Document ID: FDA-2015-N-2406-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Market Claims in 
Direct-to-Consumer Prescription Drug Print Ads
Posted Date: 2016-05-04T04:00Z

[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26807-26811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10396]

[[Page 26807]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2406]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Market Claims in 
Direct-to-Consumer Prescription Drug Print Ads

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 3, 
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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
title, ``Market Claims in Direct-to-Consumer Prescription Drug Print 
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 20993-002, PRAStaff@fda.hhs.gov.

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.

Market Claims in Direct-to-Consumer Prescription Drug Print Ads--OMB 
Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    The marketing literature divides product attributes (``cues'') into 
intrinsic and extrinsic. Intrinsic cues are physical characteristics of 
the product (e.g., size, shape), whereas extrinsic cues are product-
related but not part of the product (e.g., price and brand name) (Refs. 
1 and 2). Research has found that both intrinsic and extrinsic cues can 
influence perceptions of product quality (Ref. 3). Consumers may rely 
on product cues in the absence of explicit quality information. The 
objective quality of prescription drugs is not easily obtained from 
promotional claims in direct-to-consumer (DTC) ads; thus consumers may 
rely upon extrinsic cues to inform their decisions. Market claims such 
as ``#1 Prescribed'' and ``New'' may act as extrinsic cues about the 
product's quality, independent of the product's intrinsic 
characteristics. Prior research has found that market leadership claims 
can affect consumer beliefs about product efficacy, as well as their 
beliefs about doctors' judgments about product efficacy (Ref. 4). One 
limitation of these prior studies is the lack of quantitative 
information about product efficacy in the information provided to 
respondents. Research indicates that providing consumers with efficacy 
information generally improves understanding and facilitates 
decisionmaking (Refs. 5 and 6). Efficacy information may moderate the 
effect of the extrinsic cue by providing insight into characteristics 
that would otherwise be unknown. Other research has shown that 
consumers are able to use information about efficacy to inform 
judgments about the product (Refs. 6 and 7).
    The Office of Prescription Drug Promotion (OPDP) plans to 
investigate, through empirical research, the impact of market claims on 
prescription drug product perceptions with and without quantitative 
information about product efficacy. This will be investigated in DTC 
print advertising for prescription drugs.

I. Design Overview and Procedure

    The design consists of two parts: A main study and a followup 
study. We will conduct two sequential pretest waves prior to the main 
study and one pretest prior to the followup study. The purpose of the 
pretests are to (1) ensure the stimuli are understandable and viewable, 
(2) identify and address any challenges to embedding the stimuli within 
the online survey, and (3) ensure the study questions are appropriate 
and meet the study's goals.
    Participants in the main study will be randomly assigned to view 
one of nine versions of an ad, as depicted in table 1. The two 
variables of interest are type of market claim (#1 Prescribed, New) and 
type of efficacy information (High, Low, or None). Efficacy information 
will be operationalized in the form of realistic quantitative 
information (for example, ``46 percent of patients felt their nerve 
pain reduced by at least half, compared to baseline'').

                                           Table 1--Main Study Design
----------------------------------------------------------------------------------------------------------------
                                                                              Type of market claim
                                                              --------------------------------------------------
                                                                #1 Prescribed         New         None (control)
----------------------------------------------------------------------------------------------------------------
Efficacy Level Information:                                    ...............  ...............  ...............
    High.....................................................               A                B                 C
    Low......................................................               D                E                F
    None (control)...........................................               G                H                I
----------------------------------------------------------------------------------------------------------------

    In the followup study, participants (n = 216) will complete a 15-
minute paired choice experiment. Participants will be asked to choose 
between two hypothetical drugs based on print ads, one of which 
includes a market claim from the Main Study (#1 Prescribed or New). The 
ads also include different efficacy information (for example, ``46 
percent of patients felt their nerve pain reduced by at least half, 
compared to baseline'' versus ``51 percent of patients felt their nerve 
pain reduced by at least half, compared to baseline''). Figure 1 
depicts an example choice. Participants are asked to indicate which 
drug they would prefer. They are given 48 such choice sets, which vary 
in efficacy information and the presence of the market claim.

