Recombinant DMA Advisoiy Committee - 6/9-10/94 
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 EBC. Copies must also 
be submitted to the Plant Working Group of the RAC." 
XIII-A. AMENDMENT TO PART VI OF THE POINTS TO CONSIDER OF THE NIH 
GUIDELINES REGARDING EXPEDITED REVIEW OF SINGLE PATIENT HUMAN 
GENE TRANSFER PROTOCOLS/DR WTVEL 
In a letter dated April 29, 1994, Dr. Nelson A Wivel, Executive Secretary, RAC, 
requested that Item #4 of Part VI, Expedited Review of Single Human Gene Transfer 
Patients, of the Points to Consider, should be amended to clarify submission requirements 
for Expedited Review. 
The Procedures to be Followed for Expedited Review currently reads: 
"4. Regardless of the method of review, the Points to Consider must be the 
standard of review for all gene transfer protocols. 
The proposed amendment reads: 
"4. Regardless of the method of review, the Points to Consider must be the 
standard of review for all gene transfer protocols; therefore, submission of 
the Points to Consider is required." 
The RAC approved a motion made by Ms. Buc and seconded by Dr. Chase to amend 
Part VI of the Points to Consider regarding expedited review of single patient human 
gene transfer protocols by a vote of 13 in favor, 0 opposed, and no abstentions. 
XIII-B. CHAIR REMARKS 
Dr. Walters noted that there is an expanding volume of information that is currently 
published regarding human gene therapy. He noted two new journals in this field, i.e., 
Gene Therapy and Cancer Gene Therapy, in addition to Human Gene Therapy which is 
now published monthly. Dr. Parkman remarked that NIH has expanded its funding of 
research programs involving human gene therapy. One such example comes from the 
National Heart, Lung, and Blood Institute which is requesting gene therapy proposals for 
the treatment of heart and cardiovascular diseases. The National Institute of Child 
Health and Human Development has recently requested applications for prenatal gene 
therapy research proposals for the treatment of degenerative central nervous system 
diseases. 
XIV. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
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