11 
Dr. Miller contrasted the RAC and FDA process. In the RAC process, NIH publishes 
notice of proposal review in the Federal Register . Working group meetings are 
called if necessary, and the proposals are reviewed by RAC which generally 
meets in public session. RAC then offers advice to the NIH Director, vho an- 
nounces his decision in the Federal Register . Proposals submitted to FDA are 
reviewed by in-house reviewers, and a decision is reached by agency staff. 
The type of decisions RAC currently offers to NIH would be made by agency staff. 
The agency process turns more or less automatically unless a generic problem 
arises; an advisory committee meeting may be called to evaluate generic issues. 
FDA expects internal review will function on a thirty day clock. The EPA 
review system operates on a ninety day clock, and reviews will be performed by 
EPA staff. It is unlikely agency advisory committees will participate in pro- 
posal reviews because of time and volume constraints. Dr. Miller said analogies 
between RAC and the preposed agency advisory committees should not be overdrawn. 
Dr. Clowes asked whether a submitter could appeal an agency decision. Dr. Miller 
replied that the agencies have internal appeal mechanisms, but the submitter 
could not appeal to the Biotechnology Science Board because no mechanisms for 
external review exist. 
Dr. Clowes said the processes proposed in the De conker 31, 1984, Federal Register 
represent a major departure from the procedures RAC has used so successfully. 
He felt the agency advisory committees proposed in the Federal Register announce- 
ment should function as RAC has functioned in the past, and the proposed Biotech- 
nology Science Board should have authority over the agency advisory committees. 
RPC could aid the board in developing a uniform set of guidelines for the 
agencies and could assure that EPA does not refight past battles. Continuity 
in this oversight process should be preserved; this process need not begin 
again at sqm re one. 
Dr. Clowes felt all proposals should be reviewed by the Biotechnology Science 
Board, and these reviews should be open to the public when possible. Dr. Clowes 
felt meetings of the agency advisory committees should also be open to the 
public. The working group could suggest language to this effect be added to 
the December 31, 1984, Federal Register notice. 
Dr. Goldhammer of the Industrial Biotechnology Association ( IBA) said expert 
committees advise the EPA on specific issues . Members of these committees are 
recruited from outside of the agency. Dr. Walters asked if these meetings are 
open to the public. Dr. Goldhammer said seme portions of the meetings may be 
open to the public ; reviews of proprietary proposals are closed , however . 
Dr. Vfelters asked whether the FPA announces reviews. Dr. Goldhammer said EPA 
announces reviews in the Federal Register ; this announcement gives the name of 
the company, the date of the review, and the regime under which the proposal 
was received; e.g., pesticide. 
Dr. McKinney said EPA and FDA operate under statutes; these statutes are difficult 
to modify. He suggested comments by the working group on the issue of public 
access would not affect the manner in which these agencies function. He asked 
Dr. Gartland why the Cabinet Council Working Group had not addressed the issue 
of how NSF ard NIH, which are not regulatory agencies, would perform review/s. 
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