81 FR 73410 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animation in Direct-to-Consumer Advertising
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 206 (October 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 206 (October 25, 2016)
| Page Range | 73410-73416 | |
| FR Document | 2016-25727 |
[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)] [Notices] [Pages 73410-73416] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25727] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0538] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animation in Direct- to-Consumer Advertising 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 November 25, 2016. 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 ``Animation in Direct-to-Consumer Advertising.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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. Animation in Direct-to-Consumer Advertising OMB Control Number 0910-NEW Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(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. Advertisers use many techniques to increase consumer interest in their ads, including the use of animated spokes-characters. These characters may be fictional or nonfictional and human or nonhuman (Ref. 1). Despite variations in form, animated characters are often used to grab attention, increase ad memorability, and enhance persuasion to ultimately drive behavior (Refs. 2-4). Animated characters have long been used for low-involvement products (e.g., food products) and have made their way into direct-to-consumer (DTC) prescription drug advertising. However, to our knowledge, one study (Ref. 5) has examined how animation affects attitudes toward products and risk perceptions in drug ads, and no studies have examined how various animation strategies (e.g., symbolizing the disease vs. the benefit) and product characteristics (e.g., low-risk medication vs. high-risk medication) influence these perceptions. [[Page 73411]] Animation in Drug Ads. Animation is used in prescription drug ads in a variety of ways. Perhaps the simplest way is the use of rotoscoped animation, which involves tracing live-action images frame-by-frame to create animated characters. ABILIFY has used this technique in advertisements (Ref. 6). In this instance, the animated character was not central to the informational content of the ad; instead, the animation appeared to be a visual technique to attract attention. Whether a drug ad with a rotoscoped human results in greater comprehension of product benefit and risk information than an ad with a human actor is unclear. The few studies that have examined this technique in drug ads have found that animated human characters either had no effect on perceived product risk (Ref. 7) or led to poorer recognition of drug side effects (Ref. 6). Animation also has been used in drug ads to symbolize the disease (e.g., IMITREX and LAMISIL ads), the sufferer (e.g., MYBETRIQ and ZOLOFT), the benefit (e.g., ROZEREM), the mode of administration (e.g., FLUZONE), and the mechanism of action (e.g., LUNESTA). Drug companies may use a personified nonhuman character to illustrate, in a visually memorable way, the medical condition or drug attributes. Using secondary data from copy-testing studies, Pashupati found that drug ads featuring animated characters led to much stronger brand recall and brand association scores (Ref. 8); however, the other elements of these studies (e.g., ad characteristics, presence of control group) are unclear. Animated characters may provide marketers with a way to explain product benefits in an engaging and even humorous manner. Thus, the majority of research on animated characters in advertising focuses on outcomes such as product evaluations (Ref. 9), emotional responses (Refs. 1, 10-11), brand attitudes (Ref. 12), and perceived product value (Ref. 13). The extent to which emotional responses can be fostered by animated characters is especially relevant to this study, as the positive effects these animations induce might transfer to the brands being advertised. It is also possible that animated characters may lead to lower perceived risk by minimizing or camouflaging side effects (Ref. 14). Animation and Message Communication. Personifying animated characters may interfere with message communication. Although personification may increase involvement with the characters in the ad (i.e., perceived as engaging and likeable), it may not increase involvement with the message itself (e.g., risk and benefit information). Whether personified characters lead to reduced comprehension of risk and benefit information in drug ads is an important and unanswered question. Based on a theory called the limited capacity model of mediated message processing (Ref. 15), advertising content that is engaging, relevant, and maximizes audio/visual redundancy should improve learning and memory (Ref. 16). However, others argue that the entertainment aspects can distract from learning key information and may lead to message complexity that interferes with message communication (Ref. 17). It is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk, or otherwise hinders comprehension of drug risks and benefits. To investigate these issues, we will conduct a two-part experimental study to examine how: (1) Type of animation and (2) nonhuman personification in drug ads influence consumer comprehension, processing, and perception of risk and benefit information. Understanding how issues of animation and personification affect perceptions of both risks and benefits can inform FDA regarding how prescription drug risk and benefit information is processed. These strategies will be examined across two different medical conditions to see if the findings are consistent across patient populations. General Research Questions 1. How does consumer processing of a DTC prescription drug ad differ depending on whether the ad is live-action, rotoscoped, or animated? 2. Does consumer processing differ depending on whether the sufferer, the disease, or the benefit is the focus of the animation? Design To test these research questions, we will conduct two experiments. Both experiments will be examined in two different medical conditions: Chronic dry eye and psoriasis. The mock drugs we will create for these conditions mimic currently available medications and were chosen for their variance in serious side effects, i.e., medications for psoriasis have very long, serious lists of risks and side effects, whereas chronic dry eye medications have relatively few risks and side effects. The first experiment will examine whether animation itself influences consumer processing, defined as consumer recall of risks and benefits, perceptions of risks and benefits, and attitudes and emotional responses to the ad, the brand, the product, and the character (table 1). We will examine two different types of animation in addition to a control ad which will be shot with live actors: An ``in-between'' animation technique, rotoscoping, in which live scenes are drawn to look animated, and full animation with nonhuman characters. The live action and rotoscoped ad will be identical except for the rotoscope treatment. The animated ad will follow the theme and message as closely as possible within the limitations of animation itself. The benefits