Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disease Awareness and Prescription Drug Promotion on Television, 30724-30730 [2019-13734]

Download as PDF 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 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices Disease Awareness and Prescription Drug Promotion on Television jspears on DSK30JT082PROD with NOTICES OMB Control Number 0910–NEW I. Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. FDA’s Center for Drug Evaluation and Research (CDER), Office of Prescription Drug Promotion (OPDP) is responsible for ensuring that prescription drug promotional materials are truthful, balanced, and accurately communicated. This project is being proposed as part of the research program of OPDP. OPDP’s research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study falls under the topic of both target populations and advertising features. Because we recognize the strength of data and the confidence in the robust nature of the findings is improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 https://www.fda.gov/about-fda/centerdrug-evaluation-and-research/officeprescription-drug-promotion-opdpresearch. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a direct-toconsumer (DTC) survey conducted in 1999. The present research concerns disease awareness and prescription drug promotion communications on television. When pharmaceutical companies market a new drug, they often also release disease awareness communications about the medical condition the new drug is intended to treat (Refs. 1 and 2). FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion. Prior research has documented that in both print (Ref. 3) and online (Ref. 4) contexts, consumers tend to conflate the information presented in prescription drug promotional materials with information presented in disease awareness communications. Specifically, the results of these studies suggest consumers incorrectly ascribe benefits to a prescription drug as a result of being exposed to information in a disease awareness communication that broadly describes the symptoms and negative consequences of the disease. There are ways in which this effect can be attenuated. For example, prior research has indicated that greater visual distinctiveness between the two ad types can ameliorate such confusion (Ref. 3). The present research seeks to extend previous studies of print and online promotion to the context of television promotion, and broadly examine the extent to which perceptual similarity between the two communication types, as well as their temporal proximity and exposure frequency, may lead to viewer confusion and the nature of that confusion. This research is being conducted to determine how the similarity, temporal positioning, and frequency of exposure to disease awareness communications and prescription drug television promotion impact consumer perception and understanding of the benefits and risks of a prescription drug product. These objectives will be achieved using two experimental studies. The first study will explore the impact on consumer perception and comprehension of different levels of PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 30725 temporal separation between the disease awareness communication and prescription drug promotion within a single period of television programming, as well as the level of similarity versus distinctiveness between these communication types. Temporal separation is defined as the spacing or proximity between the disease awareness communication and prescription drug promotion in the hour-long programming, for example, if they are shown back-to-back or if they are separated by other ads or television programming. Similarity/distinctiveness is defined by variations between the disease awareness communication and prescription drug promotion, including visual and presentation elements such as the setting, actors, and colors. The second study will experimentally examine the impact of disease awareness communication temporal separation and exposure frequency on consumer perception and comprehension. Temporal separation in this second study again refers to the spacing or proximity between the disease awareness communication and prescription drug promotion but is operationally defined as either 1 day or 1 week. Exposure frequency is defined as the number of times that participants will view the disease awareness communication, either one, three, or six times. The results of this latter study will examine the practice of ‘‘seeding the market,’’ in which pharmaceutical companies release disease awareness communications before releasing product promotion communications. Similarity versus distinctiveness will also be examined in this study. We propose the following hypotheses for this research: A. Study 1 H1: Increased perceptual similarity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H2: Increased temporal proximity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. B. Study 2 H1: Increased frequency of exposure to a disease awareness communication before exposure to a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H2: Increased temporal proximity between a disease awareness E:\FR\FM\27JNN1.SGM 27JNN1 30726 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices communication condition, plus one control condition where participants will not view a disease awareness communication. The extent to which the disease awareness communication is perceptually similar to the product promotion communication will vary, as will the temporal separation of the disease awareness communication and product promotion communication. Table 1 depicts our design visually. In each instance, conflation is defined as the extent to which an individual remembers and attributes benefits to a product that is based on information presented in a disease awareness communication and not in the drug promotion. To address these hypotheses, Study 1 will employ a 3x4 factorial design in which participants are randomly assigned to one disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H3: Increased perceptual similarity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. TABLE 1—STUDY 1 EXPERIMENTAL DESIGN Disease awareness and product ad temporal separation Perceptual similarity to product ad Disease awareness ad Yes ............................. No ............................... In neighboring commercial pods Within same commercial pod 1 Back to back In non-neighboring commercial pods Similar. Semi-similar. Distinct. N/A. 1 A commercial pod refers to a group of ads into which the test ad is inserted, designed to simulate an advertising break during a television program. As depicted in table 2, by neighboring commercial pods, we mean commercial pods separated only by television programming and no other commercial pods. By non-neighboring commercial pods, we mean commercial pods separated by both television programming and one or more (one, as studied here) other commercial pods. TABLE 2—STUDY 1 SEQUENCE Sequence Condition 6 Back to back ............... Same pod ................... Neighboring pods ........ Non-neighboring pods Control ........................ 1 TV min 1 ........... ........... ........... ........... ........... 2 min 2 DA,P 3 DA, P DA ..... DA ..... P ....... 5 min 1 ........... ........... ........... ........... ........... 2 min 2 ........... ........... P ....... ........... ........... 5 min 1 ........... ........... ........... ........... ........... 2 min 2 ........... ........... ........... P ....... ........... min 1 2 min 2 6 min 1 2 min 2 5 min 1 2 min 2 5 min 1 2 min 2 5 min 1 ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... DA ..... ........... ........... ........... ........... ........... ........... ........... ........... DA ..... ........... ........... ........... ........... ........... ........... ........... DA, P DA, P P ....... P ....... P ....... ............ ............ ............ ............ ............ 5 Program. Pod. = Disease Awareness Communication; P = Product Promotion. 