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Federal Register / Vol. 59, No. 90 / Wednesday, May 11, 1994 / Notices 
Appendix L-II-B. The Introduced DNA 
consists of well/characterized genes 
containing no sequences harmful to humans, 
animals, or plants. 
Appendix L-Il-C, The vector consists of 
DNA: 
(i) From exempt host-vector systems (see 
Appendix C); 
(ii) From plants of the same or closely 
related sp>ecies: 
(iii) From nonpathogenic prokaryotes or 
nonpathogenic lower eukaryotic plants; 
(iv) From plant pathogens only if 
sequences resulting in production of disease 
symptoms have been deleted; or 
(v) Chimeric vectors constructed from 
sequences defined in (i) or (iv) above. The 
DNA may be introduced by any suitable 
method. If sequences resulting in production 
of disease symptoms are retained for 
purposes of Introducing the DNA into the 
plant, greenhouse-grown plants must be 
shown to be free of such sequences before 
such plants, their derivatives, or seed can be 
used in field tests. 
Appendix L-U-D. Plants are grown in 
controlled access fields under specified 
conditions appropriate for the plant under 
study and the geographical location. Such 
conditions should include provisions for 
using good cultural and pest control 
practices, for physical isolation from plants 
of the same species outside of the 
experimental plot in accordance with 
pollination characteristics of the species, and 
the prevention of plants containing 
recombinant DNA from becoming established 
in the environment. Review by the IBC 
should include an appraisal by scientists 
knowledgeable of the crop, its production 
practices, and the local geographical 
conditions. Procedures for assessing 
alterations in and the spread of organisms 
containing recombinant DNA must be 
developed. The results of the outlined tests 
must be submitted for review by the IBC. 
Copies must also be submitted to the Plant 
Working Group of the RAC 
XrV. Amendment to Part VI of the 
Points To Consider, NTH Guidelines, 
Regarding Expedite Review/Dr. Wivel 
On April 29, 1994, Dr. Nelson Wivel 
of the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bethesda, Maryland, requested that part 
VI, Procedures to be Followed for 
Expedited Review, of the Points to 
Consider be amended to clarify 
submission requirements for ^pedited 
Review. 
The Procedures to be Followed for 
Expedited Review ciurently reads: 
“4. Regardless of the metnod of 
review, the Points to Consider must be 
the standard review for all gene transfer 
protocols.” 
The proposed amendment reads; 
”4. Reg^less of the method of 
review, the Points to Consider must be 
the standard review for all gene transfer 
protocols; therefore, submission of the 
Points to Consider is required.” 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements” (45 FR 
39592, June 11, 1980) requires a 
statement concerning the official 
government programs contained in the 
Catalog of F^eral 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 not to be 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. 
Dated: May 4, 1994. 
Suzanne Medgyesi-Mitschang, 
Acting Deputy Director for Science Policy ana 
Technology Transfer. 
(FR Doc. 94-11466 Filed 5-10-94; 8:45 am) 
BtCUNO CODE 4140-01-4> 
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Recombinant DNA Research, Volume 19 
