14776 Federal Register / Vol. 57, No. 70 / Wednesday, April 22, 1992 / Notices 
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The requested amendment would use 
CD-34 + cells (the peripheral blood stem 
cell fraction) transduced with the gene 
coding for adenosine deaminase (ADA) 
as a supplemental therapy for patients 
with ADA deficiency. The request was 
published for comment in the Federal 
Register on January 3, 1992 (57 FR 316), 
and a correction notice published in the 
Federal Register on July 18, 1991 (56 FR 
33174). 
During the meeting on February 10-11, 
1992, the RAC met to review this 
amendment to the protocol. The RAC, 
by a vote of 11 in favor, 3 opposed and 2 
abstentions, approved the amendment 
to the protocol. The following section 
may be appended to appendix D-XV: 
Appendix D-XV 
In addition to the conditions outlined in the 
initial approval, patients may be given a 
supplement of CD 34+ enriched periphe. J 
blood lymphocytes (PBL) which have been 
placed in culture conditions that favor 
progenitor cell growth. This enriched 
population of cells will be transduced with 
the retroviral vector, GlNaSvAd. GlNaSvAd 
is similar to LASN, yet distinguishable by the 
polymerase chain reaction (PCR). LASN has 
been used to transduce peripheral blood T 
lymphocytes with the ADA gene. 
Lymphocytes and myeloid cells will be 
isolated horn patients over time and assayed 
for the presence of the LASN or GlNaSvAd 
vectors. The primary objectives of this 
protocol are to transduce CD 34+ peripheral 
blood cells with the adenosine deaminase 
gene, administer these cells to patients, and 
determine if such cells can differentiate into 
lymphoid and myeloid cells in vivo. There is 
a potential for benefit to the patients in that 
these hematopoietic progenitor cells may 
survive longer, and divide to yield a broader 
range of gene-corrected cells. 
I accept this recommendation and 
appendix D-XV of the NIH Guidelines 
will be amended accordingly. 
F. Amendment to Sections Ul-A and IV- 
C of the NIH Guidelines Regarding 
Notice of Meeting and Proposed 
Actions: Amendment to Introduction, 
Parts II, and V of the Points to Consider 
Regarding Review by the Human Gene 
Therapy Subcommittee 
During the HGTS meeting on July 30- 
31, 1991, a Working Group on the Future 
Role of the Recombinant DNA Advisory 
Committee was established to prepare a 
report about the feasibility of merging 
the HGTS and the RAC. This request 
was published for comment in the 
Federal Register on November 7, 1991 
(56 FR 56415). 
The HGTS received a report from this 
working group during its meeting on 
November 21-22, 1991, which 
recommended that: (i) All eligible HGTS 
members be added to the RAC as full 
voting members: or (ii) all of the HGTS 
members be added to the RAC as non- 
voting members; or (iii) joint meetings 
would be held in which the HGTS would 
vote on the proposed action first 
followed by the full RAG During the 
meeting, the following motion passed by 
a vote of 11 in favor, 2 opposed, and no 
abstentions: 
We move to recommend to the 
Recombinant DNA Advisory Committee, that 
its subcommittee, the Human Gene Therapy 
Subcommittee, be merged into the parent 
committee. The number of meetings per year 
of the Recombinant DNA Advisory 
Committee would increase to four per year. 
There would be a transition period of one 
year in which the Recombinant DNA 
Advisory Committee would begin to review 
proposed actions as the sole review group. 
The following provisions would apply: (i) The 
Human Gene Therapy Subcommittee would 
codify a set of guidelines for shortening the 
review process, and (ii) the eligible members 
of the Human Gene Therapy Subcommittee 
would be brought onto the Recombinant DNA 
Advisory Committee as full voting members 
in keeping with the nomination process for 
Federal Advisory Committees. 
The HGTS forwarded the proposal to 
the RAC for consideration during the 
February 10-11, 1992, meeting. 
In a letter dated December 23, 1991, 
Dr. Nelson Wivel, Director, Office of 
Recombinant DNA Activities, National 
Institutes of Health, Bethesda, 
Maryland, stated that amendments will 
need to be made to the NIH Guidelines 
in sections m-A and IV-C and to the 
Points to Consider in the Design and 
Submission of Protocols for the Transfer 
of Recombinant DNA into the Genome 
of Human Subjects in the Introduction, 
Parts II, and V, in the event that the 
HGTS recommendations are accepted. If 
the recommendation on having more 
meeting dates to accommodate the 
expected increase in human gene 
transfer/ therapy protocols is accepted, 
the Notices of Meeting and Proposed 
Actions will need to be changed from 
thirty days to fifteen days to allow 
expedited review. Changes are required 
in Sections m-A and IV-C of the NIH 
Guidelines. If the recommendation to 
have the HGTS merge into the parent 
committee is approved, all references to 
the HGTS will need to be deleted in the 
Points to Consider, in the Introduction, 
and Parts IL and V. 
These requests were published for 
comment in the Federal Register on 
January 3, 1992 (57 FR 316). 
During the meeting on February 10, 
1992, the RAC met to review the 
requests of the HGTS and Dr. Wivel. 
The RAG by a vote of 14 in favor. 0 
opposed and no abstentions, approved: 
(1) To eliminate review of the human 
gene transfer/therapy protocols by the 
HGTS: this established sole review of 
the protocols by the RAC: and (2) to 
change all references to thirty day 
Notice of Meeting and Proposed Actions 
to fifteen days. The RAC also 
recommended increasing the number of 1 
times the committee meets from three 
times a year to four times a year. 
The following sections will be 
amended In the NIH Guidelines: 
Sections m-A IV-C-l-b-{l), section 
IV-C-2, section IV-C-3-b-(l). section 
IV-C-3-b-{2)). The amended sections 
will read: 
Section IH-A. Experiments That Require 
RAC Review and NIH and IBC Approval 
Before Initiation 
Experiments in this category cannot be 
initiated without submission of relevant 
information on the proposed experiment to 
NIH, the publication of the proposal in the 
Federal Register for 15 days of comment, 
review by the RAG and specific approval by 
NIH. The containment conditions for such 
experiments will be recommended by the 
RAC and set by NIH at the time of approval. 
Such experiments also require * * *. 
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 s 
meeting citing the major actions will be 
published in the Federal Register at least 15 j 
days before the meeting, and the Director, 
NIH, will also publish the proposed actions in 
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. The 
Director’s final decision * * *. 
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 as 
• • • 
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: The 
Introduction, Parts H, 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 
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Recombinant DNA Research, Volume 15 