and risks of the product will be identical, although the ad's storyline may vary somewhat to account for a nonhuman protagonist. Table 1--Experiment 1: Animation Design ---------------------------------------------------------------------------------------------------------------- Type of Animation ----------------------------------------------------------------------------------------------------------------- Nonhuman Rotoscoped Medical condition sufferer human sufferer Human sufferer ---------------------------------------------------------------------------------------------------------------- Chronic Dry Eye..............................................Psoriasis.................................................... ---------------------------------------------------------------------------------------------------------------- The second experiment will examine whether the object of the animation influences consumer processing of the ad (table 2), defined as consumer recall of risks and benefits, perceptions of risks and benefits, and attitudes and emotional responses to the ad, the brand, the product, and the character. The animation will focus on the animated character who will personify either the sufferer of the medical condition, the disease itself, or the [[Page 73412]] benefit from the drug. In this study, all ads will contain the same kind of full animation and the general theme will be as similar as possible, accounting for the variations in focus of character. The experiments will be conducted concurrently, and the same participants in the nonhuman sufferer groups will be part of both. Table 2--Experiment 2: Personification Design ---------------------------------------------------------------------------------------------------------------- Nonhuman Personification ----------------------------------------------------------------------------------------------------------------- Medical condition Sufferer Disease Benefit ---------------------------------------------------------------------------------------------------------------- Chronic Dry Eye.............................................. Psoriasis.................................................... ---------------------------------------------------------------------------------------------------------------- In both cases, a professional firm will create all ads such that they are indistinguishable from currently running DTC ads. Pretesting will take place before the main study to evaluate the procedures and measures used in the main study. We will recruit adults who have experienced chronic dry eye or psoriasis. We will exclude individuals who work in healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. We propose to test 300 participants for the pretest. Each experiment will include 30 participants per condition for a total of 180 participants each, but 60 of those in the nonhuman sufferer conditions will overlap between the two experiments. We will need 1,500 unique participants for the main study to obtain 90 percent power to detect a moderately small effect size. There will be 150 participants per condition for a total of 900 participants in each experiment, with 300 participants in the overlapping nonhuman sufferer conditions. In both experiments, participants who have been diagnosed with either chronic dry eye or psoriasis will be recruited via an opt-in Internet panel to watch one ad for a prescription drug that treats their medical condition. In experiment 1, participants will be randomly assigned to view either a live-action, rotoscoped, or fully animated ad. All themes in experiment 1 will focus on the main character as the sufferer of the condition. In experiment 2, participants will be randomly assigned to a personification condition: Sufferer, disease, or benefit. All ads in experiment 2 will be fully animated. Participants will watch the ad once and then answer an online survey with questions addressing recall of risks and benefits, perceptions of risks and benefits, and attitudes and emotional responses to the ad, the brand, the product, and the character. The questionnaire is available upon request. Participation is estimated to take approximately 25 minutes. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With online surveys, several participants may be completing the survey at the time that the total target sample is reached. Those participants are allowed to complete the survey, which can result in the number of completes going slightly over the target number. Thus, our target number of completes is 1,500, so we have rounded up by an additional 150, or 10 percent, to allow for some overage. In the Federal Register of March 2, 2016 (81 FR 10867), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received a number of comments as enumerated and discussed here. Of these comments, 22 were out of the scope of the proposed project (``Ban DTC'' or ``Ban animated DTC''). 1. AbbVie (Comment 1) Note that the accuracy of the findings will be highly dependent on the quality of the stimuli (i.e., the animation). (Response 1) We agree. 2. Lilly (Comment 2) Assume that stimuli will conform to FDA regulations and standards. (Response 2) Reviewers from the Office of Prescription Drug Promotion have been involved throughout the development of the stimuli to ensure that the mock ads conform to FDA regulations and standards. (Comment 3) Question the use of such a large (n = 300) pretest and recommends the use of a qualitative, in-person pretest. (Response 3) Before the pretests and main studies are conducted, we will conduct nine cognitive interviews to obtain verbal in-person feedback on the questionnaires and the stimuli. We believe this will accomplish what this commenter is suggesting. The pretest is designed to test procedures, verify that the online questionnaire is working as intended, identify and correct any challenges to nesting the stimuli within the questionnaire, and examine data trends to check that the manipulations and questionnaire items are appropriate. A qualitative in-person pretest would not meet those objectives. (Comment 4) Recommend screening and quotas by length of time since diagnosis as this may influence the urgency with which individuals watch the ads and their familiarity with previous treatments. (Response 4) We have included a question toward the end of the questionnaire to measure time since diagnosis, which will enable us to assess its association with attention to the ad and statistically control for it if necessary. However, statistical control will likely be unnecessary, since random assignment to conditions in our study design should prevent there from being systematic differences among groups in time since diagnosis or any other extraneous variable. (Comment 5) For question 5, the item ``think rather than feel'' seems out of place in the question bank and Lilly recommends deletion. (Response 5) The items in Question 5 make up a validated scale developed by Stephenson and Palmgreen (Ref. 18). Niederdeppe (Ref. 19) used the same scale items to measure cognitive processing. There may be psychometric consequences to deleting this item--in other words, the reliability of the scale may be reduced if we remove this item. Since it was previously validated as a scale, we will maintain the item. (Comment 6) Questions 6 and 8 (``In your opinion, if 