approval by the National Institutes of Health 
(NIH) , may be sent by the sutmitter to the 
NIH or to another Federal agency that has 
jurisdiction for review and approval. Cnee 
approval, or other applicable clearances, 
have been obtained from a Federal agency 
other than the NIH (whether the experiment is 
referred to that agency by the NIH or sent 
directly there by the submitter), the 
experiment may proceed without the necessity 
for NIH review or approval. However, any 
experiment that involves the administration 
of gene therapy to human subjects, (see 
Section III-A-4 of the Guidelines) will not 
proceed without prior review by the NIH 
Recombinant DNA Advisory Canmittee and NIH 
approval . " 
The proposal was put to a vote and the result of the voting was 
17 in favor, none opposed, and no abstentions. 
VI_. PROPOSED REVISIONS OF APPENDICES C-II, C-III, AND C-IV TO 
THE NIH GUIDELINES 
Mr. Mitchell then asked Dr. McKinney to discuss the proposal 
(tabs 1284, 1286/IV) made by Dr. Frank Young, Commissioner of 
FDA, to revise Appendices C-II, C-III, and C-IV of the NIH 
Guidel ines . 
The proposal is to delete the following language from these 
^?pen dices : 
"For these exempt laboratory experiments, BL1 
physical containment conditions are 
recommended. 
"For large-scale (LS) fermentation experiments 
BL1-LS physical containment conditions are 
recommended. However, following review by the IBC 
of appropriate data for a particular host-vector 
system, some latitude in the application of BL1-LS 
requirements as outlined in Appendix K-II-A 
through K-II-F is permitted." 
And substitute: 
"For these exempt laboratory experiments, the 
appropriate physical containment conditions need 
be no greater than those for the host organism 
unmodified by recombinant DNA techniques. 
Recombinant DNA Research, Volume 1 1 
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