77. If a grantee fails to abide by said Guidelines, 
as promulgated, he/shc is subject to various sanctions. 
G52.26 of the Public Health Service Regulations, 42 CFR §52.26, 
provides that 
"The Secretary may with respect to any grant 
award or class of av/ards impose additional 
conditions prior to or at the time of any award 
v/hen in his judgment such conditions are 
necessary to assure or protect advancement of 
the approved project, the interests of the 
public health, or the conservation of grant 
funds." 28 Fed Reg. 10420, Sept. 26, 1963* 
§52. 11(a) of the Public Health Service Regulations, 42 CFR 
052.11(a), provides for an exception to the general eligibility 
of persons for grants when 
"(3) Any individual, corporation, institution, 
agency or other such person who, having prev- 
iously received a grant av;ard has failed vri.ll- 
fully and materially in the judgment of the 
Secretary to comply with accounting or other 
requirements applicable to such prior award, 
such disqualification to continue until termin- 
ated in the public interest by the Secretary." 
2 8 Fed. Reg. 10420, Sent. 26, 1963, as amended at 
33 Fed. Reg. 9821, July 9, 1968. 
§74.112 of the regulations of the DHEW, 45 CFR §74.112, provides 
for termination of a grant when there is a violation of its 
terms and conditions: 
"Y/hen a grantee has materially failed to comply 
vrith the terms and conditions of a grant, the 
granting agency may suspend the grant, in accord- 
ance vrith §74.113, terminate the grant for cause, 
as provided in §74.114, or take such other 
remedies os may be legally available and appro- 
priate in the circumstances." 
78. The said Guidelines have the force of lav/, are 
"rules" within the meaning of the term as defined in the APA, 
and are subject to the rulemaking requirements of section 4 of 
the APA, 5 U.S.C. §553. 
79. In the conception, development, and promulgation of 
the Recombinant DHA Research Guidelines, the defendants have 
/iolated a..d c*..*»rcgardcd the dccasaonmakmg processes required 
by section 4 of the APA, in that defendants have, among other 
29 
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