Federal Register / Vol. 59, No. 162 / Tuesday, August 23, 1994 / Notices 
43429 
Institutional Review Board reviews and 
approvals of the proposal should be 
completed before submission to NIH. 
Certain experiments involving 
deliberate transfer of recombinant DNA 
or DNA or RNA derived from 
recombinant DNA into one or more 
human subjects may qualify for the 
Accelerated Review process (see Section 
IH— B — 2). Certain categories of 
experiments involving the deliberate 
transfer of recombinant DNA or DNA or 
RNA derived from recombinant DNA 
into one or more human subjects and 
that are not covered by Section V-U, 
may be considered exempt from RAC 
and/or NIH/ORDA review and/or NIH 
Director approval and only require 
registration with NIH/ORDA (see 
Section m-G-7).” 
Section IH-A is proposed to' read: 
“Section m-A. Experiments that 
Require Institutional Biosafety 
Committee Approval, RAC Review, and 
NIH Director Consideration Before 
Initiation (see Section IV-C-l-b-fl)). 
“Section m-A-1. Major Actions 
“Experiments described in Sections 
III-A-l-a and IH-A-2 cannot be 
initiated without submission of relevant 
information on the proposed experiment 
to the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Suite 323, 6006 Executive Boulevard, 
MSC 7052, Bethesda, Maryland 20892- 
7052, (301) 496-9838, the publication of 
the proposal in the Federal Register for 
15 days of comment, review by the RAC, 
and specific approval by the NIH. The 
con tainm ent conditions for such 
experiments will be recommended by 
the RAC and, except as provided in 
Section III-A-2, will be set by the NIH 
at the time of approval. Such 
experiments require Institutional 
Biosafety Committee approval before 
initiation. Specific experiments already 
approved are included in Appendix D 
which may be obtained from the Office 
of Recombinant DNA Activities, 
National Institutes of Health, Suite 323, 
6006 Executive Boulevard, MSC 7052, 
Bethesda, Maryland 20892-7052, (301) 
496-9838. 
“Section m-A-1. Deliberate transfer 
of a drug resistance trait to 
microorganisms that are not known to 
acquire the trait naturally (see Section 
V-B), if such acquisition could 
compromise the use of the drug to 
control disease agents in humans, 
veterinary medicine, or agriculture. 
“Section III-A-2. Major Actions 
Involving Human Gene Transfer 
Experiments 
“Experiments involving the deliberate 
transfer of recombinant DNA or DNA or 
RNA derived from recombinant DNA 
into one or more human subjects under 
Section I-A-l, and that are determined 
appropriate for RAC review and NIH 
Director consideration shall be 
considered as a Major Action, except 
that the NIH Director will make a 
recommendation to the FDA 
Commissioner who will make the final 
decision on the proposed experiment.” 
Sections III-B-2 and -3 is proposed to 
be deleted: 
" Section lH-B-2. Accelerated Review of 
Human Gene Transfer Experiments 
“As determined by NIH/ORDA, in 
consultation with the RAC Chair and 
one or more RAC members, as 
necessary, certain categories of human 
gene transfer experiments may be 
considered as Minor Actions and 
qualify for Accelerated Review and 
approval (see' Section IV-C-l-b-(2)-(a), 
Appendix M— III-A, and Appendix M- 
V). The RAC Chair will present a report 
of all NIH/ORDA approved human gene 
transfer protocols -at the next regularly 
scheduled RAC meeting. If NIH/ORDA 
determines that an experiment does not 
qualify for the Accelerated Review 
process, the Principal Investigator must 
submit the proposal for full RAC review 
2: 8 weeks prior to the next scheduled 
RAC meeting (See Section III-A-2). 
“Section UI-B-3. Minor Modifications to 
Human Gene Transfer Experiments 
“A minor modification in a human 
gene transfer protocol is a modification 
that does not significantly alter the basic 
design of the protocol and that does not 
increase risk to human subjects or the 
environment After approval has been 
obtained by the relevant Institutional 
Biosafety Committee and Institutional 
Review Board, NIH/ORDA will Consider 
the change in consultation with the RAC 
Chair and one or more RAC members, 
as necessary. Submit minor 
modifications to the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, Room 
4B11, Bethesda, Maryland 20892, (301) 
496-9838. The RAC Chair will provide 
a report on any such approvals at the 
next regularly scheduled RAC meeting.” 
Section IH-C-7 (Experiments that 
Require Institutional Biosafety 
Committee Approval Before Initiation/ 
Human Gene Transfer Experiments Not 
Covered by Sections III-A-2, III-B-2, 
m-B-3, and Not Considered Exempt 
Under Section V-U) is proposed to be 
deleted: 
“Section III— C-7. Human Gene 
Transfer Experiments Not Covered by 
Sections HI-A-2, IH-B-2, IU-B-3, and 
Not Considered Exempt Under Section 
V-U 
“Certain experiments involving the 
transfer of recombinant DNA or DNA or 
RNA derived from recombinant DNA 
into one or more human subjects that 
are not covered by Sections III-A-2 , III- 
B-2, IU-B-3, and that are not 
considered exempt under Section V-U 
must be registered with NIH/ORDA. The 
relevant Institutional Biosafety 
Committee and Institutional Review 
Board must review and approve all 
experiments in this category prior to 
their initiation." 
Section IV--B- 4 - e -(5) (Roles and 
Responsibilities/Responsibilities of the 
Principal Investigator During the 
Conduct of Research) is proposed to be 
inserted: 
“Section IV-B-4-e-(5). Comply with 
semi-annual data reporting and adverse 
event reporting requirements for FDA- 
approved human gene transfer 
experiments (see Appendix M-I-C).” 
Section IV— C— 1-h— (l) 
(Responsibilities of die National 
Institutes of Health/Specific .• 
Responsibilities) currently reads: 
“Section IV-C-l-b-{l). Major 
Actions. To execute Major Actions, the 
NIH Director shall seek the advice of the 
RAC and provide an opportunity for 
public and Federal agency comment. 
Specifically, the Notice of Meeting and 
Proposed Actions to the NIH Guidelines 
shall be published in the Federal 
Register at least 15 days before the RAC 
meeting (not applicable for Expedited 
Review single patient human gene 
transfer experiments considered under 
Appendix M-VI). The NIH Director’s 
decision, at his/her discretion, may be 
published in the Federal Register for 15 
days of comment before final action is 
taken. The NIH Director’s final decision, 
along with responses to public 
comments, shall be published in the 
Federal Register. The RAC and 
Institutional Biosafety Committee Chairs 
shall be notified of the following 
decisions:” 
Section IV-C-l-b-(l) is proposed to 
read: 
“Section IV-C-l-b-(i). Major 
Actions. To execute Major Actions, the 
NIH Director shall seek the advice of the 
RAC and provide an opportunity for 
public and Federal agency comment 
Specifically, the Notice of Meeting and 
Proposed Actions shall be published in 
the Federal Register at least 15 days 
before the RAC meeting. The NIH 
Director’s decision/recommendation, at 
his/her discretion, may be published in 
the Federal Register for 15 days of 
comment before final action is taken. 
The NIH Director’s final decision/ 
recommendation, along with responses 
to public comments, shall be published 
in the Federal Register. The RAC and 
Recombinant DNA Research, Volume 20 
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