Federal Register / Vol. 59, No. 29 / Friday, February 11, 1994 / Notices 
6705 
process, the PI must submit the proposal for 
full RAC review at least 8 weeks prior to the 
next scheduled RAC meeting (see Section III- 
A-3). See Part III-A of the Points to Consider 
for guidelines for submission of human gene 
transfer protocols." 
(Addition) "Section lII-B-3. Minor 
.Modifications to Human Gene Transfer 
Experiments." 
(Addition) “A minor change in a human 
gene transfer protocol is a change that docs 
not significantly alter the basic design of the 
rotocol and that does not increase risk to 
uman subjects or the environment. NIH 
(ORDA) will consider the change. In 
consultation with the RAC Chair and one or 
more RAC members, as necessary, after 
approval has been obtained by the relevant 
IRB and IBC The RAC Chair will provide a 
report on any such approvals at the next 
regularly scheduled RAC meeting." 
(No Changes — Section III-C through Ill-C- 
6 .) 
(Addition] "Section lll-C-6. Human Gene 
Transfer Experiments not Covered by 
Footnote 21." 
(Addition] "Experiments involving the 
transfer of recombinant DNA or DNA or RNA 
derived from recombinant DNA into one or 
more human sub)octs, and that are not 
covered by Footnote 21, must be registered 
with NIH (ORDA). lire relevant IBC and IRB 
must review all experiments in this category 
prior to their Initiation. For experiments in 
this category, the registration document must 
include;" 
(Note; The RAC will discuss the 
information that should be filed with ORDA 
for experiments in this category.) 
(No Changes — Section III-O through IV-C- 
IB.) 
"Section IV-C-l-b-(l), Major Actions" 
(Amended) "To execute major actions, the 
NIH Director must seek the advice of the RAC 
and provide an opportunity for pubic and 
Federal agency comment. Specifically, the 
agenda of the RAC meeting citing the major 
actions shall be published in the Federal 
Register at least 15 days before the meeting, 
and the NIH Director shall also publish the 
proposed actions in the Federal Register for 
comment at least 15 days before the meeting 
(not applicable for Exp^ited Review human 
gene transfer experiments considered under 
Part VI of the Prints to Consider. In addition, 
the NIH Director's proposed decision, at his/ 
her discretion, may be published in the 
Federal Register for 15 days of comment 
before final action is taken. The RAC and IBC 
Chairs shall be notified of the following 
decisions:" 
(No changes — Section IV-C-l-b-(l)-(a) 
through rV-C-l-b-dHO ) 
(Amended) “Section rV-C-l-b-{2). Minor 
Actions" 
(Amended) “NIH (ORDA) shall carry out 
certain functions as delegated to it by the 
NIH Director (see Section fV-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 RAC and IBC Chairs:" 
(Delete the current Section IV-C-l-b-{2)- 
(a). Interpreting and determining 
containment levels up>on request by ORDA;) 
(Addition) “Section IV-C-l-l>-{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):“ 
(Addition) "Section IV-C-b-(2)-(b). 
Reviewing and approving minor changes to 
human gene transfer protocols approved 
under Si^ion IU-A-3 and III-B-2;" 
(Renumbered) “Section IV-C-l-b-(2)-(c). 
Changing containment levels for experiments 
that are specified In the NIH Guidelines (see 
Section III);" 
(Renumbered) “Section IV-C-l-b-(2}-{d). 
Assigning containment levels for 
experirnents not explicitly considered in the 
NIH Guidelines;" 
(Renumbered) "Section IV-C-l-b-(2)-(e). 
Revising the Qassification of Etiologic 
Agents for the purpose of these NIH 
Guidelines (See Footnote 1).” 
(Delete Section rV-C-l-b-(3). Other 
Actions. The NIH Director's decision will be 
transmitted to the RAC and IBC Chairs:] 
(Renumbered) "Section IV-C-l-b-(2)-(f). 
Interpreting the NIH Guidelines for 
experiments to %vhich the NIH Guidelines 
specifically ass!^ containment levels;" 
(Renumberedr'Section IV-C-l-b-(2)-(g). 
Setting containment under Section III-C-1- 
d and Section III-C-3-d;" 
(Renumbered) "Section IV-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);” 
(Renumbered) “Section IV-C-l-b-(2)-(i). 