[[Page 26808]]

[GRAPHIC] [TIFF OMITTED] TN04MY16.000

II. Procedure

    Pretests: Each participant will be randomly assigned to view a 
print ad for a fictitious prescription drug indicated to treat diabetic 
neuropathy and will be asked to complete an online survey assessing 
their benefit/risk perceptions, intentions, and attitudes toward the 
drug. Based on the pretest findings, we will revise and remove poorly 
performing survey items prior to full-scale testing.
    Main study: Each participant will be randomly assigned to view a 
print ad for a fictitious prescription drug for diabetic neuropathy and 
will be asked to complete an online survey assessing their benefit/risk 
perceptions, intentions, and attitudes toward the drug.
    Followup study: Each participant will be asked to view a series of 
pairs of print ads for a product that treats diabetic neuropathy. One 
ad will contain a market claim. Both ads will contain quantitative 
efficacy information that varies along a continuum of effectiveness in 
a series of 48 trials. In each comparison, participants will be asked 
to choose one of the two drugs.
    In the Federal Register of July 20, 2015 (80 FR 42823), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Six submissions were received; three from 
biopharmaceutical companies (AbbVie, Eli Lilly, Merck), two that were 
anonymous, and one from Danny Weiss, PharmD. The comments from the two 
anonymous submitters and Dr. Weiss requested the United States ban DTC 
advertising for pharmaceuticals. This is outside the scope of this 
project. We summarize and respond to the other comments as follows.
    (Comment 1) From AbbVie: Respondents may view ``benefits'' and 
``risks'' more generally versus ``side effects'' as a specific inquiry. 
For example, ``side effects'' could be interpreted as adverse effects 
or adverse events, and as such, elicit a much more specific response 
than ``risks'' which could be seen more broadly. We suggest that ``side 
effects'' be eliminated from question 4 to keep questions 3 and 4 as 
both general in nature.
    (Response) We are interested in recall of both risks and side 
effects, and so we inquire about both. Inquiring about risks only may 
artificially reduce the quantity of recall. Moreover, we counterbalance 
the presentation of questions 3 and 4 in efforts to account for any 
influence of question ordering. It would be feasible to instead inquire 
about risks and side effects in separate questions; however, in our 
experience, we find that consumers tend to think about risks and side 
effects together, which makes sense given the typical presentation of 
risks and side effects in direct-to-consumer promotional materials.
    (Comment 2) From AbbVie: The answers to questions 7 through 12 may 
be biased by attitudes toward advertising in general and may go well 
beyond the pharmaceutical ad they are shown.
    (Response) By asking these questions, we hope to detect any 
differences in perceived effectiveness and risk between those exposed 
to different experimental conditions. For example, those exposed to an 
ad with a #1 Prescribed market claim may perceive the product to be 
more effective than those in the control condition. We acknowledge 
participants may bring their own opinions about advertising to the 
study. However, these opinions tend to be evenly distributed across 
experimental conditions based on random assignment procedures. Thus, 
any differences result from the experimental manipulations.
    (Comment 3) From AbbVie: We acknowledge we have not seen the test 
ad; but, we wish to point out that questions 13 and 17 rely on the ad 
presenting numeric efficacy and safety information that can be 
interpreted by respondents.
    (Response) Prior research has shown that consumers can reach 
numeric judgments about efficacy and risk despite no numeric 
information being presented (Ref. 5). As described in our study design 
(see table 1), we are not manipulating quantitative safety information 
and not all test ads contain quantitative efficacy information. We have 
worked with an expert reviewer in OPDP to produce efficacy claims that 
are realistic for this drug product class.
    (Comment 4) From AbbVie: Question 18 relies on the ad presenting 
information about the seriousness of one or more ``side effects'' that 
the respondent could rank. We do not usually see print ads that present 
details about the extent of the seriousness of one or more side 
effects. In the absence of this presentation, how are respondents to 
answer this question?
    (Response) We find that consumers are generally able to 
differentiate between the seriousness of various risks and side 
effects, and also that they can make judgments about the overall (gist) 
seriousness of the risks and side effects. We ask this question with 
the intention to detect whether or not exposure to market claims and 
efficacy information impacts risk perceptions.
    (Comment 5) From AbbVie: The answers to questions 21 to 26 may 
reflect a patient's perception of their doctor rather than the ad. 
Therefore, the answers may not reflect what was communicated in the ad 
but rather

[[Page 26809]]