2 Commercial 3 DA Study 2 will employ a 2x2x3 factorial design in which participants are randomly assigned to one disease awareness communication condition. The varying factors in Study 2 are the temporal separation between the disease promotion communication. Table 3 visually depicts our design. Of note, to reduce the overall number of experimental conditions for Study 2, no semi-similar experimental condition is used. awareness and product promotion communication, the number of exposures to the disease awareness communication, and the perceptual similarity of the disease awareness communication to the product TABLE 3—STUDY 2 EXPERIMENTAL DESIGN Time delay until product ad exposure (temporal separation) Exposures to disease awareness ad Perceptual similarity of ads One exposure One Day ............................ One Week ......................... Three exposures Six exposures Similar ............................... Distinct .............................. Similar ............................... Distinct .............................. TABLE 4—STUDY 2 SEQUENCE jspears on DSK30JT082PROD with NOTICES Disease awareness ad exposure phase Delay Six Exposures ................ Similarity 1 day ........ 1 week ..... VerDate Sep<11>2014 20:15 Jun 26, 2019 similar ....... distinct ...... similar ....... distinct ...... Jkt 247001 Product ad exposure phase Day —————————————————————————————————————————————→ 1 2 5 6 9 10 11 x x x x x x x x x x x x x x x x x x x x x x x x x x PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 12 E:\FR\FM\27JNN1.SGM 13 14 15 16 17 x x 27JNN1 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices 30727 TABLE 4—STUDY 2 SEQUENCE—Continued Three Exposures ............ 1 day ........ 1 week ..... One Exposure ................ 1 day ........ jspears on DSK30JT082PROD with NOTICES 1 week ..... similar ....... distinct ...... similar ....... distinct ...... similar ....... distinct ...... similar ....... distinct ...... Study 1 and 2 Sample. The targeted voluntary sample for both studies will comprise adults who self-report a current asthma diagnosis, a lifetime incidence of asthma, or experience a large number of asthma symptoms. These groups are believed to be very likely to be targeted by disease awareness and product promotion communications for asthma. The combined incidence rate of these groups is 22.2 percent (Refs. 5 and 6). In addition, several exclusion criteria are specified. These include: (1) Training or employment as a healthcare professional, (2) employment with a pharmaceutical company, an advertising agency, a market research company, or the Department of Health and Human Services, and (3) participation in market research within the past 3 months on the topic of prescription drugs. Pretest participants will also be ineligible for the main study. Pretesting. Pretesting will take place before the main studies to evaluate the procedures used in the main studies. Each of the two pretests will have the same design as its respective main study (pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both pretests will be to: (1) Ensure that the mock stimuli are understandable, viewable, and delivering intended messages; (2) identify and eliminate any challenges to embedding the mock stimuli within the online survey; (3) ensure that survey questions are appropriate and meet the analytical goals of the research; and (4) pilot test the methods, including examining response rates and timing of survey. The two pretests will be conducted simultaneously.1 Based on pretest findings, we will refine the mock stimuli, survey questions, and data collection process, as necessary, to optimize the full-scale study conditions. Measurement. Our planned analyses are designed to address the key hypotheses. For both Study 1 and Study 1 Pretesting will be preceded by cognitive interviewing, not described here. Cognitive interviews are used to probe a small sample of participants on how and why they responded to various questions as they did, resulting in strong measurement instruments. VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 x x x x x x x x x x x x x x x x 2, we anticipate that the primary analysis will be analysis of variance to compare the main and interaction effects of the experimental factors. The focal dependent variable will be conflation—a measure of memory and perceptions regarding the promoted drug relative to the information presented in the disease awareness communication. Conflation will be measured by using the number of benefits that are incorrectly attributed to the prescription drug product based on responses to a number of both openended and closed-ended items. Other key dependent variables will reflect perceptions and attitudes toward the product ad. These include measures of: 1. Perception of product promotion effectiveness; 2. Behavioral intentions toward the drug; 3. Perceived efficacy of the drug; and 4. Perceived risks of the drug. In addition to the primary variables of interest, we have also identified potential covariates that will be included in the analyses: 1. Knowledge about asthma; 2. Health literacy; and 3. Perceived ad effectiveness. We expect that knowledge about asthma and increased health literacy may moderate any conflation that results from ad similarity, temporal proximity, and frequency of exposure. Perceptions of promotion effectiveness, on the other hand, can be examined both as an outcome/dependent variable but also as a covariate that examines involvement with the product promotion. Greater involvement may attenuate conflation in that it directs more in-depth processing of both the disease awareness communication and product promotion, and therefore more correct understanding of the claims in each (Refs. 7 to 9). In the Federal Register of October 17, 2018 (83 FR 52472), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received six comments that were PRA related. Within those submissions, FDA PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 x x x x x x x x received multiple comments that the Agency has addressed. Two additional comments were received that were not responsive to the four collection of information topics solicited and therefore are not discussed in this document. (Comment 1) Four comments suggested that FDA provide copies of stimuli in the Federal Register for public comment. Relatedly, one comment requested a copy of the participant consent documents. (Response) We have described the purpose of the study, the design, the population of interest, and have provided the questionnaire to numerous individuals upon request. Our full stimuli are under development during the PRA process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise the research. The consent form is available as part of the information collection submission to OMB. (Comment 2) Three comments expressed support for FDA’s determination to take an evidenceinformed approach to its regulation of sponsor communications. (Response) We appreciate this support. (Comment 3) Three comments suggested that selecting asthma sufferers as the target population limits the applicability of the results, or that asthma sufferers’ prior knowledge regarding asthma may bias their responses. (Response) Researching each medical condition, or general population sample, requires significant resources. We are committed to conducting this research using our available resources while ensuring the integrity of the research by collecting data on a high prevalence condition (i.e., >20% incidence rate) for which participants might be thought of as sufficiently representative of the average consumer, thus allowing us to draw conclusions about broad perceptual and cognitive processing outcomes. (Comment 4) Three comments suggested that use of mock E:\FR\FM\27JNN1.SGM 27JNN1 jspears on DSK30JT082PROD with NOTICES 30728 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices advertisements, products, and environments do not represent what happens in the real world. (Response) In response to Federal Register notices for prior research under our research program, commenters have suggested the opposite, which is that use of real materials (i.e., existing drug ads) could have confounding results due to consumer familiarity with medicines and drug classes used to treat their existing condition. We sought to address this concern by utilizing realistic mock materials. Additionally, utilizing mock materials allows for precise manipulation of the stimuli fitting with our research questions and is the most common practice in the field. (Comment 5) Two comments expressed concern about use of ‘‘conflation’’ as a dependent variable. (Response) The present research seeks to extend previous studies of print and online promotion to the context of television promotion and as such utilizes many of the same dependent measures, including the key dependent measure of ‘‘conflation.’’ Conflation as defined in this notice reflects the key outcome of interest given the research questions posed and therefore has been retained. (Comment 6) Two comments suggested that the open-ended response questions are open to interpretation and data variability and encouraged FDA to revise these to close-ended questions. (Response) The purpose of the openended items is to measure unaided participant recall of claims made in the prescription drug promotion. These responses will be content coded using an inductive approach and numeric codes will be assigned to the openended responses. Quantifying openended responses provides structure and reduces the interpretation associated with a qualitative coding scheme. After sanitizing open-ended comments (removing obscenities, proper names, and any case-specific information), two reviewers will read the responses and develop a coding scheme to establish theme descriptions, numeric codes, and coding rules. Two coders will receive training and will code 25 percent of the responses. After achieving high intercoder reliability (e.g., kappa = .75), the remaining responses will be divided between the coders. Open-ended coding will then be merged with the data set for analysis. Additionally, we have tested these response options in cognitive interviewing and found them to be effective for their intended purpose. We have also received positive feedback on these measures from our consultations with expert peer reviewers. These measures have therefore been retained. VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 (Comment 7) Two comments suggested adding a control condition to Study 2 whereby participants only see the prescription drug product ad before completing the survey. (Response) For Study 2, the primary questions are related to both frequency of exposure and delay. A control condition that features no disease awareness communications makes the delay factor redundant, and comparisons can be made between no exposure and repeated exposure. Therefore, a control condition for Study 2 is unnecessary given the current design. (Comment 8) Two comments suggested that Studies 1 and 2 are highly similar and thus only one study needs to be conducted. One of these comments suggested dropping Study 2 and utilizing the resources that would have been allotted to instead create different iterations of temporal separation for Study 1. (Response) Studies 1 and 2 include overlap in their independent and dependent variables. However, they are unique in that Study 1 will explore outcomes within a single period of television programming, whereas Study 2 will examine outcomes over time mirroring the practice of ‘‘seeding the market,’’ in which pharmaceutical companies release disease awareness communications before releasing product promotion communications. Both studies offer significant and unique value to FDA and therefore both studies have been retained. (Comment 9) One comment suggested separating recall of the ad from recall of the product into separate questions. (Response) The question reads, ‘‘Do you recall seeing a commercial for [Drug X], a prescription product for asthma?’’ This question is intended to assess recall of the commercial for [Drug X] and is not intended to assess recall for this fictitious product beyond this commercial. We hope this clarification is helpful for understanding why we intend to retain the present version of this question. (Comment 10) One comment suggested that pretesting be conducted to ensure that stimuli reflect the intended manipulations. (Response) FDA intends to conduct both cognitive interviewing and pretesting to ensure the stimuli reflect the intended manipulations. (Comment 11) One comment suggests that the proposed research overlooks the positive aspects of disease awareness campaigns, and to address this, steps can be taken such as adding questions about behavioral intentions to the questionnaire. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 (Response) FDA acknowledges that there are positive aspects of disease awareness campaigns. This research is intended to evaluate specific research questions as outlined in the 60-day Federal Register notice and therefore dependent measures align with these research questions. As an overall strategy to reduce participant burden, we do not intend to ask questions that do not inform these research questions. (Comment 12) One comment suggested relocating non-terminating screening questions to the end of the questionnaire to reduce participant fatigue. (Response) The purpose of including the screening items at the beginning of the questionnaire is to ensure a diverse sample using predetermined quotas, and for required statistical analyses following completion of the data collection. Retaining the screening items at the beginning of the questionnaire will allow for comparisons between non-respondents and respondents. (Comment 13) One comment suggested adding a ‘‘Don’t know’’ response option wherever applicable. (Response) We understand the value of providing such responses for items of a factual nature. The drawback to providing such response options to these questions, however, is that we may lose information by allowing respondents to choose an easy response instead of giving the item some thought. Research has demonstrated that providing ‘‘no opinion’’ options likely results in the loss of data without any corresponding increase in the quality of the data. Thus, we prefer not to add these options to the survey. (Comment 14) One comment suggested that FDA develop a clear, overarching research agenda and provide a comprehensive list of its prescription drug promotion studies. (Response) The 60-day Federal Register notice for this study describes OPDP’s research agenda, how this study fits into that agenda, and provides the web address of OPDP’s research page, which includes links to the latest Federal Register notices and peerreviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a DTC survey conducted in 1999. (Comment 15) One comment suggested that the current research duplicates prior work conducted in online and print contexts. (Response) The present research seeks to extend previous studies of print and online promotion to the context of television promotion. In previous Federal Register notices under our E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices research program, we have been advised by commenters that findings for one form of advertising should not be assumed to broadly apply to other forms of advertising. Additionally, we note that the present research includes unique elements beyond advertising format that have not previously been studied. An example of this is assessment of ‘‘seeding the market’’ in Study 2 whereby sponsors initially release a disease awareness ad for a period of time, followed by release of a product promotion ad. (Comment 16) One comment suggested that the time commitment required for participation may result in a self-selected sample of individuals with more time available (e.g., students). (Response) Participants will be recruited through online panels, which include a diverse range of participants in regard to age, race/ethnicity, income, education, and employment. We also have proposed the use of soft quotas to further ensure that we will recruit a diverse sample. Finally, we were able to recruit a diverse sample for cognitive interviewing and although a smaller sample size than will be recruited for the pretests and main studies, the sample was not overrepresented in any demographic categories. (Comment 17) One comment suggested that the calculated burden is appropriate but requested additional detail about other requirements that may add to burden in addition to the time in the study itself. (Response) Data collection will occur online, so the burden estimate reflects time spent answering the screener, stimuli viewing, survey completion, thus reflecting overall study time and requirements. (Comment 18) One comment identified errors in the questionnaire. (Response) Thank you for noting these errors. All identified errors have been fixed. (Comment 19) One comment suggested adding intermediate response values to questions that omitted them (e.g., 1 = no improvement, to 6 = substantial improvement). (Response) These questions were developed through scale validation research. We did not encounter any confusion on the part of respondents during cognitive testing of the questionnaire. We will retain these questions in their original form. (Comment 20) One comment suggested that because ‘‘prescription drug information’’ has become a political topic in recent years, the introduction to the questionnaire should be revised to avoid saying that ‘‘[w]e will use your feedback to. . .improve prescription drug information for people like you.’’ The concern is that this information may bias responses depending on participant views of ‘‘prescription drug information.’’ (Response) The proposed research concerns prescription drug information and so we need to provide this context to participants to orient them to the questions that follow. Moreover, institutional review boards typically require transparency about the topic of the research. We have therefore retained this language in our study materials. (Comment 21) One comment noted that ‘‘[p]erceptions of promotion effectiveness’’ is described as both a dependent variable and a covariate, and to avoid distortion in the model, recommends selection of a different covariate. (Response) Perception of promotion effectiveness is described as a dependent variable, differing from perceived ad effectiveness, which 30729 measures perception of the disease awareness communications. The purpose of including perceived ad effectiveness as a covariate is that perception of the disease awareness communications may directly affect conflation, which could require statistical adjustment. (Comment 22) One comment suggested expanding the participant exclusion criteria to include individuals studying health fields and product marketing (beyond pharmaceuticals). (Response) We currently exclude individuals who work for a pharmaceutical company, an advertising agency, a market research company, or the Department of Health and Human Services. These criteria exclude individuals working in advertising or market research beyond pharmaceuticals, but do not necessarily exclude students studying these fields. To ensure a diverse sample, we generally aim to limit our exclusion criteria. However, please note that random assignment to experimental condition should ensure that these individuals are approximately evenly distributed across conditions. (Comment 23) One comment requested information about how learning effects would be controlled for given the multiple exposures. (Response) For Study 2, learning effects are accounted for by the exposure frequency manipulation. Participants are randomly assigned to see the disease awareness ad once, three times, or six times. For Study 1, all participants see the ads the same number of times, except participants randomly assigned to the control condition who do not see the disease awareness ad. FDA estimates the burden of this collection of information as follows: TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity jspears on DSK30JT082PROD with NOTICES Study Study Study Study Study Study Study Study 1 2 1 2 1 2 1 2 Number of responses per respondent Total annual responses Pretest screener ........................ Pretest screener ........................ screener ..................................... screener ..................................... Pretest ........................................ Pretest ........................................ .................................................... .................................................... 385 329 3,007 2,643 270 158 2,105 1,269 1 1 1 1 1 1 1 1 385 329 3,007 2,643 270 158 2,105 1,269 Total ................................................. ........................ ........................ ........................ 1 There Average burden per response 0.08 0.08 0.08 0.08 1.33 0.53 1.33 0.53 (∼5 minutes) ....................... (∼5 minutes) ....................... (∼5 minutes) ....................... (∼5 minutes) ....................... (∼1 hour 20 minutes) ......... (∼32 minutes) ..................... (∼1 hour 20 minutes) ......... (∼32 minutes) ..................... 31 26 241 211 360 84 2,800 673 .................................................... 4,426 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Total hours E:\FR\FM\27JNN1.SGM 27JNN1 30730 Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices jspears on DSK30JT082PROD with NOTICES 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. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Bulik, B.S. (March 11, 2018). ‘‘Unbranded Pharma Ads—What Are They Good For? Actually Quite a Bit, Marketing Panelists Say.’’ Available at https:// www.fiercepharma.com/marketing/ unbranded-pharma-ad-what-are-theygood-for-actually-quite-a-bit-marketerpanelists-say?mkt_tok=eyJpIjoiWkRnel pUSmlORFpoWkdNMSIsInQiOiJPa ENIUERpT0tnUmt6Y1BPMk9LTnpre UI3bUtPOVRzRnh1RzNuWUtYQmp0 cWJhcW05UFhlcllwTzI3V0RJSnd jVkZLR3NGUHBLamJOZmJSK2FZ eWtIVXczeFRFcmtEV0NFaVdCSjAr Umx4dUlRVHZpUzFFOW lVY0dNb1RzOU9Xay J9&mrkid=20932234. Accessed on April 12th, 2019. 2. Bulik, B.S. (December 21, 2016). ‘‘Avanir Shelves Danny Glover PBA Awareness Ad in Favor of Branded Nuedexta Effort.’’ Available at https:// www.fiercepharma.com/marketing/ avanir-launches-nuedexta-brandcampaign-retires-danny-glover-pbadisease-awareness-ad. Accessed on April 12, 2019. 3. * Aikin, K.J., H.W. Sullivan, and K.R. Betts, ‘‘Disease Information in Direct-toConsumer Prescription Drug Print Ads.’’ Journal of Health Communication, 21:228–239, 2016. 4. * Sullivan, H.W., A.C. O’Donoghue, D.J. Rupert, et al., ‘‘Are Disease Awareness Links on Prescription Drug websites Misleading? A Randomized Study.’’ Journal of Health Communication, 21:1198–1207, 2016. 5. * Centers for Disease Control and Prevention. (2018a, May 18). ‘‘2016 National Health Interview Survey (NHIS) Data.’’ Retrieved from https:// www.cdc.gov/asthma/nhis/2016/table21.htm. 6. * Centers for Disease Control and Prevention. (2018b, May 15). ‘‘Most Recent Asthma Data.’’ Retrieved from https://www.cdc.gov/asthma/most_ recent_data.htm. 7. Petty, R.E. and J.T. Cacioppo, ‘‘Issue Involvement Can Increase or Decrease VerDate Sep<11>2014 20:15 Jun 26, 2019 Jkt 247001 Persuasion by Enhancing MessageRelevant Cognitive Responses.’’ Journal of Personality and Social Psychology, 37:1915–1926, 1979. doi: 10.1037/0022– 3514.37.10.1915. 8. Petty, R.E. and J.T. Cacioppo, ‘‘The Elaboration Likelihood Model of Persuasion.’’ Advances in Experimental Social Psychology, 19:123–205, 1986. doi: 10.1016/S0065–2601(08)60214–2. 9. Petty, R.E., J.T. Cacioppo, and R. Goldman, ‘‘Personal Involvement as a Determinant of Argument-Based Persuasion.’’ Journal of Personality and Social Psychology, 41:847–855, 1981. doi: 10.1037/0022– 3514.41.5.847. Dated: June 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–13734 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–D–1828] E19 Optimisation of Safety Data Collection; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘E19 Optimisation of Safety Data Collection.’’ The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some latestage pre- or postmarketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The draft guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information. DATES: Submit either electronic or written comments on the draft guidance by September 25, 2019 to ensure that the Agency considers your comment on SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–1828 for ‘‘E19 Optimisation of Safety Data Collection.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30724-30730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13734]