100 people take [DRUG X], for how many will the drug work?'') may be difficult to answer, as pharmaceutical ads rarely have specific side effect information. Recommend changing to ask how frequently side effects will occur, from ``very frequent'' to ``never occurs.'' (Response 6) We agree and will revise these questions to focus on perceived frequency or likelihood of side effects and efficacy in more general terms. (Comment 7) Questions 13 and 14 (overall comprehension closed-ended [[Page 73413]] questions) may be too difficult to answer because they are nuanced and involve multiple concepts. Recommend changing to an open-ended response. (Response 7) We appreciate the commenter's concerns about the complexity of the response options. We will examine the closed-ended questions in cognitive testing, with careful attention to participant's ability to understand and choose among the response options. If participants have notable difficulty with the closed-ended questions, we will revise them to enhance accessibility, or we will replace those items with open-ended items. (Comment 8) Question 16b for Chronic Dry Eye does not have any question or response options. (Response 8) We have since developed question and response options for this item. (Comment 9) Recommend moving questions 17-28 to before question 15 because questions 15 and 16 are specific and starting with question 17, questions again refer to general ad perceptions. (Response 9) We always approach question ordering carefully, attempting to balance a number of considerations, including the reduction of bias from one question to another, flow, and importance of each item. In this case, we feel that specific claim comprehension is more important than the other more general questions in our questionnaire, which is why they are placed afterwards. We will examine this issue closer in cognitive testing. (Comment 10) Recommend reducing question 18 to only ``like/ dislike'' because the results will be too similar and will be confounded. (Response 10) We selected these items because they have been used consistently in past research. We use three items rather than one to achieve reliability, which provides a fuller understanding of the dependent variable. However, we will pay close attention to this in cognitive testing to ensure that participants are not confused or annoyed by the three questions. (Comment 11) For question 21, recommend adding clarifying language: ``. . . in terms of dealing with your psoriasis/chronic dry eye'' to provide context for participant to understand how to compare themselves with the character. (Response 11) We will present the additional context as an alternative way of asking the question in cognitive interviews. (Comment 12) Recommend removing question 26 about how ``eerie'' the character is because the essence of this question is answered in question 25 and the question is leading, as it directs participants to respond only negatively about their perceptions of the character. (Response 12) Given the uncanny valley theory concerning rotoscoped images (Ref. 6), we feel it is crucial to maintain this specific question about the eeriness of the character. (Comment 13) Recommend adding an open-ended question, preferably near the beginning of the survey (e.g., after question 2), about how well they feel they took away all of the relevant information and understood the risks and benefits of the drug after viewing the ad. (Response 13) Although we do not include questions that directly measure perceived understanding of the overall message, risks, and benefits, much of the questionnaire is focused on measuring participants' memory and comprehension of that information in the ad. (Comment 14) Recommend adding demographic questions about how much television participants watch per week and whether English is their primary language to provide extra detail for analyses. (Response 14) We appreciate this suggestion and will add the recommended demographic items to the questionnaire. (Comment 15) Recommend adding another open-ended question about whether any additional information could have or should have been included in the ad (e.g., disease information, accessibility of the drug) to provide information on what participants feel could be added and communicated via DTC ads. (Response 15) This is a great question and may provide fruitful avenues for future research. We will include the item in the pretest and if timing is not an issue, we will maintain it in the main study. 3. Merck (Comment 16) Concerned that execution-specific learnings from this research may not translate readily into FDA DTC policy/guidance. The research may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions. (Response 16) On the contrary, this particular study has the potential to directly influence policy in an area that we have no prior research on. We have attempted to address the execution-specific nature of the research by investigating our questions in two distinct medical conditions with two distinct products and ad executions. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to. (Comment 17) FDA should conduct research on how all of the elements investigated previously combine to influence DTC viewing. (Response 17) We appreciate this suggestion and will look for opportunities to do so in the future. Note we have conducted research combining the results of two previous studies--toll-free wording and distraction--in our recent eye-tracking study. 4. GSK (Comment 18) Suggests a number of additional reasons for animation besides those stated in the FRN: Education, to help consumers quickly identify relevant ads, and to de-personalize an ad to make it more relevant to a variety of people. (Response 18) We will keep these in mind in writing up the results of the studies. (Comment 19) The proposed research may oversimplify animation by not incorporating multiple types of animation or examining ads that are 100 percent versus partially animated, and thus be unlikely to yield any general conclusions about the use of animation. (Response 19) We acknowledge that we are not studying all types and executions of animation. As the first study of its kind, we feel the animation manipulations that we propose to examine will provide information on a reasonable number of variations (i.e., full animation, rotoscoping, and three different foci of animated character). We will ensure that our conclusions are reasonable with regard to the issues we studied. (Comment 20) The proposed methodology fails to measure the relevance of the ads. A copy-testing methodology, whereby the ads are embedded in a clutter reel, may more accurately gauge the recall of risks and benefits that might occur in the real world. (Response 20) We needed to make difficult choices in this study, as in all of our studies, regarding the tradeoff between experimental control and real-world generalizability. Given the lack of data available regarding animation in DTC, we chose to err on the side of experimental control in this study. Our [[Page 73414]] research questions involve the issue of recall and comprehension of the ads when people have watched the ads. Depending on the findings of the current study, further research examining the effects of animation within a clutter reel or considering other variables may be warranted. (Comment 21) Advertising