80 FR 34672 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 116 (June 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34672-34677 | |
| FR Document | 2015-14880 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34672-34677] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14880] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1794] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads 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. DATES: Fax written comments on the collection of information by July 17, 2015. 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 ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-To-Consumer Prescription Drug Ads.'' 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads; 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. In a typical promotional campaign, consumers may be exposed to a direct-to-consumer (DTC) prescription drug ad any number of times. Perceptual and cognitive effects of increased ad exposure frequency have been studied extensively using non-drug ads. For instance, one study demonstrated that a commercial message repeated twice generates better recall than a message broadcast only once (Ref. 1). Another study demonstrated that increased ad exposures improve product attitudes and recall for product attributes, particularly when the substance of the repeat messages is varied (Ref. 2). Generally, it has been argued that first exposure to an ad results in attention, second exposure affects learning of the advertised message, and third and [[Page 34673]] subsequent exposures reinforce the learning effects of the second exposure (Ref. 3). To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads. Prescription drug ads are unique in that they are required to provide both benefit and risk information whereas other ad types tend to include only benefit information. The Office of Prescription Drug Promotion (OPDP) plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads through empirical research. The main study will be preceded by up to two pretests designed to delineate the procedures and measures used in the main study. Across pretests and the main study, participants will be individuals who have been diagnosed with seasonal allergies. All participants will be 18 years of age or older. We will exclude individuals who work in healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Participants will be recruited in one of two geographic locations (Washington, DC and Raleigh, North Carolina) for in-person administration of protocols. The experimental design is summarized below. Participants will be randomly assigned to view a prescription drug ad one, two, or four times as part of clutter reels embedded in 42 minutes of TV programming. They will then answer preprogrammed survey questions on laptops. Measures are designed to assess perception, memory, judgments about the ad, intentions to use the medication advertised, and possible moderators of effects, such as need for cognition and demographics. The questionnaire is available upon request. Table 1--Study Design -------------------------------------------------------------------------------------------------------------------------------------------------------- Episode #1 Episode #2 Experimental arm number ----------------------------------------------------------------------------------------------------------------------- Clutter Reel 1 Clutter Reel 2 Clutter Reel 3 Clutter Reel 4 Clutter Reel 5 Clutter Reel 6 -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 (views ad 1 time)............. .................. .................. .................. .................. .................. Mock DTC ad 2 (views ad 2 times)............ .................. .................. Mock DTC ad....... .................. .................. Mock DTC ad 3 (views ad 4 times)............ Mock DTC ad....... .................. Mock DTC ad....... Mock DTC ad....... .................. Mock DTC ad -------------------------------------------------------------------------------------------------------------------------------------------------------- In the Federal Register of November 12, 2014 (79 FR 67172), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received five public submissions. In the following section, we outline the observations and suggestions raised in the comments and provide our responses. Comments that are not PRA- relevant (e.g., ``Ban DTC'') or do not relate to the proposed study are not included below or addressed in our responses. (Comment from Valeant Pharmaceuticals) Develop and publish a strategic plan for how FDA will collate and make use of data from all FDA-sponsored studies concerning consumer and physician perception and comprehension of prescription drug advertising and promotion. (Response) The OPDP research Web page (Ref. 4) has recently been updated to reflect the current status of completed and ongoing research. As stated on our Web page, OPDP maintains an active research program designed to investigate applied and theoretical issues in the communication of risk and benefit information in DTC and professional promotional prescription drug materials. OPDP's research supports FDA's goal of science-based policy while maintaining its commitment to protect the public health. The research provides FDA management with evidence that can be considered along with other relevant research in future policy decisions. (Comment from Valeant Pharmaceuticals) Provide data to confirm limiting the study recruitment to Washington, DC and Raleigh Durham, NC area is representative of the entire United States. (Response) The research questions examined in this study (e.g., risk and benefit recall as a function of the number of target ad exposures) are believed to apply to human judgment and decision making and not to be contingent upon geographic residence. We acknowledge that collecting data across a greater number of geographic locations may provide value, but choose to allocate our limited funding in ways we believe more appropriately ensure the integrity of the research. For example, the requirement that participants view 60 minutes of programming led us to collect data in person, which allows for us to supervise participant engagement with the survey and therefore ensure that stimuli are, in fact, viewed. Although the current research includes limited geographic diversity, note that other forms of diversity (e.g., gender, age, and race) will be sought during recruitment and accounted for in our analyses. (Comment from Valeant Pharmaceuticals) Six exposures during the same 42-minute television program are not reflective of how advertising is delivered and could inadvertently bias the results. (Response) The study design has been revised such that the experimental groups will view