§ 1114.15 - Supplemental applications.

§ 1114.15 Supplemental applications.

(a) Supplemental PMTA submission. Applicants that have received a marketing granted order for a tobacco product may, as an alternative format of submitting an application that meets the content requirements of § 1114.7, submit a supplemental PMTA to seek marketing authorization for modifications to such product, which result in a new tobacco product under section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act. Supplemental PMTAs must include new information concerning modifications that create the new tobacco product but allow the applicant to satisfy the remaining application requirements by cross-referencing applicable content from the previously submitted PMTA for the original tobacco product. Applicants may submit supplemental PMTAs only for modifications that require the submission of limited new information or where specified in a rule under section 907 of the FD&C Act. Except as permitted in a rule under section 907 of the Federal Food, Drug, and Cosmetic Act, an applicant may not submit a supplemental PMTA where:

(1) Modifications to the product that result in the new tobacco product require the submission of new information or revisions to the PMTA for the original product to the extent that reviewing a supplemental application for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review.

(2) The marketing granted order for the original tobacco product has been withdrawn; or

(3) The marketing granted order for the original tobacco product has been temporarily suspended or is subject to temporary suspension or withdrawal proceedings by FDA, except where authorized in writing by FDA.

(b) Required format. The supplemental PMTA must comply with format requirements of § 1114.7(b), except that an applicant must include certain content in a supplemental PMTA by cross-referencing a PMTA, or, where applicable, a supplemental PMTA, for an original tobacco product that is owned by that applicant, and may include other content by cross-referencing a tobacco product master file and postmarket reports for the original tobacco product. FDA will not consider content included by cross-reference to other sources of information outside of the submission.

(c) Required content. The supplemental PMTA 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 contain the full text of all the information described in the following sections:

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

(ii) New product information (as described in paragraph (d) of this section);

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

(iv) Labeling (as described in § 1114.7(f)) if the labeling is not identical to the labeling submitted in the PMTA or postmarket reports for the original product;

(v) Postmarket information (as described in paragraph (e) of this section); and

(vi) Certification statement (as described in paragraph (f) of this section);

(2) The application must include the following sections by cross-reference to the PMTA for the original tobacco product and contain any additional information 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)) if the labeling is identical to the labeling that was submitted in the PMTA or postmarket reports for the original tobacco product;

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

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

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

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

(d) New product information. The application must contain a section that includes:

(1) Full descriptions of each modification to the product and comparisons to the original product version described in the previously authorized PMTA;

(2) A statement as to whether the new tobacco product, if it receives a marketing granted order, will replace the original tobacco product, will be a line extension of the original tobacco product, or will be introduced as an additional product by the same manufacturer;

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

(4) A concluding summary of how the new tobacco product meets the requirements to receive a marketing granted order, including how the data and information contained in both the supplemental PMTA and cross-referenced from the previously authorized PMTA constitute valid scientific evidence and establishes that the PMTA meets the requirements of section 910(c) of the Federal Food, Drug, and Cosmetic Act to receive a marketing granted order, including that permitting the new tobacco product to be marketed would be appropriate for the protection of the public health determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.

(e) Postmarket reports.

(1) If an applicant has submitted postmarket reports for the original tobacco product, the applicant must include all such reports in the application by cross-reference.

(2) If an applicant is required to, but has not yet submitted a postmarket report, the applicant must submit a report as part of its application that contains all of the information for the original tobacco product that would otherwise be required in a report under § 1114.41 covering the period of time from when it received a marketing granted order for the original tobacco product to when it submits the supplemental PMTA.

(f) Certification statement. The application must contain the following certification, with the appropriate information inserted as indicated by parenthetical italicized text, signed by an authorized representative of the applicant:

“I, (name of responsible official), on behalf of (name of applicant), certify that (new tobacco product name) has a different (describe each modification to the product) than (name of original tobacco product) described in (STN of the PMTA for the original product) but is otherwise identical to (name(s) of original tobacco product). I certify that (name of applicant) understands this means there is no other modification to the materials, ingredients, design, composition, heating source, or any other feature of the original tobacco product. I also certify that (name of applicant) will maintain all records that substantiate the accuracy of this application 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 applicant'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.”