concepts are generally not designed to be adapted or translated to different creative formats, and because whether an ad is animated or in live action is an integral part of the concept itself, this is an inherent limitation of the research. (Response 21) We agree that animated ads often have different storylines or different approaches to conveying information from live action ads. However, if we were to use completely different ads for our animated, rotoscoped, and live-action ads, we would be unable to determine what caused any differences in our dependent variables. Indeed, by maintaining as much similarity as possible among these three conditions, we will be able to determine whether it is the animation form per se that causes differences or not. 5. Regeneron Pharmaceuticals (Comment 22) Encourage FDA to acknowledge that this study is exploratory and that results will not be generalizable beyond the two medical conditions studied. (Response 22) We acknowledge that this is the first study to directly examine animation in DTC advertising. We are always mindful of how far we can extrapolate our research. We chose to examine two different medical conditions because this will provide some assurance that our findings are not exclusive to one medical condition or execution, if that is what we find. We note that the strength of the study is in its experimental design. Participants will be randomly assigned to cells, which will allow us to determine whether differences exist between different levels of our independent variables. Random assignment will somewhat allay concerns about demographic differences and other individual characteristics, which should even out across cells. However, we agree that other medical situations may cause different reactions and we will acknowledge the limitations of our study, which include not examining all medical conditions and levels of risk, in any writeup we produce. (Comment 24) The major statement is required to be in the audio and the amount and type of risk information will vary by drug. We request that the professional ad agency designing the TV ads ensure that the major statement is presented consistently across the ads studied for the given ``mock drug.'' (Response 24) We have designed the fictitious ads to very closely align with both FDA policies and with the types of DTC ads that currently air on TV. Our ads have been reviewed by staffers in the Office of Prescription Drug Promotion multiple times throughout the ads' development. The mock products closely mimic existing drugs in their respective classes. We agree that the quality of the ads strongly influences the success of our research and the professional development of these ads is a high priority. (Comment 25) An imbalance of gender distribution in the diseases and study groups could skew the results due to potential gender differences in consumer processing and perception of information from drug ads. To ensure a gender balance between the study groups, we propose a randomization scheme stratified by gender. Also, please capture patient demographic information and important confounding factors and report on a comparison of the baseline patient characteristics. (Response 25) Stratified randomization by gender would be methodologically appropriate and conservative, but in practice would make our already complex survey even more complicated. We will acknowledge a potential gender-disease confound as a limitation of the design in reports of the results. (Comment 26) While the results from this proposed study may suggest hypotheses on difference in how prescription drug risk and benefit information may be perceived by consumers viewing live versus animation ads, the results from this study should not be used to guide or influence FDA's current thinking on the use of animation in DTC ads. More robust and controlled studies will be required in the future to test specific hypotheses generated from this two-part survey experiment. (Response 26) Although this is the first study to directly examine animation in DTC ads the way we have proposed here, the research we have designed is robust and well controlled. As trained research psychologists, we adhere to the highest standards in terms of rigorous control, prespecified hypotheses, appropriate statistical analyses, and reasonable and responsible interpretations. Our research undergoes many internal and external reviews before and after data collection, including a stringent OMB review (of which public comment is a part), multiple levels of internal clearance, and peer review at well- respected academic journals in relevant fields. Although FDA never exclusively uses the findings of one scientific study to make policy decisions, the quantitative research we conduct is one part of the calculus that FDA uses to inform policy decisions. 6. AstraZeneca (Comment 27) Recommend that questions 18 and 19 be switched in order to avoid participants being confused by the questions. Also suggest some kind of bolding for emphasis. (Response 27) We agree that formatting these questions to emphasize and differentiate the target object will be useful and have no problem changing the order of questions 18 and 19 and will do so. (Comment 28) The term ``main character'' needs to be clarified. As it is, it could mean the human character or the animated character which may, or may not, be the human character. (Response 28) Participants will only view one version of the ad corresponding to the ad condition to which they've been randomized, and each ad will either be animated or live action. In terms of screen time and storyline, a single character will be dominant in each ad. We do not expect ambiguity surrounding who the main character is in each ad, but we will test this phrase in cognitive interviewing. (Comment 29) For question 23, the commenter agrees that trust is a useful metric to study but questions whether our options are valid measures of trust, particularly ``ethical.'' Suggest the use of the following adjectives instead: Exaggerated, deceptive, manipulative, trustworthy, informative, credible. (Response 29) The negative adjectives on the list are from an existing scale (Refs. 20-21) and we would like to keep those consistent with the prior literature. We will revise the positive adjectives to reflect the commenter's suggestion: Trustworthy, informative, credible, and reliable. (Comment 30) For questions 24 and 25, suggest the addition of ``hopeful,'' ``empowered,'' and ``informed.'' (Response 30) The emotional reaction questions were adapted from existing scales (Ref. 22), but we think it would be useful to test a longer set of emotions in cognitive interviews and narrow down from there. (Comment 31) We feel that question 26 should be deleted because it is a leading question. If not deleted, change ``eerie'' to ``strange.'' (Response 31) We agree that this is an unusual question and may seem offputting without context. However, [[Page 73415]] previous research has compared live action and rotoscoped action in advertisements and has determined that people feel uncomfortable with rotoscoping because it is very similar to what we expect from live renditions, but not exactly. This theory is called the uncanny valley theory (Ref. 6). Question 26 comes directly from this previous research and we feel strongly that we need