the ad one, two, or four times over the course of the 60-minute viewing period. Additional details about this change are provided in later responses. (Comment from Valeant Pharmaceuticals) Consumer comprehension of benefit and risk is not solely based on the viewing of the DTC TV ad in isolation. Consumer comprehension should take into account the role of the healthcare professional and other materials. (Response) We appreciate that consumer judgment and decision making often results from multiple information sources. In many cases, DTC TV ads serve as the first source of information received, and therefore may influence whether or not additional information is sought, and ultimately whether or not a product is requested from a healthcare professional. Through broad research on DTC advertising, we seek to ensure that consumers are appropriately informed about the risks and benefits of prescription drugs across all information sources, when viewed in isolation or in combination with other sources. (Comment from Valeant Pharmaceuticals) Because the study is limited to one DTC TV ad and one therapeutic area, the results should not be broadly applied to other forms of advertising or other therapeutic areas. (Response) We agree that results should not be broadly applied to other forms of advertising. We do not agree that results necessarily need be restricted to the selected therapeutic [[Page 34674]] area. Our primary research question for the study is whether increasing ad exposure frequency will result in different risk or benefit perceptions than less exposure to the ad. This question pertains to human perception and judgment and is not thought to be unique to any particular therapeutic area. Nonetheless, we agree that replication of this research using other forms of advertising and different therapeutic areas would be valuable. (Comment from Abbvie) It is not clear how the proposed collection is necessary for the proper performance of FDA's functions. It is difficult to ascertain how the Agency will utilize the results of this study within its statutory authority. For example, should the results of this study demonstrate that the frequency of ad exposure matters, how would the Agency modify the airing frequency of DTC TV ads or the frequency at which consumers are exposed to the advertisements in a real world setting? Rather than conduct this study, we suggest that FDA resources and taxpayer dollars would be better directed to research that enhances the quality of how we communicate benefit and risk information to consumers regardless of the medium and the frequency of the exposure. Guidance is needed on the best practices for communicating benefit and risk information to consumers who are prescribed prescription drugs. This is particularly important as the quality of the communication has the power to result in a better informed consumer. (Response) This research reflects the need to understand not only the message that consumers receive, but also the delivery of those messages, and how that delivery influences perception, judgment, and decision making. It may be that full comprehension of benefit information is achieved upon a single exposure, whereas full comprehension of risk information requires multiple exposures. Insight on this topic may allow FDA to make more informed judgments regarding consumer information processing of DTC television ads. (Comment from Abbvie) Should the Agency proceed with this study, FDA could enhance the quality, utility, and clarity of the information to be collected by avoiding introducing bias into the way the survey is conducted. For example, in the draft survey (version 10.22.14), FDA creates an artificial setting in which participants are instructed to watch the commercials that air during a 90-minute TV program during which the same ad airs three to six times. This is very different from the airing and viewing frequency of DTC ads that occur today. Hence, we question the applicability of the results of this study to a real world setting. (Response) Please note that stimuli play for 60 minutes (not 90), and that the original design involved airing of the ad one, three, or six times (not three to six). We appreciate that six viewings would be unusual and so the study design has been revised such that the experimental groups will view the ad one, two, or four times over the course of the 60-minute viewing period. Additional details about this change are provided in later responses. (Comment from Eli Lilly) The FDA sample does not currently include a ``General Population'' control group, as all participants will be screened to qualify when identified as suffering from seasonal allergies, a condition that could be relieved by the drug described in advertisement. It may be helpful to the FDA's analysis plan to include a control group. (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 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 from Eli Lilly) In the proposed study design, respondents will watch a 42-minute television program with an embedded clutter reel of ads. Within this time period, respondents will be exposed to a drug ad 1, 3, or 6 times and then administered a survey instrument. While we acknowledge that a consumer can be exposed to an ad 6 times or more, we do not believe 6 exposures in such a compressed time period represents a reasonable real-world experience and is likely to overstate consumer reaction, particularly given that such reactions will be tested immediately after viewing. We believe the current design imposes a risk of creating artificial differences between the study arms by skewing perception, judgment, retention of information, intent, etc., ultimately leading to erroneous conclusions and unactionable expectations. Specifically, research data on multiple ad exposures and ``effective frequency'' is long established. Based upon multiple studies, experience, and client preference across industries, a leading global media-buying firm with whom we work generally adheres to two (2) ``units'' per hour as its standard (i.e. a broadcast advertisement is delivered to the intended audience in a single program no more than twice each hour). While there may be occasions where some advertisers allow for increased frequency (such as holiday weeks or the like), the norm tends to gravitate to no more than two per hour. This implies that in the consumer packaged goods space, 6 exposures in a 42-minute television program exceeds standard practice. In the drug advertising category, that level of exposure would be well beyond reasonable expectations. We recommend that FDA limit study arms to more realistic scenarios (e.g. 1, 2, and 3 exposures) or, alternatively, to spread out the higher frequency arm (e.g. 6) over a longer study period, preferably with