• 1996
  • Notice of Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on November 22, 1996. The NIH published this Proposed Actions to modify NIH's oversight of human gene therapy.
  • Notice of Intent to Proposed Amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on July 8, 1996. The NIH published a Notice of Intent to modify NIH's oversight of gene therapy.

• 2002 
  • Notice of Actions under the NIH Guidelines, published in the Federal Register May 24, 2002
• 2001
  • Notice of Actions under the NIH Guidelines, published in the Federal Register January 5, 2001.
  • Notice of Actions to amend the NIH Guidelines to enhance oversight of human gene transfer research by modifying the requirements for the reporting and analysis of serious adverse events in human gene transfer research studies governed by the NIH Guidelines, published in the Federal Register November 19, 2001.
  • Notice of Actions amending Appendix B-I of the NIH Guidelines to establish criteria for designating strains of E. coli as risk group 1 agents, published in the Federal Register December 11, 2001.
  • Notice of Actions amending the provisions of the NIH Guidelines 
    relating to the Recombinant DNA Advisory Committee (RAC) by authorizing a minimum of 15 voting members and establishing the charter of the committee as the controlling document for the membership and procedures of the RAC, published in the Federal Register December 11, 2001.
• 2000
  • Notice of Actions under the NIH Guidelines, published in the Federal Register October 10, 2000.
• 1999
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules Regarding Appendix B--Risk Group 1 (RG1) Agents , published in the Federal Register on May 11, 1999.
• 1998
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules Regarding Electronic Submission of Protocols, published in the Federal Register on May 11, 1998.
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules , published in the Federal Register on February 17, 1998.
• 1997
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on October 31, 1997. The NIH published this action to increase the usefulness and productivity of public discussion of human gene transfer research. Specifically, the NIH shall: (1) relinquish all approval responsibilities for recombinant DNA experiments involving human gene transfer to the Food and Drug Administration (FDA), which holds statutory authority for such approval; (2) continue NIH registration of human gene transfer protocols; (3) continue RAC discussion of novel human gene transfer experiments without RAC approval of individual protocols; (4) regularly convene Gene Therapy Policy Conferences; (5) enhance public awareness and access to human gene transfer clinical trial information.
  • Procedures for Submission of Human Gene Transfer Protocols
    The Procedures for submission of human gene transfer protocols will continue to be according to the NIH Guidelines, Appendix M, The Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into the Genome of One or More Human Subjects (Points to Consider).
  • Notice of Environmental Assessment and Finding of No Significant Impact , published in the Federal Register on November 4, 1997.
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules , published in the Federal Register on October 14, 1997. The NIH published this action to amend Appendix B, Appendix B-III-D, Risk Group 3--Viruses and Prions and Appendix B-IV-D, Risk Group 4--Viral Agents.
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on October 29, 1997. The NIH published this action to amend Appendix M, Submission Requirements.
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules , published in the Federal Register on January 31, 1997. The NIH published this action to reduce the membership of the Recombinant DNA Advisory Committee from 25 to 15 members.
• 1996
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on March 12, 1996.  This Notice of Action addresses Amendments to Section IV and Appendix M of the NIH Guidelines Regarding Semiannual/Annual Data Reporting
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on January 19, 1996.  This Notice of Action addresses Amendments to Sections II, III, IV, V, Appendices B, C, H, and Q of the NIH Guidelines Regarding Updating the Classification of Microorganisms
• 1995
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on April 27, 1995.  This Notice of action addresses nine items: 1) Amendments to Section I, Scope of the NIH Guidelines, 2) Amendments to Section III, Experiments Covered by the NIH Guidelines, 3) Amendments to Section IV, Roles and Responsibilities, 4) Amendments to Section V, Footnotes and References of Section I through IV, 5) Amendments to Appendix C, Exemptions under Section III-E-6, 6) Amendments to Appendix F, Containment Conditions for Cloning of Genes Coding for the Biosynthesis of Molecules Toxic for Vertebrates, 7) Amendments to Appendix G, Physical Containment, 8) Amendments to Appendix I, Biological Containment, and 9) Amendments to Appendix M, The Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into the Genome of One or More Human Subjects 
• 1994
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on August 5, 1994.  This Notice of Action addresses three items:  1) Amendment to Appendix M-I-D of the NIH Guidelines Regarding Informed Consent for Human Gene Transfer Protocols, 2) Amendment to Appendix M-VI of the NIH Guidelines Regarding Procedures to be Followed for Expedited Review of Single Patient Human Gene Transfer Experiments, and 3) Deletion of Appendix L of the NIH Guidelines Regarding Release into the Environment.
  • Notice of Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules, published in the Federal Register on July 5, 1994.  This Notice of Action addresses four separate Actions: 1) Amendment to Sections II, III-C, III-D, V, Appendices C-I, and G and Addition of Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Plants, and Appendix Q, Physical and Biological Containment for Recombinant DNA Research Involving Animals of the NIH Guidelines,  2) Amendment to Sections I-C-1-b-(2) and Deletion of Section III-A-2 of the NIH Guidelines Regarding Deliberate Release,  3) Amendments to Sections I, III, IV, and V, and Appendix M of the NIH Guidelines Regarding NIH/ORDA Review and Approval of Certain Categories of Human Gene Transfer Experiments That Qualify for the Accelerated Review Process, and 4) Amendments to Section V-U of the NIH Guidelines Regarding Recombinant DNA Vaccines.