reflect the patient-doctor relationship (e.g., patient perception of 
their doctor).
    (Response) We are endeavoring to replicate the results of Mitra et 
al. (Ref. 4), who found that market leadership claims affected consumer 
beliefs about doctor's judgments.
    (Comment 6) From AbbVie: In the table headers for questions 27 and 
28, please change ``claim'' to ``statement'' so that it matches the 
text in the question.
    (Response) We will make this change.
    (Comment 7) From AbbVie: It is beneficial to rotate the order of 
response choices in questions 27 and 28 as is done in prior questions. 
Some of the features a-h are broad (b. pictures and images) while some 
are specific (e. percentages). It would be better to compare the very 
general features in a question and group the very specific features 
into another question to compare like features.
    (Response) We will make this change.
    (Comment 8) From AbbVie: For questions 35 to 38, rather than rank 
from Strongly Disagree to Strongly Agree, which are absolutes, it would 
be better to rank by frequency from Never to Always; this moves the 
response to how often patients perceive this and away from absolutes.
    (Response) We acknowledge that it is difficult to rank agree/
disagree on all drugs. However, a scale range of Always-Never is 
unipolar; we can't assess whether respondents think the opposite, e.g., 
that New drugs tend to be more risky or that the #1 Prescribed drug is 
more risky. Our intention is to use these items as a moderator when 
examining the impact of the experimental manipulations (i.e., market 
claims, efficacy claims) on benefit and risk perceptions, intentions to 
take the product, and other outcomes. We believe the most relevant 
scale for this analysis is the current Strongly Disagree to Strongly 
Agree scale. Although it would be interesting to assess participant 
responding using both scales, doing so may not add significant value 
relative to the additional burden it would pose for participants.
    (Comment 9) From AbbVie: We suggest that all the features of 
question 43a to h be stated in the affirmative/positive. For example, 
question 43h should be worded as ``the drug has few side effects'' to 
be consistent with features of question 43a to g that are positively 
stated.
    (Response) The proposed item, ``the drug has few side effects,'' 
assesses a different outcome than our current question, ``the drug has 
serious side effects.'' We have also added items assessing ``drug cost 
and/or copay'' and ``doctor's recommendation.'' For consistency, we 
will change the wording so that all features are neutral (for instance: 
The drug's side effects, opinions of people I know, how often the drug 
is prescribed).
    (Comment 10) From Lilly: Given the proposed FDA research questions, 
Lilly believes the design is appropriate and the sample size will allow 
for breakouts by each cell. In advertising A/B tests, in which this is 
similar to, all aspects of the stimulus not being tested are held the 
same in order to reduce bias and isolate the feature being tested. We 
strongly recommend that this guideline is followed in this study.
    (Response) We intend to hold all features other than the 
manipulations constant in the stimuli.
    (Comment 11) From Lilly: One research objective for the main study 
suggests that the study will measure perceptions of the doctors' 
acceptance of the drug by respondents. Since respondents will only be 
seeing a print ad and not interacting with a doctor, we believe the 
research setting will be too artificial to gain meaningful insights 
into this topic. We recommend removing the section (questions 21 to 
26).
    (Response) Please see response to Comment 5 from AbbVie.
    (Comment 12) From Lilly: The details of the followup study are less 
clear than the main study. What are the techniques and what are the 
dependent measures on which the respondent will be asked to decide?
    (Response) The followup study assesses the relative weighting of a 
market claim and efficacy in decisionmaking. Participants are asked to 
choose a drug out of two options that vary in (1) the presence of a 
market claim and (2) efficacy. We will examine product preference as a 
function of efficacy using logistic regression. The difference in 
efficacy between the two drugs on each choice set will be a continuous 
predictor variable and drug choice will be a binary outcome variable. 
Critically, we will examine whether, and to what extent, the efficacy-
choice relationship varies as a function of an added market claim; 
thus, market claim presence will be an interaction term. The experiment 
uses a discrete choice approach common in psychology and economics 
(Ref. 8).
    (Comment 13) From Lilly: We suggest FDA stratify the sample for 
both studies across demographic variables to ensure it is 
representative of the U.S. diabetic population.
    (Response) We are applying demographic quotas to achieve a 
representative sample.
    (Comment 14) From Lilly: The questionnaire employs a number of 
different Likert scales that differ on the number of scale values and 
definition of values. Lilly suggests using a standard five-point scale 
with a mid-point and definitions for each value for all scalar 
questions.
    (Response) We have changed the Likert scales to be internally 
consistent.
    (Comment 15) From Lilly: For questions 9 and 16, by asking the 
respondents to perceive overall quality of the drug, the survey risks 
introducing perceptions outside of experimental control into the study. 
Overall quality is a very broad topic and might be dependent on the 
graphics, wording, and personal biases that are outside of the market 
claims and efficacy levels being tested. We suggest removing these 
questions, or changing the question to ``overall efficacy.''
    (Response) By asking these questions, we hope to detect any 
differences in perceived quality between those exposed to different 
experimental conditions. For example, those exposed to an ad with a #1 
Prescribed market claim may perceive the product to be of higher 
quality than those in the control condition. By keeping all ad elements 
beyond the experimental manipulations (market claims, efficacy claims) 
constant, we can ensure that significant differences between conditions 
are a result of the manipulations rather than any extraneous factors. 
Random assignment to conditions should also distribute any random 
variance equally across all cells.
    (Comment 16) From Lilly: We recommend removing questions 13 and 17 
as they have the potential to be misinterpreted or simply difficult for 
the respondent to answer if the stimulus is not communicating 
prevalence of the drug's side effects or benefits using precise 
numbers.
    (Response) Please see response to Comment 3 from AbbVie.
    (Comment 17) From Lilly: For questions 27 and 28, we recommend 
slightly changing the wordings for the possible answer choices to 
``Yes/No, claim is/is not mentioned as a benefit in the ad'' for 
question 27, and ``Yes/No, claim is/is not mentioned as a side effect 
or risk in the ad'' for question 28.
    (Response) We agree that more specific wording would be helpful and 
have revised the answer choices to read ``Yes, statement is mentioned 
in the ad'' and ``No, statement is not mentioned in the ad.''
    (Comment 18) From Lilly: Recommend removing question 31 as the 
question is an inverse of question 30 to avoid confounding data.

