DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda. Maryland 20205 
Decenyoer 18, 1981 
MEMORANDUM 
TO: Interested Parties 
FRCM: Director, Office of Recanbinant ENA Activities 
SUBJECT: Proposed Revisions of NIH Guidelines for Research 
Involving Recombinant ENA Molecules 
Ccnments are invited on two proposals for a major revision of the National 
Institutes of Health (NIH) Guidelines for Research Involving Recombinant ENA 
Molecules. 
The Recombinant ENA A3visory Committee (RAC) has developed a proposed revision 
and reccnmended that it be published for cement. This proposal appears in 
the Federal Register dated December 4 , 1981 . 
The major features of this proposal are: 
1. The Guidelines would cease to be mandatory and would become a 
voluntary oode of standard practice. The following requirements 
would be eliminated: that institutions have an Institutional Bio- 
safety Cemmittee (IBC), that investigators obtain prior afproval 
from the IBC before beginning certain experiments, and that inves- 
tigators obtain prior approval from NIH before beginning certain 
experiments. The section of the Guidelines specifying that non- 
coi^iance could lead to loss of NIH funds would also be eliminated. 
2. Section III of the Guidelines giving containment levels would be 
greatly sin^Jlified, and most experiments currently requiring P2 or 
P3 containment would be recemmended at PI. 
3. The prohibitions section (I-D) of the Guidelines would be eliminated, 
although two of the current prohibitions (I-D-2 and I-D-5) would be 
retained as admonishments. 
An alternative proposal appears as item 7 in the Federal Register notice of 
December 7, 1981. 
The major features of this proposal are: 
1. The Guidelines would continue to be mandatory for institutions 
receiving NIH funding. Certain experiments would require prior 
review by NIH, certain experiments would require prior review by an 
IBC, and certain experiments would require notice to an IBC simulta- 
neously with initiation of the experiment. 
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