§ 1114.17 - Resubmissions.

§ 1114.17 Resubmissions.

(a) General. An applicant may, as an alternative format of submitting an application that meets the content requirements of § 1114.7 or 1114.15 (if applicable), submit a resubmission to address deficiencies set forth in a marketing denial order. The resubmission must contain new information necessary to address application deficiencies and cross-reference applicable content from the PMTA that received the marketing denial order. An applicant may utilize the resubmission format for the same tobacco product for which FDA issued a marketing denial order or a new tobacco product that results from modifications to the product necessary to address the deficiencies described in a marketing denial order. An applicant may not submit a resubmission when:

(1) It incorporates new information or revisions to the PMTA for the original product to the extent that reviewing a resubmission for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review; or

(2) The marketing denial order states that the applicant may not submit a resubmission.

(b) Required format. The resubmission must comply with format requirements of § 1114.7(b), except that an applicant must include content in the resubmission by cross-referencing the PMTA, or, where applicable, supplemental PMTA, that received the marketing denial order. An applicant may also include content in a resubmission by cross-reference to a TPMF. FDA will not consider content included by cross-reference to other sources of information outside of the submission.

(c) Required content. The resubmission must provide sufficient information for FDA to determine whether any of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply to the application.

(1) The application must include the full text of the information described in the following paragraphs:

(i) General information that identifies the submission as a resubmission (as described in paragraph § 1114.7(c));

(ii) Response to deficiencies (as described in paragraph (d) of this section); and

(iii) Certification statement (as described in paragraph (e) of this section).

(2) The application must include the following sections from the PMTA that received a marketing denial order by cross-reference to the PMTA and contain all additional information, in full text or by reference to a tobacco product master file, that is necessary to supplement or update the cross-referenced information:

(i) Descriptive information (as described in § 1114.7(d));

(ii) Product samples (as described in § 1114.7(e));

(iii) Labeling (as described in § 1114.7(f));

(iv) Statement of compliance with 21 CFR part 25 (as described in § 1114.7(g));

(v) Summary of all research findings (as described in § 1114.7(h));

(vi) Product formulation (as described in § 1114.7(i));

(vii) Manufacturing (as described in § 1114.7(j)); and

(viii) Health risk investigations (as described in § 1114.7(k)).

(d) Response to deficiencies.

(1) The application must include a section that lists and provides a separate response to each deficiency described by FDA in the original marketing denial order, including all data and information necessary to complete each response, and that also addresses any applicant-identified deficiencies.

(2) Where an applicant modifies the product in a way that would result in a new tobacco product under section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act in order to address the deficiencies, the application must also include:

(i) A full description of each modification to the product and comparisons of that change to the original version of the product described in the previously submitted PMTA; and

(ii) All data and information relating to each modification to the product that would be required in an application under § 1114.7.

(e) Certification statement. The application must contain one of the two following certifications that corresponds to the application, with the appropriate information inserted as indicated by parenthetical italicized text, signed by an authorized representative of the applicant.

(1) Same tobacco product certification. An application for the same tobacco product must contain the following certification:

“I, (name of responsible official), on behalf of (name of applicant), certify that this submission for (new tobacco product name(s)) responds to all deficiencies outlined in the marketing denial order issued in response to (STN of the previously submitted PMTA) and the new tobacco product described herein is identical to the product described in the previously submitted PMTA. I certify that (name of applicant) understands this means there is no modification to the materials, ingredients, design, composition, heating source, or any other feature. I also certify that (name of applicant) will maintain all records that substantiate the accuracy of this statement, and ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR 1114.45. I certify that this information and the accompanying submission are true and correct, and that I am authorized to submit this on the company's behalf. I understand that under section 1001 of title 18 of the United States Code, anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal penalties.”

(2) Different tobacco product certification. An application for a different tobacco product than the original tobacco product that results from changes necessary to address the deficiencies must contain the following certification:

“I, (name of responsible official), on behalf of (name of applicant), certify that this submission for (new tobacco product name(s)) responds to all deficiencies outlined in the marketing denial order issued in response to (STN of the previously submitted PMTA) and the new tobacco product described herein has a different (describe each modification to the product) than (name(s) of original tobacco product) described in (STN of the previously submitted PMTA) but is otherwise identical to (name(s) of original tobacco product) described in (STN of the previously submitted PMTA). I certify that (name of applicant) understands this means there is no modification to the materials, ingredients, design features, heating source, or any other feature of the original tobacco product, except for the (describe each modification to the tobacco product). I also certify that (name of applicant) will maintain all records that substantiate the accuracy of this statement, and ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR 1114.45. I certify that this information and the accompanying submission are true and correct, and that I am authorized to submit this on the company's behalf. I understand that under section 1001 of title 18 of the United States Code, anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal penalties.”