Federal Register / Vol. 57, No. 78 / Wednesday, April 22, 1992 / Notices 
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forwarded to the NIH Director for a decision 
which will then be published in the Federal 
Register. 
Introduction. (4) * * * The IRB and IBC 
may. at their discretion, condition their 
approval on further specific deliberation by 
the RAC. Consideration of proposals by the 
RAC may proceed simultaneously with 
review by any other Federal agencies 
provided that the RAC is notified of the 
simultaneous review. Meetings of the RAC 
will be open to the public except where trade 
secrets or proprietary information would be 
disclosed. The committee * * *. 
Introduction. (6) * * * Part ID summarized 
other requested documentation that will 
assist the RAC in their review of the 
proposals. Part IV specified reporting 
requirements. 
Introduction. (7) The RAC will not at 
present entertain proposals for germ line 
alterations * * *. 
Introduction. (9) In their evaluation of 
proposals involving the transfer of 
recombinant UNA into human subjects, the 
RAC will consider whether the design * * *. 
Accordingly, this document requests 
information that will enable the RAC to 
assess the possibility that the proposed 
experiments will inadvertently affect 
reproductive cells or lead to infection of other 
people (e.g., treatment of personnel or 
relatives). 
Introduction. (10) In recognition of the 
social concern that surrounds the subject of 
gene transfer, the RAC will cooperate with 
other groups * * *. 
Introduction. (12) * * * Investigators 
submitting proposals that employ essentially 
the same vector systems (or with minor 
variations), and/or that are based on the 
same preclinical testing as proposals 
previously reviewed by the RAC, may refer to 
preceding documents without having to 
rewrite such materials. 
Part IL Special Issues. Although the 
following issues are beyond the normal 
purview of local ERBs, the RAC requests that 
the investigators respond to questions A and 
B below. 
Part V. Minor Modifications. A minor 
change in a protocol approved by the RAC is 
a change that does not significantly alter the 
basic design of a protocol and that does not 
increase risk to the subjects. If the change 
has been approved by the relevant IRB and 
IBC, then the Chair of the RAC may give 
approval. It is expected that the Chair will 
consult with one or more members of the 
committee, as necessary. The Chair will 
report on any such approvals at the next 
regularly scheduled meeting of RAC. 
I accept this recommendation to 
amend accordingly the NTH Guidelines 
in sections EQ-A and IV-C and to amend 
the Points to Consider in the 
Introduction, Parts Q, and V. 
G. Amendment to Appendices B-l-B-1 
and B-I-B-2 of the NIH Guidelines 
regarding the Bacterial Order, 
Actinomycetales 
In a written request dated April 15, 
1991, Dr. Diane O. Fleming, representing 
the Mid-Atlantic Biological Safety 
Association, requested that only 
pathogenic genera and species of the 
bacterial order, Actinomycetales, be 
included in Appendix B-I-B-l of the 
NIH Guidelines. 
It was proposed that the following 
pathogens be included in the list of 
Bacterial Agents in Appendix B-I-B-l of 
the NIH Guidelines as follows: 
Actinomadura madurae, 
Actinomadura pelletieri, Actinomyces 
bovis, Actinomyces israelii, Nocardia 
asteroides, Nocardia brasiliensis 
In appendix B-I-B-2, the entry under 
Actinomycetes would be deleted. 
This request was reviewed at the RAC 
meeting on May 30-31, 1991. Following a 
discussion there was agreement that 
Actinomyces should be removed from 
the list of fungi and reclassified as 
bacteria. There was disagreement, 
however, about the number of species to 
be listed as pathogens. Reviewers and 
committee members expressed concern 
that the number of possible pathogens 
may be larger than the six species 
proposed for inclusion. The RAC 
requested that Dr. Fleming consult with 
leading experts on Actinomycetales and 
develop a revised and expanded list of 
potential pathogens to be reviewed at 
the RAC meeting on October 7-8, 1991. 
This request was published for comment 
in the Federal Register on September 3, 
1991 (56 FR 43686). 