a longitudinal design, to more closely represent how consumers receive and process information in a real-world environment. (Response) We appreciate this insight. The study design has been revised such that the experimental groups will view the ad one, two, or four times over the course of the 60-minute viewing period. We consider the one and two exposure conditions to be realistic. The four-exposure condition, while limited in its ecological validity, allows for experimental examination of ``excessive'' exposures, which may be associated with outcomes such as consumer wearout; that is, deterioration or diminishment of effects of ad repetition on mental processing after a certain amount of exposure. Also, it is important to note that in studying advertising effects, it is necessary to create enough difference in the manipulations between experimental groups to allow for variation in outcomes to be detected. Given the laboratory setting, it is not possible to extend the viewing period longer than 1 hour without significantly increasing the burden on respondents. (Comment from Eli Lilly) We were unable to determine if the study arms that will see multiple exposures will be exposed to the same version of the ad or variations of the ad. We recommend utilizing the same version of the ad for consistency between the study arms. (Response) These participants will view the same ad across all exposures. (Comment from Eli Lilly) In the pre-stimulus instructions/ disclosure section, we recommend removing ``on behalf of a public health agency.'' This language may trigger the respondent, who would see it before being exposed to the clutter reel, to be on the alert for health-related content and create bias that is not accurate in a real- world setting. [[Page 34675]] (Response) We agree with this concern. This language has been revised to ``on behalf of a government agency.'' (Comment from Eli Lilly) In the post-stimulus/survey instrument instructions section, we recommend removing references to (a) ``a drug ad'' and, (b) specific product name. Introducing this language provides the name of the product they are asked to identify in the first survey instrument question. It may also create unnecessary bias by identifying for the respondent the subject of the survey instrument. (Response) These references have been removed. (Comment from Eli Lilly) We recommend combining Questions 6 and 7 (risks and benefits) and randomizing the order. We believe this will more accurately represent recall rather than grouping risks together and benefits together. (Response) In natural settings, consumers may think about drug benefits and risks simultaneously or separately. We argue that there are empirical advantages to collecting data on these measures separately. There is literature to suggest personally relevant threatening information may be defensively processed (Refs. 5, 6, and 7) and thus processed differently than benefit information. We prefer to compare responses to benefit and risk items to one another, and combining them into one question would hinder this analysis. Moreover, note that in related literature, these constructs are typically measured with independent scales, or at least independent scales within a single scale. This assessment is based on an ongoing literature review concerning item and scale measure development. Additionally, splitting these measures reduces psychological burden on participants. It is believed to be easier for participants to respond to seven items concerning benefits in one matrix, followed by seven items concerning risks in another matrix, than for participants to respond to 14 items about both benefits and risks in a single matrix. Omitting items would reduce our ability to adequately measure either benefits or risks. Relatedly, collecting data on benefits and risks separately may increase the likelihood that participants take time to process each item and respond accurately. (Comment from Eli Lilly) We recommend adding a ``Don't Know'' answer choice for Questions 9, 10, and 13 as respondents may be unable to assess the likelihood or seriousness of side effects, or effectiveness of the product. The current range of answers may force inaccurate or speculative responses; a ``Don't Know'' answer would be a legitimate choice and informative for the study. Our standard practice is to provide a ``Don't Know'' option whenever it could be a valid answer. (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 by Krosnick et al. (Ref. 8) 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 from Eli Lilly) We recommend randomizing the answers to Question 15 to avoid order bias. We note that the answer choices are in sequence of probable behavior after being informed by advertising. (Response) Indeed, ordering of items was chosen to reflect sequence of probable behavior after being informed by advertising. We believe maintaining this continuum most appropriately reflects decision making on the part of the consumer. Moreover, we have conducted surveys both with and without randomizing these items, and no differences in responses were observed. (Comment from Eli Lilly) For Question 16, we suggest explicitly stating ``after being prescribed by a doctor'' to the end of the question. The question currently does not provide this context, leaving respondents to interpret whether or not they are to consider how they feel about ``taking'' Drug X without guidance from a learned intermediary. We believe this may render the data on this question ambiguous. (Response) We have incorporated this suggestion into the revised questionnaire. (Comment from Eli Lilly) For Questions 20 a and b, we suggest spelling out ``FDA.'' (Response) We have incorporated this suggestion into the revised questionnaire. (Comment from Eli Lilly) For Questions 20 a and c, we recommend eliminating the adverb ``extremely'' as it may create ambiguity. It would be reasonable for some people to answer ``false'' to ``extremely effective'' while also believing simply ``effective'' was true, while other respondents may not see a distinction. This may skew the data artificially toward ``false.'' (Response) Indeed, participants may respond differently depending on whether or not the adverb ``extremely'' is included. The item is designed to assess perceptions of whether only extremely effective products are approved by the FDA (likewise, only ``serious'' risks are assessed in Q20b and Q20d.) We prefer to retain this item because it captures the intended outcome we wish to measure, whereas an item that excludes the adverb ``extremely'' would not. Also note that these items have been previously published elsewhere and we prefer to match the original language (Ref. 9). (Comment from Eli Lilly) We recommend eliminating Question 20 g, which seems redundant