the question as it is to ground our comparison of live action and rotoscoping in the prior literature. (Comment 32) Question 29 about anthropomorphism seems inappropriate to gauge audience acceptance of the premise. Suggest using a question such as: ``To what extent do/can bodily organs or pills have personalities?'' (Response 32) The purpose of question 29 is to measure an individual difference variable, namely to what extent people tend to anthropomorphize. The question is modified from a validated measure (Ref. 23). We do not intend to assess people's acceptance of animated DTC ads through this question. Instead, we are using this as a possible moderator variable to explain some of the variance we might find in responses to other questions. Indeed, another commenter wrote that we should measure demographics and other possibly confounding variables. This is one of these variables. The amount of humanization people ascribe to nonhuman objects may influence their attitudes and perceptions, and these items have been validated in past research. It is not an outcome measure. FDA estimates the burden of this collection of information as follows: Table 3--Estimated Burden ---------------------------------------------------------------------------------------------------------------- Number of Average burden Activity Number of responses per Total annual per response (in Total hours respondents respondent responses hours) ---------------------------------------------------------------------------------------------------------------- Pretesting ---------------------------------------------------------------------------------------------------------------- Number to complete the 660 1 660 .08 (5 minutes). 53 screener (assumes 50% eligible). Number of completes........... 330 1 330 .42 (25 minutes) 139 ---------------------------------------------------------------------------------------------------------------- Main Study ---------------------------------------------------------------------------------------------------------------- Number to complete the 3,300 1 3,300 .08 (5 minutes). 264 screener (assumes 50% eligible). Number of completes........... 1,650 1 1,650 .42 (25 minutes) 693 --------------------------------------------------------------------------------- Total Hours............... .............. .............. .............. ................ 1,149 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. References 1. Callcott, M.F. and W. Lee, ``Establishing the Spokes-Character in Academic Inquiry: Historical Overview and Framework for Definition.'' Advances in Consumer Research. 1995; 22:144-151. 2. Bell, J.A., ``Creativity, TV Commercial Popularity, and Advertising Expenditures.'' International Journal of Advertising. 1992;11(2):165-72. 3. Heiser, R.S., J.J. Sierra, and I.M. Torres, ``Creativity Via Cartoon Spokespeople in Print Ads: Capitalizing on the Distinctiveness Effect.'' Journal of Advertising. 2008;37(4):75-85. 4. Luo, J.T., P. McGoldrick, S. Beatty, and K.A. Keeling, ``On- Screen Characters: Their Design and Influence on Consumer Trust.'' Journal of Service Marketing. 2006;20(2):112-24. 5. Bhutada, N.S., B.L. Rollins, and M. Perri, ``Impact of Animated Spokes-Characters in Print Direct-To-Consumer Advertising: An Elaboration Likelihood Modeal Approach.'' Health Communication. 2016. DOI: 10.1080/10410236.2016.1138382. 6. Clayton, R.B. and G. Lesher, ``The Uncanny Valley: The Effects of Rotoscope Animation on Motivational Processing of Depression Drug Messages.'' Journal of Broadcasting and Electronic Media. 2015;59(1):57-75. 7. Bhutada, N.S., B.L. Rollins, and M. Perri, ``Animation in Print Direct-To-Consumer Advertising of Prescription Drugs: Impact on Consumers. At the 32nd Association for Marketing and Healthcare Research Annual Meeting and Conference, February 27-March 1, 2013, Big Sky, MT. 8. Pashupati, K, ``Beavers, Bubbles, Bees, and Moths: An Examination of Animated Spokescharacters in DTC Prescription Drug Advertisements and Web sites.'' Journal of Advertising Research. 2009;49(3):373-93. 9. Chandler, J. and N. Schwarz, ``Use Does Not Wear Ragged the Fabric of Friendship: Thinking of Objects as Alive Makes People Less Willing to Replace Them.'' Journal of Consumer Psychology. 2010;20(2):138-145. 10. Callcott, M.F. and B.J. Phillips, ``Observations: Elves Make Good Cookies: Creating Likeable Spokescharacter Advertising.'' Journal of Advertising Research. 1996;36(5):73-79. 11. Garretson, J.A. and R.W. Niedrich, ``Spokes-Characters: Creating Character Trust and Positive Brand Attitudes.'' Journal of Advertising. 2004;33(2):25-36. 12. Delbaere, M., E.F. McQuarrie, and B.J. Phillips, ``Personification in Advertising: Using a Visual Metaphor to Trigger Anthropomorphism.'' Journal of Advertising. 2011;40(1):121-130. 13. Hart, P.M., S.R. Jones, and M.B. Royne, ``The Human Lens: How Anthropomorphic Reasoning Varies by Product Complexity and Enhances Personal Value.'' Journal of Marketing Management. 2013;29(1-2):105- 121. 14. Moyer-Guse E., C. Mahood, and S. Brookes, ``Entertainment- Education in the Context of Humor: Effects on Safer Sex Intentions and Risk Perceptions.'' Health Communication. 2011;26(8):765-774. 15. Lang, A, ``The Limited Capacity Model of Motivated Mediated Message Processing.'' The Sage Handbook of Mass Media Effects. New York: Sage;2009:193-204. 16. Garretson, J.A. and S. Burton, ``The Role of Spokescharacters as Advertisement and Package Cues in Integrated Marketing Campaigns.'' Journal of Marketing. 2005;69(4):118-132. 17. Lang, A, ``Using the Limited Capacity Model of Motivated Mediated Message Processing to Design Effective Cancer Communication Messages.'' Journal of Communication. 2006;56:557-580. 18. Stephenson, M.T. and P. Pamgreen, ``Sensation-Seeking, Perceived Message Value, Personal Involvement, and Processing of Anti- Marijuana PSAs.'' Communication Monographs. 2001;68:49-71. 19. Niederdeppe, J.D., ``Syntactic Indeterminancy, Perceived Message Sensation, Value-Enhancing Features, and Message Processing in the Context of Anti-Tobacco Advertisements.'' Communication Monographs. 2005;72(3):324-44. 20. Parvanta, S., L. Gobson, H. Forquer, et al., [[Page 73416]] ``Applying Quantitative Approaches to the Formative Evaluation of Antismoking Campaign Messages.'' Social Marketing Quarterly. 2013;19(4):242-64. 21. Thomas, V., K. Fowler, and P. Grimm, ``Conceptualization and Exploration of Attitude Toward Advertising Disclosures and its Impact on Perceptions of Manipulative Intent.'' Journal of Consumer Affairs. 2013;47(3):564-87. 22. Richins, M., ``Measuring Emotions in the Consumption Experience.'' Journal of Consumer Research. 1997;24:127-46. 23. Waytz, A., J. Cacioppo, and N. Epley, ``Who Sees Human? The Stability and Importance of Individual Differences in Anthropomorphism.'' Perspectives on Psychological Science. 2010;5:216-32. Dated: October 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25727 Filed 10-24-16; 8:45 am] BILLING CODE 4164-01-P
![73410 Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / Notices
this public workshop must register received by November 15, 2016. If DATES: Fax written comments on the
online by November 28, 2016. Early selected for presentation, any collection of information by November
registration is recommended because presentation materials must be emailed 25, 2016.
