Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke, 30721-30724 [2019-13758]

Download as PDF 30721 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices before, manufacturers who submit 510(k)s and receive marketing clearance will continue to be exempt from the Electronic Product Radiation Control reporting requirements in 21 CFR 1002.12, for diagnostic ultrasound devices, as described in the notice to industry entitled ‘‘Exemption from Reporting under 21 CFR 1002’’ dated February 24, 1986.1 FDA considered comments received on the draft guidance that appeared in the Federal Register of October 2, 2017 (82 FR 45856). FDA revised the guidance as appropriate in response to the comments. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 801 .............................................................................................. 820 .............................................................................................. Premarket Notification ................................................................ Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Reporting and Recordkeeping for Electronic Products—General Requirements. Premarket Approval of Medical Devices .................................... De Novo Classification Process (Evaluation of Automatic Class III Designation). Q-submissions ............................................................................ 1002 and 1010 ........................................................................... 814, subpart A–E ........................................................................ 513(f)(2) FD&C Act ..................................................................... ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. Dated: June 21, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–13687 Filed 6–26–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0075] jspears on DSK30JT082PROD with NOTICES https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Marketing Clearance of Diagnostic Ultrasound Systems and Transducers’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 560 to identify the guidance you are requesting. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 29, 2019. SUMMARY: HHS. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful 1 Available at https://www.fda.gov/downloads/ Radiation-EmittingProducts/RadiationEmitting ProductsandProcedures/MedicalImaging/ UCM509874.pdf. ADDRESSES: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke AGENCY: Food and Drug Administration, VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 0910–0120 0910–0485 0910–0073 0910–0025 0910–0231 0910–0844 0910–0756 Constituents in Tobacco Products and Tobacco Smoke.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke OMB Control Number 0910–NEW SUPPLEMENTARY INFORMATION: E:\FR\FM\27JNN1.SGM 27JNN1 jspears on DSK30JT082PROD with NOTICES 30722 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act) was signed into law. This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). In accordance with that authority, on May 10, 2016 (81 FR 28974), FDA issued a final rule deeming all products that meet the statutory definition of tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA’s tobacco product authority. The deemed products include electronic nicotine delivery systems, cigars, waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future. Among other requirements, section 904(e) of the FD&C Act (21 U.S.C. 387d(e)) requires FDA to establish, and periodically revise as appropriate, a list of harmful and potentially harmful constituents (HPHCs), including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. Section 904(d)(1) of the FD&C Act further requires that this list be published in a format that is understandable and not misleading to a lay person (the Section 904(d) list). FDA has undertaken a rigorous science-based research approach to ensure that the Section 904(d) list is not misleading to lay persons. As part of this research, FDA is seeking to conduct an experimental/quantitative study (4,500 online surveys), consisting of adult and youth (aged 13 to17) participants to evaluate the best way to convey information about HPHCs in tobacco products and tobacco smoke, by brand and by quantity in each brand and subbrand, in a format that is understandable and not misleading to a lay person. Participants will view sample formats and complete an online survey that will include questions regarding their understanding of the HPHC information presented to them. The purpose of the research is to gain VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 insight on consumer comprehension of, and preferences regarding, HPHC presentations that will inform the Agency’s efforts in connection with publishing the Section 904(d) list. In the Federal Register of February 11, 2019 (84 FR 3188), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received comments from six individuals or organizations, three of which were PRA related. (Comment) One comment recommended that FDA make the study design, sample formats, and all study measures available for public comment. (Response) FDA notes that the study protocol, list formats, and the survey questionnaire are available for review upon request and are described in detail as part of the overall information