33094 
NOTICES 
For registration of projects de- 
scribed in B and C above, the follow- 
ing Information must be submitted: 
1. A short title for the project. 
2. Registry number of project. 
3. Start and end dates of the project. 
4. The name of the principal investi- 
gator and the name and address of the 
institution, including the department 
In which the research is being con- 
ducted and the location of the project. 
5. The source of support for the 
project. 
6. A description of each project and 
the name of the investigator responsi- 
ble for the research. Descriptions 
should Indicate information on the 
sources of DNA. nature of Inserted 
DNA sequences, and the host-vector 
systems being used. Ordinarily, no 
more than two pages of description for 
each series of experiments are neces- 
sary. 
7. An assessment of the level(s) of 
physical and biological containment 
required by the Guidelines for each 
series of experiments. 
8. A statement that an Institutional 
Biosafety Committee has reviewed the 
project and found It to be in compli- 
ance with the NIH Guidelines. 
9. The signatures of the principal In- 
vestigator. the chairperson of the IBC. 
and the institutional official. 
10. The date of signature by the In- 
stitutional official. This date will be 
used for reference purposes. 
E. Rerieic. Institutions will be noti- 
fied in writing of ORDA's review of 
the information submitted for regis- 
tration of recombinant DNA projects 
not supported by NIH. If review by 
ORDA finds that the protocols do not 
conform to standards set forth In the 
Guidelines, the institution is expected 
to take appropriate action to bring the 
protocols into compliance with NIH 
standards. 
V. Lowering of Containment Levels 
for Purified DNA and Characterized 
Clones. 
A. Purified DNA Other Than Plas- 
mids, Bacteriophages, and Other Vir- 
uses. 
The Guidelines stipulate that the 
formation of DNA recombinants from 
cellular DNA's that have been purified 
and which are free of harmful genes 
can be carried out under lower con- 
tainment conditions than those re- 
quired for the corresponding shotgun 
experiment. IBC approval is sufficient 
for such a reduction of containment 
level, except for (i) primate DNA, 
which also requires prior NIH approv- 
al. or (il) any lowering of containment 
to levels below P1 + EK1. which also 
requires prior NIH approval (see sec. 
III-A-3-a of the Guidelines). 
The IBC must notify ORDA In writ- 
ing of all such actions. Many of these 
actions will be in the context of sub- 
mission of a new or revised MUA. 
B. Characterized Clones of DNA Re- 
combinants. The Guidelines permit 
IBC s to give approval for a single-step 
reduction in physical or biological con- 
tainment on receipt of evidence of 
characterization of a clone derived 
from a shotgun experiment and its 
probable freedom from harmful genes 
(see sec. III-A-3-b of the Guidelines). 
IBC approval is sufficient for such a 
reduction except for (1) primate DNA 
which requires prior NIH approval, or 
(il) any lowering of containment to 
levels below P1 + EK1, which also re- 
quires prior NIH approval. The IBC 
must notify ORDA In writing of all 
such actions. Such notification must 
clearly indicate the name of the prin- 
cipal investigator and the project sup- 
porting the work. 
Reduction of containment levels by 
more than one step, use of primate 
DNA. or cases involving lowering of 
containment to levels below P1+EK1 
require prior approval by NIH. In the 
latter cases, complete information 
must be submitted to ORDA. Many of 
these cases are expected to require 
review by the RAC at its next sched- 
uled meeting. 
VI. Exceptions and Exemptions to 
the Guidelines. 
A. Exceptions. Exceptions to prohib- 
ited experiments require express ap- 
proval by the Director. NIH. on recom- 
mendation of the RAC after appropri- 
ate notice and opportunity for public 
comment (see sec. I-D of the Guide- 
lines). 
B. Exemptions. Classes of exempt 
experiments, which are not covered by 
the Guidelines, are cited in section I-E 
of the Guidelines. It is anticipated 
that additional exemptions for specific 
experiments which fall into the cate- 
gories cited in sections I-E-4 and I-E-5 
of the Guidelines may be granted by 
the Director. NIH, on the recommen- 
dation of the RAC and after appropri- 
ate notice and opportunity for public 
comment. 
C. Requests for Exceptions and Ex- 
emptions. Requests for an exception 
to a prohibition cr an exemption from 
the Guidelines must be submitted to 
ORDA accompanied by adequate doc- 
umentation. Because the handling of 
requests for exceptions and exemp- 
tions will probably be a time-consum- 
ing process, investigators are strongly 
urged to discuss the proposed request 
with the staff of ORDA by telephone 
In advance of submission of a formal 
request. Decisions or requests for ex- 
ceptions or exemptions will be pub- 
lished In the Recombinant DNA Tech- 
nical Bulletin. 
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