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Federal Register / Vol. 52. No. 163 / Monday. August 24, 1987 / Notices 
experiments, the other deals with 
containment recommended for large- 
scale fermentation. One ad hoc 
consultant said that the proposed 
language was not an improvement and 
recommended not changing the current 
wording regarding laboratory 
experiments. A RAC member felt that 
the proposal clarifies the wording of this 
section, noting that the “latitude" 
allowed in the application of BLl-LS 
requirements is somewhat subjective. 
Another RAC member said that the part 
of the proposal dealing with laboratory 
experiments is not necessary, but that 
some version of the wording regarding 
large-scale fermentation should be 
adopted. It was agreed that the 
laboratory-scale and large-scale aspects 
should be considered separately. 
The RAC then moved that in 
Appendices C-II, C— III. and C-IV, the 
paragraph regarding containment for 
laboratory experiments should be 
retained as currently worded in the NIH 
Guidelines, and the proposed paragraph 
regarding large-scale fermentation 
should be accepted with the addition of 
the word "generally" after “conditions," 
as follows: 
For large-scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions generally need be no 
greater than those for the host organism 
unmodified by recombinant DNA techniques. 
The RAC voted to accept this motion 
by a vote of 13 in favor, none opposed, 
and 2 abstentions. 
In reviewing this recommendation and 
in agreement with the intent of the RAC, 
I conclude that it would be appropriate 
for clarity to remove the word 
‘^generally" and include a statement that 
the Institutional Biosafety Committee 
(IBC) may choose to specify a higher 
level of containment. Accordingly, I 
accept the RAC's recommendation as 
modified as follows: 
For large-scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions need be no greater 
than those for the host organism unmodified 
by recombinant DNA techniques: the IBC can 
specify higher containment if it deems it 
necessary. 
Appendices C-II. C— III. and C-IV are 
modified accordingly. 
II. Summary of Actions 
A. Revisions of Sections I-A and III-A 
of the NIH Guidelines 
The following paragraph is added as 
the second paragraph to Section I-A of 
the NIH Guidelines: 
Any recombinant DNA experiment which 
according to these Guidelines requires 
approval by the National Institutes of Health 
(NIH). may be sent by the submitter to the 
NIH or to another Federal agency that has 
jurisdiction for review and approval. Once 
approval, or other applicable clearances, has 
been obtained from a Federal agency other 
than the NIH (whether the experiment is 
referred to that agency by the NIH, or sent 
directly there by the submitter), the 
experiment may proceed without the 
necessity for NIH review or approval. 
However, any experiment that involves the 
administration of gene therapy to human 
subjects (see Section III— A— 4 of the 
Guidelines) may not proceed without prior 
review by the NIH Recombinant DNA 
Advisory Committee and NIH approval. 
The following paragraph is deleted 
from Section III-A: 
If the experiments in this category are 
submitted for review to another Federal 
agency, the submitter shall notify ORDA; 
ORDA may then determine that such review 
serves the same purpose, and based on that 
determination, notify the submitter that no 
RAC review will take place, no NIH approval 
is necessary, and the experiment may 
proceed upon approval from the other 
Federal agency. 
B. Revisions of Appendices C-II, C-III, 
and C-IV 
The third paragraph of Appendix C-II, 
the fourth paragraph of Appendix C-III, 
and the third paragraph of Appendix 
C-IV are modified to read as follows: 
For large-scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions need be no greater 
than those for the host organism unmodified 
by recombinant DNA techniques; the IBC can 
specify higher containment if it deems it 
necessary. 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing. NIH invites readers to 
direct questions to the information 
address above about whether individual 
Programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
Dated: August 12, 1987. 
fames B. Wyngaarden, 
Director, National Institutes of Health. 
[FR Doc. 87-19119 Filed 8-21-87; 8:45 am] 
BILLING CODE 4140-01-M 
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Recombinant DNA Research, Volume 13 
