152.95—Citation of all studies in the Agency's files pertinent to a specific data requirement.
An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent of that data requirement. The applicant who selects this cite-all option must submit to the Agency:
(a)
A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;
(1)
For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and
(2)
For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:
(i)
A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
(ii)
Identification of the specific data requirement(s) for which the offer to pay for data is being made;
(iv)
An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and
(c)
An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected.