Common use of Functions of t he principal test spon- sor Clause in Contracts

Functions of t he principal test spon- sor. Wh e n t es t i n g i s bei n g co n d u c t ed p ur s u a n t t o a co n se n t a g r ee m e n t , t h e p r i n cip a l t es t spo n so r will be r espo n- s ible fo r s u b m i tt i n g i n t e r i m p r og r ess a n d fi n a l r epo r t s t o E P A, i nfo r m i n g t h e Age n c y of a ny p r oposed c h a n ges i n s t a n d a r ds fo r t h e develop m e n t of d a t a , s t u d y pl a n s o r t es t i n g sc h ed u les, a n d co mm un ic a t i n g wi t h t h e Age n c y a bo u t l a bo r a t o ry i n spec t io n s a n d o t h e r m a t - t e r s affec t i n g t h e p r og r ess of t es t i n g. [51 F R 23715, J un e 30, 1986, a s a m e n ded a t 54 F R 36314, S ep t . 1, 1989; 60 F R 34466, J u l y 3, 1995] ( a) M a nufa c t ur e r s a n d/o r p r ocesso r s w h o h a ve s ig n ed a co n se n t a g r ee m e n t a n d w h o fa il t o co m pl y wi t h t h e t es t r eq u i r e m e n t s, t es t s t a n d a r ds, G L P r eg- u l a t io n s, sc h ed u les, o r o t h e r p r ovisio n s co n t a i n ed i n t h e co n se n t a g r ee m e n t , o r i n m odific a t io n s t o t h e a g r ▇▇ ▇ ▇ ▇ ▇ ▇ dop t ed p ur s u a n t t o § 790.68, will 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 . ( b) T h e Age n c y co n s ide r s fa il ur e t o co m pl y wi t h a ny a spec t of a co n se n t a g r ee m e n t t o be a ‘‘p r o h ibi t ed a c t ’’ un de r sec t io n 15 of T SCA, s u bjec t t o a ll of t h e p r ovisio n s of t h e Ac t a pplic a ble t o viol a t io n s of sec t io n 15. S ec t io n 15(1) of T SCA m a k es i t un l a wfu l fo r a ny pe r - so n t o fa il ▇ ▇ ▇ efu se t o co m pl y wi t h a ny ru le o r o r de r iss u ed un de r sec t io n 4. Co n se n t a g r ee m e n t s a dop t ed p ur s u a n t t o t h i s p a r t a r e ‘‘o r de r s iss u ed un de r sec t io n 4’’ fo r p ur poses of sec t io n 15(1) of T SCA. ( c) M a nufa c t ur e r s a n d/o r p r ocesso r s w h o viol a t e co n se n t a g r ee m e n t s a r e s u bjec t t o c r i m i n a l a n d/o r civil li a bil- i t y . U n de r t h e pe n a l t y p r ovisio n s of sec t io n 16 of T SCA, s u c h fi r m s co u ld be s u bjec t t o a civil ▇▇ ▇ ▇ ▇ ▇ ▇ of u p t o $25,000 pe r viol a t io n wi t h e a c h d a y i n viol a t io n co n s t i t u t i n g a sep a r a t e viol a- t io n of sec t io n 15. I n t e n t io n a l viol a- t io n s co u ld le a d t o t h e i m posi t io n of c r i m i n a l pe n a l t ies of u p t o $25,000 fo r e a c h d a y of viol a t io n a n d i m p r i so n- m e n t fo r u p t o o n e y e a r . I n a ddi t io n , E P A co u ld i n vo k e t h e r e m edies a v a il- a ble un de r sec t io n 17 of T SCA, i n cl u d- i n g see k i n g a n i n j un c t io n t o co m pel a d h e r e n ce t o t h e r eq u i r e m e n t s of t h e co n se n t a g r ee m e n t .

Functions of t he principal test spon- sor. Wh e n t es t i n g i s bei n g co n d u c t ed p ur s u a n t t o a co n se n t a g r ee m e n t , t h e p r i n cip a l t es t spo n so r will be r espo n- s ible fo r s u b m i tt i n g i n t e r i m p r og r ess a n d fi n a l r epo r t s t o E P A, i nfo r m i n g t h e Age n c y of a ny p r oposed c h a n ges i n s t a n d a r ds fo r t h e develop m e n t of d a t a , s t u d y pl a n s o r t es t i n g sc h ed u les, a n d co mm un ic a t i n g wi t h t h e Age n c y a bo u t l a bo r a t o ry i n spec t io n s a n d o t h e r m a t - t e r s affec t i n g t h e p r og r ess of t es t i n g. [51 F R 23715, J un e 30, 1986, a s a m e n ded a t 54 F R 36314, S ep t . 1, 1989; 60 F R 34466, J u l y 3, 1995] ( a) M a nufa c t ur e r s a n d/o r p r ocesso r s w h o h a ve s ig n ed a co n se n t a g r ee m e n t a n d w h o fa il t o co m pl y wi t h t h e t es t r eq u i r e m e n t s, t es t s t a n d a r ds, G L P r eg- u l a t io n s, sc h ed u les, o r o t h e r p r ovisio n s co n t a i n ed i n t h e co n se n t a g r ee m e n t , o r i n m odific a t io n s t o t h e a g r ▇▇ ▇ ▇ ▇ ▇ ▇ ee m e n t a dop t ed p ur s u a n t t o § 790.68, will 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 . ( b) T h e Age n c y co n s ide r s fa il ur e t o co m pl y wi t h a ny a spec t of a co n se n t a g r ee m e n t t o be a ‘‘p r o h ibi t ed a c t ’’ un de r sec t io n 15 of T SCA, s u bjec t t o a ll of t h e p r ovisio n s of t h e Ac t a pplic a ble t o viol a t io n s of sec t io n 15. S ec t io n 15(1) of T SCA m a k es i t un l a wfu l fo r a ny pe r - so n t o fa il ▇ ▇ ▇ efu se t o co m pl y wi t h a ny ru le o r o r de r iss u ed un de r sec t io n 4. Co n se n t a g r ee m e n t s a dop t ed p ur s u a n t t o t h i s p a r t a r e ‘‘o r de r s iss u ed un de r sec t io n 4’’ fo r p ur poses of sec t io n 15(1) of T SCA. ( c) M a nufa c t ur e r s a n d/o r p r ocesso r s w h o viol a t e co n se n t a g r ee m e n t s a r e s u bjec t t o c r i m i n a l a n d/o r civil li a bil- i t y . U n de r t h e pe n a l t y p r ovisio n s of sec t io n 16 of T SCA, s u c h fi r m s co u ld be s u bjec t t o a civil ▇▇ ▇ ▇ ▇ ▇ ▇ of u p t o $25,000 pe r viol a t io n wi t h e a c h d a y i n viol a t io n co n s t i t u t i n g a sep a r a t e viol a- t io n of sec t io n 15. I n t e n t io n a l viol a- t io n s co u ld le a d t o t h e i m posi t io n of c r i m i n a l pe n a l t ies of u p t o $25,000 fo r e a c h d a y of viol a t io n a n d i m p r i so n- m e n t fo r u p t o o n e y e a r . I n a ddi t io n , E P A co u ld i n vo k e t h e r e m edies a v a il- a ble un de r sec t io n 17 of T SCA, i n cl u d- i n g see k i n g a n i n j un c t io n t o co m pel a d h e r e n ce t o t h e r eq u i r e m e n t s of t h e co n se n t a g r ee m e n t .