§1114.7. Required content and format. — Inbound Citations

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(2) The marketing granted order for the original tobacco product has been withdrawn; or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

(a) 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.

(ii) Is not administratively complete because it does not appear to contain the information required by § 1114.7 (excluding product samples), § 1114.15 or § 1114.17, as applicable;

A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway.

(2) FDA may notify an applicant that FDA has determined that a change described in a periodic report made under this section results in a new tobacco product outside the scope of the marketing granted order, requiring the submission of a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and issuance of a marketing granted order if the applicant seeks to market the new tobacco product, unless the new tobacco product can be legally marketed through a different premarket pathway.

(b) 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.

(b) 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.

(i) Does not comply with the applicable format requirements in § 1114.7(b), § 1114.15, or § 1114.17 (as applicable);

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

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

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

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

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

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

(2) If FDA accepts an application for further review, FDA will issue an acknowledgement letter to the applicant that specifies the PMTA STN. If FDA determines that it will require product samples as part of the PMTA, it will send instructions on how and where to submit product samples, as described in § 1114.7(e) of this chapter.

(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;

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

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

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

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

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

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

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

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

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

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

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

(iii) An inventory of ongoing and completed studies about the tobacco product conducted by, or on behalf of, the applicant that are within the scope of § 1114.7(k) and that have not been previously reported;

(A) The health risks of the new tobacco product as described in either § 1114.7(k)(1)(i)(A), (B), or (C));

(A) The health risks of the new tobacco product as described in either § 1114.7(k)(1)(i)(A), (B), or (C));

(A) The health risks of the new tobacco product as described in either § 1114.7(k)(1)(i)(A), (B), or (C));

(B) The health risks of the new tobacco product compared to the health risks generally presented by products in the same product category as well as products in at least one different category that are used by the consumers an applicant expects will use its new tobacco product (as described in a portion of § 1114.7(k)(1)(i)(D)).

(C) The abuse liability of the new tobacco product (as set forth in § 1114.7(k)(1)(ii)(A));

(D) How consumers would be expected to actually use the product, such as use frequency, use trends over time, and how such use affects the health risks of the product to individual users (as described in § 1114.7(k)(1)(ii)(B));

(E) The potential impact that the marketing of the new tobacco product would have on the likelihood that current tobacco product users would change their tobacco product use behavior, such as starting to using the new tobacco product, using the product in conjunction with other tobacco products, or, after using the product, switching to or switch back to other tobacco products that may present increased risks to individual health (i.e., any of the information set forth in either § 1114.7(k)(1)(ii)(C), (D), (E), or (F));

(E) The potential impact that the marketing of the new tobacco product would have on the likelihood that current tobacco product users would change their tobacco product use behavior, such as starting to using the new tobacco product, using the product in conjunction with other tobacco products, or, after using the product, switching to or switch back to other tobacco products that may present increased risks to individual health (i.e., any of the information set forth in either § 1114.7(k)(1)(ii)(C), (D), (E), or (F));

(E) The potential impact that the marketing of the new tobacco product would have on the likelihood that current tobacco product users would change their tobacco product use behavior, such as starting to using the new tobacco product, using the product in conjunction with other tobacco products, or, after using the product, switching to or switch back to other tobacco products that may present increased risks to individual health (i.e., any of the information set forth in either § 1114.7(k)(1)(ii)(C), (D), (E), or (F));

(E) The potential impact that the marketing of the new tobacco product would have on the likelihood that current tobacco product users would change their tobacco product use behavior, such as starting to using the new tobacco product, using the product in conjunction with other tobacco products, or, after using the product, switching to or switch back to other tobacco products that may present increased risks to individual health (i.e., any of the information set forth in either § 1114.7(k)(1)(ii)(C), (D), (E), or (F));

(F) The impact of the tobacco product and its label, labeling, or advertising, to the extent that advertising has been studied, on tobacco product use behavior of current nonusers of tobacco products (i.e., any of the information described in § 1114.7(k)(1)(iii));

(G) The impact of the product and its label, labeling, or advertising, to the extent that advertising has been studied, on individuals' perception of the product and their use intentions (i.e., any of the information described in § 1114.7(k)(1)(iv)); and

(H) The ways in which human factors can affect the health risks of the new tobacco product (i.e., any of the information described in § 1114.7(k)(1)(v));

(2) A PMTA must contain a description of the applicant's plans to market the new tobacco product, for at least the first year the product would be marketed after receiving a marketing granted order, in way that is both consistent with the applicant's discussion of the increased or decreased likelihood of changes in tobacco product use behavior, including switching, initiation, cessation, and polyuse, under § 1114.7(l), and permits FDA to determine permitting the new tobacco product to be marketed would be appropriate for the protection of public health. The description must include actions to market the product that would be taken by the applicant, on behalf of the applicant, or at the applicant's direction, and also discuss any restrictions on the sales and distribution the applicant proposes to be included in a marketing order under section 910(c)(1)(B) of the Federal Food Drug and Cosmetic Act. The description of marketing plans must contain, at minimum:

(i) A description of the specific group(s) to which the labeling, advertising, marketing, promotion, and other consumer-directed activities for the new tobacco product would be targeted (i.e., the intended audience(s));

(ii) A discussion of how the labeling, advertising, marketing, promotion, and other consumer-directed activities for the new tobacco product would be targeted to reach the intended audience(s) identified in paragraph (i) and what other group(s) would foreseeably be exposed to those materials and activities as a result;

(iii) A discussion of, for individuals below the minimum age of sale, how access to the new tobacco product would be restricted and exposure to the labeling, advertising, marketing, promotion, and other consumer-directed activities would be limited; and

(iv) A concluding summary describing how the applicant's plans for marketing the new tobacco product are consistent with the applicant's discussion of the increased or decreased likelihood of changes in tobacco product use behavior, including switching, initiation, cessation, and polyuse, under § 1114.7(l) and permits FDA to determine permitting the new tobacco product to be marketed would be appropriate for the protection of public health.

(a) FDA may request, or an applicant may submit on its own initiative, an amendment to a PMTA containing information that is necessary for FDA complete the review of a pending PMTA. An amendment must include the appropriate form and specify the STN assigned to the original submission and, if submitted other than at FDA's request, the reason for submitting the amendment. An amendment must also include the certification statement set forth in § 1114.7(m), with the appropriate information inserted, and signed by an authorized representative of the applicant.