A second list of potential pathogens 
was submitted to the RAC. This 
included 63 organisms, a number that 
was reduced to 56 by clarification of 
taxonomic names and was reviewed by 
Dr. Lechevalier at Rutgers University, 
Dr. Blaine Beaman of die University of 
California at Davis, and Drs. Michael 
McNeil and Richard Knudsen at the 
Centers for Disease Control (CDC). Drs. 
McNeil and Knudsen presented a 
synopsis of their review at the RAC 
meeting of October 7-8, 1991. 
During the October 7-8, 1991, RAC 
meeting, a motion was passed by a vote 
of 19 in favor, 0 opposed, and no 
abstentions to create an ad hoc working 
group within the RAC, plus outside 
consultants, to provide an amended list 
of pathogens. 
On November 13, 1991, the RAC 
Working Group on Actinomycetales 
held a telephone conference call for the 
purpose of proposing a list of pathogens. 
Drs. B. Murray, D. Fleming, D.lCrogstad, 
and M. Schaechter participated. 
Originally, a list of 19 organisms was 
developed; this included both the proven 
pathogens identified by the CDC and the 
suspected pathogens identified by the 
CDC that were also part of risk group 2 
(BL-2) in the German classification, 
"Klassifizierung DerBakterien Nach 
Den Im Ungang Mit Ihnen Auftretenden 
Gefahren. " These d organisms are as 
follows: 
Actinomadura madurae, 
Actinomadura pelletieri, Amycolata 
autotrophica, Dematophilus congolensis, 
Gordona bronchialis, Gordons sputi, 
Nocardia asteroides, Nocardia 
brasiliensis, Nocardia otitidiscaviarum, 
Nocardia farcinica, Nocardia nova, 
Nocardia transvalensis, Nocardiopsis 
dassonvillei, Rhodococcus equi, 
Rhodococcus aichiensis, Rhodococcus 
chubuensis, Rhodococcus rhodochrous, 
Rhodococcus ruber, Streptomyces 
Somaliensis. 
Alternatively, a list of organisms 
representing only proven pathogens, as 
established by the CDC, would read as 
follows: 
Amycolata autotrophica, 
Dermatophilus congolensis, Nocardia 
asteroides, Nocardia brasiliensis, 
Nocardia otitidiscaviarum, Nocardia 
transvalensis, Rhodococcus equi. 
The request was published for 
comment in the Federal Register on 
January 3, 1992 (57 FR 316). 
During the meeting on February 10, 
1992, the RAC discussed the 
recommendations of the Working Group 
on Actinomycetales. The RAG by a vote 
of 13 in favor, 0 opposed, and no 
abstentions, accepted the working 
group's recommendation to adopt the 
CDC classification of organisms with 
proven pathogenicity. 
The following proven pathogens of the 
bacterial order, Actinomycetales, will be 
added to Apendix B-I-B-l, Bacterial 
Agents: 
“Amycolata autotrophica, 
Dermatophilus congolensis, Nocardia 
asteroides, Nocardia brasiliensis, 
Nocardia otitidiscaviarum, Nocardia 
transvalensis, Rhodococcus equi." 
The following organisms will be 
deleted from appendix B-4-B-2, Fungal 
Agents: 
“Actinomycetes (including Nocardia 
species, Actinomyces species, and 
Arachnia propionica)[2]." 
I accept this recommendation and 
Appendices B-I-B-l and B-I-B-2 of the 
NIH Guidelines will be amended 
accordingly. 
H. Amend Appendices B-I-C-land B-I- 
B-l in the NIH Guidelines Regarding 
Mycobacterium Avium 
In a letter dated December 18, 1991, 
Dr. William R. Jacobs, Jr., of the Albert 
Einstein College of Medicine, Bronx, 
New York, requested a lowering of the 
classification Mycobacterium avium 
from a Class m bacterial agent to a 
Class II bacterial agent M. avium would 
move from Appendix B-4-C-1 to 
Appendix B-I-B-l in the NIH 
Recombinant DNA Research, Volume 15 
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