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Federal Register / Vol. 58. No. 175 / Monday. September 13, 1993 / Notices 
with the retrovirus vector, PHaMDRl/A, 
and readministered to patients. Patients 
will be monitored for the presence and 
expression of the MDR-1 gene. The 
investigators will determine whether 
MDR-1 expression increases following 
chemotherapy." 
/. Addition of Appendix D-LVI to the 
N1H Guidelines 
The following section is added to 
Appendix D: 
“Dr. Enzo Paoletti of Virogenetics 
Corporation, Troy, New York, may 
conduct experiments with poxvirus 
vectors NYVAC, ALVAC, and TROVAC 
at Biosafety Level 1.” 
K. Amendment to Section IV-C-3-c of 
the NIH Guidelines Regarding the 
Responsibility of the Office of 
Recombinant DNA Activities 
Section IV-C-3-c will read as 
follows: 
‘TV-O-3-c. Serve as the focal point 
for data management of NIH-approved 
human gene transfer protocols as 
required in the Reporting Requirements 
section of the Points to Consider.” 
L. Amendment to Section UI-A-4 of the 
NIH Guidelines and the Points To 
Consider in the Design and Submission 
of Protocol for the Transfer of 
Recombinant DNA Into the Genome of 
Human Subjects 
Section III-A— 4 will read asTollows: 
4, ni-A-4. Deliberate transfer of 
recombinant DNA or DNA or RNA 
derived from recombinant DNA into one 
or more human subjects (21) * • *” 
The terms “subject” and "subjects” 
will be changed throughout the NIH 
Guidelines to “one or more human 
subjects.” 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements” (45 FR 
39592) requires a statement concerning 
the official 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 
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 to be not 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: September 3. 1993. 
Ruth L. Kirschstein, 
Acting Director, National Institutes of Health. 
(FR Doc 93-22261 Filed 9-10-93; 8:45 am! 
BILLING CODE 4 140-0 CM 
[496] 
Recombinant DNA Research, Volume 18 
