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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
to be exempt from the NIH Guidelines 
because they consist entirely of DNA 
I segments from species that exchange 
DNA by known physiological processes 
or otherwise do not present a significant 
risk to health or the environment; 
Section IV-C-l-b-{lHd). Permitting 
I experiments specified by Section III-A; 
I Section IV-C-l-b-{l)-{e). Certifying 
1 new host-vector systems with the 
i exception of minor modifications of 
i already certified systems (the standards 
and procedures for certification are 
described in Appendix I-II). Minor 
modifications constitute (e.g., those of 
minimal or no consequence to the 
properties relevant to containment); and 
j Section IV-C-l-b-{lHf). Adopting 
other changes in the NIH Guidelines. 
' Section IV-C-l-t>-(2). Minor Actions 
' NIH/ORDA shall carry out certain 
functions as delegated to it by the NIH 
Director (see Section IV-C-3). Minor 
Actions (as determined by NIH/ORDA 
in consultation with the RAC Chair and 
one or more RAC members, as 
necessary) will be transmitted to the 
i RAC and Institutional Biosafety 
! Committee Chairs: 
Section IV-C-l-b-(2)-(a). 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 III-B-2); 
Section IV-C-l-b-(2)-(b). Reviewing 
and approving minor changes to human 
I gene transfer protocols under Section 
I III-A-2 and III-B-2; 
Section IV-C-l-b-(2)-(c). Changing 
containment levels for experiments that 
are specified in Section III; 
Section IV-C-l-b-(2)-(d). Assigning 
I containment levels for experiments not 
I explicitly considered in the NIH 
I Guidelines; and 
Section IV-C-l-b-(2)-(e). Revising 
the Classification of Etiologic Agents for 
the purpose of these NIH Guidelines 
(see Section V-A). 
Section IV-(>-l-b-(2)-(f). Interpreting 
the NIH Guidelines for experiments to 
which the NIH Guidelines do not 
specifically assign containment levels; 
Section rV-C-l-b-(2)-(g). Setting 
containment under Sections Ill-C-l-d 
and III-C-2-b; 
Section rV-C-l-b-(2)-(h). Approving 
minor modifications of already certified 
host-vector systems (the standards and 
procedures for such modifications are 
described in Appendix I-II); 
Section IV-C-l-b-(2)-(i). 
Decertifying already certified host- 
vector systems; 
Section IV-C-l-b-(2)-(j). Adding new 
entries to the list of molecules toxic for 
vertebrates (see Appendix F); and 
Section IV-C-l-D-(2)-(k). Determining 
appropriate containment conditions for 
experiments according to case 
precedents developed under Section IV- 
C-l-b-(2)-(c). 
Section IV-C-l-b-(3). The NIH 
Director shall conduct, support, and 
assist training programs in laboratory 
safety for Institutional Biosafety 
Committee members. Biological Safety 
Officers, Principal Investigators, and 
laboratory staff. 
Section IV-C-2. Recombinant DNA 
Advisory Committee (RAC) 
The RAC is responsible for carrying 
out specified functions cited below as 
well as others assigned under its charter 
or by the DHHS Secretary, the DHHS 
Assistant Secretary for Health, and the 
NIH Director. The RAC consists of 25 
members including the Chair, appointed 
by the DHHS Secretary or his/her 
designee, at least fourteen of whom are 
selected from authorities knowledgeable 
in the fields of molecular genetics, 
molecular biology, recombinant DNA 
research, or other scientific fields. At 
least six members of the RAC shall be 
persons knowledgeable in applicable 
law, standards of professional conduct 
and practice, public attitudes, the 
environment, public health, 
occupational health, or related fields. 
Representatives from Federal agencies 
shall serve as non-voting members. 
Nominations for the I^C may be 
submitted to the Office of Recombinant 
DNA Activities, National Institutes of 
Health, Building 31, Room 4B11, 
Bethesda, Maryland 20892, (301) 496- 
9838. 
All meetings of the RAC shall be 
announced in the Federal Register, 
including tentative agenda items, 15 
days before the meeting. Final agendas, 
if modified, shall be available at least 72 
hours before the meeting. No item 
defined as a Major Action under Section 
rV-C-l-b-(l) may be added to an agenda 
following Federal Register publication. 
The RAC shall be responsible for 
advising the NIH Director on the actions 
listed in Sections IV-C-l-b-(l). 
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 shall carry out such other 
functions as may be delegated to it by 
Recombinant DNA Research, Volume 19 
the NIH Director, including those 
authorities described in Section rV-C-1- 
b-(2). ORDA’s responsibilities include, 
but are not limited to the following: 
Section IV-C-3-a. Reviewing ana 
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- 
1 and Appendices F-I 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 III-B-2); 
Section IV-C-3-c. Reviewing and 
approving minor changes to human 
gene transfer protocols approved under 
Sections IU-A-2 and III-B-2, in 
consultation with the RAC Chair and 
one or more RAC members, as 
necessary; 
Section IV-C-3-d. 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 IV-C-3-e. Publishing in the 
Federal Register: 
Section IV— C — 3— e— (1). 
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 III-A-2 and 
III-B-2 and registered with NIH/ORDA 
as required under Section III-C-7; 
Section rV-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 III-B-3 and 
a list of experiments registered with 
NIH/ORDA as described in Section, III- 
C-7. 
Section IV-C-4. Other NIH 
Components 
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