NOTICES 
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minor changes in research protocols to 
the IBC. Minor changes need not be 
reported to NIH until an updated 
MUA is required (see section II-B of 
this appendix). 
2. Protocols for Which Containment 
Levels are Not Explicitly Specified by 
the NIH Guidelines. Investigators who 
wish to initiate recombinant DNA ex- 
periments for which containment 
levels are not explicitly stated in the 
guidelines or in announcements from 
ORDA must obtain approval from the 
NIH prior to initiating the proposed 
experiments. 
Because it is anticipated that the 
setting of containment levels for this 
class of experiments will require 
review by the Recombinant DNA Advi- 
sory Committee, investigators are 
strongly urged to provide to ORDA in 
writing full information on the pro- 
posed experiments prior to submission 
of a formal MUA. 
F. Shipping Requirements. 
Note. — Requirements regarding shipment 
and transfer of recombinant DNA materials 
may be incorporated by reference into the 
MUA (see illustration in this appendix). 
All MUA's must indicate that the 
principal investigator (program direc- 
tor, fellow, or candidate) agrees to 
comply with the following provisions 
pertaining to shipment or transfer of 
recombinant DNA materials: 
1. Prior to shipment or transfer of 
recombinant DNA materials within 
the United States, the sending labora- 
tory shall obtain a written statement 
from the requesting laboratory that: 
a. Research involving recombinant 
DNA molecules' shall be conducted in 
compliance with NIH guidelines, this 
appendix, and other NIH instructions, 
and 
b. The project proposed by the re- 
questing laboratory has been reviewed 
and approved by the IBC of the re- 
questing laboratory. 
2. Prior to shipment of recombinant 
DNA materials to a country other 
than the United States, the sending 
laboratory shall obtain a statement 
from the requesting laboratory stating 
that research involving recombinant 
DNA molecules shall be conducted in 
accordance with the containment 
levels specified by the NIH guidelines, 
or applicable national guidelines if 
such have been adopted by the coun- 
try in which the research is to be con- 
ducted. 
3. The sending investigator shall 
maintain a record of all shipments of 
recombinant DNA materials. 
Note. — See section II-D-3 of the guide- 
lines for restrictions on distribution of certi- 
fied host-vector systems. 
III. Policy and Procedures for Re- 
combinant DNA Research Supported 
by NIH and Conducted in Foreign 
Countries. 
A. Policy. Many countries in which 
NIH-supported recombinant DNA re- 
search may be conducted have adopt- 
ed guidelines for the conduct of this 
research which are either comparable 
to or based on principles similar to 
those of the NIH guidelines for recom- 
binant DNA research. Also, many 
countries have existing organizations 
and procedures to review and register 
recombinant DNA research, and re- 
quire documentation similar to that of 
NIH. If such guidelines and proce- 
dures exist and are comparable to the 
NIH guidelines, review and approval 
by the appropriate national body in 
the country in which the research is to 
be conducted, in general, will be ac- 
cepted as assurance that the research 
will be conducted in a responsible 
manner and in accord with national 
guidelines. However, NIH reserves the 
right to withhold funding if the safety 
practices to be employed are not rea- 
sonably consistent with the NIH 
guidelines. 
B. Requirements and Procedures for 
NIH-Supported Research in Countries 
with Guidelines. The following proce- 
dures apply both to NIH awards in 
foreign countries and to U.S. investiga- 
tors intending to conduct recombinant 
DNA research with NIH support in 
foreign countries which have adopted 
guidelines. For applications for NIH 
awards in foreign countries, the re- 
quired documentation (see below) may 
be included with the application, or 
may be submitted at a later date, but 
must be submitted prior to the time of 
award. For U.S. investigators intend- 
ing to conduct recombinant DNA re- 
search abroad, the documentation 
should be submitted prior to initiation 
of the project. 
For all NIH-supported research 
abroad using recombinant DNA tech- 
nology. a document providing the fol- 
lowing information must be submitted 
to NIH: 
1. A description of each proposed 
project and the individual investigator 
responsible for the research, if other 
than the principal investigator. De- 
scriptions should indicate the sources 
of DNA, nature of inserted DNA se- 
quences, hosts and vectors to be used, 
and must be of sufficient detail to pro- 
vide information about the research 
without need for reference to other 
documentation. Ordinarily, no more 
than two pages of description for each 
series of experiments are necessary. 
2. An assessment of the level(s) of 
physical and biological containment 
required by the guidelines of the coun- 
try in which the research is to be con- 
ducted. 
3. Documentation that the research 
project is in compliance with the ap- 
plicable national guidelines and, where 
required, has been registered with the 
appropriate national body in the coun- 
try in which the research is to be con- 
ducted. If approval of the national 
body is required prior to initiation of 
the research, the documentation must 
indicate that such approval has been 
received. 
4. The signatures of both a responsi- 
ble official and the principal investiga- 
tor. 
5. The date of signature of the re- 
sponsible official. This will become the 
date of the document for future refer- 
ence. 
C. Requirements Regarding Coun- 
tries Which Have Not Adopted Guide- 
lines. NIH funds may not be used for 
the conduct of recombinant DNA re- 
search in a country which has not 
adopted national guidelines, unless the 
research is in full compliance with 
NIH Guidelines and the procedures re- 
quired for U.S. grant applications have 
been fulfilled— i.e., establishment of 
an institutional biosafety committee, 
filing of an MUA, etc. 
IV. Registration of Recombinant 
DNA Projects. 
A. NIH-Supported Projects. An NIH- 
approved MUA will constitute registra- 
tion of projects awarded by NIH. For 
immediate initiation of projects pend- 
ing with NIH see "Important Note” 
under section II-B of this appendix. 
B. Required Registration of Non- 
NIH Projects. The guidelines require 
that institutions receiving NIH funds 
for recombinant DNA research shall 
inform NIH of all initiated recombin- 
ant DNA projects subject to the guide- 
lines (see section IV-C-1 of the guide- 
lines). For these projects, the required 
information must be submitted within 
30 days of the IBC's approval. 
C. Voluntary Registration of Non- 
NIH Projects. The guidelines stipulate 
that any institution which is not re- 
quired to comply with the guidelines 
may nevertheless register with the 
NIH ongoing projects involving recom- 
binant DNA research subject to the 
guidelines (see section IV-C-2 of the 
guidelines). 
D. Procedures for Registration. The 
procedures in this section apply to reg- 
istration of projects in B and C above. 
Because non-NIH projects filed with 
the NIH will immediately be added to 
the register of ongoing recombinant 
DNA research, institutions may regis- 
ter only those projects which are on- 
going or about to be initiated. Institu- 
tions should not submit pending pro- 
jects to this register. 
Institutions must register these pro- 
jects directly with ORDA. It is the re- 
sponsibility of the institution to insure 
that this information is accurate and 
up-to-date by submitting any neces- 
sary revised information on a timely 
basis. Institutions are responsible for 
notifying ORDA when a project is 
completed or terminated so that it 
may be removed from the register. 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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