facilities are limited and, therefore, FDA to Jill Marion (see FOR FURTHER ADDRESSES: To ensure that comments on
may limit the number of participants INFORMATION CONTACT) no later than the information collection are received,
from each organization. If time and December 2, 2016. No commercial or OMB recommends that written
space permit, onsite registration on the promotional material will be permitted comments be faxed to the Office of
day of the public workshop will be to be presented or distributed at the Information and Regulatory Affairs,
provided beginning at 7:30 a.m. public workshop. OMB, Attn: FDA Desk Officer, FAX:
If you need special accommodations FDA is holding this public workshop 202–395–7285, or emailed to oira_
due to a disability, please contact Susan to obtain information on the role of submission@omb.eop.gov. All
Monahan, Office of Communications hospitals in evidence generation and comments should be identified with the
and Education, Center for Devices and surveillance. In order to permit the OMB control number 0910–NEW and
Radiological Health, Food and Drug widest possible opportunity to obtain title ‘‘Animation in Direct-to-Consumer
Administration, 10903 New Hampshire public comment, FDA is soliciting Advertising.’’ Also include the FDA
Ave., Bldg. 66, Silver Spring, MD 20993, either electronic or written comments docket number found in brackets in the
301–796–5661, FAX: 301–847–8142, on all aspects of the public workshop heading of this document.
susan.monahan@fda.hhs.gov no later topics. The deadline for submitting FOR FURTHER INFORMATION CONTACT: FDA
than November 21, 2016. comments related to this public PRA Staff, Office of Operations, Food
To register for the public workshop, workshop is January 6, 2017. and Drug Administration, Three White
please visit FDA’s Medical Devices Transcripts: Please be advised that as Flint North, 10A63, 11601 Landsdown
News & Events—Workshops & soon as a transcript is available, it will St., North Bethesda, MD 20852,
Conferences calendar at http:// be accessible at http:// PRAStaff@fda.hhs.gov.
www.fda.gov/MedicalDevices/ www.regulations.gov. It may be viewed
SUPPLEMENTARY INFORMATION: In
NewsEvents/WorkshopsConferences/ at the Division of Dockets Management
compliance with 44 U.S.C. 3507, FDA
default.htm. (Select this meeting/public (see ADDRESSES). A transcript will also
has submitted the following proposed
workshop from the posted events list.) be available in either hardcopy or on
collection of information to OMB for
Please provide complete contact CD–ROM, after submission of a
review and clearance.
information for each attendee, including Freedom of Information request. The
name, title, and affiliation, address, Freedom of Information office address is Animation in Direct-to-Consumer
email, and telephone number. Those available on the Agency’s Web site at Advertising
without Internet access should contact http://www.fda.gov. A link to the OMB Control Number 0910–NEW
Susan Monahan to register (see special transcript will also be available
accommodations contact). Registrants approximately 45 days after the public Section 1701(a)(4) of the Public
will receive confirmation after they have workshop on the Internet at http:// Health Service Act (42 U.S.C.
been accepted. You will be notified if www.fda.gov/MedicalDevices/ 300u(a)(4)) authorizes the FDA to
you are on a waiting list. NewsEvents/WorkshopsConferences/ conduct research relating to health
Streaming Webcast of the Public default.htm. (Select this public information. Section 1003(d)(2)(C) of the
Workshop: This public workshop will workshop from the posted events list). Federal Food, Drug, and Cosmetic Act
also be Webcast. The Webcast link will (the FD&C Act) (21 U.S.C. 393(b)(2)(c))
Dated: October 19, 2016.
be available on the registration Web authorizes FDA to conduct research
Leslie Kux,
page after November 28, 2016. relating to drugs and other FDA-
Associate Commissioner for Policy. regulated products in carrying out the
Organizations are requested to view
using one connection per location. [FR Doc. 2016–25735 Filed 10–24–16; 8:45 am] provisions of the FD&C Act.
Requests for Oral Presentations: This BILLING CODE 4164–01–P Advertisers use many techniques to
public workshop includes a public increase consumer interest in their ads,
comment session and topic-focused including the use of animated spokes-
sessions. During online registration you DEPARTMENT OF HEALTH AND characters. These characters may be
may indicate if you wish to present HUMAN SERVICES fictional or nonfictional and human or
during a public comment session or nonhuman (Ref. 1). Despite variations in
Food and Drug Administration
participate in a specific session, and form, animated characters are often used
which topics you wish to address. FDA [Docket No. FDA–2016–N–0538] to grab attention, increase ad
has included general topics in this memorability, and enhance persuasion
document. FDA will do its best to Agency Information Collection to ultimately drive behavior (Refs. 2–4).
accommodate requests to make public Activities; Submission for Office of Animated characters have long been
comments. Individuals and Management and Budget Review; used for low-involvement products (e.g.,
organizations with common interests are Comment Request; Animation in food products) and have made their way
urged to consolidate or coordinate their Direct-to-Consumer Advertising into direct-to-consumer (DTC)
presentations and request time for a AGENCY: Food and Drug Administration, prescription drug advertising. However,
joint presentation, or submit requests for HHS. to our knowledge, one study (Ref. 5) has
designated representatives to participate ACTION: Notice. examined how animation affects
in the focused sessions. Following the attitudes toward products and risk
mstockstill on DSK3G9T082PROD with NOTICES
close of registration, FDA will SUMMARY: The Food and Drug perceptions in drug ads, and no studies
determine the amount of time allotted to Administration (FDA or we) is have examined how various animation
each presenter and the approximate announcing that a proposed collection strategies (e.g., symbolizing the disease
time each oral presentation is to begin, of information has been submitted to the vs. the benefit) and product
and will select and notify participants Office of Management and Budget characteristics (e.g., low-risk medication
by November 29, 2016. All requests to (OMB) for review and clearance under vs. high-risk medication) influence
make oral presentations must be the Paperwork Reduction Act of 1995. these perceptions.
VerDate Sep<11>2014 16:58 Oct 24, 2016 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1](https://thefederalregister.org/doc/81_FR_73616/page/1.svg)
![73412 Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / Notices
benefit from the drug. In this study, all as similar as possible, accounting for the concurrently, and the same participants
ads will contain the same kind of full variations in focus of character. The in the nonhuman sufferer groups will be
animation and the general theme will be experiments will be conducted part of both.
