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D. Additional Proposals. 
1. Upon reviewing the proposed 
revised Guidelines, several members of 
the Working Group for Revision of the 
Guidelines requested that the language 
of the current Guidelines in Section III- 
C be evaluated by the RAC. 
That language of the current 
Guidelines is as follows: 
“HI-C. Experiments That Require IBC 
Notice Simultaneously With Initiation 
of Experiments. Experiments not 
included in Sections III-A, III-B, III-D, 
and subsections of these Sections are to 
be considered in Section III-C. All such 
experiments can be carried out at Pi 
containment. For experiments in this 
category, a registration document as 
described in Section III-B must be dated 
and signed by the investigator and filed 
with the local IBC. The IBC shall review 
all such proposals, but the IBC review 
prior to initiation of the experiment is 
not required.” 
It was noted that non-exempt 
experiments which might merit more 
stringent review by RAC or by the IBC 
prior to initiation of the experiment 
might not be adequately described in 
Sections III-A and BI-B and thus would 
automatically fall into Section III-C. The 
working group members requested that 
the language of that Section be 
evaluated at the next RAC meeting in 
the hope that language to alert 
researchers and IBCs of this possibility 
might be developed. 
One possible suggested clariHcation 
would be to modify the sixth paragraph 
of Part III, Containment Guidelines for 
Covered Experiments. That paragraph 
currently reads: “IF AN EXPERIMENT 
FALLS INTO BOTH CLASS III-A AND 
ONE OF THE OTHER CLASSES, THE 
RULES PERTAINING TO CLASS lU-A 
MUST BE FOLLOWED. If an experiment 
fails into Class III-D and either III-B or 
III-C as well, it can be considered 
exempt from the requirements of the 
Guidelines.” 
The proposed modification would 
read: “IF AN EXPERIMENT FALLS 
INTO BOTH CLASS ffl-A AND ONE OF 
THE OTHER CLASSES, THE RULES 
PERTAINING TO CLASS HI-A MUST 
BE FOLLOWED. If an experiment fails 
into Class III-D and either III-B or III-C 
as well, it can be considered exempt 
from the requirements of the Guidelines. 
Should doubt arise as to which section 
covers a proposed protocol, ORDA 
should be contacted.” 
2. At the April meeting, the working 
group recommended deletion of several 
sections of the Guidelines which were 
not incorporated into the proposed 
revised Guidelines as published in Part 
C of this Federal Register document. 
NIH staff felt that retention of these 
sections would permit greater flexibility 
in interpreting and administering the 
Guidelines. Those sections which the 
working group suggested should be 
deleted but which NIH staff have not 
removed from the proposed revised 
Guidelines published in part C are: 
a. Section IV-C-7 of Section IV-C, 
General Definitions, which reads: “IV- 
C-7. ‘Director, NIH’ or ‘Director’ means 
the Director of the National Institutes of 
Health and any other officer or 
employee of NIH to whom authority has 
been delegated.” 
Section IV-C-7 has been renumbered 
I-D-5 in the proposed revised 
Guidelines (Part C of this document]. 
b. Section IV-D-5-b and its 
subsections of Section IV-D-5, Printipal 
Investigator, which reads: 
“IV-D-5-b. Submissions by the PI to 
NIH. The PI shall: 
“rV-D-5-b-(l). Submit information to 
NIH (ORDA) in order to have new 
host-vector systems certiBed; 
“IV-D-5-b-(2). Petition NIH, with notice 
to the IBC, for exemptions to these 
Guidelines; 
“IV-D-5-b-{3}. Petition NIH, with 
concurrence of the IBC, for approval 
to conduct experiments specified in 
Section III-A of the Guidelines; 
“IV-D-5-b-(4). Petition NIH for 
determination of containment for 
experiments requiring case-by-case 
review; * 
“IV-D-5-b-(5). Petition MH for 
determination of containment for 
experiments not covered by the 
Guidelines.” 
Section IV-D-5-b has been 
renumbered IV-B-5-c in the proposed 
revised Guidelines (part C of this 
document). 
c. Section rV-E-l-b-(l)-{a) and 
Section IV-E-l-b-(l)-(b) of Section IV- 
E-l-b, Specific Responsibilities of the 
Director, NIH, which reads: 
“IV-E-l-b-(l)-(a). Chfinging 
containment levels for types of 
experiments that are specified in the 
Guidelines when a major action is 
involved; 
“rV-E-l-b-(l)-(b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered in the Guidelines when a 
major action is involved”: 
Sections IV-E-l-b-(l)-(a)’and IV-E- 
l-b-(l)-(b) have been renumbered 
Section IV-C-l-^l)-(a) and IV-C-1- 
b-(l)-(b] respectively in the proposed 
revised Guidelines (part C of this 
document). 
d. Section IV-Er-l-b-(2) and its 
subsection which read: 
“IV-E-l-b-(2). The Director is also 
responsible for the following lesser 
actions, (For these, the Director must 
seek the advice of the RAC. The 
Director's decision will be transmitted 
to the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin)'. 
“IV-E-l-b-(2)-(a). Interpreting and 
determining containment levels upon 
request by ORDA: 
“IV-E-l-b-(2)-(b). Changing 
contaiiunent levels for experiments 
that are speciBed in the Guidelines 
(see Section III); 
“IV-E-l-b-(2)-(c). Assigning 
containment levels for experiments 
not explicity considered in the 
Guidelines; 
“IV-E-l-b-(2)-(d). Designating certain 
class 2 agents as class 1 for the 
purpose of these Guidelines (see 
Footnote 1 and Appendix B);” 
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