collection request submitted to OMB for review. (Comment) One comment suggested that FDA add a control group that does not view a sample format to our study design. (Response) FDA considered the utility of adding a no-exposure control group to this study. However, FDA determined that this is not in line with the study aims. The aims of the study are derived from section 904(e) of the FD&C Act which requires FDA to publish a list of HPHCs in each brand and sub-brand of tobacco product, in a way that people find understandable and not misleading. Therefore, the proposed study will test different formats of HPHC lists to meet this statutory requirement. A condition in which people do not see a list of HPHCs in a tobacco product does not approximate real-life conditions. (Comment) One comment suggested that FDA should clarify whether the HPHC sample formats will include smokeless brands since items in the draft survey are exclusive to cigarettes. The comment also noted that FDA should clarify whether smokeless tobacco and exclusive cigarette users will only view HPHC lists in their respective categories. (Response) HPHC sample formats will not include smokeless brands because HPHC lists for cigarettes are the focus of the proposed study. All participants will view HPHC lists for cigarettes only to allow for a parsimonious and focused design that is adequately powered to detect effects. (Comment) One comment suggested that FDA should use validated survey measures, establish the validity of other metrics prior to use, and consider using validated risk perception metrics. (Response) FDA agrees that validated items should be used whenever possible. FDA engaged in a multistep PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 process to select validated survey items for this study. First, FDA conducted a literature review and used available validated survey measures, including measures from past HPHC research (Ref. 1). However, for some outcomes (e.g., knowledge about the tested format), validated measures do not exist because questions are specific to the stimuli. Second, FDA conducted qualitative research to inform our measures. Based on insights uncovered during this research, we created and modified survey items. Third, FDA conducted cognitive testing to refine the measures. It should be noted that there are many ways to measure these constructs, including harm perceptions. The harm perceptions items that FDA used are based on a systematic review that identified the most commonly measured tobacco-related health consequences in the literature (Ref. 2). (Comment) One comment suggested that FDA should get end-user input into the development and refinement of the survey items. The comment suggested that survey items should be subject to cognitive testing, with individuals representing end users until the point of saturation is reached. (Response) FDA agrees that it is important to test a survey before collecting responses. As part of the research program, FDA conducted 54 indepth interviews, ‘‘Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products’’ (OMB control number 0910–0796), as a first step to develop items. Based on the findings from that study and a literature review to uncover validated measures, FDA developed a draft survey. Next, FDA cognitively tested the draft survey and stimuli and refined each by reducing redundant content and editing any confusing items. FDA reached saturation in both qualitative studies. (Comment) One comment suggested that including a midpoint on some of the scales (e.g. ‘‘neutral’’ and ‘‘neither agree nor disagree’’) may be difficult for some respondents to understand. The comment suggested that FDA incorporate a ‘‘don’t know’’ response option for some items including the HPHC general knowledge questions. (Response) The inclusion of a ‘‘don’t know’’ response on the knowledge items was made in order to best match the source of those items (Refs. 1 and 3). That is, FDA included a ‘‘don’t know’’ option when the source item did so. Although it is true that individuals interpret middle options like ‘‘neutral’’ in different ways, these personal interpretations should be randomly distributed across condition and thus E:\FR\FM\27JNN1.SGM 27JNN1 jspears on DSK30JT082PROD with NOTICES Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices not affect the comparisons among the stimuli (Ref. 4). (Comment) One comment recommended that FDA ask several of the post-test items (e.g., items 33, 34, 38) during the pre-test so that we can obtain a baseline estimate of misperceptions and determine whether there was any change in respondents’ incorrect beliefs following exposure to the stimulus. (Response) The primary purpose of this study is to test formats to see if they are understandable and not misleading. This can be achieved by comparing post-test measures of understanding and misleading across conditions and does not require a pre-test. We note that participants may have baseline misperceptions that are not accounted for in this design; however, since we are collecting data from a representative sample of people, we can account for these differences during the analysis. Further, as these items are part of a validated scale if FDA selects only a few items to ask in the pre-test, this may lead to data that is not reliable or