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

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: Notice.

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

SUMMARY: 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).

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 ``Disease Awareness and Prescription Drug Promotion on 
Television.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: 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, 
[email protected]. For copies of the questionnaire contact: Office 
of Prescription Drug Promotion (OPDP) Research Team, 
[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.

[[Page 30725]]

Disease Awareness and Prescription Drug Promotion on Television

OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    FDA's Center for Drug Evaluation and Research (CDER), Office of 
Prescription Drug Promotion (OPDP) is responsible for ensuring that 
prescription drug promotional materials are truthful, balanced, and 
accurately communicated. This project is being proposed as part of the 
research program of OPDP. OPDP's research program provides scientific 
evidence to help ensure that our policies related to prescription drug 
promotion will have the greatest benefit to public health. Toward that 
end, we have consistently conducted research to evaluate the aspects of 
prescription drug promotion that we believe are most central to our 
mission, focusing in particular on three main topic areas: Advertising 
features, including content and format; target populations; and 
research quality. Through the evaluation of advertising features we 
assess how elements such as graphics, format, and disease and product 
characteristics impact the communication and understanding of 
prescription drug risks and benefits; focusing on target populations 
allows us to evaluate how understanding of prescription drug risks and 
benefits may vary as a function of audience; and our focus on research 
quality aims at maximizing the quality of research data through 
analytical methodology development and investigation of sampling and 
response issues. This study falls under the topic of both target 
populations and advertising features.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is improved through the results of 
multiple converging studies, we continue to develop evidence to inform 
our thinking. We evaluate the results from our studies within the 
broader context of research and findings from other sources, and this 
larger body of knowledge collectively informs our policies as well as 
our research program. Our research is documented on our homepage, which 
can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research/office-prescription-drug-promotion-opdp-research. The 
website includes links to the latest Federal Register notices and peer-
reviewed publications produced by our office. The website maintains 
information on studies we have conducted, dating back to a direct-to-
consumer (DTC) survey conducted in 1999.
    The present research concerns disease awareness and prescription 
drug promotion communications on television. When pharmaceutical 
companies market a new drug, they often also release disease awareness 
communications about the medical condition the new drug is intended to 
treat (Refs. 1 and 2). FDA is interested in whether and to what extent 
this practice may result in consumers confusing or otherwise 
misinterpreting the different information and claims presented in 
disease awareness communications and prescription drug promotion. Prior 
research has documented that in both print (Ref. 3) and online (Ref. 4) 
contexts, consumers tend to conflate the information presented in 
prescription drug promotional materials with information presented in 
disease awareness communications. Specifically, the results of these 
studies suggest consumers incorrectly ascribe benefits to a 
prescription drug as a result of being exposed to information in a 
disease awareness communication that broadly describes the symptoms and 
negative consequences of the disease. There are ways in which this 
effect can be attenuated. For example, prior research has indicated 
that greater visual distinctiveness between the two ad types can 
ameliorate such confusion (Ref. 3). The present research seeks to 
extend previous studies of print and online promotion to the context of 
television promotion, and broadly examine the extent to which 
perceptual similarity between the two communication types, as well as 
their temporal proximity and exposure frequency, may lead to viewer 
confusion and the nature of that confusion.
    This research is being conducted to determine how the similarity, 
temporal positioning, and frequency of exposure to disease awareness 
communications and prescription drug television promotion impact 
consumer perception and understanding of the benefits and risks of a 
prescription drug product. These objectives will be achieved using two 
experimental studies. The first study will explore the impact on 
consumer perception and comprehension of different levels of temporal 
separation between the disease awareness communication and prescription 
drug promotion within a single period of television programming, as 
well as the level of similarity versus distinctiveness between these 
communication types. Temporal separation is defined as the spacing or 
proximity between the disease awareness communication and prescription 
drug promotion in the hour-long programming, for example, if they are 
shown back-to-back or if they are separated by other ads or television 
programming. Similarity/distinctiveness is defined by variations 
between the disease awareness communication and prescription drug 
promotion, including visual and presentation elements such as the 
setting, actors, and colors. The second study will experimentally 
examine the impact of disease awareness communication temporal 
separation and exposure frequency on consumer perception and 
comprehension. Temporal separation in this second study again refers to 
the spacing or proximity between the disease awareness communication 
and prescription drug promotion but is operationally defined as either 
1 day or 1 week. Exposure frequency is defined as the number of times 
that participants will view the disease awareness communication, either 
one, three, or six times. The results of this latter study will examine 
the practice of ``seeding the market,'' in which pharmaceutical 
companies release disease awareness communications before releasing 
product promotion communications. Similarity versus distinctiveness 
will also be examined in this study.
    We propose the following hypotheses for this research:

A. Study 1

    H1: Increased perceptual similarity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    H2: Increased temporal proximity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.

B. Study 2

    H1: Increased frequency of exposure to a disease awareness 
communication before exposure to a prescription drug promotion will 
result in significantly more conflation of the information presented in 
both pieces.
    H2: Increased temporal proximity between a disease awareness

[[Page 30726]]

communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    H3: Increased perceptual similarity between a disease awareness 
communication and a prescription drug promotion will result in 
significantly more conflation of the information presented in both 
pieces.
    In each instance, conflation is defined as the extent to which an 
individual remembers and attributes benefits to a product that is based 
on information presented in a disease awareness communication and not 
in the drug promotion.
    To address these hypotheses, Study 1 will employ a 3x4 factorial 
design in which participants are randomly assigned to one disease 
awareness communication condition, plus one control condition where 
participants will not view a disease awareness communication. The 
extent to which the disease awareness communication is perceptually 
similar to the product promotion communication will vary, as will the 
temporal separation of the disease awareness communication and product 
promotion communication. Table 1 depicts our design visually.

                                                          Table 1--Study 1 Experimental Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Disease awareness and product ad temporal separation
                                      Perceptual similarity --------------------------------------------------------------------------------------------
        Disease awareness ad              to product ad                                   Within same           In neighboring       In non-neighboring
                                                                  Back to back         commercial pod \1\      commercial pods        commercial pods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Yes................................  Similar...............
                                     Semi-similar..........
                                     Distinct..............
No.................................  N/A...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ A commercial pod refers to a group of ads into which the test ad is inserted, designed to simulate an advertising break during a television program.
  As depicted in table 2, by neighboring commercial pods, we mean commercial pods separated only by television programming and no other commercial pods.
  By non-neighboring commercial pods, we mean commercial pods separated by both television programming and one or more (one, as studied here) other
  commercial pods.


                                                                                    Table 2--Study 1 Sequence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Sequence
                               -----------------------------------------------------------------------------------------------------------------------------------------------------------------
           Condition                                                                                                                                                             2 min    5 min
                                6 min \1\  2 min \2\  5 min \1\  2 min \2\  5 min \1\  2 min \2\  5 min \1\  2 min \2\  6 min \1\  2 min \2\  5 min \1\  2 min \2\  5 min \1\     \2\      \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Back to back..................  .........  DA,P \3\.  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  DA, P...  .......
Same pod......................  .........  DA, P....  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  DA, P...  .......
Neighboring pods..............  .........  DA.......  .........  P........  .........  .........  .........  .........  .........  .........  .........  DA.......  .........  P.......  .......
Non-neighboring pods..........  .........  DA.......  .........  .........  .........  P........  .........  .........  .........  DA.......  .........  .........  .........  P.......  .......
Control.......................  .........  P........  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  .........  P.......  .......
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ TV Program.
\2\ Commercial Pod.
\3\ DA = Disease Awareness Communication; P = Product Promotion.

    Study 2 will employ a 2x2x3 factorial design in which participants 
are randomly assigned to one disease awareness communication condition. 
The varying factors in Study 2 are the temporal separation between the 
disease awareness and product promotion communication, the number of 
exposures to the disease awareness communication, and the perceptual 
similarity of the disease awareness communication to the product 
promotion communication. Table 3 visually depicts our design. Of note, 
to reduce the overall number of experimental conditions for Study 2, no 
semi-similar experimental condition is used.

