43430 
Federal Register / Vol. 59. No. 162 / Tuesday, August 23, 1994 / Notices 
Institutional Biosafety Committee Chairs 
shall be notified of the following 
decisions:” 
Section IV-C-l-b-{l}-{d) currently 
reads: 
“Section IV-C-l-b— ( 1 ) — (d)- 
Permitting experiments specified by 
Section LU-A;" 
Section IV-C-l-b-{l}-{d) is proposed 
to read: 
“Section IV— C— 1— b — (lj — (d). 
Permit ting experiments specified by 
Section DI-A-1;” 
Section IV-C-l-b-(l)-{e) is proposed 
to be included 
“Section IV-C-l-b-OWe). 
Recommendations made by the NIH 
Director to the FDA Commissioner 
regar ding RAC-reviewed human gene 
transfer experiments (see Appendix M- 
1-B);“ 
Renumber r emainin g sections in IV- 
C— 1 — b— (l). 
Sections IV-G- 1 — b-{2)— a and —(b) 
(Responsibilities of the National 
Institutes of Health/Minor Actions) is 
proposed to be deleted: 
"Section IV-C-l-b-{2Ha). Reviewing 
and approving certain experiments 
involving the deliberate transfer of 
recombinant DNA or DNA or RNA 
derived from recombinant DNA into one 
or more human subjects that qualify for 
, the Accelerated Review process (see 
Section E-B-2); 
“Section IV-C-l-b— ( 2 ) — (b). 
Reviewing and approving minor 
changes to human gene transfer 
protocols under Section HI-A -2 and III— 
B-2;" 
Renumber remaining sections in IV- 
C-l-b-(2). 
Section IV-C-3 (Responsibilities of 
the National Institutes of Health/Office 
of Recombinant DNA Activities) 
currently reads: 
"Section IV-C-3. Office of 
Recombinant DNA Activities (ORDA) 
“ORDA shall serve as a focal point for 
information on recombinant DNA 
activities and provide advice to all 
within and outside NIH including 
institutions, Biological Safety Officers, 
Principal Investigators, Federal 
agencies, state and local governments, 
and institutions in the private sector. 
ORDA 6 hall carry out such other 
functions as may be delegated to it by 
the NIH Director, Including those 
authorities described in Section IV-C- 
1— b — (2). ORDA *8 responsibilities 
include, but are not linuted to the 
following: 
"Section IV-C-3-a. Reviewing and 
approving experiments in conjunction 
with ad hoc experts involving the 
cloning of genes encoding for toxin 
molecules that are lethal for vertebrates 
at an LDy> £100 nanograms per kilogram 
body weight in organisms other than 
Escherichia coli K -12 (see Section III— 
B ~1 and Appendices F-4 and F— II); 
“Section IV-C-3— b. Reviewing and 
approving certain experiments 
involving the deliberate transfer of 
recombinant DNA or DNA or RNA 
derived from recombinant DNA into one 
or more human subjects, in consultation 
with the RAC Chair and one or more 
RAC members, as necessary, that qualify 
for the Accelerated Review process (see 
Section HI— B — 2 ); 
“Section IV-C-3— c. Reviewring and 
approving minor changes to human 
gene transfer protocols approved under 
Sections IH-A-2 and IH-B- 2 , in 
consultation with the RAC Chair and 
one or more RAC members, as 
necessary; 
“Section IV-G-3-cL Reviewring and 
approving the membership of an 
institution's Institutional Biosafety 
Committee, and where it finds the 
Institutional Biosafety Committee meets 
the requirements set forth in Section IV- 
B -2 will give Its approval to the 
Institutional Biosafety Committee 
membership; 
“Section IV-C-3-e. Publishing in the 
Federal Register: 
“Section IV-G-3-e-(l). 
