Federal Register / Vol. 59, No. 127 / Tuesday. July 5, 1994 / Notices 
34473 
published for public comment in the 
Federal Register on December 30, 1988 
(53 FR 53262). The RAC Working Group 
on Transgenic Animals proposed 
additional modifications to Appendices 
P and Q which were published for 
public conament in the Federal Register 
on April 18. 1988 (53 FR 12752). 
Further revisions were approved by the 
RAC at its January 30. 1989. meeting. 
Throughout all of the meetings, 
discussions, and revisions, the intent of 
the Federal agencies and interested 
parties has been to describe working 
conditions that would minimize the risk 
to both the researcher and the 
environment from any possible harm or 
adverse effects due to the conduct of 
research involving recombinant DNA 
containing organisms. 
On June 24, 1994, an Environmental 
Assessment of Appendices P and Q was 
completed by the NIH and USDA, and 
there was a finding of no significant 
impact. Copies of the Environmental 
As.sessment are available from the Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4Bll, Bethesda, Maryland 
20892.(301)496-9838. 
The actions are detailed in Section 
II — Summary of Actions. I ar;cept these 
recommendations, and the NIH 
Guidelines will be amended 
accordingly. 
8 Amendment to Sections l-C-l-b-(2) 
nnd Deletion of Section llI-A-2 of the 
\'!H Guidelines Hegnrding DeHhernte 
Hflense 
On December 6, 1‘190, the RAC 
Planning Subcommittee recommended 
that the requirement for RAC review of 
experiments involving deliberate 
environmental release of organisms 
(.ontaining rerjombinant DNA be 
eliminated from the NfH Guidelines. 
1 his recommendation reflects the far t 
that the Federal regulatory agencies, the 
USDA. and the Environmental 
Protection Agency (EPA). are 
responsible for the review and approval 
of environmental release experiments 
rile proposed amendment was 
published for public comment in the* 
Federal Register on April 29, 1991 ('>0 
I K 19776). The RAC reviewed and 
re< ommended approval of the proposed 
amendment at its May 30-31. 1991. 
meeting 
I he a(.tions are detailed in .Section 
II — ^ .Summary of Actions. 1 ar.r.ept these* 
rei.ommendatious. and the Nil I 
t^/uidelines will b<i ami;mli*d 
II < ordingl^ 
C. Amendments to Sections I, III, IV, 
and V, and Appendix M of the NIH 
Guidelines Regarding NIH/ORDA 
Review and Approval of Certain 
Categories of Human Gene Transfer 
Experiments That Qualify for the 
Accelerated Re\iew Process 
On December 3, 1993, and March .3- 
4, 1994, the Working Group on 
Accelerated Review Protocols presented 
an overview of the proposed 
amendments to the NIH Guidelines. The 
proposed amendments will: (1) 
Establish an accelerated review process 
for certain categories of human gene 
transfer experiments, (2) allow the NIH/ 
Office of Recombinant DNA Activities 
to assign the appropriate review 
category to all human gene transfer 
proposals that are submitted in 
compliance with the NIH Guidelines. (3) 
allow the NIH/Office of Recombinant 
DNA Activities to approve those 
categories of human gene transfer 
experiments that qualify for the 
accelerated review process in 
consultation with the Chair and one or 
more RAC members, as neces.sary, and 
(4) exempt certain experiments 
involving the transfer of recombinant 
DNA or DNA or RNA derived from 
recombinant DNA into one or more 
human subjects which are not covered 
by Section V-U. All human gene 
transfer experiments approved by the 
NlH/Office of Recombinant DNA 
Activities through the accelerated 
review process will be provided in a 
report by the RAC Chair at the next 
regularly scheduled R^C meeting and 
will be included in the list of approved 
experiments which is available from the 
Office of Recombinant DNA Activities, 
National Institutes of Health, Building 
31. Room 4B11, Bethesda, Marvland 
20892,(301)496-98.38. 
The proposed amendments were 
published for public comment in the 
Federal Register on No\ ember 9, 199.3 
(58 FR 59612) and Febniary 11. 1994 (.59 
FR 6702). The RAC reviewed and 
unanimously recommended approval of 
the proposed amendments at its Man.h 
3-4, 1994, meeting. 
The actions are detailed in Sin:tion 
II — .Summary of Actions. 1 accept these 
recommendations, and the Nil I 
Guidelines will be amended 
accordingly. 
IJ. Amendmenls la Sec tion V-U of the 
NIH Guidelines Regarding Recombinant 
DNA Vaccines 
On March 3, l‘.F)4.lhe Working Grou|) 
on Va<-cinc*s pres«}nted an overview of 
the profxjsed amendment to Ihe footnote 
111 Se< tion V-IJ. I he propi>sed 
amendment will derme those* categories 
Recombinant 
of experiments involving the 
administration of recombinant DNA 
vaccines that are exempt from RAC 
review and NIH and Institutional 
Biosafety Committee approval. 
The proposed amendment was 
published for public comments in the 
Federal Register on February 11, 1994 
(59 FR 6702). The proposed amendment 
was revised by the RAC at its March 3- 
4, 1994, meeting. The revised 
amendment was unanimously 
approved. 
The action is detailed in Section II — 
Summary of Actions. I accept this 
recommendation, and the NIH 
Guidelines will be amended 
accordingly. 
II. Summary of Actions 
A. Amendment to Section 1. Scope oj 
the NIH Guidelines 
The amended version of Section I 
reads as follows: 
Section I. Scope of the NIH Guidelines 
.Section I-A. Purpose 
The purpose of the NTH Guidelines is 
to specify practices for constructing nnd 
handling: (i) Recombuiant 
deoxyribonucleic acid (DNA) molecules, 
and (ii) organisms and viruses 
containing recombinant DNA 
molecules. 
Section I-A-1. Any recombinant DNA 
experiment, w'hich according to the NIH 
Guidelines requires approval by the 
NIH, must be submitted to the NIH or 
to another Federal agency lliat has 
jurisdiction for review and approval. 
Once approval, or other applicable 
clearances, has been obtained from a 
Federal agency other than the NIH 
(whether the experiment is referred to 
that agency by the NIH or sent directly 
there by the submitter), the experiment 
may proceed without the necessity for 
NIH review or approval (.see exceptions 
ill .Sections l-A-2 and l-A-3). 
Section I-A-2. Certain experiments 
that invoK’e the deliberate transfer of 
recnmhinnnt DNA or DNA or RNA 
derived from recombinant DNA into one 
or morf; human subjects (see Section V- 
G) shall he c:onsidered Major Actions 
(see Section IV-C-l-l)-(l)), and shall 
require RAC review and NIH Dirt*ctor 
;i[)proval, if determined by NIH/ORDA 
in consultation with the RAC Chair and/ 
or one or more RAC members, as 
iHK.essary, to: (i) Represent novel 
characteristics (e g., target disease or 
vix lor), (ii) represent an uncertain 
degree of risk to human health or the 
environment, or (iii) contain 
information determined to rerpiire 
liiilher public review (see Se< tion 111 
A 2). 
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DNA Research, Volume 19 
