EEPAKIMEOT OF HEALTH AND HUMAN SERVICES 
PUBLIC HEALTH SERVICE 
NATICMU. DeTIUJTES OF HEALTH 
RECCMBIWVW' D^ft ADVISORY COMMITTEE 
lARGE-SCALE REVIEW WORKING 0«XJP 
MINUTES OF MEETING 
SEPTE>fflER 9, 1981 
Dr. Kenneth Bems called the second meeting of the Large-^cale Review Working 
Group to order at 2:15 p.m. , Wednesday, September 9, 1981. He then briefly 
introduced the n«jor topic of discussion. He recedled to the group that the 
Recait»inant CNA Advisory Conmittee (RAC) had discussed, at the April 23-24, 
1981 meeting, a proposal by Drs. David Baltinore and Allan Canpbell to oonvert 
the NIH Guidelines for Research Involving Recombinant CNA Molecules to a 
"code of standard practice." In response, RAC formed a working group to 
revfew the status of the NIH Guidelines and to develop recommendations con- 
cerning their status. During the summer of 1981 the Working Group for Revi- 
sion of the Guidelines constructed a proposal which was to be presented to 
the RAC at the September 10-11, 1981 meeting. One aspect of the Working 
Group proposal would eliminate the prohibition against scale-up above the 
10 liter limit. As the proposal hais not been published for thirty days of 
public comment, no final action can be taken by the RAC at the September 1981. 
meeting. Dr. Bems said that the Large-Scale Review Working Group should 
nevertheless, consider the possible uipact of adoption of such a proposal f 
RAC review of large-scale experiments would be eliminated if this proposal 
is accepted by RAC and adopted by the NIH. 
Dr. Bems also pointed out to the Large-Scale Review Working Group that RAC 
would discuss at its Septerber 10-11, 1981 meeting a proposal by Dr. Irving 
Johnson of Lilly Research Laboratories to modify Section I-D-6 of the Guidelines. 
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