                                      Table 3--Study 2 Experimental Design
----------------------------------------------------------------------------------------------------------------
                                                                   Exposures to disease awareness ad
   Time delay until product ad        Perceptual     -----------------------------------------------------------
 exposure (temporal separation)    similarity of ads     One exposure       Three exposures      Six exposures
----------------------------------------------------------------------------------------------------------------
One Day.........................  Similar...........
                                  Distinct..........
One Week........................  Similar...........
                                  Distinct..........
----------------------------------------------------------------------------------------------------------------


                                                                                    Table 4--Study 2 Sequence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Disease awareness ad exposure phase
                                                                  Product ad exposure phase
                                                                            --------------------------------------------------------------------------------------------------------------------
                                            Delay            Similarity      Day ------------------------------------------------------------------------------------------[rarr]
                                                                            --------------------------------------------------------------------------------------------------------------------
                                                                                  1        2        5        6        9       10       11       12       13       14       15       16       17
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Six Exposures......................  1 day.............  similar...........       x        x        x        x        x        x        x
                                                         distinct..........       x        x        x        x        x        x        x
                                     1 week............  similar...........       x        x        x        x        x        x                                                              x
                                                         distinct..........       x        x        x        x        x        x                                                              x

[[Page 30727]]

 
Three Exposures....................  1 day.............  similar...........                                  x        x        x        x
                                                         distinct..........                                  x        x        x        x
                                     1 week............  similar...........                                  x        x        x                                                              x
                                                         distinct..........                                  x        x        x                                                              x
One Exposure.......................  1 day.............  similar...........                                                    x        x
                                                         distinct..........                                                    x        x
                                     1 week............  similar...........                                                    x                                                              x
                                                         distinct..........                                                    x                                                              x
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Study 1 and 2 Sample. The targeted voluntary sample for both 
studies will comprise adults who self-report a current asthma 
diagnosis, a lifetime incidence of asthma, or experience a large number 
of asthma symptoms. These groups are believed to be very likely to be 
targeted by disease awareness and product promotion communications for 
asthma. The combined incidence rate of these groups is 22.2 percent 
(Refs. 5 and 6). In addition, several exclusion criteria are specified. 
These include: (1) Training or employment as a healthcare professional, 
(2) employment with a pharmaceutical company, an advertising agency, a 
market research company, or the Department of Health and Human 
Services, and (3) participation in market research within the past 3 
months on the topic of prescription drugs. Pretest participants will 
also be ineligible for the main study.
    Pretesting. Pretesting will take place before the main studies to 
evaluate the procedures used in the main studies. Each of the two 
pretests will have the same design as its respective main study 
(pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both 
pretests will be to: (1) Ensure that the mock stimuli are 
understandable, viewable, and delivering intended messages; (2) 
identify and eliminate any challenges to embedding the mock stimuli 
within the online survey; (3) ensure that survey questions are 
appropriate and meet the analytical goals of the research; and (4) 
pilot test the methods, including examining response rates and timing 
of survey. The two pretests will be conducted simultaneously.\1\ Based 
on pretest findings, we will refine the mock stimuli, survey questions, 
and data collection process, as necessary, to optimize the full-scale 
study conditions.
---------------------------------------------------------------------------

    \1\ Pretesting will be preceded by cognitive interviewing, not 
described here. Cognitive interviews are used to probe a small 
sample of participants on how and why they responded to various 
questions as they did, resulting in strong measurement instruments.
---------------------------------------------------------------------------

    Measurement. Our planned analyses are designed to address the key 
hypotheses. For both Study 1 and Study 2, we anticipate that the 
primary analysis will be analysis of variance to compare the main and 
interaction effects of the experimental factors.
    The focal dependent variable will be conflation--a measure of 
memory and perceptions regarding the promoted drug relative to the 
information presented in the disease awareness communication. 
Conflation will be measured by using the number of benefits that are 
incorrectly attributed to the prescription drug product based on 
responses to a number of both open-ended and closed-ended items.
    Other key dependent variables will reflect perceptions and 
attitudes toward the product ad. These include measures of:
    1. Perception of product promotion effectiveness;
    2. Behavioral intentions toward the drug;
    3. Perceived efficacy of the drug; and
    4. Perceived risks of the drug.
    In addition to the primary variables of interest, we have also 
identified potential covariates that will be included in the analyses:
    1. Knowledge about asthma;
    2. Health literacy; and
    3. Perceived ad effectiveness.
    We expect that knowledge about asthma and increased health literacy 
may moderate any conflation that results from ad similarity, temporal 
proximity, and frequency of exposure. Perceptions of promotion 
effectiveness, on the other hand, can be examined both as an outcome/
dependent variable but also as a covariate that examines involvement 
with the product promotion. Greater involvement may attenuate 
conflation in that it directs more in-depth processing of both the 
disease awareness communication and product promotion, and therefore 
more correct understanding of the claims in each (Refs. 7 to 9).
    In the Federal Register of October 17, 2018 (83 FR 52472), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six comments that were PRA 
related. Within those submissions, FDA received multiple comments that 
the Agency has addressed. Two additional comments were received that 
were not responsive to the four collection of information topics 
solicited and therefore are not discussed in this document.
    (Comment 1) Four comments suggested that FDA provide copies of 
stimuli in the Federal Register for public comment. Relatedly, one 
comment requested a copy of the participant consent documents.
    (Response) We have described the purpose of the study, the design, 
the population of interest, and have provided the questionnaire to 
numerous individuals upon request. Our full stimuli are under 
development during the PRA process. We do not make draft stimuli public 
during this time because of concerns that this may contaminate our 
participant pool and compromise the research. The consent form is 
available as part of the information collection submission to OMB.
    (Comment 2) Three comments expressed support for FDA's 
determination to take an evidence-informed approach to its regulation 
of sponsor communications.
    (Response) We appreciate this support.
    (Comment 3) Three comments suggested that selecting asthma 
sufferers as the target population limits the applicability of the 
results, or that asthma sufferers' prior knowledge regarding asthma may 
bias their responses.
    (Response) Researching each medical condition, or general 
population sample, requires significant resources. We are committed to 
conducting this research using our available resources while ensuring 
the integrity of the research by collecting data on a high prevalence 
condition (i.e., >20% incidence rate) for which participants might be 
thought of as sufficiently representative of the average consumer, thus 
allowing us to draw conclusions about broad perceptual and cognitive 
processing outcomes.
    (Comment 4) Three comments suggested that use of mock

