3 
basic research in biotechnology. The ccnmittees chartered by the FDA, USDA, 
and EPA will primarily address commercial applications. 
Each agency will send to its advisory ccnmittee a summary of each application 
relating to reccmbinant CNA, recombinant RNA, or cell fusion submitted for 
funding or review, regardless of vhether the agency is requesting a scientific 
review. Any agency of the federal government may request that one or more of 
the scientific advisory ccnmittees review its applications. The Biotechnology 
Advisory Board may also request that an agency direct its scientific advisory 
ccnmittee to review an application. When the review is completed, the ccnmittee 
will submit its report to the agency requesting the review. It will also submit 
to the Biotechnology Advisory Board for review and c ament a copy of the report, 
redacted to delete confidential business information and supplemented with such 
additional nonproprietary information as is necessary to appreciate the scientific 
significance of the report. The Biotechnology Science Board will be chartered 
by the Department of Health and Human Services (DHHS) and will report to the 
Assistant Secretary for Health. The membership will include two members frcm 
each agency-based scientific advisory ccnmittee. 
Mr. Mitchell said the oversight mechanism preposed in the Federal Register 
announcement raises several questions. The Federal Register announcement does 
not clearly state the procedure by vhich an applicant would choose the review 
forum. The first issue, thus, is vhether applicants will "forum shop;" i.e., 
go frcm advisory canmittee to advisory ccmmittee in the hope of obtaining the 
most favorable review. 
The second issue is how the applicant or the public will knew the proper 
review forum has been chosen. Heretofore, the NIH and RAC have served as the 
central oversight focus. Applicants knew vhere to submit proposals and the 
public could be aware a proposal would be reviewed. Will confusion or 
uncertainty develop under the preposed system? 
Mr. Mitchell said the December 31, 1984, Federal Register does not clearly 
spell out the respective specific duties of each agency advisory committee; 
these duties should be very clearly defined. 
Mr. Mitchell said the Federal Register does not address the issue of vhether 
each agency would establish their own guidelines; guidelines developed by one 
agency could differ substantially frcm the guidelines of other agencies and 
frcm the NIH Guidelines for Research Involving Reccmbinant DNA Molecules. 
Mr. Mitchell said the Federal Register announcenent does not indicate the degree 
of public participation on the agency advisory ccnmittees, and this should be 
clarified. He felt public members, i.e., those who represent the concerns of 
the public, play a necessary role on review committees. Although the majority 
of members should be chosen for their technical expertise, public members 
should be appointed to the agency advisory ccnmittees. The participation of 
the scientific conrnunity and the public in oversight efforts should be encouraged 
rather than discouraged. Under the current NIH review system, participation 
by these groups is encouraged. Mr. Mitchell felt this tradition should be 
continued. Meetings of all the agency advisory ccnmittees should be open to 
[ 333 ] 
