Common use of Review and Modification Clause in Contracts

Review and Modification. (1) Upo n r eceip t of a s t u d y pl a n , E P A will r e- view i t t o de t e r m i n e w h e t h e r i t co m - plies wi t h p a r a g r a p h ( b) of t h i s sec t io n . If E P A de t e r m i n es t h a t t h e s t u d y pl a n does n o t co m pl y wi t h p a r a g r a p h ( b) of t h i s sec t io n , E P A will n o t ify t h e s u b- m i tt e r t h a t t h e pl a n i s i n co m ple t e a n d will ide n t ify t h e deficie n cies a n d t h e s t eps n ecess a ry t o co m ple t e t h e pl a n . I t i s t h e r espo n s ibili t y of t h e t es t spo n- so r t o r eview t h e s t u d y p r o t ocols t o ▇▇- ▇ ▇ ▇ ▇ ▇ ▇ ▇ if t h e y co m pl y wi t h a ll t h e m a n d a t o ry t es t i n g co n di t io n s a n d r e- q u i r e m e n t s i n t h e t es t s t a n d a r ds ( i . e., ‘‘s h a ll s t a t e m e n t s’’). (2) T h e s u b m i tt e r will h a ve 15 d a y s af t e r t h e d a y i t r eceives a n o t ice un de r p a r a g r a p h ( c)(1) of t h i s sec t io n t o s u b- m i t a pp r op r i a t e i nfo r m a t io n t o m a k e t h e s t u d y pl a n co m ple t e. (3) If t h e s u b m i tt e r fa il s t o p r ovide a pp r op r i a t e i nfo r m a t io n t o co m ple t e a s t u d y pl a n wi t h i n 15 d a y s af t e r h a vi n g r eceived a n o t ice un de r p a r a g r a p h ( c)(1) of t h i s sec t io n , t h e s u b m i tt e r will be co n s ide r ed t o be i n viol a t io n of t h e co n se n t a g r ee m e n t a n d s u bjec t t o e n- fo r ce m e n t p r oceedi n gs p ur s u a n t t o § 790.65 ( c) a n d ( d). (4) T h e t es t spo n so r s h a ll s u b m i t a ny a m e n d m e n t s t o s t u d y pl a n s t o E P A a t t h e a dd r ess specified i n § 790.5( b).