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Federal Register / Vol. 57, No. 2 / Friday. January 3, 1992 / Notices 
fifteen days of comment, review by the 
RAC, and specific approval by N1H. 
‘Section IV-C-l-b-(l). Major Actions. 
To execute major actions the Director, 
NIH, must seek the advice of the RAC 
and provide an opportunity for public 
and Federal agency comment. 
Specifically, the agenda of the RAC 
meeting citing the major actions will be 
published in the Federal Register at 
least 15 days before the meeting, and the 
Director, NIH, will also publish the 
proposed action the Federal Register for 
comment at least 15 days before the 
meeting. In addition, the 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. 
‘Section 1V-C-2. Recombinant DNA 
Advisory Committee. * * * All meetings 
of the RAC will be announced in the 
Federal Register, including tentative 
agenda items, 15 days in advance of the 
meeting with final agendas (if modified) 
available at least 72 hours before the 
meeting. 
‘Section IV— C— 3— b — (1). 
Announcements of RAC meetings and 
agendas at least 15 days in advance; 
‘Section IV-C-3-b-(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 * * *’ 
“II. Review of Human Gene Therapy/ 
Transfer Protocols. 
“ The Points to Consider in the Design 
and Submission of Protocols for the 
Transfer of Recombinant DNA into the 
Genome of Human Subjects document 
(Federal Register of March 1, 19S0) and 
the NIH Guidelines need to be amended 
to reflect exclusive review of protocols 
by the Recombinant DNA Advisory 
Committee. The Points to Consider will 
be amended as follows: 
‘Introduction. RAC consideration of 
each proposal will be on a case-by-case 
basis and will follow publication of a 
precis of the proposal in the Federal 
Register, and an opportunity for public 
comment. 
‘Section IV-B. If the change has been 
approved by the relevant IR8, and IBC, 
then the Chair of the Recombinant DNA 
Advisory' Committee may give approval. 
It is expected that the Chairs will 
consult with one or more members of 
the committee, as necessary. 
‘Section V. Minor Modifications. A 
minor change in protocol approved by 
the Recombinant DNA Advisory 
Committee is a change that does not 
significantly alter the basic design of a 
protocol and that does not increase risk 
to the subjects.' ” 
IX. Amend Appendices B-I-8-1 and B- 
I-B-2 of the NIH Guidelines regarding 
the Bacterial Order, Actinomycetales 
In a written request dated April 15, 
1991, Dr. Diane O Fleming of Merck & 
Co., Inc., Somerset, New Jersey, 
requested that only pathogenic genera 
and species of the bacterial order, 
Actinomycetales , be included in 
Appendix B-I-B-l of the NIH 
Guidelines. 
It was proposed that the following 
pathogens be included in the list of 
Bacterial Agents in appendix B-I-B-l of 
the NIH Guidelines as follows: 
Actinomadwa madurae 
Actinomadura pelletieri 
Actinomyces bovis 
Actinomyces israelii 
Nocardia asteroides 
Nocardia brasiliensis 
In appendix B-I-B-2, the entry under 
Actinomycetes would be deleted. 
This request was reviewed at the 
Recombinant DNA Advisory Committee 
meeting on May 30-31, 1991. Following a 
discussion there was agreement that the 
Actinomyces should be reclassified as 
bacteria and removed from the list of 
fungi. However, there was disagreement 
about the number of species to be listed 
as pathogens. The number was thought 
to be considerably larger than the six 
species proposed for inclusion. Dr. 
Fleming was asked to consult with 
leading experts in the field and return 
with a revised list of pathogens, to be 
reviewed at the Recombinant DNA 
Advisory Committee meeting on 
October 7-8, 1991. 
This request was published for 
comment in the Federal Register on 
September 3, 1991 (56 FR 43686). 
During the October 7-8, 1991, 
Recombinant DNA Advisory Committee 
meeting, a motion was passed by a vote 
of 19 in favor, 0 opposed, and no 
abstentions to create an ad hoc working 
group within the Recombinant DNA 
Advisory Committee with outside 
consultants to provide an amended list 
of pathogens. 
X. Amend Appendices B-I-C-l and B-I- 
B-l in the NIH Guidelines regarding 
Mycobacterium avium 
In a letter dated December 18, 1991, 
Dr. William R. Jacobs, Jr., of the Albert 
Einstein College of Medicine, Bronx, 
New York, requested lowering the 
classification of Mycobacterium avium 
from a Class III bacterial agent to a 
Class II bacterial agent. M. avium would 
move from appendix B-I-C-l to 
appendix B-I-B-l in the NIH 
Guidelines. 
XI. Other Matters To Be Considered by 
the Committee 
Attendance by the public will be 
limited to space available. Members of 
the public wishing to speak at this 
meeting may be given such opportunity 
at the discretion of the Chair. 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, room 4B11, Bethesda, Maryland 
20892, Phone (301) 496-9838, FAX (301) 
496-9839, will provide materials to be 
discussed at this meeting, a roster of 
committee members, and substantive 
program information. A summary of the 
meeting will be available at a later date. 
OMB'a “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. 
Dated: December 24, 1991. 
Jay Moskowitz, 
Associate Director for Science Policy and 
Legislation. NIH. 
(FR Doc. 92-108 Filed 1-2-92: 8:45 am] 
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