Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46263 
should be made only by the laboratory 
director (see Appendix G — III— 2)." 
k. Table 1 and Table II of Appendix C 
are deleted and the following table is 
substituted. 
TABLE 1.— Possible Alternative Combina- 
tions of Physical and Biological Con- 
tainment Safeguards 
Classification of 
physical and 
biological 
containment 
Alternate physical containment 
Alter- 
nate 
biologi- 
cal 
contain- 
ment 
Labora- 
tory 
facilities 
Labors 
tory 
prac- 
tices 
Contain- 
ment 
equip- 
ment 
BL3/HV2 
BL3 
BL3 
BL3 
HV2 
BL3 
BL3 
BL4 
HV1 
BL3/HV1 
BL3 
BL3 
BL3 
HV1 
BL3 
BL3 
BL2 
HV2 
BL4/HV1 
BL4 
BL4 
BL4 
HV1 
BL4 
BL4 
BL3 
HV2 
8. Appendix H. Shipment 
a. Wherever the terms "PI, P2, P3, P4" 
appear, the term “BLl" is substituted for 
the term “PI;” the term “BL2" is 
substituted for "P2;” the term "BL3" is 
substituted for "P3;” and the term “BL4" 
is substituted for "P4.” 
b. Appendix H— III of Appendix H, 
Shipment, is modified to read as follows: 
Appendix H— III. Information on 
packaging and labeling of etiologic 
agents is shown in Figures 1, 2, and 3. 
Additional information on packaging 
and shipment is given in the ‘Laboratory 
Safely Monograph — A Supplement to 
the NIH Guidelines for Recombinant 
DNA Research,' available from the 
Office of Recombinant DNA Activities 
and in 'Biosafety in Microbiological and 
Biomedical Laboratories' (see Appendix 
G-III-2)." 
9. Appendix K, Physical Containment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules. 
a. Wherever the terms “PI, P2, P3, P4" 
appear, the term "BLl” is substituted for 
the term "Pi;" the term "BL2" is 
substituted for the term “P2;" the term 
"BL3" is substituted for “P3;" and the 
term “BL4" is substituted for “P4." 
b. Wherever the terms “Pl-LS, P2-LS. 
P3-LS, P4-LS" appear, the term "BLl- 
LS" (for Biosafety Level 1 — large-Scale) 
is substituted for term, “Pl-LS;" the term 
"BL2-LS” is substituted for "P2-LS;" and 
the term “BL3-LS" is substituted for 
"P3-LS." 
Dated: November 15, 1984. 
James B. YVyngaarden, M.D., 
Director, National Institutes of Health. 
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, Nil I 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 Catalogue of 
Federal Domestic Assistance are 
affected. 
|KR Doc 84-30641 Filed 11-21-84: 8:45 am| 
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