definiens: means, with respect to particular [ * * * ] in which the [ * * * ] has [ * * * ] and is otherwise [ * * * ], a written package ( or electronic access to w ritten documentation ) that contains at least the fo llowing for such [ * * * ] and, to the extent available, for any [ * * * ] for such [ * * * ] : ( a ) all [ * * * ], including the [ * * * ] and [ * * * ], ( b ) all [ * * * ] and the, ( c ) the [ * * * ], ( d ) all reco rds of [ * * * ], ( e ) the [ * * * ], ( f ) the [ * * * ], ( g ) a [ * * * ] for a [ * * * ] such [ * * * ], ( h ) a [ * * * ] of the [ * * * ] and [ * * * ], ( i ) all [ * * * ], ( j ) list of [ * * * ] and [ * * * ] showing such [ * * * ], ( k ) an [ * * * ] of [ * * * ] ( [ * * * ], and [ * * * ] ) and [ * * * ], ( l ) [ * * * ] o n all [ * * * ], ( m ) [ * * * ] on of [ * * * ] and [ * * * ], ( n ) t he [ * * * ] for the [ * * * ], ( o ) all [ * * * ] regarding the [ * * * ], ( p ) the [ * * * ] and with [ * * * ], ( q ) [ * * * ] of the [ * * * ] and siz e of all [ * * * ] through [ * * * ], and ( r ) a [ * * * ] of the [ * * * ] and [ * * * ] for each of the [ * * * ]