7448 Federal Register / Vol. 55. No. 41 / Thursday, March 
Appendix H— Shipment 
Recombinant DNA molecules contained in 
. an organism or in a viral genome shall be 
shipped under the applicable regulations of 
the U.S. Postal Service (39 CFR. part III]; the 
U.S. Public Health Service (42 CFTl. part 72|: 
the U.S. Department of Agriculture [9 CFR. 
Bubchapters D and E: 7 CFR. part 340j: and/or 
the U.S Department ofTransportation (49 
CFR parts 171-179). 
For purposes of the NIH Guidelines: 
Host organisms or viruses will be shipped 
as etiologic agents regardless of whether or 
not they contain recombinant DNA if they are 
regulated as human pathogens by the U.S. 
Public Health Service |42 CFR part 72] or as 
animal pathogens or plant pests under the 
Animal and Plant Health Inspection Service 
(APHIS). U.S. Department of Agriculture 
[Titles 9 and 7 C^ respectively). 
Additionally, host' organisms and viruses 
will be shipped as etiologic agents if they 
contain recombinant DNA when: 
A. the recombinant DNA indudes the 
complete genome of a host organism or virus 
regulated as a human or animal pathogen or a 
plant pest or 
B. the recombinant DNA codes for a tonn 
or other factor directly Involved in elidting 
human, animal or plant disease or inhibiting 
plant growth and is carried oaan expression 
vector or within the host chromosome and/or 
when the host organism contains a 
conjugation proficient plasmid or a 
generalized transducing phage: or 
C the recombinant DNA comes from a host 
organism or virus regulated as a human or 
animal pathogen or as a plant pest and has 
not been adequately characterized to 
demonstrate that it does not code for a factor 
involved in elidting human, animal or plant 
disease. 
. Appendix H-1 — Footnotes and References of 
Appendix H 
For further information on shipping 
etiologic agents, please contact (1) Centers 
for Disease .ContioL ATTN: Biohaards . 
CohtrorOffice.'1600 Cliftonltoa'd. Atlanta. ' 
Georgia 30333. (404) 630-3833. FTS 236-3883: 
(2) Department ofTransportation. ATTN: 
Office of Hazardous Materials 
Transportation. 400 7th Street SW, 
Washington. DC 20590. (202) 366-4545; or (3| 
Department of .Agriculture. ATTN: Animal & 
Plant Health Inspection Service. 6505 Belcrest 
Road. Hyattsville. Maryland 20782. (301) 436- 
7885 for Animal Pathogens. (301) 436-7812 for 
Plant Pests. 
D. Amendment of Appendix A. Sublist 
A. and Appendix B-I-B-1 of the NIH 
Guidelines Regarding Klebsiella 
oxytoca. 
Sublist A, No. 6 will read as follows: 
6. Genu.s Klebsiella (including oxytoca). 
Appendix B-I-B-1 will read as follows: 
Klebsiella — all spedes except oxytoca. 
E. Points to Consider for Protocols for 
the Transfer of Recombinant DNA into 
the Genome of Human Subjects. 
This document provides basic 
information & guidance for scientists 
and clinical investigators who are 
preparing proposals for NIH 
consideration under Section III-A— 4 of 
the NIH Guidelines requiring 
experiments involving the transfer of 
recombinant DNA into human subjects 
to be reviewed by the RAC and 
approved by NIH. 
F. Amendment to Appendix D-XIV of 
the NIH Guidelines. 
The following section is added to 
Appendix D: 
Appendix D-XTV. 
' - . U.& Army Medical Research Institute of 
- Infectious Diseases (USAMRIID) may 
conduct certain experiments involving 
products of a yellow fever virus originating 
from the 17-D yellow fever clone at the 
Biosafety Level 3 containment level using 
1 1990 / Notices 
HEPA niters and vaccination of laboratory 
personneL 
In addition. USAMRIID may cundud 
certain experiments involving vaedne studies 
of Vennuelan equine encephalitis virus at 
the Biosafety Level 3 containment level using 
HEPA niters and vaccination of laboratory ■ 
personnel. 
OMB's “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
ofTicial 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 tbe 
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 whi^ DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in tbe public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In additioru NIH could 
. not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
intemationaL have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing. NIH invites readers to 
direct questioiu to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: February 15. 1990. 
William F. Raub, 
Acting Director, National Institutes of Health. 
(FR Doc 90-4688 Filed 2-28-90, 8:45 am) 
- Biuma CODE 4140-evw 
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Recombinant DNA Research, Volume 14 