with 20 f. If respondents were to answer False for 20 f but True for 20 g, it would provide no insight but could skew perceptions of the data. If the question is retained, we recommend eliminating the word ``in'' (i.e. ``believe in''), which in this context may connote a broader judgment about the drug industry, for which there is ample existing data, than of the regulatory oversight of drug advertisements. The language creates bias by implying that misleading information is embedded in drug ads, skewing the data toward ``false.'' (Response) We have deleted Q20g, and modified Q20f as follows: ``All of the information in prescription drug commercials is approved by the U.S. Food and Drug Administration.'' In addition, we have added the following items: ``All of the benefit information in prescription drug commercials is approved by the U.S. Food and Drug Administration,'' and ``All of the risk information in prescription drug commercials is approved by the U.S. Food and Drug Administration.'' (Comment from Eli Lilly) For Question 20 h, we recommend changing the word ``safest'' to ``safe,'' which may force respondents to make a subjective judgment about what constitutes ``safest'' (i.e. is there a set of safest, or simply the single-most safest drug?) even though they may believe that all advertised drugs have been deemed to be safe. This may strongly skew data toward ``false.'' (Response) We appreciate that asking about ``safest'' versus ``safe'' drugs will likely result in different responses. We prefer to retain the current language because it captures the intended outcome we wish to measure. Nonetheless, we will be careful to restrict our interpretation of findings pertaining to this question based on these potential differences in responding. [[Page 34676]] (Comment from Eli Lilly) Questions 21 a and b seem to be leading questions that may strongly bias respondents to presuppose that the ad is misleading and that the survey instrument is simply trying to understand the extent to which it is misleading. We acknowledge that the answer choices allow respondents to select ``not at all misleading,'' but four-fifths of the answer options represent degrees of ``misleading,'' which may create strong response bias. Although 21 c provides the alternative question, by the time the respondents reach this question they will have been biased by the previous two questions that the ad is misleading, skewing the data toward ``not truthful.'' We recommend this section be revised. (Response) These three items were included in the survey for the purposes of cognitive testing. Results from cognitive testing suggest that participants have difficulty answering the question about ``truthful'' because they feel they do not know the truth. They generally provide the same answer to both questions that ask about how misleading the ad is. We therefore will omit questions 21a and 21c. (Comment from Eli Lilly) For Questions 24 and 25, we recommend adding ``or difficult'' to the question to minimize biasing respondents that the product is ``easy'' to use and to make the question and answer choices consistent. (Response) We have incorporated this suggestion into the revised questionnaire. (Comment from Eli Lilly) We are concerned that Question 27 has potential to create bias and to confuse respondents. It contains language that may trigger respondents to believe they should be ``concerned'' to some extent. The question language combined with the inference of doctor's involvement is potentially confusing. We suggest revising this question, perhaps to something more simple like: ``If you were considering taking [Drug X], how would you feel about the side effects mentioned in the ad?'' (Response) The suggested revised version of Q27 points out to participants that the ad notes side effects and so also ``biases'' participants but in a slightly different way. The core assumption that there are always side effects to be considered in some form seems sufficiently reflective of contemporary DTC prescription drugs and thus we prefer not to change the language. (Comment from Eli Lilly) For Question 28, we recommend using ``Neither Agree nor Disagree'' as the midpoint of the scale, consistent with previous scale language in the survey instrument. (Response) This measure of need for cognition has been published and validated in the literature (Ref. 10). Thus, we prefer not to change the wording. (Comment from Eli Lilly) Question 28 b is potentially unclear. We recommend revising the question. (Response) This measure of need for cognition has been published and validated in the literature. Thus, we prefer not to change the wording. (Comment from Eli Lilly) Question 29 seems to have an omitted word. We recommend revising to: ``How confident are you about filling out medical forms by yourself?'' (Response) This is an item that has been used in the literature, and thus we prefer not to change the wording (Ref. 11). (Comment from Eli Lilly) We recommend revising Question 31 by deleting or amending the language ``Below are statements other people have made about their medications.'' This language appears unnecessary and may bias respondents by implying that, because the statements are included in the survey instrument, they are truthful and may warrant the respondents to feel that way to some extent. (Response) This item has been validated in the literature (Ref. 12) and thus we prefer not to change the language. (Comment from Eli Lilly) Also for Question 31, we recommend using ``Neither Agree nor Disagree'' as the language midpoint of the scale, consistent with previous scale language in the survey instrument. (Response) This item is from the Beliefs in Medicines Questionnaire. This item has been validated in the literature and thus we prefer not to change the language. (Comment from Eli Lilly) In Questions 35 and 36, we believe there could be variability in consumers' definition of what constitutes ``serious'' side effect without additional definition. We recommend the survey design consider providing additional context for the consumer in the question wording. (Response) We agree there is likely to be variability in how consumers define serious side effects. We examined these items in cognitive testing. Based on results from that cognitive testing, respondents generally define ``serious'' side effects as those that require medical attention or that are life threatening. It does not seem that respondents have trouble answering this question. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described below, we will have sufficient power to detect small-to-medium sized effects in the main study. FDA estimates the burden of this collection of information as follows: Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Pretest 1 screener completes 1,050 1 1,050 .08 (5 min.) 84 (assumes 10% eligible)......... Pretest 2 screener completes 1,050 1 1,050 .08 (5 min.) 84 (assumes 10% eligible)......... Number of main study screener 6000 1 6000 .08 (5 min.) 480 completes (assumes 10% eligible)...................... Pretest 1 completes \2\......... 