Federal Register / V’ol. 46, No. 234 / Mondwy, December 7, 1981 / Notice: 
5973 ? 
chromosomal or viral DNA source, 
though one or more of the segments may 
be synthetic equivalent. 
■’III-D-3. Those that consist entirely of 
DNA from a prokaryotic host, including 
its indigenobs plasmids or viruses, when 
propagated only in that host (or a 
closely related strain of the same 
species) or when transferred to another 
host by well established physiological 
means; also, those that consist entirely 
of DNA from a eukaryotic host, 
including its chloroplasts. mitochondria, 
or plasmids (but excluding viruses), 
when propagated only in that host (or a 
closely related strain of the same 
species). 
■‘IIJ-D-4. Certain speclHed 
recombinant DNA molecules that 
consist entirely of DNA segments from 
different species that exchange D.NA by 
known physiological processes, though 
one or more of the segments may be a 
synthetic equivalent. A list of such 
exchangers will be prepared and 
periodically revised by the Director, 
NIH. with advice of the RAC. after 
appropriate notice and opportunity for 
public comment. (See Section IV-E-l-b- 
(l)-(d).) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list is in Appendix A. An updated 
list may be obtained from the Office of 
Recombinant DNA Activities. National 
Institutes of Health. Bethesda, Maryland 
20205. 
“in-D-5. Other classes of 
recombinant DNA molecules, if the 
Director. NIH, with advice of the RAC, 
after appropriate notice and opportunity 
for public comment, finds that they do 
not present a significant risk to health or 
the environment. (See Section IV-E-1- 
b-{l)-(d).) Certain classes are exempt as 
of publication of these Revised 
Guidelines. The list is In Appendix C. 
An updated list may be obtained from 
the Office of Recombinant DNA 
Activities; National Institute.s of Health, 
Bethesda. Maryland 20205.'* 
D. Current Section IV. Roles and 
Responsibilities. Changes as necessary 
to reP.ect changes in Parts I-III only. 
E. Current Section V. Footnotes and 
References. Changes as necessary to 
reflect changes in Parts I-III. 
F. Current Appendices. Delete 
sections subsumed by proposed 
guideline changes; i.e. delete Appendix 
D and entries 1. 2. 3. 5. 7, 10. 11. 12. 14. 
15. 17. la 20, 22. 24, 25, 26. 27, 2a 29. 33. 
and 34 of Appendix E. 
Footnotes 
• Classification of Etioicftic Ag(-nts on the 
basis of Hazard. (4th Edition. July 1974). U.& 
Department of Health. Fxlucatlon and 
Welfare. Public Health Service, Centers for 
Disease ControL Office of Biosafety, Atlanta. 
Georgia 30333. 
** All activities. Including storage of 
variola and whitepox are retricted to tlur 
single national faulty (World Health 
Organization (WHO) CoUaborating Center 
for Smallpox Research. Center for Disease 
Control In Atlanta). 
" • A USDA permlL required for import 
and Inlerstate commerce of pathogens, may 
be obtained from the Animal anti Plant 
Health Inspection Service USDA. Fodern! 
Building. Hyattsvtlle, MD 20782. 
OMB's "Mandatory Information 
Requirements for Federal A,<isislnnce Program 
Anntnmcements” (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 
serveral 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 OMB 
Circular A-9S because they fit the description 
of "programs not considered appropriate" in 
Section 8-{b)-(4) and (S) of that Circular, 
Dated: November 20. 1981. 
Richard M. Krause. 
Director, Natiana! Institute of Allergy and 
Infectious Diseases. National Institutes of 
Health. 
|PR r>oc. SI-M4SS PIIkI n-*-St S<4S nml 
WUJNO COOC 4140-et-H 
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