valid. As these items are part of a larger scale that has been used and tested in previous research, only selecting a few questions may alter how participants respond to these and other questions in the survey. Also, these items have not been tested to be used alone. (Comment) One comment suggested that FDA add an attention check and measures of believability, truthfulness, or skepticism to provide additional context for the study results. (Response) The knowledge items in the survey are inherently an attention check because the participant can use the information in the stimulus to answer questions. Adding an attention check will not provide any additional benefit. Adding additional measures about believability, truthfulness, or skepticism are outside of the scope and purpose of this study. (Comment) One comment suggested that FDA oversample vulnerable populations including youth, minorities, and those with low levels of education in our survey. An additional comment commended FDA for including youth aged 13 to 17 in this study as it is critically important because most tobacco consumers begin using tobacco before the age of 18. Further, including youth in the sample underscores FDA’s recognition that it is possible to survey youth about the comprehension of information about tobacco without violating ethical standards. (Response) FDA agrees, we have established quotas in the recruitment to ensure that the sample is comprised of at least 20 percent of low socioeconomic VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 participants (income of less than $25,000 year) and at least 20 percent of adults without a high school diploma or GED. These proportions are not exclusive because low education and low socioeconomic status are strongly correlated. Further, the study sample will include approximately 1,500 adolescent tobacco users and adolescents at risk for using tobacco (ages 13 to 17). (Comment) One comment suggested that FDA collect demographic information pertaining to race/ethnicity, age, and education level. (Response) FDA agrees, we already plan to collect this demographic information as part of the screening procedures. (Comment) One comment suggested that FDA ask participants where they would look for information about tobacco constituents. (Response) FDA appreciates the suggestion. As previously mentioned in our comment responses FDA conducted 54 indepth interviews where this was assessed. There is also an item on the survey that asks, ‘‘Where would you most like to see information on chemicals in cigarettes and cigarette smoke?’’ The response options are ‘‘on cigarette packs,’’ ‘‘in stores,’’ and ‘‘online.’’ Between this item and the indepth interviews FDA conducted, this will provide FDA with adequate information on where participants would look for information about tobacco constituents. (Comment) One comment suggested that FDA add ‘‘to the best of your knowledge’’ at the beginning of questions 6 through 10. (Response) FDA does not believe this is necessary as these questions include a ‘‘don’t know’’ response option. Further, these questions were used in previous research (Ref. 1). (Comment) There were a few comments about the ‘‘understanding’’ section of the survey. One comment suggested that FDA add nicotine, acetone, and carbon monoxide to this section. Another comment suggested that FDA expand the ‘‘Understanding’’ section to include a section on addiction. The comment suggested that the section list specific constituents and ask participants if they cause addiction. One comment suggested that FDA modify the question that asks, ‘‘does smoking cause addiction’’ and change it to ‘‘does smoking cigarettes cause addiction.’’ (Response) FDA appreciates these suggestions. FDA declines to add additional items or modify items in the ‘‘understanding’’ section as it is consistent with prior research. Further, PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 30723 these items were part of cognitive testing and did not cause confusion. Prior research deliberately selected two chemicals that would be familiar to respondents (ammonia and lead) and three that would be unfamiliar (1aminonaphthalene, acrylonitrile, and isoprene) (Ref. 1). Further, even though there is not a specific question about the link between certain chemicals and addiction, FDA assesses participants’ understanding of whether smoking causes addiction in items 11 to 24. (Comment) There were two comments that asked FDA to add additional items measuring participants behavior. One comment suggested that FDA should add additional questions so that the survey could also determine how likely someone is to not only switch brands, but also whether they are likely to quit or switch to a different product. Another comment suggested that FDA add questions to the post-test to measure the behavioral impacts of these formats including cessation intentions. (Response) Although measuring these behavioral intentions and outcomes are interesting, these questions are outside the scope of this study. The focus of this study is to assess whether displays of HPHC information are understandable and not misleading per the statutory requirement. (Comment) FDA received two comments that supported the collection of this information. One comment urged FDA to move forward promptly with this