(a) Required reports. Each applicant that receives a marketing granted order must submit to FDA all information required by the terms of the marketing granted order and by this section as described below. Each postmarket report must be well-organized, legible, and written in English. Documents that have been translated from another language into English (e.g., original study documents written in a language other than English) must be accompanied by the original language version of the document, a signed statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation.
(1) Periodic reports. Each applicant must submit a periodic report to the Center for Tobacco Products (CTP) within 60 calendar days of the reporting dates specified in the applicant's marketing granted order for the life of the order and as may be required for the submission of a supplemental PMTA under § 1114.15. The report must include the following:
(i) A cover letter that contains the PMTA STN, tobacco product name(s) (including the original name described in the PMTA if different), company name, date of report, and reporting period;
(ii) A description of all changes made to the manufacturing, facilities, or controls during the reporting period, including:
(A) A comparison of each change to what was described in the PMTA;
(B) The rationale for making each change and, if any, a listing of any associated changes; and
(C) The basis for concluding that each change does not result in a new tobacco product that is outside the scope of the marketing granted order and will not result in a finding that the marketing granted order must be withdrawn or temporarily suspended under section 910(d) of the Federal Food, Drug, and Cosmetic Act;
(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;
(iv) Full reports of information published or known to, or which should be reasonably known to, the applicant concerning scientific investigations and literature about the tobacco product that have not been previously reported, including significant findings from publications not previously reported;
(v) A summary and analysis of all serious and unexpected adverse experiences associated with the tobacco product that have been reported to the applicant or that the applicant is aware of, accompanied by a statement of any changes to the overall risk associated with the tobacco product, and a summary of any changes in the health risks, including the nature and frequency of the adverse experience, and potential risk factors;
(vi) A summary of sales and distribution of the tobacco product for the reporting period, to the extent that the applicant collects or receives such data, including:
(A) Total U.S. sales reported in dollars, units, and volume with breakdowns by U.S. census region, major retail markets, and channels in which the product is sold;
(B) The Universal Product Code that corresponds to the product(s) identified in the PMTA; and
(C) Demographic characteristics of product(s) purchasers, such as age, gender, race or ethnicity, geographic region, and tobacco use status;
(vii) A summary of the implementation and effectiveness of policies and procedures regarding verification of the age and identity of purchasers of the product; and
(viii) A summary of all formative consumer research studies conducted (if any), among any audiences, in the formation of new labeling, advertising, marketing, or promotional materials, not previously submitted, including qualitative and quantitative research studies used to determine message effectiveness, consumer knowledge, attitudes, beliefs, intentions and behaviors toward using the products, and including the findings or these studies and copies of the stimuli used in testing;
(xi) A summary of all consumer evaluation research studies conducted (if any), among any audiences, not previously submitted, to determine the effectiveness of labeling, advertising, marketing, or promotional materials and shifts in consumer knowledge, attitudes, beliefs, intentions, and behaviors toward using the products, and including the findings of these studies and copies of the stimuli used in testing;
(xii) A summary of the creation and dissemination of the products' labeling, advertising, marketing, and promotional materials (if any), including a list of all entities involved and a description of their involvement, including a description of contractual agreements with such entities;
(xiii) Specimens of all labeling and descriptions of all labeling changes that have not been previously submitted under section 905(i) of the Federal Food, Drug, and Cosmetic Act, including the date the labeling was first disseminated and the date when dissemination was completely terminated;
(xiv) Full color copies of all advertising for the tobacco product that has not been previously submitted, and the original date the materials were first disseminated and the date when their dissemination was completely terminated;
(xv) A description of the implementation of all advertising and marketing plans, not previously submitted to FDA, by channel and by product, including strategic creative briefs and paid media plans, and the dollar amount(s) and flighting of such plans, by channel and by product, including a description of any of the following activities that an applicant may have engaged in:
(A) Use of competent and reliable data sources, methodologies, and technologies to establish, maintain, and monitor highly targeted advertising and marketing plans and media buys, including a list of all data sources used to target advertising and marketing plans and media buys;
(B) Targeting of specific group(s) by age-range(s), including young adults, ages 21 to 24, and other demographic or psychographic characteristics that reflect the intended target audience, including the source of such data;
(C) With respect to individuals below the minimum age of sale, actions taken to restrict access to the products and exposure to the products' labeling, advertising, marketing, or promotion, or other consumer-directed activities;
(D) Use of owned, earned, shared, or paid media to create labeling for, advertise, market, or promote the product;
(E) Use of partners, influencers, bloggers, or brand ambassadors to create labeling for, advertise, market, or promote the product;
(F) Consumer engagements conducted by the applicant, on its behalf, or at its direction, including events at which the products were demonstrated and how access was restricted to individuals at or above the minimum age of sale;
(G) Use of public-relations or other communications outreach to create labeling for, advertise, market, or promote the products;
(xvi) A summary of media tracking and optimization, by channel, by product, and by audience demographics (e.g., age, gender, race/ethnicity, geographic region), including a summary of any real-time digital media monitoring and including a summary of implementation of any corrective and preventive measures to identify, correct, and prevent delivery of advertising to individuals below the minimum age of sale, not previously submitted;
(xvii) An analysis of the actual delivery of advertising impressions, by channel, by product, and by audience demographics, that have not been previously submitted, and verified against post-launch delivery-verification reports submitted to the applicant from an accredited source, where applicable;
(xviii) Additional information required to be reported under the terms of a marketing granted order (if applicable); and
(xix) An overall assessment of how the tobacco product continues to be appropriate for the protection of the public health.
(2) Serious and unexpected adverse experience reporting. The applicant must report all serious and unexpected adverse experiences associated with the tobacco product that have been reported to the applicant or of which the applicant is aware to CTP's Office of Science through the Health and Human Services' Safety Reporting Portal or in another manner designated by FDA (if applicable) within 15 calendar days after the report is received by the applicant.
(b) FDA review of postmarket reports. (1) As part of its review of a postmarket report, FDA may require the applicant to submit additional information to enable it to determine whether a change results in a new tobacco product, or to facilitate a determination of whether there are or may be grounds to withdraw or temporarily suspend the marketing granted order.
(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.