Decertifying already certified host-vector 
systems;" 
(Renumberod) “Section IV-C-l-b-(2)-{j). 
Adding new entries to the list of molecules 
toxic for vertebrates (see Appendix F);" 
(Renumbered/ Amended) “Section IV-C-1- 
b-(2>-(k). Determining appropriate 
containment conditions for experiments 
according to case precedents developed 
under Sc^ion rV-C-l-b-(2)-{d).) 
(Renumbered) “Section lV-C-l-b-(4). The 
Director, NIH. shall conduct, support, and 
assist training programs in laboratory safety 
for IBC members. BSOs, Pis, and laboratory 
staff." 
(Amended] “Section IV-C-2. Recombinant 
DNA Advisory Committee (RAC) * • • The 
RAC shall be responsible for advising the 
Director, NIH, on the actions listed in Section 
IV-C-l-b-(l)." 
(Amended) “Section IV-C-3. The Office of 
Recombinant DNA Activities (ORDA). The 
ORDA shall serve as a focal point for 
information on recombinant DNA activities 
and provide advice to all within and outside 
NIH including Institutions. BSOs, Pis. 
Federal agencies, state and local 
governments, and Institutions in the private 
sector. The ORDA shall carry out such other 
functions as may be delegate to it by the 
Director, NIH including those authorities 
described in Section rV-C-l-b-(2). In 
addition, ORDA shall be responsible for the 
following." 
(No Changes — Section IV-C-3-a.) 
(Addition) “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 Ill-B-2);" 
(Addition) “Section IV-C-3-c. Reviewing 
and approving minor changes to human gene 
transfer protocols approved under Sections 
III-A-3 and III-B-2. in consultation with the 
RAC Chair and one or more RAC members, 
as necessary;" 
(Renumbered) “Section rV-C-3-d. 
Reviewing and approving IBC membership;" 
(Renumbered) "Section IV-G-3-e. 
Publishing in the Federal Register" • 
(Renumwred] “Section IV-C-3-e-(l). 
Announcements of RAC meetings and 
agendas at least 15 in advance;" 
(No Changes) “NOTE — If the agenda for a 
RAC meeting is modified, ORDA shall make 
the revised agenda available to anyone upon 
request at least seventy-two hours in advance 
of the meeting." 
(Renumber^) “Section rV-C-3-e-(2). 
Proposed major actions of the type falling 
under Section IV-C-l-b-(l) at least 15 days 
prior to the RAC meeting at which they will 
be considered; and" 
(Delete old Section IV-C-3-c-(3). The NIH 
Director's final decision on recommendations 
made by the RAC) 
(Renumbered/ Amended) “Section IV-C-3- 
t Serve as the focal point for data 
management of NIH-approved human gene 
transfer protocols approved under Section 
ni-A-3 and IlI-B-2 and registered with NIH 
(ORDA) as required under Section IH-C-6." 
(Renumber^) “Section IV-C-3-g. Serve as 
executive secretary of the RAC" 
(Addition) “Section IV-C-3-h. Maintain a 
list of major and minor actions to the NIH 
Guidelines approved under Sections IIl-A-3 
and ni-B-2 and a list of experiments 
registered with NIH (ORDA) as described in 
S^ion UI-C-6." 
(No Changes — Section IV-C— 4 through V- 
T). 
(The RAC Will Consider Revision of this 
Footnote.) “Footnote 21. Sections IIl-A-3 
and ni-B-2 cover only those experiments in 
which the intent is to modify stably the 
genome of cells of one or more human 
subjects. Other experiments involving the 
deliberate transfer of recombinant DNA into 
one or more human subjects such as feeding 
of bacteria containing recombinant DNA or 
the administration of vaccines containing 
recombinant DNA are not covered in 
Sections III-A-3 and III-B-2 
(The RAC may Modify this Footnote 
According to Footnote 21 Revision) 
“Footnote 22. For recombinant DNA 
experiments in which the intent is to modify 
stably the genome of cells of one or more 
human subjects (see Sections IIl-A-3 and 111- 
B-2)." 
(No Changes — Section VI.) 
The proposed amendments to the Points to 
Consider are as follows: 
(Amended) “These Points to Consider 
apply to research conducted at or sponsored 
by an Institution that receives any support for 
recombinant DNA research from the NIH. 
Researchers not covered by the NIH 
Recombinant DNA Research, Volume 19 
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