study. (Response) FDA appreciates this comment and intend to move forward with the study promptly. We note that data collection will occur within 2 months following OMB approval. (Comment) One comment noted that FDA was required to publish a list of constituents in a format that is understandable and not misleading to a lay person by June 2012. However, no such list has been published. The comment also noted that it is important for FDA to ensure that information is disclosed in a way that is not misleading. (Response) FDA agrees that the proposed study is important to help FDA fulfill its statutory requirement. FDA has undertaken an extensive program of research to ensure that we not only publish a list of constituents in a manner that is understandable and not misleading, but also avoid any unintended consequences of such a list. (Comment) One comment noted that FDA should make it clear that characterizations of information on the list by tobacco product manufacturers in advertising or promotional material are subject to the requirements of the E:\FR\FM\27JNN1.SGM 27JNN1 30724 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices provisions of section 911 of the Tobacco Control Act (21 U.S.C. 387k) regarding modified risk claims. (Response) Thank you for this suggestion. However, this comment is outside the scope of the present study as it is about the implementation of the public displays of HPHCs and not about testing the display. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Type of respondent Total annual responses Average burden per response Total hours Youth Screener .................................................................... Youth Survey ....................................................................... 1,800 1,500 1 1 1,800 1,500 0.05 0.33 90 500 Total Youth Hours ......................................................... ........................ ........................ ........................ ........................ 590 Adult Screener ..................................................................... Adult Survey ......................................................................... 3,400 3,000 1 1 3,400 3,000 0.05 0.33 170 1,000 Total Adult Hours .......................................................... ........................ ........................ ........................ ........................ 1,170 Total Burden Hours ...................................................... ........................ ........................ ........................ ........................ 1,760 1 There are no capital costs or operating and maintenance costs associated with this collection of information. For this study, potential participants will be recruited by a market research firm that maintains an internet panel, and information will be collected through self-administered, online screening tests and surveys of youth aged 13 to17 and adults aged 18 and older. Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be requested to complete a screening test to determine eligibility for participation in the study, estimated to take approximately 3 minutes (0.05 hour) per screening test, for a total of 260 hours for screening activities. Respondents who qualify for the study will be directed to the survey. Approximately 4,500 participants (1,500 youth and 3,000 adults) will complete the survey, estimated to take 20 minutes (0.33 hour) per survey, for a total of 1,500 hours for completion of both adult and adolescent samples. The length of time to complete the screening test and survey are based on the research firm’s experience that panel members answer approximately 2.5 questions per minute. This data collection will take place one time in 2019. Thus, the total estimated burden is estimated to be 1,760 hours. II. References jspears on DSK30JT082PROD with NOTICES Number of responses per respondent The following references marked with an asterisk (*) are on display at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. 1. Byron, M.J., A.J. Lazard, E. Peters, et al. (2018). ‘‘Effective Formats for Communicating Risks from Cigarette Smoke Chemicals.’’ Tobacco Regulatory Science, 4(2), 16–29. doi:10.18001/TRS.4.2.2. * 2. O’Brien, E.K., A. Persoskie, and J. Tam (2019). ‘‘Multi-Item Measures of Tobacco Health Perceptions: A Review,’’ American Journal of Health Behavior, 43(2), 266–278. doi:10.5993/AJHB.43.2.4. 3. Brewer, N.T., J.C. Morgan, S.A, Baig, et al. (2017). ‘‘Public Understanding of Cigarette Smoke Constituents: Three US Surveys.’’ Tobacco Control, 26(5), 592–599. * 4. Nadler, J.T., R. Weston, and E.C. Voyles (2015). ‘‘Stuck in the Middle: The Use and Interpretation of Mid-Points in Items on Questionnaires,’’ The Journal of General Psychology, 142(2), 71–89. Dated: June 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–13758 Filed 6–26–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3516] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disease Awareness and Prescription Drug Promotion on Television AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00035 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). SUMMARY: Fax written comments on the collection of information by July 29, 2019. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Disease Awareness and Prescription Drug Promotion on Television.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. For copies of the questionnaire contact: Office of Prescription Drug Promotion (OPDP) Research Team, DTCresearch@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30721-30724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13758]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0075]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study on 
