4 
an advisory committee looking at this entire matter and that Admin- 
istrator Costle would soon have their views for a reply to the Secretary. 
Dr. Logan of the Occupational Safety and Health Administration (OSHA) , 
Department of Labor, said that a response to the Califano letter would 
go out as soon as possible. 
Dr. Fredrickson reported that he and Dr. Donald Kennedy, Commissioner 
of Food and Drugs, in light of the comments FDA had received, had jointly 
drafted a supplement to the NIH Guidelines to provide industry with a 
voluntary approach to compliance. Back in May, Peter Libassi, then 
General Counsel for the Department of Health, Education, and Welfare, 
had held meetings with representatives from the Pharmaceutical Manu- 
facturers Association and public interest groups to review the draft 
supplement. (In the fall of 1978, as chairman of the HEW committee 
responsible for the final Guidelines, Mr. Libassi had reviewed the 
proposed revision with these groups.) The PMA representati ves now en- 
dorsed the voluntary approach in principle but wished to make further 
recommendations on the protection of proprietary information. The 
environmental and public representatives, on the other hand, objected 
to the voluntary approach and urged that alternatives of legislation or 
regulation be considered. They specifically requested that the Secretary 
direct OSHA to exercise its authority. 
Dr. Fredrickson noted that in light of the Libassi meeting he had 
spoken to Secretary Califano, who had requested the advice of the Inter- 
agency Committee on the voluntary approach and the NIH draft supplement. 
Specifically, the Secretary had sought the Committee's views on the 
following questions: 
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