Dr. Fredrickson 
- 2 - 
11/2/76 
The particular provisions of the Guidelines which impact on intellectual 
property rights and volume restrictions are those which impose forma- 
lized approval and reporting requirements on the principal investigator 
as outlined in the chapter entitled "Roles and Responsibilities" FR (41) 
131 on page 27920, and related portions of the Guidelines. We believe 
that an acceptable mechanism can be worked out for keeping your office 
currently advised of the extent of involvement of PMA member firms in 
recombinant DNA research without the necessity for such formalized pro- 
cedures. Our member firms, which are so engaged, could assure your 
office of the existence of institutional biohazards committees, a concept 
which the industry has already endorsed. Minutes of the meetings of such 
committees could be made available in an edited form which would provide 
the safeguards which are considered necessary to protect intellectual 
property rights and at the same time provide the necessary assurances of 
compliance with the safety provisions of the Guidelines regarding physical 
and biological containment levels. Such minutes could be made available 
to appropriate officials of your office, provided that the information thus 
provided would be protected from public disclosure. 
It is suggested that the details concerning allowable exemptions from the 
requirements, as published, can best be discussed at a meeting between 
representatives of your office, the PMA and affected member firms as sug- 
gested earlier by Dr. John G. Adams of our staff. I am confident that such 
a meeting will satisfactorily resolve the administrative problems involved 
and achieve your purpose in assuring compliance with the Guidelines by the 
pharmaceutical industry. We are pleased to offer our cooperation in your 
efforts to provide guidance in this new and important field of research and 
will look forward to hearing from you in the near future concerning the 
above suggestion. 
sincerely yours. 
Enclosures 
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