Federal Register / Vol. 57, No. 78 / Wednesday, April 22, 1992 / Notices 
14779 
Section IV-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. No item defined 
• • • 
Section IV-C-3-b-{l). Announcements of 
RAC meetings and agendas at least 15 days 
in advance; NOTE — If the agenda * * *. 
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 
The following sections will be 
amended to the Points to Consider: 
Introduction, parts n, and V. This 
document was published in the Federal 
Register on March 1, 1990 (55 FR 7437). 
amended September 12, 1990 (55 FR 
37565), and amended July 18, 1991 (56 FR 
33174). The amended sections will read: 
Introduction. (1) * * * 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. RAC's 
recommendation on each proposal will be 
forwarded to the NIH Director for a decision 
which will then be published in the Federal 
Register. 
Introduction. (4) * * * The IRB and D3C 
may, at their discretion, condition their 
approval on further specific deliberation by 
the RAC. Consideration of proposals by the 
RAC may proceed simultaneously with 
review by any other Federal agencies 
provided that the RAC is notified of the 
simultaneous review. Meetings of the RAC 
will be open to the public except where trade 
secrets or proprietary information would be 
disclosed. The committee * * * 
Introduction. (6) * * * Part in summarized 
other requested documentation that will 
assist the RAC in their review of the 
proposals. Part IV specified reporting 
requirements. ■ 
Introduction. (7) The RAC will not at 
present entertain proposals for germ line 
alterations * ' *. 
Introduction. (9) In their evaluation of 
proposals involving the transfer of 
recombinant DNA into human subjects, the 
RAC will consider whether the design * * *. 
Accordingly, this document requests 
information that will enable the RAC to 
assess the possibility that the proposed 
experiments will inadvertently affect 
reproductive cells or lead to infection of other 
people (e.g., treatment of personnel or 
relatives). 
Introduction. (10) In recognition of the 
social concern that surrounds the subject of 
gene transfer, the RAC will cooperate with 
other groups * * *. 
Introduction. (12) * * * Investigators 
submitting proposals that employ essentially 
the same vector systems (or with minor 
variations), and/or that are based on the 
same preclinical testing as proposals 
previously reviewed by the RAC, may refer to 
preceding documents without having to 
rewrite such materials. 
Part II. Special Issues. Although the 
following issues are beyond the normal 
purview of local ERBs, the RAC requests that 
the investigators respond to questions A and 
B below. 
Part V. Minor Modifications. A minor 
change in a protocol approved by the RAC is 
a change that does not significantly alter the 
basic design of a protocol and that does not 
increase risk to the subjects. If the change 
has been approved by die relevant IRB and 
IBC, then the Chair of the RAC may give 
approval. It is expected that the Chair will 
consult with one or more members of the 
committee, as necessary. The Chair will 
report on any such approvals at the next 
regularly scheduled meeting of RAC. 
I accept this recommendation to 
amend accordingly the NIH Guidelines 
in sections III-A and IV-C and to amend 
the Points to Consider in the 
Introduction, parts II, and V. 
G. Amendment to Appendices B-l-B-1 
and B-I-B-2 of the NIH Guidelines 
Regarding the Bacterial Order, 
A ctinomycetales 
Appendix B-I-B-l, Bacterial Agents, 
the following organisms will be added: 
Amycolata autotrophica 
Dermatophilus congolensis 
Nocardia asteroides 
Nocardia brasiliensis 
Nocardia otitidiscaviarum 
Nocardia transvalensis 
Rhodococcus equi 
Appendix B-I-B-2, Fungal Agents, the 
following organisms will be deleted: 
"Actinomycetes (including Nocardia 
species, actinomyces species, and 
Arachnia propionica)[2]” 
H. Amend Appendices B-I-C-l and B-I- 
B-l in the NIH Guidelines Regarding 
Mycobacterium Avium 
Appendix B-I-C-l, Bacterial Agents, 
the following organism will be deleted; 
Mycobacterium avium 
Appendix B-I-B-l, Bacterial Agents, 
the following organism will be added: 
Mycobacterium avium 
OMB's Mandatory Information 
Requirements for Federal Assistance 
Program Announcements (45 FR 39592) 
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 to be not 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. 
EFFECTIVE DATE: April 17, 1992. 
Bemadinfl Healy, 
Director, National Institutes of Health. 
[FR Doc. 92-9368 Filed 4-17-92; 8:45 am) 
BILLING COOE 4410-01-U 
Recombinant DNA Research, Volume 15 
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