Measuring Consumer Comprehension of Displays of Harmful and Potentially 
Harmful Constituents in Tobacco Products and Tobacco Smoke

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
29, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Experimental Study on Measuring Consumer Comprehension of 
Displays of Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke.'' Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    Experimental Study on Measuring Consumer Comprehension of Displays 
of Harmful and Potentially Harmful Constituents in Tobacco Products and 
Tobacco Smoke OMB Control Number 0910-NEW

[[Page 30722]]

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. This 
law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
granted FDA the authority to regulate the manufacture, marketing, and 
distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, 
and smokeless tobacco products to protect the public health and to 
reduce tobacco use by minors. The Tobacco Control Act also gave FDA the 
authority to issue regulations deeming other products that meet the 
statutory definition of a tobacco product to be subject to chapter IX 
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016 (81 FR 28974), 
FDA issued a final rule deeming all products that meet the statutory 
definition of tobacco product, except accessories of newly deemed 
tobacco products, to be subject to FDA's tobacco product authority. The 
deemed products include electronic nicotine delivery systems, cigars, 
waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were 
not already subject to the FD&C Act, and other tobacco products that 
may be developed in the future.
    Among other requirements, section 904(e) of the FD&C Act (21 U.S.C. 
387d(e)) requires FDA to establish, and periodically revise as 
appropriate, a list of harmful and potentially harmful constituents 
(HPHCs), including smoke constituents, to health in each tobacco 
product by brand and by quantity in each brand and subbrand. Section 
904(d)(1) of the FD&C Act further requires that this list be published 
in a format that is understandable and not misleading to a lay person 
(the Section 904(d) list).
    FDA has undertaken a rigorous science-based research approach to 
ensure that the Section 904(d) list is not misleading to lay persons. 
As part of this research, FDA is seeking to conduct an experimental/
quantitative study (4,500 online surveys), consisting of adult and 
youth (aged 13 to17) participants to evaluate the best way to convey 
information about HPHCs in tobacco products and tobacco smoke, by brand 
and by quantity in each brand and subbrand, in a format that is 
understandable and not misleading to a lay person. Participants will 
view sample formats and complete an online survey that will include 
questions regarding their understanding of the HPHC information 
presented to them. The purpose of the research is to gain insight on 
consumer comprehension of, and preferences regarding, HPHC 
presentations that will inform the Agency's efforts in connection with 
publishing the Section 904(d) list.
    In the Federal Register of February 11, 2019 (84 FR 3188), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from six individuals 
or organizations, three of which were PRA related.
    (Comment) One comment recommended that FDA make the study design, 
sample formats, and all study measures available for public comment.
    (Response) FDA notes that the study protocol, list formats, and the 
survey questionnaire are available for review upon request and are 
described in detail as part of the overall information collection 
request submitted to OMB for review.
    (Comment) One comment suggested that FDA add a control group that 
does not view a sample format to our study design.
    (Response) FDA considered the utility of adding a no-exposure 
control group to this study. However, FDA determined that this is not 
in line with the study aims. The aims of the study are derived from 
section 904(e) of the FD&C Act which requires FDA to publish a list of 
HPHCs in each brand and sub-brand of tobacco product, in a way that 
people find understandable and not misleading. Therefore, the proposed 
study will test different formats of HPHC lists to meet this statutory 
requirement. A condition in which people do not see a list of HPHCs in 
a tobacco product does not approximate real-life conditions.
    (Comment) One comment suggested that FDA should clarify whether the 
HPHC sample formats will include smokeless brands since items in the 
draft survey are exclusive to cigarettes. The comment also noted that 
FDA should clarify whether smokeless tobacco and exclusive cigarette 
users will only view HPHC lists in their respective categories.
    (Response) HPHC sample formats will not include smokeless brands 
because HPHC lists for cigarettes are the focus of the proposed study. 
