conducted and supported by the NIH, and other 
policy issues of concern to the Director, Will." 
41 Fed. Reg. 2105, January 14, 1976. 
67. The notices of the meetings of the Recombinant DUA 
Molecule Program Advisory Committee and the Advisory Committee 
to the Director of the NIH, as set forth in the preceding 
Paragraphs 61 through 66, do not constitute the "general 
notice of proposed rule making" as required by subsection (b) 
of section 4 of the APA, 5 U.S.C. §553(b). The aforesaid 
notices fail to indicate that a rulemaking proceeding is to 
take place. They fail to make reference to the legal 
authority under which the rule is proposed. And they fail to 
set forth either the substance or terms of the proposed rules 
or a description of the subjects and issues involved. 
68. The aforesaid notices are not calculated to elicit 
comment for a rulemaking proceeding and are inadequate. 
69. The proposed guidelines were not published in the 
Federal Register in order to make then available for public 
scrutiny and give the public adequate opportunity for partici- 
pation. 
70. Public hearings were held neither on the proposed 
guidelines as a whole, nor on the many controversial factual 
issues concerning the guidelines, matters of great public 
concern and controversy and having an enormous impact on the 
human environment and the entire ecosphere. 
71. On June 23, 1976, Donald S. Fredrickson, Director of 
NIH, with the concurrence of the Secretary of DHEU, and the 
Assistant Secretary for Health of DHEW, who are the defendants 
herein, promulgated the Recombinant DMA Research Guidelines 
which govern the conduct of NIH supported research using 
recombinant DMA techniques. 
72. The said Guidelines, a3 promulgated, were effective 
immediately upon release, on June 23, 1976. 
27 
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