Title 21

SECTION 1105.10

1105.10 Refusal to accept a premarket submission.

§ 1105.10 Refusal to accept a premarket submission.

(a) FDA will refuse to accept for review, as soon as practicable, a premarket tobacco product application, modified risk tobacco product application, substantial equivalence application, or exemption request or subsequent abbreviated report for the following reasons, if applicable:

(1) The submission does not pertain to a tobacco product as defined in 21 U.S.C. 321(rr).

(2) The submission is not in English or does not contain complete English translations of any information submitted within.

(3) If submitted in an electronic format, the submission is in a format that FDA cannot process, read, review, and archive.

(4) The submission does not contain contact information, including the applicant's name and address.

(5) The submission is from a foreign applicant and does not identify an authorized U.S. agent, including the agent's name and address, for the submission.

(6) The submission does not contain a required FDA form(s).

(7) The submission does not contain the following product-identifying information: The manufacturer of the tobacco product; the product name, including the brand and subbrand; the product category and subcategory; package type and package quantity; and characterizing flavor.

(8) The type of submission is not specified.

(9) The submission does not contain a signature of a responsible official, authorized to represent the applicant, who either resides in or has a place of business in the United States.

(10) For premarket tobacco applications, modified risk tobacco product applications, substantial equivalence applications, and exemption requests only: The submission does not include a valid claim of categorical exclusion in accordance with part 25 of this chapter, or an environmental assessment.

(b) If FDA finds that none of the reasons in paragraph (a) of this section exists for refusing to accept a premarket submission, FDA may accept the submission for processing and further review. FDA will send to the submitter an acknowledgement letter stating the submission has been accepted for processing and further review and will provide the premarket submission tracking number.

(c) If FDA finds that any of the reasons in paragraph (a) of this section exist for refusing to accept the submission, FDA will notify the submitter in writing of the reason(s) and that the submission has not been accepted, unless insufficient contact information was provided.

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