TABLE 2—EXPERIMENT 2: PERSONIFICATION DESIGN
Nonhuman Personification
Medical condition Sufferer Disease Benefit
Chronic Dry Eye .......................................................................................................................... • • •
Psoriasis ...................................................................................................................................... • • •
In both cases, a professional firm will To examine differences between challenges to nesting the stimuli within
create all ads such that they are experimental conditions, we will the questionnaire, and examine data
indistinguishable from currently conduct inferential statistical tests such trends to check that the manipulations
running DTC ads. as analysis of variance. and questionnaire items are appropriate.
With online surveys, several A qualitative in-person pretest would
Pretesting will take place before the
participants may be completing the not meet those objectives.
main study to evaluate the procedures
survey at the time that the total target (Comment 4) Recommend screening
and measures used in the main study.
sample is reached. Those participants and quotas by length of time since
We will recruit adults who have
are allowed to complete the survey, diagnosis as this may influence the
experienced chronic dry eye or which can result in the number of
psoriasis. We will exclude individuals urgency with which individuals watch
completes going slightly over the target the ads and their familiarity with
who work in healthcare or marketing number. Thus, our target number of
settings because their knowledge and previous treatments.
completes is 1,500, so we have rounded (Response 4) We have included a
experiences may not reflect those of the up by an additional 150, or 10 percent, question toward the end of the
average consumer. We propose to test to allow for some overage. questionnaire to measure time since
300 participants for the pretest. Each In the Federal Register of March 2, diagnosis, which will enable us to
experiment will include 30 participants 2016 (81 FR 10867), FDA published a assess its association with attention to
per condition for a total of 180 60-day notice requesting public the ad and statistically control for it if
participants each, but 60 of those in the comment on the proposed collection of necessary. However, statistical control
nonhuman sufferer conditions will information. FDA received a number of will likely be unnecessary, since
overlap between the two experiments. comments as enumerated and discussed random assignment to conditions in our
We will need 1,500 unique participants here. Of these comments, 22 were out of study design should prevent there from
for the main study to obtain 90 percent the scope of the proposed project (‘‘Ban being systematic differences among
power to detect a moderately small DTC’’ or ‘‘Ban animated DTC’’). groups in time since diagnosis or any
effect size. There will be 150 other extraneous variable.
participants per condition for a total of 1. AbbVie
(Comment 5) For question 5, the item
900 participants in each experiment, (Comment 1) Note that the accuracy of
‘‘think rather than feel’’ seems out of
with 300 participants in the overlapping the findings will be highly dependent
place in the question bank and Lilly
nonhuman sufferer conditions. on the quality of the stimuli (i.e., the
recommends deletion.
In both experiments, participants who animation).
(Response 1) We agree. (Response 5) The items in Question 5
have been diagnosed with either chronic make up a validated scale developed by
dry eye or psoriasis will be recruited via 2. Lilly Stephenson and Palmgreen (Ref. 18).
an opt-in Internet panel to watch one ad (Comment 2) Assume that stimuli will Niederdeppe (Ref. 19) used the same
for a prescription drug that treats their conform to FDA regulations and scale items to measure cognitive
medical condition. In experiment 1, standards. processing. There may be psychometric
participants will be randomly assigned (Response 2) Reviewers from the consequences to deleting this item—in
to view either a live-action, rotoscoped, Office of Prescription Drug Promotion other words, the reliability of the scale
or fully animated ad. All themes in have been involved throughout the may be reduced if we remove this item.
experiment 1 will focus on the main development of the stimuli to ensure Since it was previously validated as a
character as the sufferer of the that the mock ads conform to FDA scale, we will maintain the item.
condition. In experiment 2, participants regulations and standards. (Comment 6) Questions 6 and 8 (‘‘In
will be randomly assigned to a (Comment 3) Question the use of such your opinion, if 100 people take [DRUG
personification condition: Sufferer, a large (n = 300) pretest and X], for how many will the drug work?’’)
disease, or benefit. All ads in recommends the use of a qualitative, in- may be difficult to answer, as
experiment 2 will be fully animated. person pretest. pharmaceutical ads rarely have specific
Participants will watch the ad once and (Response 3) Before the pretests and side effect information. Recommend
then answer an online survey with main studies are conducted, we will changing to ask how frequently side
questions addressing recall of risks and conduct nine cognitive interviews to effects will occur, from ‘‘very frequent’’
mstockstill on DSK3G9T082PROD with NOTICES
benefits, perceptions of risks and obtain verbal in-person feedback on the to ‘‘never occurs.’’
benefits, and attitudes and emotional questionnaires and the stimuli. We (Response 6) We agree and will revise
responses to the ad, the brand, the believe this will accomplish what this these questions to focus on perceived
product, and the character. The commenter is suggesting. The pretest is frequency or likelihood of side effects
questionnaire is available upon request. designed to test procedures, verify that and efficacy in more general terms.
Participation is estimated to take the online questionnaire is working as (Comment 7) Questions 13 and 14
approximately 25 minutes. intended, identify and correct any (overall comprehension closed-ended
VerDate Sep<11>2014 16:58 Oct 24, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1](https://thefederalregister.org/doc/81_FR_73616/page/3.svg)
![73416 Federal Register / Vol. 81, No. 206 / Tuesday, October 25, 2016 / Notices
‘‘Applying Quantitative Approaches to review the ICR online at http:// for public safety and to effectively
the Formative Evaluation of Antismoking www.reginfo.gov. Follow the manage bears and people to minimize
Campaign Messages.’’ Social Marketing instructions to review Department of the conflicts. Summary statistics (without
Quarterly. 2013;19(4):242–64.
