73. On July 7, 1976, the said Guidelines, and the decision 
of the Director of the MU concerning the promulgation of the 
Guidelines, were published in the federal Register, 14 days 
after they had become effective. Neither the final version of 
the Guidelines or any earlier version had been previously 
published in the Federal Register. 
74. The said Guidelines, as promulgated, set forth 
detailed rules categorizing experiments, determining whi ch 
types of experiments are prohibited, and for those permitted, 
the conditions under which they may be performed. See, 41 Fed. 
Reg. 27914-20, July 7, 1976. 
75* The said Guidelines, as promulgated, create an 
administrative framework, assigning roles and responsibilities 
for the governing of recombinant DNA research to (l) the 
principal investigator, (2) institutional biohazards committees 
in institutions where the research is to be conducted, (3) 
NIH Initial Review Groups (Study Sections), (4) the NIH 
Recombinant DNA Molecule Program Advisory Committee, and (5) 
the NIH staff. See, 41 Fed. Reg. 27920-21, July 7, 1976. 
76. The said Guidelines, as promulgated, set forth the 
following responsibilities of the MH staff: 
11 (i) Assuring that no NIH grants or contracts are 
awarded for DNA recombinant research unless they 
(a) conform to these guidelines, (b) have been 
properly reviewed and recommended for approval, 
and (c) include a properly executed Memorandum 
of Understanding and Agreement 
(iii) receiving and reviewing applications for 
approval to lower containment levels when a cloned 
DNA recombinant derived from a shotgun experiment 
has been rigorously characterized and there is 
sufficient evidence that it is free of harmful 
genes, 
and (v) performing site inspections of all P4 
physical containment facilities, engaged in DNA 
recombinant research, and of other facilities as 
deemed necessary." 
41 Fed. Reg. 27921, July 7, 1976. 
2(5 
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