All participants will view HPHC lists for cigarettes only to allow for 
a parsimonious and focused design that is adequately powered to detect 
effects.
    (Comment) One comment suggested that FDA should use validated 
survey measures, establish the validity of other metrics prior to use, 
and consider using validated risk perception metrics.
    (Response) FDA agrees that validated items should be used whenever 
possible. FDA engaged in a multistep process to select validated survey 
items for this study. First, FDA conducted a literature review and used 
available validated survey measures, including measures from past HPHC 
research (Ref. 1). However, for some outcomes (e.g., knowledge about 
the tested format), validated measures do not exist because questions 
are specific to the stimuli. Second, FDA conducted qualitative research 
to inform our measures. Based on insights uncovered during this 
research, we created and modified survey items. Third, FDA conducted 
cognitive testing to refine the measures. It should be noted that there 
are many ways to measure these constructs, including harm perceptions. 
The harm perceptions items that FDA used are based on a systematic 
review that identified the most commonly measured tobacco-related 
health consequences in the literature (Ref. 2).
    (Comment) One comment suggested that FDA should get end-user input 
into the development and refinement of the survey items. The comment 
suggested that survey items should be subject to cognitive testing, 
with individuals representing end users until the point of saturation 
is reached.
    (Response) FDA agrees that it is important to test a survey before 
collecting responses. As part of the research program, FDA conducted 54 
indepth interviews, ``Consumer Comprehension of Displays of Harmful and 
Potentially Harmful Constituents (HPHCs) in Tobacco Products'' (OMB 
control number 0910-0796), as a first step to develop items. Based on 
the findings from that study and a literature review to uncover 
validated measures, FDA developed a draft survey. Next, FDA cognitively 
tested the draft survey and stimuli and refined each by reducing 
redundant content and editing any confusing items. FDA reached 
saturation in both qualitative studies.
    (Comment) One comment suggested that including a midpoint on some 
of the scales (e.g. ``neutral'' and ``neither agree nor disagree'') may 
be difficult for some respondents to understand. The comment suggested 
that FDA incorporate a ``don't know'' response option for some items 
including the HPHC general knowledge questions.
    (Response) The inclusion of a ``don't know'' response on the 
knowledge items was made in order to best match the source of those 
items (Refs. 1 and 3). That is, FDA included a ``don't know'' option 
when the source item did so. Although it is true that individuals 
interpret middle options like ``neutral'' in different ways, these 
personal interpretations should be randomly distributed across 
condition and thus

[[Page 30723]]

not affect the comparisons among the stimuli (Ref. 4).
    (Comment) One comment recommended that FDA ask several of the post-
test items (e.g., items 33, 34, 38) during the pre-test so that we can 
obtain a baseline estimate of misperceptions and determine whether 
there was any change in respondents' incorrect beliefs following 
exposure to the stimulus.
    (Response) The primary purpose of this study is to test formats to 
see if they are understandable and not misleading. This can be achieved 
by comparing post-test measures of understanding and misleading across 
conditions and does not require a pre-test. We note that participants 
may have baseline misperceptions that are not accounted for in this 
design; however, since we are collecting data from a representative 
sample of people, we can account for these differences during the 
analysis. Further, as these items are part of a validated scale if FDA 
selects only a few items to ask in the pre-test, this may lead to data 
that is not reliable or valid. As these items are part of a larger 
scale that has been used and tested in previous research, only 
selecting a few questions may alter how participants respond to these 
and other questions in the survey. Also, these items have not been 
tested to be used alone.
    (Comment) One comment suggested that FDA add an attention check and 
measures of believability, truthfulness, or skepticism to provide 
additional context for the study results.
    (Response) The knowledge items in the survey are inherently an 
attention check because the participant can use the information in the 
stimulus to answer questions. Adding an attention check will not 
provide any additional benefit. Adding additional measures about 
believability, truthfulness, or skepticism are outside of the scope and 
purpose of this study.
