12754 
Federal Register / Vol. 53. No. 74 / Monday. April 18. 1988 / Notices 
transmitted, the experiments may not be 
zarried out at BL1-N containment: a 
minimum containment of BLl or BL2-N 
•s required." 
The Working Croup on Transgenic 
Animals on March 28. 1988. 
recommended that this section be 
amended to read as follows: 
"This section covers experiments 
involving whole animals, both those in 
which the animal's genome has been 
altered by stable introduction of DNA 
into the germ line (transgenic animals) 
and experiments involving viable 
recombinant-DNA-modified 
microorganisms tested on whole 
animals. For the latter, other than 
viruses which are only vertically 
transmitted, the experiments may not be 
carried out at BLl-N containment: a 
minimum containment of BLl or BL2-N 
is required. 
’Caution: Special care should be used 
in the evaluation of containment 
conditions for some experiments with 
transgenic animals For example, such 
experiments might lead to the creation 
of novel mechanisms or increased 
transmission of a recombinant pathogen 
or production of undesirable traits ir. the 
host animal. In such cases, serious 
consideration should be given to 
increasing the containment conditions." 
E On September 21. 1987. the RAC 
recommended that a modified paragraph 
37 as published for comment ir. the 
Federal Register of August 11. 1987. be 
incorporated as Section III-B— 4— a of the 
K1H Guidelines as follows: 
"Recombinant DNA. or RNA 
molecules derived therefrom, from any 
source except for a eukaryotic viral 
genome may be transferred to any non- 
human vertebrate or any invertebrate 
organism and propagated under 
conditions of physical containment 
comparable to BLl or BLl-N and 
appropriate to the organism under study 
|2). Animals containing sequences from 
viral vectors, if the sequences do not 
lead to transmissible infection either 
directly or indirectly as a result of 
complementation or recombination in 
animals, may be propagated under 
conditions of physical containment 
comparable to BLl or BLl-N and 
appropriate to the organism under study. 
For experiments involving recombinant 
DNA modified Class 2. 3. 4 . or 5 
organisms (1) using w hole animals, see 
Section III— B— 1." 
The Working Group on Transgenic 
Animals on March 28. 1988. 
recommended that this section be 
amended to read as follows: 
"Recombinant DNA or DNA or RNA 
molecules derived therefrom, from any 
source except for a eukary otic viral 
genome may be transferred to any non- 
human vertebrate or any invertebrate 
organism and propagated under 
conditions of physical containment 
comparable to BLl or BLl-N and 
appropriate to the organism under study 
[2]. Animals containing sequences from 
viral vectors, if the sequences do not 
lead to transmissible infection either 
directly or indirectly as a result of 
complementation or recombination in 
animals, may be propagated under 
conditions of physical containment 
comparable to BLl or BLl-N and 
appropriate to the organism under study 
Experiments involving the introduction 
of other sequences from eukaryotic viral 
genomes into animals are covered under 
III— B — »— b. For experiments involving 
recombinant DNA modified Class 2. 3. 4. 
or 5 organisms (1) using whole animals, 
see Section II1-B-1." 
F On September 21. 1987. the RAC 
recommended that paragraph 41 as 
published for comment in the Federal 
Register of August 11. 1987. be 
incorporated as Section III— B — 4— b of the 
NIH Guidelines, as follows: 
"For experiments involving whole 
animals and not covered by Section III— 
B-l or Section 1II-B — 4— a. the appropriate 
containment will be determined by the 
IBC (22 23)." 
The Working Group on Transgenic 
Animals on March 28. 1938. 
recommended that this section be 
amended to read as follows: 
"For experiments involving 
recombinant DNA or DNA or RNA 
derived therefrom, involving whole 
animals, including transgenic animals, 
and not covered by Section III— B— 1 or 
Section III— B — 4— a. the appropriate 
containment will be determined bv the 
IBC (22)." 
V. Proposed Amendment of Appendix A 
To Include Pseudomonas Mendocina 
In a letter dated March 28. 1988. Dr. 
Burt D. Ensley of AMGen. Thousand 
Oaks. California, requests that 
Pseudomonas mendocina be included in 
Sublist A of Appendix A of the NIH 
Guidelines. Data in support of the 
request are included in the submission. 
VI. Proposed Amendment of Appendix 
G-IV To Include Bacillus licheniformis 
In a letter dated March 30. 1988. Dr. 
Joseph R. Fordham of Nova 
Laboratories. Inc.. Danbury. 
Connecticut, request that Bacillus 
licheniformis be included to the title and 
to the first sentence of Appendix C-IV 
of the NIH Guidelines. This section 
would be amended to read as follows: 
Appendix C-IV — Experiments Involving 
Bacillus Sublilit or Bacillus licheniformis 
Host-Vector Systems 
"Any asporogenic Bacillus subtilis or 
Bacillus licheniformis strain. . . .** 
Data in support of the request aie included 
in the submission. 
OMB s "Mandatory Information 
Requirements for Federal Assistance Prog'an 
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 o f Federal 
Domestic Assistance ere affected. 
Dated. April 5. 1988 
James C Hill. 
Acting Director. National Institute of Allergx 
and In fectious Diseoses. 
(FR Doc. 88-8368 Filed 4-15-88 8.45 am) 
Billing codc 4i«o-ov-u 
Recombinant DNA Research. Volume 13 
[125] 