125 1 125 1.5 188 Pretest 2 completes \2\......... 125 1 125 1.5 188 Number of completes, main study 620 1 620 1.5 930 \2\............................ ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,954 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Note: While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some potential overage in the burden table. As data is being collected in two locations simultaneously, it may be possible that the target will be exceeded if alternates are included in order to try to achieve the target. [[Page 34677]] References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site address in this reference section, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) 1. Singh, S. N., D. Linville, and A. Sukhdial, ``Enhancing the Efficacy of Split Thirty-Second Television Commercials: An Encoding Variability Application,'' Journal of Advertising, 24, pp. 13-23 (1995). 2. Haugtvedt, C. P., et al., ``Advertising Repetition and Variation Strategies: Implications for Understanding Attitude Strength,'' Journal of Consumer Research, 21, pp. 176-189 (1994). 3. Naples, M. J., ``Effective Frequency: Then and Now,'' Journal of Advertising Research, 37, pp. 7-12 (1997). 4. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm. 5. Janis, I. L. and S. Feshbach, ``Effects of Fear-Arousing Communications,'' Journal of Abnormal and Social Psychology, 48, pp. 78-92 (1953). 6. Liberman, A. and S. Chaiken, ``Defensive Processing of Personally Relevant Health Messages,'' Personality and Social Psychology Bulletin, 18, pp. 669-679 (1992). 7. Smith, S. M. and R. E. Petty, ``Message Framing and Persuasion: A Message Processing Analysis,'' Personality and Social Psychology Bulletin, 22, pp. 257-268 (1996). 8. Krosnick, J. A., A. L. Holbrook, M. K. Berent, et al., ``The Impact of `No Opinion' Response Options on Data Quality: Non- Attitude Reduction or an Invitation to Satisfice?'' Public Opinion Quarterly, 66, pp. 371-403 (2002). 9. Woloshin, S. and L. M. Schwartz, ``Communicating Data About the Benefits and Harms of Treatment: A Randomized Trial,'' Annals of Internal Medicine, 155, pp. 87-96 (2011). 10. Cacioppo, J. T. and R. E. Petty, ``The Efficient Assessment of Need for Cognition,'' Journal of Personality Assessment, 48, pp. 306-307 (1984). 11. Chew, L. D., J. M. Griffin, M. R. Partin, et al., ``Validation of Screening Questions for Limited Health Literacy in a Large VA Outpatient Population,'' Journal of General Internal Medicine, 23, pp. 561-566 (2008). 12. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medication,'' Psychology & Health, 14, pp. 1-24 (1999). Dated: June 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14880 Filed 6-16-15; 8:45 am] BILLING CODE 4164-01-P
![34672 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
annually, for a total of two responses. SUMMARY: The Food and Drug DATES: Fax written comments on the
We estimate the reporting burden to be Administration (FDA) is announcing collection of information by July 17,
2 hours per response, for a total burden that a collection of information entitled, 2015.
of 4 hours. We estimate that two ‘‘Food and Cosmetic Export Certificate ADDRESSES: To ensure that comments on
respondents will submit one Form FDA Applications Process’’ has been the information collection are received,
1993 report annually, for a total of two approved by the Office of Management OMB recommends that written
responses. We estimate the reporting and Budget (OMB) under the Paperwork comments be faxed to the Office of
burden to be 0.5 hours per response, for Reduction Act of 1995. Information and Regulatory Affairs,
a total burden of 1 hour. We estimate FOR FURTHER INFORMATION CONTACT: FDA OMB, Attn: FDA Desk Officer, FAX:
that two respondents will submit one PRA Staff, Office of Operations, Food 202–395–7285, or emailed to oira_
Form FDA 1815 report annually, for a and Drug Administration, 8455 submission@omb.eop.gov. All
total of two responses. We estimate the Colesville Rd., COLE–14526, Silver comments should be identified with the
reporting burden to be 0.5 hours per Spring, MD 20993–0002, OMB control number 0910-New and
response, for a total burden of 1 hour. PRAStaff@fda.hhs.gov. title ‘‘Impact of Ad Exposure Frequency
With regard to records maintenance, on Perception and Mental Processing of
we estimate that approximately two SUPPLEMENTARY INFORMATION: On April Risk and Benefit Information in Direct-
recordkeepers will spend 0.05 hours 23, 2015, the Agency submitted a To-Consumer Prescription Drug Ads.’’
annually maintaining the additional proposed collection of information Also include the FDA docket number
pasteurization records required by entitled, ‘‘Food and Cosmetic Export found in brackets in the heading of this
§ 1210.15, for a total of 0.10 hours Certificate Applications Process’’ to document.
annually. OMB for review and clearance under 44 FOR FURTHER INFORMATION CONTACT: FDA
No burden has been estimated for the U.S.C. 3507. An Agency may not PRA Staff, Office of Operations, Food
tagging requirement in § 1210.22 conduct or sponsor, and a person is not and Drug Administration, 8455
because the information on the tag is required to respond to, a collection of Colesville Rd., COLE–14526, Silver
either supplied by us (permit number) information unless it displays a Spring, MD 20993–0002, PRAStaff@
or is disclosed to third parties as a usual currently valid OMB control number. fda.hhs.gov.
and customary part of the shipper’s OMB has now approved the information
collection and has assigned OMB SUPPLEMENTARY INFORMATION: In
normal business activities (type of
control number 0910–0793. The compliance with 44 U.S.C. 3507, FDA
product, shipper’s name and address).
approval expires on May 31, 2018. A has submitted the following proposed
Under 5 CFR 1320.3(c)(2), the public
copy of the supporting statement for this collection of information to OMB for
disclosure of information originally
information collection is available on review and clearance.
supplied by the Federal Government to
the recipient for the purpose of the Internet at http://www.reginfo.gov/ Impact of Ad Exposure Frequency on
disclosure to the public is not subject to public/do/PRAMain. Perception and Mental Processing of
review by the Office of Management and Dated: June 11, 2015. Risk and Benefit Information in Direct-
Budget under the Paperwork Reduction Leslie Kux, to-Consumer Prescription Drug Ads;
Act. Under 5 CFR 1320.3(b)(2)), the Associate Commissioner for Policy.
