APPENDIX B TO APPENDIX C 
NIH Intramural Research 
Because NIH intramural research projects are reviewed in a different 
fashion than extramural projects, different procedures are applicable than 
those proposed in Appendix A. 
At present, the Chief of the Laboratory in which an investigator plans to 
utilize recombinant DNA technology requests approval through the Scientific 
Director of the relevant BID to the Deputy Director for Science, NIH with 
copies to the Associate Director for Environmental Health and Safety, DRS. 
The request for approval is in the form of a draft Memorandum of Under- 
standing and Agreement (MUzA) v/hich describes the type of experiment, nature 
of host-vector system, assessment of potential risk, proposed safety measures, 
proposed training of personnel, etc. The Deputy Director for Science then 
requests the NIH Biohazards Committee to review the research plan and pro- 
cedures proposed in the draft MUA. The recommendations of the NIH Biohazards 
Committee are forwarded to the Deputy Director for Science, NIH. Recommenda- 
tions of the NIH Biohazards Committee must be included in a final MUA, and 
the Associate Director for Environmental Health and Safety, DRS must certify 
that the safety measures included in the final MUA are available. The re- 
search cannot proceed until the final MUA is fully approved. The original 
copy of the MUA is sent to the Associate Director for Environmental Health 
and Safety, DRS witli copies to the requesting investigator, the Laboratory 
Chief, the Scientific Director and the Executive Secretary of the NIH Bio- 
hazards Committee. 
It is proposed here that a copy of the final MUA be forwarded to ORDA for 
review. If ORDA does not concur with the recommendations of the NIH Bio- 
hazards Committee, it may request the Deputy Director for Science, NIH 
to bring the matter to the attention of the Executive Committee or the 
Recombinant Advisory Committee for resolution. 
ORDA will assist the NIH Biohazards Committee with problems relating to 
assessment of biological and physical containment levels proposed by 
investigators versus those required by the Guidelines, with requests 
for the use of lower containment levels for characterized clones de- 
rived from shotgun experiments, and with requests for permission to do 
large-scale experiments with recombinants known to make harmful products ^ 
ORDA will also assist the NIH Biohazards Committee in periodic review 
and revisions of MUAs. If ORDA does not concur with the decisions of the 
NIH Biohazards Committee, it may request the Deputy Director for Science, 
NIH to bring the matter to the attention of the Executive Committee or 
the Recombinant Advisory Committee. 
Appendix C — 13 
