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Federal Register / Vol, 58 , No. -158 ^ Wednesday, August 18,' 1993' 7 Notides 
XI. Working Group Report on 
Categories of Human Gene Transfer 
Experiments That Are Exempt From 
RAC Review/ Dr. Parkman 
Dr. Robertson Parkman, Chair of the 
Working Group on Categorization of 
Protocols, will present a report on 
proposed categories of human gene 
transfer experiments that would be 
exempt from the RAC review process. 
XII. Amendment to Appendix D of the 
NIH Guidelines Regarding Actions 
Taken Under the Guidelines 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda, 
Maryland, requests an amendment to 
appendix D. Appendix D is proposed to 
read: 
“Appendix D — Actions Taken Under 
the Guidelines. 
“As noted in the subsection of Section 
IV-C-l-b-(l), the Director, NIH, may 
take certain actions with regard to the 
Guidelines after the issues have been 
considered by the RAC. Ah updated list 
of these actions are available from the 
Office of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892.” 
XIII. Amendment to the Guidelines for 
the Submission of Human Gene 
Transfer/Therapy Protocols for Review 
by the RAC of the Points to Consider/ 
NIH Guidelines 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
Nationaljlnstitutes of Health, Bethesda, 
Maryland, requests an amendment to 
the Guidelines for the Submission of 
Human Gene Transfer/Therapy 
Protocols for Review by the RAC 
(Federal Register, February 18, 1993, 
page 9104). -This amendment will 
establish consistency in protocol 
submissions and will focus oral 
responses by the principal investigators. 
The title and section I is 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 proposals must be submitted in the 
following order (1) Scientific abstract — 1 
page; (2) non-technical abstract — 1 page; (3) 
IBC and IRB approvals; (4) Points to 
Consider — 5 pages; (6) protocol — 20 pages 
excluding appendices; (7) Informed Consent 
Document — approved by the IRB; (8) 
appendices including tables, figures, and 
manuscripts; and (9) CVs — 2 pages in 
Biosketch format. When a proposal has been 
submitted previously, there should be a short 
section (<200 words) immediately following 
the abstracts that summarizes the major 
revisions 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 ORDA £2 weeks 
before the RAC meeting. 
Oral Responses to the 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 the RAC meeting is prohibited. 
Currently, the title and section I reads: 
Guidelines for the Submission of Human 
Gene Transfer/Therapy Protocols for Review 
by the Recombinant DNA Advisory 
Committee 
I. Investigator Submitted Material: 
“Written proposals should begin with the 
lay and scientific abstracts, followed by the 
Points to Consider and material provided in 
the body of an R01 format (section A-D). 
When a proposal has been submitted 
previously, there should be a short section 
(< 200 words) immediately following the 
abstracts that summarizes the major revisions 
since the last review. Length limitations are 
4-5 pages for the Points to Consider, 2 pages 
each for CVs (Biosketch format) and 20 pages 
for the body of the proposal (excluding 
tables, figures, appendices, and manuscripts). 
Data provided * * *. 
* * * written responses from the Principal 
Investigators £ 2 weeks before the RAC 
meeting. 
Oral Presentations at RAC Meetings 
provide only a brief overview of the proposal; 
they should concentrate on questions raised 
by the reviewers before and at the meeting. 
Oral presentations should be <20 minutes: 
<10 minutes for the overview and < 10 
minutes for responses to the reviewers' 
questions. 
XTV. Amendments to Appendix B of the 
NIH Guidelines Regarding Updating the 
Classification of Microorganisms/ 
Fleming 
In a letter dated June 24, 1993, Dr. 
Diane O. Fleming, President of the Mid- 
Atlantic Biological Safety Association 
requests updating Appendix B: 
Classification of Microorganisms on the 
Basis of Hazard. The Mid-Atlantic 
Biological Safety Association submitted 
an updated list of the classification of 
microorganisms for the committee to 
review which includes the latest 
taxomomy and agent risk group 
classifications as defined by the Centers 
for Disease Control. 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements” (45 FR 
39592, June 11, 1980) requires a " 
statement concerning the official 
government programs contained in the 
Catalog of Federal Domestic Assistance. 
Normally, NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the . 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined not to be cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing, NIH invites readers to 
direct questions to the information 
address above about whether individual 
programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
Daryl A. Chamblee, 
Acting Depu ty Director for Science Policy and 
Technology Transfer. 
[FR Doc. 93-20064 Filed &-17-93; 8:45 am) 
BILLING COO£ 4140-01-44 
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