[[Page 30728]]

advertisements, products, and environments do not represent what 
happens in the real world.
    (Response) In response to Federal Register notices for prior 
research under our research program, commenters have suggested the 
opposite, which is that use of real materials (i.e., existing drug ads) 
could have confounding results due to consumer familiarity with 
medicines and drug classes used to treat their existing condition. We 
sought to address this concern by utilizing realistic mock materials. 
Additionally, utilizing mock materials allows for precise manipulation 
of the stimuli fitting with our research questions and is the most 
common practice in the field.
    (Comment 5) Two comments expressed concern about use of 
``conflation'' as a dependent variable.
    (Response) The present research seeks to extend previous studies of 
print and online promotion to the context of television promotion and 
as such utilizes many of the same dependent measures, including the key 
dependent measure of ``conflation.'' Conflation as defined in this 
notice reflects the key outcome of interest given the research 
questions posed and therefore has been retained.
    (Comment 6) Two comments suggested that the open-ended response 
questions are open to interpretation and data variability and 
encouraged FDA to revise these to close-ended questions.
    (Response) The purpose of the open-ended items is to measure 
unaided participant recall of claims made in the prescription drug 
promotion. These responses will be content coded using an inductive 
approach and numeric codes will be assigned to the open-ended 
responses. Quantifying open-ended responses provides structure and 
reduces the interpretation associated with a qualitative coding scheme. 
After sanitizing open-ended comments (removing obscenities, proper 
names, and any case-specific information), two reviewers will read the 
responses and develop a coding scheme to establish theme descriptions, 
numeric codes, and coding rules. Two coders will receive training and 
will code 25 percent of the responses. After achieving high inter-coder 
reliability (e.g., [kappa]appa = .75), the remaining responses will be 
divided between the coders. Open-ended coding will then be merged with 
the data set for analysis. Additionally, we have tested these response 
options in cognitive interviewing and found them to be effective for 
their intended purpose. We have also received positive feedback on 
these measures from our consultations with expert peer reviewers. These 
measures have therefore been retained.
    (Comment 7) Two comments suggested adding a control condition to 
Study 2 whereby participants only see the prescription drug product ad 
before completing the survey.
    (Response) For Study 2, the primary questions are related to both 
frequency of exposure and delay. A control condition that features no 
disease awareness communications makes the delay factor redundant, and 
comparisons can be made between no exposure and repeated exposure. 
Therefore, a control condition for Study 2 is unnecessary given the 
current design.
    (Comment 8) Two comments suggested that Studies 1 and 2 are highly 
similar and thus only one study needs to be conducted. One of these 
comments suggested dropping Study 2 and utilizing the resources that 
would have been allotted to instead create different iterations of 
temporal separation for Study 1.
    (Response) Studies 1 and 2 include overlap in their independent and 
dependent variables. However, they are unique in that Study 1 will 
explore outcomes within a single period of television programming, 
whereas Study 2 will examine outcomes over time mirroring the practice 
of ``seeding the market,'' in which pharmaceutical companies release 
disease awareness communications before releasing product promotion 
communications. Both studies offer significant and unique value to FDA 
and therefore both studies have been retained.
    (Comment 9) One comment suggested separating recall of the ad from 
recall of the product into separate questions.
    (Response) The question reads, ``Do you recall seeing a commercial 
for [Drug X], a prescription product for asthma?'' This question is 
intended to assess recall of the commercial for [Drug X] and is not 
intended to assess recall for this fictitious product beyond this 
commercial. We hope this clarification is helpful for understanding why 
we intend to retain the present version of this question.
    (Comment 10) One comment suggested that pretesting be conducted to 
ensure that stimuli reflect the intended manipulations.
    (Response) FDA intends to conduct both cognitive interviewing and 
pretesting to ensure the stimuli reflect the intended manipulations.
    (Comment 11) One comment suggests that the proposed research 
overlooks the positive aspects of disease awareness campaigns, and to 
address this, steps can be taken such as adding questions about 
behavioral intentions to the questionnaire.
    (Response) FDA acknowledges that there are positive aspects of 
disease awareness campaigns. This research is intended to evaluate 
specific research questions as outlined in the 60-day Federal Register 
notice and therefore dependent measures align with these research 
questions. As an overall strategy to reduce participant burden, we do 
not intend to ask questions that do not inform these research 
questions.
    (Comment 12) One comment suggested relocating non-terminating 
screening questions to the end of the questionnaire to reduce 
participant fatigue.
    (Response) The purpose of including the screening items at the 
beginning of the questionnaire is to ensure a diverse sample using 
predetermined quotas, and for required statistical analyses following 
completion of the data collection. Retaining the screening items at the 
beginning of the questionnaire will allow for comparisons between non-
respondents and respondents.
    (Comment 13) One comment suggested adding a ``Don't know'' response 
option wherever applicable.
    (Response) We understand the value of providing such responses for 
items of a factual nature. The drawback to providing such response 
options to these questions, however, is that we may lose information by 
allowing respondents to choose an easy response instead of giving the 
item some thought. Research has demonstrated that providing ``no 
opinion'' options likely results in the loss of data without any 
corresponding increase in the quality of the data. Thus, we prefer not 
to add these options to the survey.
    (Comment 14) One comment suggested that FDA develop a clear, 
overarching research agenda and provide a comprehensive list of its 
prescription drug promotion studies.
    (Response) The 60-day Federal Register notice for this study 
describes OPDP's research agenda, how this study fits into that agenda, 
and provides the web address of OPDP's research page, which includes 
links to the latest Federal Register notices and peer-reviewed 
publications produced by our office. The website maintains information 
on studies we have conducted, dating back to a DTC survey conducted in 
1999.
    (Comment 15) One comment suggested that the current research 
duplicates prior work conducted in online and print contexts.
    (Response) The present research seeks to extend previous studies of 
print and online promotion to the context of television promotion. In 
previous Federal Register notices under our

[[Page 30729]]

research program, we have been advised by commenters that findings for 
one form of advertising should not be assumed to broadly apply to other 
forms of advertising. Additionally, we note that the present research 
includes unique elements beyond advertising format that have not 
previously been studied. An example of this is assessment of ``seeding 
the market'' in Study 2 whereby sponsors initially release a disease 
awareness ad for a period of time, followed by release of a product 
promotion ad.
    (Comment 16) One comment suggested that the time commitment 
required for participation may result in a self-selected sample of 
individuals with more time available (e.g., students).
    (Response) Participants will be recruited through online panels, 
which include a diverse range of participants in regard to age, race/
ethnicity, income, education, and employment. We also have proposed the 
use of soft quotas to further ensure that we will recruit a diverse 
sample. Finally, we were able to recruit a diverse sample for cognitive 
interviewing and although a smaller sample size than will be recruited 
for the pretests and main studies, the sample was not overrepresented 
in any demographic categories.
    (Comment 17) One comment suggested that the calculated burden is 
appropriate but requested additional detail about other requirements 
that may add to burden in addition to the time in the study itself.
    (Response) Data collection will occur online, so the burden 
estimate reflects time spent answering the screener, stimuli viewing, 
survey completion, thus reflecting overall study time and requirements.
    (Comment 18) One comment identified errors in the questionnaire.
    (Response) Thank you for noting these errors. All identified errors 
have been fixed.
    (Comment 19) One comment suggested adding intermediate response 
values to questions that omitted them (e.g., 1 = no improvement, to 6 = 
substantial improvement).
    (Response) These questions were developed through scale validation 
research. We did not encounter any confusion on the part of respondents 
during cognitive testing of the questionnaire. We will retain these 
questions in their original form.
    (Comment 20) One comment suggested that because ``prescription drug 
information'' has become a political topic in recent years, the 
introduction to the questionnaire should be revised to avoid saying 
that ``[w]e will use your feedback to. . .improve prescription drug 
information for people like you.'' The concern is that this information 
may bias responses depending on participant views of ``prescription 
drug information.''
    (Response) The proposed research concerns prescription drug 
information and so we need to provide this context to participants to 
orient them to the questions that follow. Moreover, institutional 
review boards typically require transparency about the topic of the 
research. We have therefore retained this language in our study 
materials.
    (Comment 21) One comment noted that ``[p]erceptions of promotion 
effectiveness'' is described as both a dependent variable and a 
covariate, and to avoid distortion in the model, recommends selection 
of a different covariate.
    (Response) Perception of promotion effectiveness is described as a 
dependent variable, differing from perceived ad effectiveness, which 
measures perception of the disease awareness communications. The 
purpose of including perceived ad effectiveness as a covariate is that 
perception of the disease awareness communications may directly affect 
conflation, which could require statistical adjustment.
    (Comment 22) One comment suggested expanding the participant 
exclusion criteria to include individuals studying health fields and 
product marketing (beyond pharmaceuticals).
    (Response) We currently exclude individuals who work for a 
pharmaceutical company, an advertising agency, a market research 
company, or the Department of Health and Human Services. These criteria 
exclude individuals working in advertising or market research beyond 
pharmaceuticals, but do not necessarily exclude students studying these 
fields. To ensure a diverse sample, we generally aim to limit our 
exclusion criteria. However, please note that random assignment to 
experimental condition should ensure that these individuals are 
approximately evenly distributed across conditions.
    (Comment 23) One comment requested information about how learning 
effects would be controlled for given the multiple exposures.
    (Response) For Study 2, learning effects are accounted for by the 
exposure frequency manipulation. Participants are randomly assigned to 
see the disease awareness ad once, three times, or six times. For Study 
1, all participants see the ads the same number of times, except 
participants randomly assigned to the control condition who do not see 
the disease awareness ad.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of
               Activity                    Number of     responses per   Total annual              Average burden per response              Total hours
                                          respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Pretest screener..............             385               1             385  0.08 (~5 minutes)...............................              31
Study 2 Pretest screener..............             329               1             329  0.08 (~5 minutes)...............................              26
Study 1 screener......................           3,007               1           3,007  0.08 (~5 minutes)...............................             241
Study 2 screener......................           2,643               1           2,643  0.08 (~5 minutes)...............................             211
Study 1 Pretest.......................             270               1             270  1.33 (~1 hour 20 minutes).......................             360
Study 2 Pretest.......................             158               1             158  0.53 (~32 minutes)..............................              84
Study 1...............................           2,105               1           2,105  1.33 (~1 hour 20 minutes).......................           2,800
Study 2...............................           1,269               1           1,269  0.53 (~32 minutes)..............................             673
                                       -----------------------------------------------------------------------------------------------------------------
    Total.............................  ..............  ..............  ..............  ................................................           4,426
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 30730]]

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. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

1. Bulik, B.S. (March 11, 2018). ``Unbranded Pharma Ads--What Are 
They Good For? Actually Quite a Bit, Marketing Panelists Say.'' 
Available at https://www.fiercepharma.com/marketing/unbranded-pharma-ad-what-are-they-good-for-actually-quite-a-bit-marketer-panelists-say?mkt_tok=eyJpIjoiWkRnelpUSmlORFpoWkdNMSIsInQiOiJPaENIUERpT0tnUmt6Y1BPMk9LTnpreUI3bUtPOVRzRnh1RzNuWUtYQmp0cWJhcW05UFhlcllwTzI3V0RJSndjVkZLR3NGUHBLamJOZmJSK2FZeWtIVXczeFRFcmtEV0NFaVdCSjArUmx4dUlRVHZpUzFFOWlVY0dNb1RzOU9XayJ9&mrkid=20932234. Accessed on April 12th, 2019.
2. Bulik, B.S. (December 21, 2016). ``Avanir Shelves Danny Glover 
PBA Awareness Ad in Favor of Branded Nuedexta Effort.'' Available at 
https://www.fiercepharma.com/marketing/avanir-launches-nuedexta-brand-campaign-retires-danny-glover-pba-disease-awareness-ad. 
Accessed on April 12, 2019.
3. * Aikin, K.J., H.W. Sullivan, and K.R. Betts, ``Disease 
Information in Direct-to-Consumer Prescription Drug Print Ads.'' 
Journal of Health Communication, 21:228-239, 2016.
4. * Sullivan, H.W., A.C. O'Donoghue, D.J. Rupert, et al., ``Are 
Disease Awareness Links on Prescription Drug websites Misleading? A 
Randomized Study.'' Journal of Health Communication, 21:1198-1207, 
2016.
5. * Centers for Disease Control and Prevention. (2018a, May 18). 
``2016 National Health Interview Survey (NHIS) Data.'' Retrieved 
from https://www.cdc.gov/asthma/nhis/2016/table2-1.htm.
6. * Centers for Disease Control and Prevention. (2018b, May 15). 
``Most Recent Asthma Data.'' Retrieved from https://www.cdc.gov/asthma/most_recent_data.htm.
7. Petty, R.E. and J.T. Cacioppo, ``Issue Involvement Can Increase 
or Decrease Persuasion by Enhancing Message-Relevant Cognitive 
Responses.'' Journal of Personality and Social Psychology, 37:1915-
1926, 1979. doi: 10.1037/0022-3514.37.10.1915.
8. Petty, R.E. and J.T. Cacioppo, ``The Elaboration Likelihood Model 
of Persuasion.'' Advances in Experimental Social Psychology, 19:123-
205, 1986. doi: 10.1016/S0065-2601(08)60214-2.
9. Petty, R.E., J.T. Cacioppo, and R. Goldman, ``Personal 
Involvement as a Determinant of Argument-Based Persuasion.'' Journal 
of Personality and Social Psychology, 41:847-855, 1981. doi: 
10.1037/0022-3514.41.5.847.

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13734 Filed 6-26-19; 8:45 am]
 BILLING CODE 4164-01-P