38046 
Federal Register / Vol. 47. No. 167 / Friday, August 27, 1982 / Notices 
Guidelines for Research Involving 
Recombinant DNA Molecules for 
research which they conduct or support. 
rV. Additional Changes 
I am incorporating into the revised 
Guidelines pubHshed today the 
following additional changes: 
A. Appendix E 
1. Certification of chi-1776 (pBR325) 
as an EK2 host-vector system. Appendix 
E has been amended to indicate 
certification of E. coli K-12 strain chi- 
1776 with plasmid pBR325 as an EK2 
host-vector system. 
2. DecertiBcation of certain E. coU K- 
12 strains. E ccli K-12 strains chi-1984. 
chi-2705. chi-20(>l. and chi-2263 have 
been decertified for use with certain 
lambda vectors. Reference to these 
strains have been deleted from 
Appendix E. 
B. Appendix F 
1. Section Appendix F-IV-E has been 
rewritten to update this Section. The 
new wording which has been 
incorporated reads as follows: 
Appendix F-IV-E. Fragments F-1. F-2. and 
F-3 of the diphtheria toxin gene (tox) may be 
cloned in £ coli K-12 under Pi -i- EKl 
contairunent conditions. Fragment F-1 and 
fragment F-2 both contain (i) some or all of 
the transcriptional control elements of tox, 
(ii) the signal peptide, and (iii) fragment A 
(the center responsible for ADP-ribosylation 
of elongation factor 2). Fragment F-3 codes 
for most of the non-toxic Fragment B of the 
toxin, and contains no sequences coding for 
any portion of the enzymatically-active 
fragment A moiety. 
2. A new Section. Appendix F-FV-G, 
has been added to reflect a case-by-case 
decision under the Guidelines. The new 
section reads as follows: 
Appendix F-IV-C. Genes from Vibrio 
fluvialia. Vibrio mimicua and non 0-1 Vibrio 
choteroe, specifying virulence factors for 
animals may be cloned under Pi + EKl 
conditions. The virulence factors to be cloned 
will be selected by testing fluid induction in 
suclding mice and in Y-1 mouse adrenal cells. 
Dated: August 18. 1982. 
Richard M. Krause. 
Director. National Institute of Allergy and 
Infectioua Diseases. National Institutes of 
Health. 
OMB’s "Mandatory Information 
Requirements for Federal Assistance Program 
Aimouncements" (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 NTH 
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. 
NIH programs are not covered by 0MB 
Circular A-95 because they fit the description 
of "programs not considered appropriate’* in 
Section d-(b)-{4) and (5) of that Circular. 
|FR Ooc. S3-23306 FiM S-2S-S2. S:45 ami 
BILUNG CODE 4140-01-M 
[5471 