OMB Control Number 0910–NEW
time, effort, and financial resources Section 1701(a)(4) of the Public
[FR Doc. 2015–14879 Filed 6–16–15; 8:45 am]
necessary to comply with a collection of Health Service Act (42 U.S.C.
BILLING CODE 4164–01–P
information are excluded from the 300u(a)(4)) authorizes the FDA to
burden estimate if the reporting, conduct research relating to health
recordkeeping, or disclosure activities DEPARTMENT OF HEALTH AND information. Section 1003(d)(2)(C) of the
needed to comply are usual and HUMAN SERVICES Federal Food, Drug, and Cosmetic Act
customary because they would occur in (the FD&C Act) (21 U.S.C. 393(b)(2)(c))
the normal course of business activities. Food and Drug Administration authorizes FDA to conduct research
Dated: June 11, 2015. relating to drugs and other FDA-
Leslie Kux, [Docket No. FDA–2014–N–1794] regulated products in carrying out the
Associate Commissioner for Policy. provisions of the FD&C Act.
[FR Doc. 2015–14888 Filed 6–16–15; 8:45 am] Agency Information Collection In a typical promotional campaign,
Activities; Submission for Office of consumers may be exposed to a direct-
BILLING CODE 4164–01–P
Management and Budget Review; to-consumer (DTC) prescription drug ad
Comment Request; Impact of Ad any number of times. Perceptual and
DEPARTMENT OF HEALTH AND Exposure Frequency on Perception cognitive effects of increased ad
HUMAN SERVICES and Mental Processing of Risk and exposure frequency have been studied
Benefit Information in Direct-to- extensively using non-drug ads. For
Food and Drug Administration Consumer Prescription Drug Ads instance, one study demonstrated that a
commercial message repeated twice
[Docket No. FDA–2014–N–2347] AGENCY: Food and Drug Administration, generates better recall than a message
HHS. broadcast only once (Ref. 1). Another
Agency Information Collection study demonstrated that increased ad
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice.
Activities; Announcement of Office of exposures improve product attitudes
Management and Budget Approval; SUMMARY: The Food and Drug and recall for product attributes,
Food and Cosmetic Export Certificate Administration (FDA) is announcing particularly when the substance of the
Applications Process that a proposed collection of repeat messages is varied (Ref. 2).
AGENCY: Food and Drug Administration, information has been submitted to the Generally, it has been argued that first
HHS. Office of Management and Budget exposure to an ad results in attention,
(OMB) for review and clearance under second exposure affects learning of the
ACTION: Notice.
the Paperwork Reduction Act of 1995. advertised message, and third and
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![34676 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
(Comment from Eli Lilly) Questions revising this question, perhaps to may bias respondents by implying that,
21 a and b seem to be leading questions something more simple like: ‘‘If you because the statements are included in
that may strongly bias respondents to were considering taking [Drug X], how the survey instrument, they are truthful
presuppose that the ad is misleading would you feel about the side effects and may warrant the respondents to feel
and that the survey instrument is simply mentioned in the ad?’’ that way to some extent.
trying to understand the extent to which (Response) The suggested revised (Response) This item has been
it is misleading. We acknowledge that version of Q27 points out to participants validated in the literature (Ref. 12) and
the answer choices allow respondents to that the ad notes side effects and so also thus we prefer not to change the
select ‘‘not at all misleading,’’ but four- ‘‘biases’’ participants but in a slightly language.
fifths of the answer options represent different way. The core assumption that (Comment from Eli Lilly) Also for
degrees of ‘‘misleading,’’ which may there are always side effects to be Question 31, we recommend using
create strong response bias. Although 21 considered in some form seems ‘‘Neither Agree nor Disagree’’ as the
c provides the alternative question, by sufficiently reflective of contemporary language midpoint of the scale,
the time the respondents reach this DTC prescription drugs and thus we consistent with previous scale language
question they will have been biased by prefer not to change the language. in the survey instrument.
the previous two questions that the ad (Comment from Eli Lilly) For (Response) This item is from the
is misleading, skewing the data toward Question 28, we recommend using Beliefs in Medicines Questionnaire.
‘‘not truthful.’’ We recommend this ‘‘Neither Agree nor Disagree’’ as the This item has been validated in the
section be revised. midpoint of the scale, consistent with literature and thus we prefer not to
(Response) These three items were previous scale language in the survey change the language.
included in the survey for the purposes instrument.
