53816 
Federal Register 4 VoL 5flL No. 299 / Monday, October 16, 1993 4 Notices 
Approval of .the request is -contingent on 
the following stipulation: {1} Principal 
investigators -using this-expression 
system -must -obtain signatures from all 
laboratory personnel certifying that they 
have been informed of the possible risks 
associated with this vector expression 
system and that they read the Product 
Information booklet. The following 
section may be added to Appendix D: 
"Appendix O-LX. 
"Tne physical containment level may 
be reduced irom Biosafety Level 3 to 
Biosafety Level 2 for aSemliki Forest 
Virus (SFV) vector expression system of 
Life Technologies, Inc., Gaithersburg, 
Maryland." 
I accept this recommendation, and 
Appendix D-LXcfthebHH 'Guidelines 
will he added accordingly. 
F. Amendment ip Section HI and 
Appendix V of the THH Guidelines 
Regarding Actions Taken Under the 
Guid elines 
Dr. Nelson A. Wived, Director, Office 
of Recombinant ONA Activities, 
National Institutes of Health, Bethesda, 
Maryland, requested an amendment to 
Section IH and Appendix D to eliminate 
the requirement for publication of 
Appendix D {Actions Taken Under the 
Guidelines} in the Federal Register and 
to allow distribution of these actions by 
the Office of Recombinant DNA 
Activities. Thas request was published 
far comment in the Federal Register oT 
August 18,1993 (58 FR 44068). Section 
m-A and Appendix D is proposed to 
read: 
"Section 1B-A— Experiments that 
Require RAC Review and BBC Approval 
Before Initiation. 
* * ‘ Specific 'experiments already 
approved in this -section may be 
obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31. Room 
4B1L, Bethesda, Maryland 20892." 
"Appendix D— Actions Taken Under 
the Guidelines. 
"As noted In the subsection of Section 
IV-C-l-h-(lj, the Director, NIH, may 
take certain actions with regard to the 
Guidelines after the issues have been 
considered by the RAC An updated list 
of these actions are available from the 
Office of Recombinant ONA Activities, 
National Institutes of Health, Building 
31, Room 4B11, Bethesda, Maryland 
20892." 
This request was reviewed and 
recommended for approval as proposed 
during the RAC meeting of September 
9-10, 1993, by a vote of 16 in favor. 0 
opposed, and no abstentions. 
I eccept this recommendation, and 
Appendix D of the NIH Guidelines will 
be amended accordingly. 
G. Amendment toiheGuidelinesforthe 
Submission of Human Gene Transfer/ 
Therapy Protocols for Review by the 
RAC of the Points to Consider/NIH 
Guidelines 
Dr. Nelson A. Wivel, Director, Qffice 
of Recombinant DNA Activities. 
National Institutes of Health. Bethesda, 
Maryland, requested an amendment to 
the Guidelines for the Submission of 
Human Gene Transfer/Therapy 
Protocols for Reviewhy the RAC 
Federal Register. February .18, 1993, 
page 9104). These amendments will 
establish consistency in the submission 
of human gene transfer protocols for 
RAC review and require that principal 
investigators focus their oral responses 
to the RAC’s questions -and comments. 
This request was published for 
comment in the Federal Register -of 
August 18, 1993 (58 fR 44098). The 
Title and Section I was proposed to 
read: 
"Guidelines for the Submission of 
Human "Gene Transfer Protocols for 
Review by the Recombinant DNA 
Advisory Committee 
"I. Investigator Submitted Material: 
"Written proposalsmust be submitted 
in the following order^l) Scientific 
abstract — 1 page; (2) nontechnical 
abstract— 1 page; { 3) institutional 
Biosafety Committee and Institutional 
Review Board approvals; (4) Points to 
Consider— 6 pages; (6) protocol — 20 
pages excluding appendioer, (7) 
Informed Consent Document— approved 
by the institutional Review Board; f 8) 
appendices including tables, figures, 
and manuscripts; and (9) -Curricula 
vitae— 2 p^es in Biographical sketch 
format When a proposal has been 
submitted previously, there should be a 
short section (5200 words) immediately 
following the abstracts that summarizes 
the ma|orre visions . since the last 
review- Data provided * * *. 
“* * * written responses (including 
critical data in response to the primary 
reviewers’ comments) must be 
submitted by the Principal Investigators 
to the Office of Recombinant DNA 
Activities £2 weeks before the RAC 
meeting. 
"Oral Responses to die RAC. Principal 
Investigators must limit their oral 
responses to the RAC only to those 
questions that are raised during the 
meeting. Oral presentations of 
previously submitted material and/or 
critical data that was not submitted >2 
weeks prior to die RAC meeting is 
prohibited,” 
This request was reviewed and 
recommended for approval as proposed 
during the RAC meeting of September 
9-10, 1993, bya vdte-oflBin favor, 1 
opposed, and no abstentions. 
I accept this recommendation, and the 
title and section I to the Guidelines for 
the Submission of Human Gene 
Transfer/Therapy Protocols for Review 
by the RAC (Federal Register, February 
18,1993, page 9104) of the NIH 
Guidelines will be amended 
accordingly. 
H. Amendments to Sections 111, TV, V 
and Appendix C and F of the NIH 
Guidelines Regarding the Cloning vf 
Toxin Molecules 
In a letter dated f uly 28. T993,Dr. 
Nelson A. Wivel. Director, Office bf 
Recombinant ONA Activities, National 
Institutes ofHealth. Bethesda, 
Maryland, requested amendments to 
Sections HI, IV, and V, and Appendices 
C and F regarding the review process for 
experiments involving the cloning of 
toxin molecules. These amendments 
will establish a new category of review 
entitled: Experiments that Require NIH 
(Office of Recombinant DNA Activities? 
ORDA) and institutional Biosafety 
Committee (IBC) Approval Before 
Initiation. Under this new category Of 
review, experiments involving the 
cloning of toxin molecules that are 
lethal for vertebrates at nn LDj© of <100 
nanograms per kilogram of body weight 
will be reviewed by NIH lORDAJ In 
consultation with ad hoc toxin experts. 
This request was published for 
comment in the Federal Register of 
August 18. 1993 (58 FR 44098). Sections 
IH, IV, V and AppendixC and F is 
proposed to read: 
"Section HI. Guidelines for Covered 
Experiments. 
"Part m discussesexperiments 
involving recombinant DNA. These 
experiments have been divided into five 
classes: 
“TII-A. Experiments which require 
specific RAC review and NIH and IBC 
approval before initiation of the 
experiment; 
"HI-B. Experiments which require 
NIH (Office of Recombinant DNA 
Activities/ORDA) and Institutional 
Biosafety Committee (IBC) approval 
before initiation of the experiment; 
“IH-C. Experiments which require 
IBC approval before initiation of the 
experiment; 
“HI-D. Experiments which require 
IBC notification at the time of the 
experiment; 
"HI-E. Experiments which are exempt 
from the procedures of the Guidelines. 
"IF AN EXPERIMENT FALLS INTO 
BOTH CLASS HI-A AND ONE OF THE 
OTHER CLASSES, THE RULES 
PERTAINING TO CLASS HI-A MUST 
BE FOLLOWED. If an experiment falls 
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Recombinant DNA Research, Volume 18 
