40 CFR 152.96 - Documentation of a data gap.

§ 152.96 Documentation of a data gap.
Except as provided in paragraph (a) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requests the data if he can demonstrate, by the procedure in this section, that no other person has previously submitted to the Agency a study that would satisfy the data requirement in question.
(a) When data gap procedures may not be used.
(1) An applicant for registration of a product containing a new chemical may not defer his obligation by the procedure in this section, unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to FIFRA section 3(c)(7)(C).
(2) An applicant for registration of a product under FIFRA section 3(c)(7) (A) or (B) may not defer his obligation by the procedure in this section if the Agency requires the data to determine:
(i) Whether the product is identical or substantially similar to another currently registered product or differs only in ways that would not substantially increase the risk of unreasonable adverse effects on the environment;
(ii) If efficacy data are required, whether the product is efficacious; or
(iii) Whether the new use would substantially increase the risk of unreasonable adverse effects on the environment, usually required when the application involves a new use of a product which is identical or substantially similar to a currently registered product.
(b) Data gap listed in a Registration Standard. The applicant may rely on a data gap that is documented by a Registration Standard without submitting the certification required by paragraph (c) of this section. If the data gap listed in the Registration Standard has been filled since the issuance of the Standard, the Agency will notify the applicant and require him to choose another method of demonstrating compliance.
(c) Certification of a data gap. Except as provided by paragraph (b) of this section, an applicant who wishes to claim that a data gap exists must certify to the Agency that:
(1) The applicant has furnished, by certified mail, to each original data submitter on the current Data Submitters List for the active ingredient in question, a notice containing the following information:
(i) The name and address of the applicant;
(ii) The name of the product, and a statement that the applicant intends to apply for registration of that product;
(iii) The name(s) of the active ingredient(s) in the procuct;
(iv) A list of the data requirements for which the applicant intends to claim under this section that a data gap exists; and
(v) A request that the data submitter identify, within 60 days of receipt of the notice, any valid study which he has submitted to the Agency that would fulfill any of the data requirement(s) listed.
(2) The applicant has, within that 60-day period, received no response, or has received a negative response, from each person notified; and
(3) The applicant has no basis to believe that any data have been submitted to the Agency that would fulfill the data requirement, and is entitled to claim that a data gap exists.
(d) Requirement to obtain permission or make offer to pay. In responding to a data gap letter, the original data submitter is not deemed to have given his authorization for the applicant to cite any study which the data submitter identifies in his response. The applicant must seek and obtain specific written authorization from, or make an offer to pay to, the original data submitter to cite the identified study in order to demonstrate compliance for the data requirement. Nothing, however, precludes the applicant from requesting written authorization or making an offer to pay at the same time that he requests confirmation of a data gap.
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§ 152.96 Claim of data gap.

(a) When a data gap may be claimed. Except as provided in paragraph (b) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requires the data if no other person has previously submitted to the Agency a valid study that would satisfy the data requirement in question.

(b) When a data gap may not be claimed -

(1) Product containing a new active ingredient. An applicant for registration of a product containing a new active ingredient may not defer his obligation by claiming a data gap unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).

(2) Product not containing a new active ingredient. An applicant for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a product not containing a new active ingredient) may not defer his obligation by claiming a data gap if the data are:

(i) Data needed to determine whether the product is identical or substantially similar to another currently registered product or differs only in ways that would substantially increase the risk of unreasonable adverse effects on the environment.

(ii) Efficacy data specific to the product, if required to be submitted to the Agency.

(iii) If a new use is proposed for a product that is identical or substantially similar to an existing product, data to demonstrate whether the new use would substantially increase the risk of unreasonable adverse effects on the environment.

(c) Approval of application with a data gap claim - (1) In accordance with § 152.115(a), any registration that is approved based upon a data gap claim shall be conditioned on the submission of the data no later than the time that the data are required to be submitted for similar products already registered.

(2) Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7).

[79 FR 6826, Feb. 5, 2014]

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