(Comment from Eli Lilly) In Questions
of cognitive testing. Results from (Response) This measure of need for
35 and 36, we believe there could be
cognitive testing suggest that cognition has been published and
variability in consumers’ definition of
participants have difficulty answering validated in the literature (Ref. 10).
what constitutes ‘‘serious’’ side effect
the question about ‘‘truthful’’ because Thus, we prefer not to change the
without additional definition. We
they feel they do not know the truth. wording.
(Comment from Eli Lilly) Question recommend the survey design consider
They generally provide the same answer
28 b is potentially unclear. We providing additional context for the
to both questions that ask about how
recommend revising the question. consumer in the question wording.
misleading the ad is. We therefore will
omit questions 21a and 21c. (Response) This measure of need for (Response) We agree there is likely to
(Comment from Eli Lilly) For cognition has been published and be variability in how consumers define
Questions 24 and 25, we recommend validated in the literature. Thus, we serious side effects. We examined these
adding ‘‘or difficult’’ to the question to prefer not to change the wording. items in cognitive testing. Based on
minimize biasing respondents that the (Comment from Eli Lilly) Question 29 results from that cognitive testing,
product is ‘‘easy’’ to use and to make the seems to have an omitted word. We respondents generally define ‘‘serious’’
question and answer choices consistent. recommend revising to: ‘‘How confident side effects as those that require medical
(Response) We have incorporated this are you about filling out medical forms attention or that are life threatening. It
suggestion into the revised by yourself?’’ does not seem that respondents have
questionnaire. (Response) This is an item that has trouble answering this question.
(Comment from Eli Lilly) We are been used in the literature, and thus we To examine differences between
concerned that Question 27 has prefer not to change the wording (Ref. experimental conditions, we will
potential to create bias and to confuse 11). conduct inferential statistical tests such
respondents. It contains language that (Comment from Eli Lilly) We as analysis of variance. With the sample
may trigger respondents to believe they recommend revising Question 31 by size described below, we will have
should be ‘‘concerned’’ to some extent. deleting or amending the language sufficient power to detect small-to-
The question language combined with ‘‘Below are statements other people medium sized effects in the main study.
the inference of doctor’s involvement is have made about their medications.’’ FDA estimates the burden of this
potentially confusing. We suggest This language appears unnecessary and collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Pretest 1 screener completes (assumes 10% eligible) ....... 1,050 1 1,050 .08 (5 min.) 84
Pretest 2 screener completes (assumes 10% eligible) ....... 1,050 1 1,050 .08 (5 min.) 84
Number of main study screener completes (assumes 10%
eligible) ............................................................................. 6000 1 6000 .08 (5 min.) 480
Pretest 1 completes 2 ........................................................... 125 1 125 1.5 188
Pretest 2 completes 2 ........................................................... 125 1 125 1.5 188
Number of completes, main study 2 ..................................... 620 1 620 1.5 930
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total .............................................................................. ........................ ........................ ........................ ........................ 1,954
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Note: While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some potential overage in the burden
table. As data is being collected in two locations simultaneously, it may be possible that the target will be exceeded if alternates are included in
order to try to achieve the target.
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![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34677
References Dated: June 11, 2015. ‘‘Naming of Drug Products Containing
Leslie Kux, Salt Drug Substances’’ that replaces the
The following references have been Associate Commissioner for Policy. draft of the same title that published on
placed on display in the Division of [FR Doc. 2015–14880 Filed 6–16–15; 8:45 am] December 26, 2013 (78 FR 78366). This
Dockets Management (see ADDRESSES) guidance is being published to explain
BILLING CODE 4164–01–P
and may be seen by interested persons how CDER is implementing the USP’s
between 9 a.m. and 4 p.m., Monday policy entitled ‘‘Monograph Naming
through Friday, and are available DEPARTMENT OF HEALTH AND Policy for Salt Drug Substances in Drug
electronically at http:// HUMAN SERVICES Products and Compounded
www.regulations.gov. (FDA has verified Preparations.’’ It is a naming and
the Web site address in this reference Food and Drug Administration labeling policy applicable to drug
section, but we are not responsible for products that contain an active
[Docket No. FDA–2013–D–1566]
any subsequent changes to the Web site ingredient that is a salt. The policy
after this document publishes in the Naming of Drug Products Containing stipulates that USP will use the name of
Federal Register.) Salt Drug Substances; Guidance for the active moiety, instead of the name
1. Singh, S. N., D. Linville, and A. Industry; Availability of the salt, when creating a drug product
Sukhdial, ‘‘Enhancing the Efficacy of Split monograph title and the strength will be
AGENCY: Food and Drug Administration, expressed in terms of the active moiety.
Thirty-Second Television Commercials: An
HHS. The policy allows for exceptions under
Encoding Variability Application,’’ Journal of
Advertising, 24, pp. 13–23 (1995). ACTION: Notice. specified circumstances. CDER is now
2. Haugtvedt, C. P., et al., ‘‘Advertising applying this policy to new prescription
SUMMARY: The Food and Drug
Repetition and Variation Strategies: drug products under development
Administration (FDA) is announcing the
Implications for Understanding Attitude under section 505 of the Federal Food,
availability of a guidance for industry
Strength,’’ Journal of Consumer Research, 21, Drug, and Cosmetic Act (the FD&C Act)
entitled ‘‘Naming of Drug Products
pp. 176–189 (1994). (21 U.S.C. 355).
