Federal Register / VoL 56, No. 138 / Thursday. July 18. 1991 / Notices - 33lBa 
neomycin resistance. The purpose of 
these gene marking studies is to 
determine if the origin of relapse arises 
from residual leukemic cells in the 
patients or from viable leukemic cells 
remaining in the bone marrow used for 
autologous transplantation. 
E. Addition of Appendix D-XX to the 
""NIH Guidelines" 
The following is added to Appendix 
D: 
Appendix D-XX 
Drs. Fred D. Ledley and Savio L C. 
Woo of Baylor College of Medicine of 
Houston, Texas, can conduct 
experiments on pediatric patients with 
acute hepatic failure who are identified 
as candidates for hepatocellular 
transplantation. Using the LNL6 vector, 
the hepato(^es will be transduced with 
the gene coding for neomycin resistance. 
The purpose of using a genetic marker is 
to demonstrate the pattern of 
engraftment of transplanted hepatocytes 
and to help determine the success or 
failure of engraftment 
F. Amend the "Points to Consider in the 
Design and Submission of Protocols for 
the Transfer of Recombinant DNA Into 
the Genome of Human Subjects" 
' Section I-E-2 will read as follows: 
I-B-2. Preclinical studies, including 
risk assessment studies. Provide results 
that demonstrate the safety, efficacy, 
and feasibility of the proposed 
procedures using animal and/or cell 
culture model systems, and explain why 
the models chosen are appropriate for 
the protocol 
ITT- Correction to the Notice of Actions 
Published In the Federal Register on 
September 12, 1990 (55 FR 37565) 
In the Summary of Actions under B. 
Addition of Appendix D-XV to NIH 
Guidelines the retroviral vector used for 
transducing the gene coding for 
adenosine deaminase (ADA) is listed as 
*TNL8*’. The retroviral vector that was 
used was “LASN". 
OMB's Mandatory Information 
Requirements for F^eral Assistance 
Program Announcements" (45 FR 39592] 
requires a statement concerning the 
official government programs contained 
in the Oitalog ofFeder^ 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 Nm program but also 
essentially every Federal research 
program in which DNa. recombinant 
molecule techniques could be use. it has 
been determined to be not cost effective ■ 
or in the pubic 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 individuals programs listed in 
the Catalog ofFedeial Domestic 
Assistance are affected. 
f 
Dated: July 12, 199L 
Bemadine Healy, 
Director. National Institutes of Health. 
(ER Doc. 91-17125 Fded 7-17-91; 8:45 am] 
Btumo CODE 4140-41-li 
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Recombinant DNA Research, Volume 14 
