3 
With regard to data which may be released to non-Government 
entities, legislation should require that the submitter identify 
any legally protectible intellectual property rights which is con- 
tained in the submitted data that is to be released by the Secretary, 
before such release is made. This provision should provide that 
notice be given to the submitter before release and that a hearing 
be allowed to the submitter if disagreement arises concerning such 
release. 
In addition, the exemptions of the Freedom of Information Act may 
be available to protect such data from improper release. 
III. The following is the language proposed by the Office of the Assistant 
Secretary for Health, DREW, to appear in the section of the suggested 
elements headed "Disclosure of Information." 
The legislation should provide that all information submitted to 
or otherwise obtained by the Secretary or his representatives 
under the legislation shall be available to the public upon 
request, except (1) information now exempt from disclosure under 
the Freedom of Information Act, and (2) other information the 
disclosure of which would cause the loss of proprietary rights. 
At the time of submission, persons submitting information should 
be able to identify those portions which they believe to be exempt. 
The Secretary should not release such Information unless: (1) he 
has found the information so identified not to be exempt after 
having given the submitter advance notice of this finding and an 
opportunity to rebut it, or (2) the public need to know so outweighs 
the interest of the submitter as to require its release. Where 
the Secretary releases information because of the public need to 
know, he shall notify the submitter setting forth the urgent 
health or environmental needs which serve as the basis for his 
action. 
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