40 CFR 152.95 - Citation of all studies in the Agency's files pertinent to a specific data requirement.

§ 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 to 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;

(b) A certification that:

(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;

(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);

(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

(v) The applicant's name, address, and contact information, including a telephone number and email address.

(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.

[ 49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code
Public Laws

Title 40 published on 2015-08-22

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 152 after this date.

  • 2016-12-05; vol. 81 # 233 - Monday, December 5, 2016
    1. 81 FR 87509 - Notification of Submission to the Secretary of Agriculture; Pesticides; Removal of Obsolete Information
      GPO FDSys XML | Text
      ENVIRONMENTAL PROTECTION AGENCY
      Notification of submission to the Secretary of Agriculture.
      See Unit I. under SUPPLEMENTARY INFORMATION .
      40 CFR Parts 152, 153, 155, 156, 160, 165, 168, 170, and 172
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