Containing Salt Drug Substances’’ The USP Salt Policy became official
3. Naples, M. J., ‘‘Effective Frequency:
which replaces the draft guidance of the on May 1, 2013, and USP is now
Then and Now,’’ Journal of Advertising
same title that published on December applying it to all new drug product
Research, 37, pp. 7–12 (1997).
26, 2013. This guidance describes the monographs for products that contain
4. http://www.fda.gov/AboutFDA/
United States Pharmacopeia’s (USP’s) an active ingredient that is a salt. It
CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
‘‘Monograph Naming Policy for Salt affects the development of new drug
ucm090276.htm.
Drug Substances in Drug Products and products because a USP monograph title
5. Janis, I. L. and S. Feshbach, ‘‘Effects of
Compounded Preparations,’’ which for a new drug product, in most
Fear-Arousing Communications,’’ Journal of became official on May 1, 2013, and instances, serves as the nonproprietary
Abnormal and Social Psychology, 48, pp. 78– how the Center for Drug Evaluation and or ‘‘established’’ name of the related
92 (1953). Research (CDER) is implementing it. drug product (section 502(e)(3) of the
6. Liberman, A. and S. Chaiken, ‘‘Defensive DATES: Submit either electronic or FD&C Act) (21 U.S.C. 352(e)). If a drug
Processing of Personally Relevant Health written comments on Agency guidances product’s label or labeling contains a
Messages,’’ Personality and Social at any time. name that is inconsistent with the
Psychology Bulletin, 18, pp. 669–679 (1992). ADDRESSES: Submit written requests for applicable monograph title, it risks
7. Smith, S. M. and R. E. Petty, ‘‘Message single copies of the guidance to the being misbranded (section
Framing and Persuasion: A Message Division of Drug Information, Center for 502(e)(1)(A)(i) of the FD&C Act).
Processing Analysis,’’ Personality and Social Drug Evaluation and Research, Food This guidance describes the USP
Psychology Bulletin, 22, pp. 257–268 (1996). and Drug Administration, 10001 New policy and discusses how CDER and
8. Krosnick, J. A., A. L. Holbrook, M. K. Hampshire Ave., Hillandale Building, industry can implement the policy.
Berent, et al., ‘‘The Impact of ‘No Opinion’ 4th Floor, Silver Spring, MD 20993– Following the policy will help reduce
Response Options on Data Quality: Non- 0002. Send one self-addressed adhesive medication errors caused by a mismatch
Attitude Reduction or an Invitation to label to assist that office in processing between the established name and
Satisfice?’’ Public Opinion Quarterly, 66, pp. your requests. See the SUPPLEMENTARY strength on the label of drug products
371–403 (2002). INFORMATION section for electronic that contain a salt. In addition, we
9. Woloshin, S. and L. M. Schwartz, access to the guidance document. anticipate that this policy will help
‘‘Communicating Data About the Benefits Submit electronic comments on the health care practitioners calculate
and Harms of Treatment: A Randomized guidance to http://www.regulations.gov. equivalent doses when changing from
Trial,’’ Annals of Internal Medicine, 155, pp. Submit written comments to the
87–96 (2011).
one dosage form to another, even if the
Division of Dockets Management (HFA– products contain active ingredients that
10. Cacioppo, J. T. and R. E. Petty, ‘‘The
305), Food and Drug Administration, are different salts, because the strengths
Efficient Assessment of Need for Cognition,’’
5630 Fishers Lane, Rm. 1061, Rockville, and names will both be based on the
Journal of Personality Assessment, 48, pp.
MD 20852. active moiety.
306–307 (1984).
11. Chew, L. D., J. M. Griffin, M. R. Partin, FOR FURTHER INFORMATION CONTACT: In the Federal Register of December
et al., ‘‘Validation of Screening Questions for Mamta Gautam-Basak, Center for Drug 26, 2013 (78 FR 78366), this guidance
Evaluation and Research (CDER), Food was published as a draft guidance. We
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Limited Health Literacy in a Large VA
Outpatient Population,’’ Journal of General and Drug Administration, 10903 New have carefully reviewed and considered
Internal Medicine, 23, pp. 561–566 (2008). Hampshire Ave., Silver Spring, MD the comments that were received on the
12. Horne, R., J. Weinman, and M. 20993, 301–796–0712. draft guidance and have made changes
Hankins, ‘‘The Beliefs About Medicines SUPPLEMENTARY INFORMATION: for clarification.
Questionnaire: The Development and This guidance is being issued
Evaluation of a New Method for Assessing I. Background consistent with FDA’s good guidance
the Cognitive Representation of Medication,’’ FDA is announcing the availability of practices regulation 21 CFR 10.115. This
Psychology & Health, 14, pp. 1–24 (1999). a guidance for industry entitled guidance represents CDER’s current
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Document Created: 2015-12-15 14:22:53
Document Modified: 2015-12-15 14:22:53
| 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 July 17, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 34672 |
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