Interior collections under review by personal information) may be generated
21. Thomas, V., K. Fowler, and P. Grimm,
‘‘Conceptualization and Exploration of OMB. to examine long-term trends in types
Attitude Toward Advertising Disclosures FOR FURTHER INFORMATION CONTACT: To and locations of bear-human
and its Impact on Perceptions of request additional information about interactions. Observations and
Manipulative Intent.’’ Journal of this ICR, contact Margaret Hazen, interactions by visitors are recorded via
Consumer Affairs. 2013;47(3):564–87. the two forms: NPS Form 10–405 and
Supervisory Park Ranger, Glacier Bay
22. Richins, M., ‘‘Measuring Emotions in the NPS Form 10–406.
Consumption Experience.’’ Journal of National Park and Preserve at Margaret_
Hazen@nps.gov (email) or at (907) 697– The NPS requires the submission of
Consumer Research. 1997;24:127–46. NPS Form 10–405 upon exiting the park
23. Waytz, A., J. Cacioppo, and N. Epley, 2608 (telephone).
‘‘Who Sees Human? The Stability and
backcountry in order to collect
SUPPLEMENTARY INFORMATION:
Importance of Individual Differences in information regarding bear sightings
Anthropomorphism.’’ Perspectives on I. Abstract within GLBA. The collection and
Psychological Science. 2010;5:216–32. The National Park Service Organic timeliness of the data collection is
Dated: October 19, 2016. Act, 54 U.S.C. 100101(a) et seq.), critical for the NPS’ ability to enhance
Leslie Kux, requires that the NPS preserve national the safety of future visitors and to
parks for the enjoyment, education, and protect the bear population at the park.
Associate Commissioner for Policy.
inspiration of this and future Information collected via NPS Form 10–
[FR Doc. 2016–25727 Filed 10–24–16; 8:45 am]
generations. Permit requirements and 405 includes:
BILLING CODE 4164–01–P
restrictions for recreational activities in • Group name;
the backcountry are governed in • Take-out date;
accordance with the regulations found • Whether visitor encountered dirty
DEPARTMENT OF THE INTERIOR campsites left by previous users or
at Title 36, Code of Federal Regulations,
Sections 1.5, 1.6, and 2.10 (36 CFR 1.5, observe unsafe or inappropriate
National Park Service behavior by other groups; and
1.6, 2.10, and 13.116). In order to
[NPS–AKR–GLBA–22231; PPWOBSADA0, • Detailed information for each
monitor resources and wildlife in the
PPMPSAS1Y.Y00000 (177)] sighting documented on the form, to
Glacier Bay National Park and Preserve
include:
Information Collection Request Sent to (GLBA) and to enhance the safety of
Æ Date/time;
the Office of Management and Budget future visitors, the park monitors all Æ Species type
(OMB) for Approval; Glacier Bay sightings and interactions by visitors Æ Total number of bears seen together
National Park and Preserve Bear with bears. The bear sighting and (for each sighting);
Sighting and Encounter Reports encounter reporting forms are an Æ Bear unit type;
extension of our statutory authority and Æ Estimation of distance between
AGENCY: National Park Service, Interior. responsibility to protect the park areas visitor and bear(s);
ACTION: Notice; request for comments. we administer and to manage the public Æ Whether the bear was aware of the
use thereof. NPS regulations codified in group;
SUMMARY: We (National Park Service, 36 CFR 1–7, 12 and 13, are designated
NPS) have sent an Information Æ Bear reaction to group;
to implement statutory mandates that Æ Activity of group;
Collection Request (ICR) to OMB for provide for resource protection and Æ Number of observers; and
review and approval. We summarize the public enjoyment. Æ Location description/campsite
ICR below and describe the nature of the Bear sighting data provides the park name/GPS position/other comments.
collection and the estimated burden and with important data used to determine Submission of a completed NPS Form
cost. We may not conduct or sponsor bear movements, habitat use, and 10–406 is required when a bear enters
and a person is not required to respond species distribution. This information camp, approaches the group, damages
to a collection of information unless it can be used in backcountry management gear, obtains food, and/or acts in an
displays a currently valid OMB control and planning, field research planning, aggressive or threatening manner
number. However, under OMB and educational outreach for visitors. towards the group. The collection and
regulations, we may continue to Bear-human interaction data is vital to timeliness of data concerning bear-
conduct or sponsor this information understand how bears respond to human contact is critical for the NPS’
collection while it is pending at OMB. people, detecting changes in bear ability to enhance the safety of future
DATES: You must submit comments on behavior, and identifying potential areas visitors and to protect the bear
or before November 25, 2016. of high bear-human conflict. Obtaining population at the park. Information
ADDRESSES: Send your comments and immediate information on bear-human collected via NPS Form 10–406
suggestions on this information conflicts allows managers to respond includes:
collection to the Desk Officer for the promptly to mitigate further conflicts. • Name and phone number of the
Department of the Interior at OMB– Proactive mitigation includes notifying primary person involved in the
OIRA at (202) 395–5806 (fax) or OIRA_ other backcountry users, issuing interaction;
Submission@omb.eop.gov (email). advisories or recommendations, or • Group type: Park visitor, concession
Please provide a copy of your comments issuing closures to prevent further employee, contractor, researcher, NPS
mstockstill on DSK3G9T082PROD with NOTICES
to Madonna L. Baucum, Information conflicts and maintain public safety. employee, or other;
Collection Clearance Officer, National Additionally, managers may respond to • Number of people who encountered
Park Service, 12201 Sunrise Valley reports of bear-human conflict with bear the bear;
Drive, Mail Stop 242, Reston, VA 20192; management techniques such as hazing • Corresponding sighting number on
or madonna_baucum@nps.gov (email). or aversive conditioning. Obtaining NPS Form 10–405; Location 1–28
Please include ‘‘1024–GLBA’’ in the current accurate information on bear (Backcountry vs. Developed Area A and
subject line of your comments. You may sightings and interactions is essential B);
VerDate Sep<11>2014 16:58 Oct 24, 2016 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1](https://thefederalregister.org/doc/81_FR_73616/page/7.svg)
Document Created: 2018-02-13 16:38:22
Document Modified: 2018-02-13 16:38:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by November 25, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 73410 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR