2 . 
(emphasis added). Further, Section IV-B-3-a(3) would require 
ORDA to make interpretations of the guidelines. We recommend 
that the guidelines explicitly provide for ORDA to advise 
voluntary private sector participants on biosafety committee 
operations, as well as interpretations of the guidelines, which 
advice we understand is now routinely available from ORDA. 
Under Section IV-C-3 of the proposed guidelines, protection 
of confidential or proprietary information would be provided 
for. However, I am not certain that such information, whether 
in the hands of the Department of Health, Education and Welfare 
or of a local or institutional biosafety committee, can be 
satisfactorily safeguarded under existing statutes (e.g., 18 
U.S.C. 1905 or 5 U.S.C. 552(b)(4)). I recommend, therefore, 
that a mechanism for protection of proprietary or confidential 
information be set forth in Section IV-C-3 in order to provide 
the private sector participants under the voluntary registration 
and certification program with greater assurance that their 
interests will not be jeopardized by the required disclosure 
for registration and certification. Specifically, I recommend 
that Section IV-C-3-a be amended by adding at the end the 
following: 
Any institution voluntarily applying for registration 
and certification under Section IV-C-2 which has 
identified confidential or proprietary information 
submitted to NIH is entitled, pending release of 
such information under subsections IV-C-3-a- (1) 
through (4) : 
(a) to receive written notice from NIH of 
the proposed release; 
(b) to have the opportunity to request 
consultation with NIH regarding the 
appropriateness of the proposed 
release within 30 days of receipt of 
such notice; and 
(c) to withdraw its application within 30 
days following receipt of written 
notification of a decision by NIH 
to release confidential or proprietary 
information. In such case, NIH shall 
[A-277] 
