SEPTEMBER 6-7 - MINUTES OF MEETING 
18 
Specifically: 
(1) the necessity for clarifying the appeal mechanism 
for FDI decisions under Section VI-F; a letter of 
understanding from OREA would be acceptable. 
(2) that a company need not v/aive any other rights 
when appealing any Freedom of Information (FOI) decision. 
(3) if an initially favorable decision under presubmission 
review is later reversed, the submitting institution 
should have 15 days notice in which to take legal action. 
(4) finally, provision is made in Sections VI-D and VI-E 
for consultation on the content of notices. The PMA 
would like to add an additional statement that if agreement 
cannot be reached, an institution retains its right 
to withdraw its submission. 
Dr. Adams said these suggestions would be submitted in writing to NIH. 
Dr. Kr imsky asked about the composition of the private sector IBCs and 
the method by which these members are selected. Dr. Johnson responded 
that the Eli Lilly IBC is composed of 9 members with 3 of these members 
coming from outside of the company. Dr. Novick asked what would happen 
if NIH disapproves of a request from industry. Dr. Adams responded that the 
firm would probably attempt to negotiate with NIH but will comply. Dr. Ahmed 
asked whether the PMA endorses legislation to make the Guidelines mandatory. 
Dr. Adams responded that the PMA much prefers voluntary compliance with 
the Guidelines; this permits greater flexibility. Mr. Dach asked whether 
PMA member companies would withdraw a submission if the HEW FOI Officer 
decides a submission labeled proprietary is not so. Dr. Adams responded 
that the firms would negotiate. Mr. Dach then asked if compliance would 
extend only to those projects which would be kept from public knowledge. 
Dr. Baltimore rephrased the question to ask, when a firm withdraws its 
submission, would the firm proceed with the experiment anyway? Dr. Adams 
responded that he assumes they would negotiate, and not go on with the 
experiment until it was negotiated. Dr. Johnson of Eli Lilly said he 
assumed that if the experiment was not approved, it would not be done. 
Dr. Agostine of Pfizer stated that if the HEW FDI Officer should disagree 
with the submitting company, the company would like to have the option of 
making a formal submission provided that the record would show that the 
company felt the material to be confidential. If there were subsequently 
a Freedom of Information Act (FDIA) request from the public for the information, 
the company would have 15 days notice before release in which time it 
could do nothing or take legal action. Dr. Schwarz asked whether firms 
might register only selected experiments, i.e., those most likely to be 
approved. Dr. Adams and Dr. Johnson responded that the PMA will totally 
comply. Dr. Kr imsky asked about the composition of the PMA. Er . Adams 
responded that the FMA is composed of 55 corporate members which represents 
approximately 145 firms. These firms account for approximately 95% of all 
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