    (Comment) One comment suggested that FDA oversample vulnerable 
populations including youth, minorities, and those with low levels of 
education in our survey. An additional comment commended FDA for 
including youth aged 13 to 17 in this study as it is critically 
important because most tobacco consumers begin using tobacco before the 
age of 18. Further, including youth in the sample underscores FDA's 
recognition that it is possible to survey youth about the comprehension 
of information about tobacco without violating ethical standards.
    (Response) FDA agrees, we have established quotas in the 
recruitment to ensure that the sample is comprised of at least 20 
percent of low socioeconomic participants (income of less than $25,000 
year) and at least 20 percent of adults without a high school diploma 
or GED. These proportions are not exclusive because low education and 
low socioeconomic status are strongly correlated. Further, the study 
sample will include approximately 1,500 adolescent tobacco users and 
adolescents at risk for using tobacco (ages 13 to 17).
    (Comment) One comment suggested that FDA collect demographic 
information pertaining to race/ethnicity, age, and education level.
    (Response) FDA agrees, we already plan to collect this demographic 
information as part of the screening procedures.
    (Comment) One comment suggested that FDA ask participants where 
they would look for information about tobacco constituents.
    (Response) FDA appreciates the suggestion. As previously mentioned 
in our comment responses FDA conducted 54 indepth interviews where this 
was assessed. There is also an item on the survey that asks, ``Where 
would you most like to see information on chemicals in cigarettes and 
cigarette smoke?'' The response options are ``on cigarette packs,'' 
``in stores,'' and ``online.'' Between this item and the indepth 
interviews FDA conducted, this will provide FDA with adequate 
information on where participants would look for information about 
tobacco constituents.
    (Comment) One comment suggested that FDA add ``to the best of your 
knowledge'' at the beginning of questions 6 through 10.
    (Response) FDA does not believe this is necessary as these 
questions include a ``don't know'' response option. Further, these 
questions were used in previous research (Ref. 1).
    (Comment) There were a few comments about the ``understanding'' 
section of the survey. One comment suggested that FDA add nicotine, 
acetone, and carbon monoxide to this section. Another comment suggested 
that FDA expand the ``Understanding'' section to include a section on 
addiction. The comment suggested that the section list specific 
constituents and ask participants if they cause addiction. One comment 
suggested that FDA modify the question that asks, ``does smoking cause 
addiction'' and change it to ``does smoking cigarettes cause 
addiction.''
    (Response) FDA appreciates these suggestions. FDA declines to add 
additional items or modify items in the ``understanding'' section as it 
is consistent with prior research. Further, these items were part of 
cognitive testing and did not cause confusion. Prior research 
deliberately selected two chemicals that would be familiar to 
respondents (ammonia and lead) and three that would be unfamiliar (1-
aminonaphthalene, acrylonitrile, and isoprene) (Ref. 1). Further, even 
though there is not a specific question about the link between certain 
chemicals and addiction, FDA assesses participants' understanding of 
whether smoking causes addiction in items 11 to 24.
    (Comment) There were two comments that asked FDA to add additional 
items measuring participants behavior. One comment suggested that FDA 
should add additional questions so that the survey could also determine 
how likely someone is to not only switch brands, but also whether they 
are likely to quit or switch to a different product. Another comment 
suggested that FDA add questions to the post-test to measure the 
behavioral impacts of these formats including cessation intentions.
    (Response) Although measuring these behavioral intentions and 
outcomes are interesting, these questions are outside the scope of this 
study. The focus of this study is to assess whether displays of HPHC 
information are understandable and not misleading per the statutory 
requirement.
    (Comment) FDA received two comments that supported the collection 
of this information. One comment urged FDA to move forward promptly 
with this study.
    (Response) FDA appreciates this comment and intend to move forward 
with the study promptly. We note that data collection will occur within 
2 months following OMB approval.
    (Comment) One comment noted that FDA was required to publish a list 
of constituents in a format that is understandable and not misleading 
to a lay person by June 2012. However, no such list has been published. 
