§ 152.99 Petitions to cancel registration.

An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy.

(a) Grounds for petition. (1) If an applicant has offered to pay compensation to an original data submitter of a study (either specifically or by filing a general offer to pay statement), the original data submitter may petition the Agency to deny or cancel the registration to which the offer related on any of the following grounds:

(i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure and describe the applicant's failure to participate in the procedure.

(ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the agreement.