Federal Register / Vol. 45, No. 164 / Thursday, August 21, 1980 / Notices 
55927 
conduqted at P3 containment or at a 
lower level as specified by NIH (See 
Section IV-E-l-b-2-(e)). 
Other experiments using E. coli K-12 
or laboratory strains of S. cerevisiae 
shall use PI physical containment and, 
except as specified in the last paragraph 
of this section, an HV1 host-vector 
system [i.e., for experiments using E. 
coli K-12 (a) the E. coli host shall not 
contain conjugation-proficient plasmids 
or generalized transducing phages, and 
(b) lambda or lambdoid or Ff 
bacteriophages or nonconjugative 
plasmids [49] shall be used as vectors. 
For experiments in S. cerevisiae, 
laboratory strains shall be used]. 
Experiments involving the insertion 
into E. coli K-12 of DNA from 
prokaryotes that exchange genetic 
information with E. coli by known 
phsyiological processes will be 
exempted from these Guidelines if they 
appear on the "list of exchangers” set 
forth in Appendix A (see Section I-E-4). 
For those not on the Appendix A list 
but which exchange genetic information 
[35] with E. coli, experiments may be 
performed with any E. coli K-12 vector 
(e.g., conjugative plasmid). When a 
nonconjugative vector is used, the E. 
coli K-12 host may contain conjugation- 
proficient plasmids, either autonomous 
or integrated, or generalized transducing 
phases." 
C. Section III-A-3-a. The last 
sentence of Section III-A-3-a would be 
amended to read as follows: 
“IBC approval is sufficient for such a 
reduction except for any lowering of 
containment under Section III-A-3-a to 
levels below Pl+JTVl, which requires 
prior consultation with NIH.” 
D. Section IIl-A-3-b. The last 
sentence of the second paragraph of 
Section III-A-3-b would be amended to 
read as follows: 
“IBC approval is sufficient for such a 
reduction except for any lowering of 
containment under Section III-A-3-b to 
levels below Pl+HVl, or reduction of 
containment levels by more than one 
step, which requires prior consultation 
with NIH." 
E. Section IV-C-3. Section IV-C-3 
would be deleted. This Section currently 
reads as follows: 
“IV-C-3. “Memorandum of 
Understanding and Agreement” or 
"MUA” is a document that (i) provides 
to NIH or other Federal funding agency 
an Institution’s certification that the 
recombinant DNA research project 
complies with the NIH Guidelines and 
(ii) contains other essential data as 
required in the Administrative Practices 
Supplement.” 
F. Section IV-D-l-c. Sections IV-D- 
1— c and IV-D-l-c-(l) through IV-D-1- 
c-(5) would be deleted. These Sections 
currently read as follows: 
“IV-D-l-c. Submit, for each 
recombinant DNA project that meets 
with its approval, a Memorandum of 
Understanding and Agreement (MUA) to 
the funding agency for approval and 
registration. (Note: No MUA is required 
for experiments described in Section III— 
O). All projects, however, can proceed 
upon IBC approval (before submission 
of the MUA to the funding agency) 
except for the following, which require 
prior approval by NIH (or other funding 
agency designated by NIH for this 
purpose): 
"IV-D-l-c(l). Projects for which 
containment levels are not specified by 
the Guidelines or NIH, 
IV-D-l-c-(2). Projects requiring P4 
containment, 
IV-D-l-c-(3). Certain reductions of 
containment levels for characterized or 
purified DNA preparations or clones 
(see Section III— A— 3), 
IV-D-l-c-(4). The first project 
conducted in a facility at P3 
containment, or, 
IV— D— 1— c— (5). The first project 
conducted by an Institution. 
Note. — The MUA shall be submitted to the 
funding agency within 30 days of the IBC 
approval. If the funding agency does not 
routinely register recombinant DNA projects 
with NIH, the MUA must be submitted to 
NIH as well as to the funding agency. 
Authority to submit MUAs (or addenda) for 
which prior approval is not required may be 
delegated to the IBC chairperson. All MUAs 
that require NIH approval before the work 
can proceed shall be submitted to the NIH by 
the institutional official to whom the IBC is 
responsible.” 
G. Section IV-D-l-d. Section IV-D-1- 
d would be deleted. This section 
currently reads as follows: 
“IV-D-l-d. Take appropriate action to 
bring protocols into compliance when 
advised by NIH or other funding agency 
that IBC-approved projects do not 
conform to standards set forth in the 
Guidelines. This responsibility may be 
delegated to the IBC. (See 
Administrative Practices Supplement for 
further details).” 
H. Section IV-D-2-f. Section IV-D-2-f 
would bq amended to read as follows: 
“IV-D-2-f. Central to implementation 
of the Guidelines is the review of 
experiments by the IBC. In carrying out 
this responsibility, the Institution shall 
comply with instructions and procedures 
specified in the Administrative Practices 
Supplement." 
I. Section IV-D-2-h. Reference to 
MUAs would be deleted in Section IV- 
D-2-h. The revised Section would read 
as follows: 
“IV-D-2-h. Upon request, the 
Institution shall make available to the 
public all minutes of IBC meetings and 
any documents submitted to or received 
from funding agencies which the latter 
are required to make available to the 
public (e.g., reports of Guideline 
violations and significant research- 
related accidents, and agency directives 
to modify projects). If comments are 
made by members of the public on IBC 
actions, the Institution shall forward to 
HIH both the comments and the IBC’s 
response.” 
J. Section lV-D-3-a. Section IV-D-3-a 
would be amended to read as follows: 
“IV-D-3-a. Reviewing for compliance 
with the NIH Guidelines all recombinant 
DNA research conducted at or 
sponsored by the Institution, and 
approving those research projects that it 
finds are in conformity with the 
Guidelines. (See Administrative 
Practices Supplement for prior NIH 
approval requirements.) This review 
shall include:” 
K. Section lV-D-3-b. Section IV-D-3- 
b would be amended to read as follows: 
“IV-D-3-b. Notifying the Principal 
Investigator (PI) of the results of their 
review.” 
The "Note” following IV-D-3-b would 
be deleted. 
L. Section IV-D-3-f Section IV-D-3-f 
would be renumbered to IV-D-3-g, and 
a new Section IV-D-3-f would be added 
as follows: 
"IV-D-3-f. The IBC may not authorize 
initiation of experiments not explicitly 
covered by the Guidelines until NIH, 
(with the advice of the RAC when 
required) establishes the containment 
requirements.” 
M. Amendment of Section IV-D-5-a- 
(1). Section IV-D-5-a-(l) would be 
amended to read as follows: 
"IV-D-5-a-(l). Initate or modify no 
recombinant DNA research subject to 
the Guidelines until the Institutional 
Biosafety Committee (IBC) has been 
appropriately notified and all other 
requirements of the Guidelines and the 
Administrative Practices Supplement 
(APS) have been met. Modify 
containment and experimental protocol 
according to recommendations of the 
IBC.” 
N. Proposed Section IV-D-5-b-(4). A 
new Section IV-D-5-b-(4) would be 
added as follows: 
"IV-D-5-b-(4). Petition NIH for 
recommendations regarding 
containment for experiments requiring 
case-by-case review.” 
O. Proposed Section IV-D-5-b-(5). A 
new Section IV-D-5-b-(5) would be 
added as follows: 
“IV-D-5-b-(5). Petition NIH for 
recommendations regarding 
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