Announcements of RAC meetings and 
agendas at least 15 days in advance 
(NOTE — If the agenda for a RAC 
meeting is modified, ORDA shall make 
the revised agenda available to anyone 
upon request at least 72 hours in 
advance of the meeting); 
“Section IV-C-3-e-{2). Proposed 
Major Actions to the NIH Guidelines 
(see Section IV-C-l-b-(l)) at least 15 
days prior to the RAC meeting; 
“Section IV-C-3-f. Serve as the focal 
point for data management of NIH- 
approved human gene transfer protocols 
approved under Sections IH-A -2 and 
IB-B-2 and registered with NIH/ORDA 
as required under Section I13-C-7; 
“Section IV-C-3-g. Serve as the 
executive secretary of the RAC; and 
“Section IV-C— 3-h. Maintain a list of 
Major and Minor Actions approved 
under Section III— A— 2 and HI— B-3 and 
a list of experiments registered with 
NIH/ORDA as described in Section III— 
C~7.“ 
Section IV-C-3 is proposed to read: 
“Section IV-C-3. Office of 
Recombinant DNA Activities (ORDA) 
"ORDA shall 6 erve as a focal point for 
information on recombinant DNA 
activities and provide advice to all 
within and outside NIH including 
Institutions, Biological Safety Officers, 
Principal Investigators, Federal 
agencies, state and local governments, 
and institutions in the private sector. 
ORDA shall carry out such other 
functions as may be delegated to it by 
the NIH Director. ORDA's 
responsibilities include, but are not 
limited to the following: 
“Section IV— C— 3— a. Reviewing and 
approving experiments in conjunction 
with ad hoc experts involving the 
cloning of genes encoding for toxin 
molecules that are lethal for vertebrates 
at an LD 50 <100 nanograms per kilogram 
body weight in organisms other than 
Escherichia coli K-12 (see Section III— 
B-l and Appendices F-I and F— II); 
“Section IV-C-3-b- Evaluating 
human gene transfer protocols 
(transmitted by the FDA) for the 
necessity for RAC review (see Appendix 
M-I-A). 
“Section IV-C-3-c. Reviewing and 
approving the membership of an 
institution’s Institutional Biosafety 
Committee, and where it finds the 
Institutional Biosafety Committee meets 
the requirements set forth in Section IV- 
B-2 will give its approval to the 
Institutional Biosafety Committee 
membership; 
“Section rV-C-3-d. Publishing in the 
Federal Register: 
“Section IV-C-3-d-(l). 
Announcements of RAC meetings and 
agendas at least 15 days in advance 
(NOTE — If the agenda for a RAC 
meeting is modified, ORDA shall make 
the revised agenda available to anyone 
upon request at least 72 hours in 
advance of the meeting); 
“Section IV-C-3-d-{2). Proposed 
Major Actions (see Section IV-C-l-b- 
( 1 )) at least 15 days prior to the RAC 
meeting; 
“Section IV-C-3-e. Serve as the focal 
point for data management of FDA- 
approved human gene transfer protocols 
(see Appendix M-I-C- 2 ); 
“Section IV-G-3-L Serve as the 
executive secretary of the RAC; and 
“Section IV-C-3-g. Maintain a list of 
Major Actions recommended for 
approval by the NIH Director to the FDA 
Commissioner, under Section HI-A- 2 .” 
Section V-U and V-V (Footnotes and 
References of Sections I— IV) is proposed 
to be deleted: 
“Section V-U. Human studies in 
which the induction or enhancement of 
an immune response to a vector- 
encoded microbial immunogen is the 
major goal, such an immune response 
has been demonstrated in model 
systems, and the persistence of the 
vector-encoded immunogen is not 
expected, are not covered under 
Sections III-A- 2 , IH-B-2. or III-B-3. 
Such studies may be Lnitiatod without 
RAC review and NIH approval if 
approved by another Federal agency. 
“Section V-V. For recombinant DNA 
experiments in which the intent Is to 
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Recombinant DNA Research, Volume 20 