The comment also noted that it is important for FDA to ensure that 
information is disclosed in a way that is not misleading.
    (Response) FDA agrees that the proposed study is important to help 
FDA fulfill its statutory requirement. FDA has undertaken an extensive 
program of research to ensure that we not only publish a list of 
constituents in a manner that is understandable and not misleading, but 
also avoid any unintended consequences of such a list.
    (Comment) One comment noted that FDA should make it clear that 
characterizations of information on the list by tobacco product 
manufacturers in advertising or promotional material are subject to the 
requirements of the

[[Page 30724]]

provisions of section 911 of the Tobacco Control Act (21 U.S.C. 387k) 
regarding modified risk claims.
    (Response) Thank you for this suggestion. However, this comment is 
outside the scope of the present study as it is about the 
implementation of the public displays of HPHCs and not about testing 
the display.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Youth Screener..................           1,800               1           1,800            0.05              90
Youth Survey....................           1,500               1           1,500            0.33             500
                                 -------------------------------------------------------------------------------
    Total Youth Hours...........  ..............  ..............  ..............  ..............             590
----------------------------------------------------------------------------------------------------------------
Adult Screener..................           3,400               1           3,400            0.05             170
Adult Survey....................           3,000               1           3,000            0.33           1,000
                                 -------------------------------------------------------------------------------
    Total Adult Hours...........  ..............  ..............  ..............  ..............           1,170
                                 -------------------------------------------------------------------------------
    Total Burden Hours..........  ..............  ..............  ..............  ..............           1,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For this study, potential participants will be recruited by a 
market research firm that maintains an internet panel, and information 
will be collected through self-administered, online screening tests and 
surveys of youth aged 13 to17 and adults aged 18 and older. 
Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be 
requested to complete a screening test to determine eligibility for 
participation in the study, estimated to take approximately 3 minutes 
(0.05 hour) per screening test, for a total of 260 hours for screening 
activities. Respondents who qualify for the study will be directed to 
the survey. Approximately 4,500 participants (1,500 youth and 3,000 
adults) will complete the survey, estimated to take 20 minutes (0.33 
hour) per survey, for a total of 1,500 hours for completion of both 
adult and adolescent samples. The length of time to complete the 
screening test and survey are based on the research firm's experience 
that panel members answer approximately 2.5 questions per minute. This 
data collection will take place one time in 2019. Thus, the total 
estimated burden is estimated to be 1,760 hours.

II. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and 
are available for viewing by interested persons between 9 a.m. and 4 
p.m., Monday through Friday; they also are available electronically at 
https://www.regulations.gov. References without asterisks are not on 
public display at https://www.regulations.gov because they have 
copyright restriction. Some may be available at the website address, if 
listed. References without asterisks are available for viewing only at 
the Dockets Management Staff.

    1. Byron, M.J., A.J. Lazard, E. Peters, et al. (2018). 
``Effective Formats for Communicating Risks from Cigarette Smoke 
Chemicals.'' Tobacco Regulatory Science, 4(2), 16-29. doi:10.18001/
TRS.4.2.2.
    * 2. O'Brien, E.K., A. Persoskie, and J. Tam (2019). ``Multi-
Item Measures of Tobacco Health Perceptions: A Review,'' American 
Journal of Health Behavior, 43(2), 266-278. doi:10.5993/AJHB.43.2.4.
    3. Brewer, N.T., J.C. Morgan, S.A, Baig, et al. (2017). ``Public 
Understanding of Cigarette Smoke Constituents: Three US Surveys.'' 
Tobacco Control, 26(5), 592-599.
    * 4. Nadler, J.T., R. Weston, and E.C. Voyles (2015). ``Stuck in 
the Middle: The Use and Interpretation of Mid-Points in Items on 
Questionnaires,'' The Journal of General Psychology, 142(2), 71-89.

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13758 Filed 6-26-19; 8:45 am]
BILLING CODE 4164-01-P