2 
Dr. Walters called the meeting of a Subworking Group on Human Gene Therapy to 
order at 9:10 a.m. on March 15, 1985. 
Dr. Walters expressed hope that the subworking group could identify the major 
issues in the comments received in response to the January 22, 1985, Federal 
Register (50 CFR 2940) announcement of the "Points to Consider in the Design 
and Submission of Human Somatic-Cell Gene Therapy Protocols" (Attachment II). 
The siioworking group would discuss appropriate responses to the comments. 
Ms. Areen asked vhether the working group would explain its responses, particu- 
larly responses to comments not incorporated into the points to consider document. 
She asked vhether the subworking group would attempt to draft these explanations 
at the March 15, 1985, meeting. 
Dr. Walters felt justifications for working group decisions vis-a-vis the comments 
would be necessary and should be publicly available. He did not feel, however, 
that the subworking group should attempt to draft justifications at the March 15, 
1985, meeting. 
Dr. Anderson asked vhether the working group would continue to accept comments 
after the close of the official public comment period. He felt the working 
group should accept all comments offered on the points to consider document. 
The subworking group agreed; they did not feel, however, that justifications 
need be offered on comments received after the close of the official comment 
period. 
Dr. Gottesman asked if the document developed by the working group in response 
to the comments would be republished in the Federal Register prior to the next 
Recanbinant ENA Advisory Ccmmitttee (RAC) meeting. Dr. Gartiand said the 
publication deadline for the Federal Register announcing the next RAC meeting 
would be April 20, 1985. Since the full working group must also consider the 
Garments, it would be difficult to revise the points to consider document in 
the time available. He noted that other working groups in the past have simply 
published points to consider documents in the Recombinant DNA Technical Bulletin 
and notified the Institutional Biosafety Committees (iBCs). 
Dr. Walters asked hew many copies of the January 22, 1985, Federal Register 
had been mailed to interested individuals. Dr. Gartiand replied that several 
thousand copies had been mailed. Included in this nurrber were individuals who 
had signed a petition sponsored by the Foundation on Economic Trends. 
Dr. Walters called the attention of the subworking group to a handout (Attach- 
ment III) which collates the comments (Attachment IV) received in response to 
the January 22, 1985, Federal Register . He began by noting the comment offered 
by Dr. Henry Miller of the Pood and Drug Administration (FDA) on the introduction 
to the points to consider document. Dr. Miller had suggested the phrase "and 
FDA regulations (21 CFR, Parts 50 and 56)" should be added to the introduction 
following the reference to the Department of Health and Human Services (DHHS) 
human subject regulations (45 CFR 46). The subsequent sentence should be 
modified to indicate that the words "these regulations" refer to the DHHS 
regulations . 
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