[[Page 26810]]

    (Response) We have removed question 31 (skepticism).
    (Comment 19) From Lilly: The instructions for the questions 35 
through 38 section seem to have an omitted word. We recommend revising 
to ``how much do you agree or disagree with the following statements?''
    (Response) Thank you for pointing this out. We will correct this.
    (Comment 20) From Lilly: We agree with placement of demographic 
questions (questions 39-44) at the end but recommend reevaluating them 
and consider removing them so as to avoid lack of response due to 
respondent fatigue.
    (Response) The comment about respondent fatigue is well taken. 
However, we are adhering to good questionnaire design in putting our 
most important dependent measures first and are willing to accept the 
potential tradeoff in missing demographic data.
    (Comment 21) From Lilly: We suggest providing a more complete list 
of choices for question 43 and placing this question earlier in the 
study.
    (Response) We appreciate this suggestion and have added questions 
about cost.
    (Comment 22) From Merck: Merck supports the importance of 
communicating information that can be understood by consumers so that 
they can make better decisions about prescription drugs. We believe 
that FDA should focus their efforts and research first on improving the 
health literacy of approved patient labeling and then on DTC print 
advertising. In addition, FDA should consider exploring the inclusion 
of benefit information in patient labeling, which may help improve 
consumer understanding and comprehension of patient labeling.
    (Response) We share the goal of improving communications about 
prescription drugs. There are efforts underway within FDA examining 
ways to improve patient labeling (Ref. 9). Although this comment is 
outside the scope of this project, we will share this information 
internally.
    (Comment 23) From Merck: Merck believes the current study design 
limits the practical utility of the information collected. The study 
proposes presenting efficacy information in the form of simple 
quantitative information. Prior OPDP research acknowledged the 
limitations of studying simple quantitative information. For many 
prescription drugs, clinical trial outcomes are often more complicated 
than simple frequencies, which limit the applicability of this 
research. Numeracy challenges are common in people with inadequate 
health literacy. Numeracy challenges are not well represented in online 
research, and hence the proposed methodology may not detect a lack of 
comprehension.
    (Response) We are pleased Merck has read FDA's prior research in 
the area of communicating quantitative information. As this is the 
first study examining the impact of quantitative efficacy information 
on the perception of market share claims, we felt it was better to 
start with relatively straightforward, though not simplistic, 
quantitative efficacy information. We have worked with an expert 
reviewer in OPDP to product efficacy claims that are realistic for this 
drug product class. The efficacy claim communicates both the level of 
expected benefit and the likelihood of experiencing that benefit. We 
encourage additional research on this topic utilizing increasingly 
complex quantitative information.
    We have included a measure of numeracy in our questionnaire. We 
acknowledge that online panels may underrepresent individuals with 
extremely low health literacy. Thus, any differences we find as a 
function of numeracy in our sample may be magnified in the general 
population.
    (Comment 24) From Merck: Merck recommends a mixed-method approach 
to reach limited-literacy respondents. The phone or Web approach allows 
for a broad, diverse geographic sample. Respondents with low health 
literacy are not typically represented in these databases, and may need 
to be recruited in less traditional places, such as literacy centers, 
senior centers, and health clinics. Additionally, if a desktop computer 
is required, this may inadvertently eliminate respondents from low 
socioeconomic status, who are less likely to have a desktop computer 
and more likely to have internet only on their mobile device.
    (Response) We acknowledge that internet administration is not 
perfect and have chosen this method to maximize our budget. We will 
permit the survey to be taken on a variety of devices. We are excluding 
phones because the stimuli cannot be fully viewed on a very small 
screen.
    (Comment 25) From Merck: For the followup study, we recommend 
reducing the number of trials for respondents across health literacy 
levels, as respondent fatigue can occur, resulting in reduced focus and 
unreliably responses. Refining the methodology to present fewer choices 
to each respondent, and assuring the clarity of the information 
presented, would help to enhance comprehension.
    (Response) We agree that minimizing respondent burden is a 
priority. We estimate that the 48 trials and instructions would require 
less than 8 minutes, on average. Pretest data may reveal that the 
experiment can be shortened without loss to validity, in which case we 
will reduce the number of trials.
    (Comment 26) From Merck: Questions 6, 32, and 50 include 
percentages. According to Health Literacy Missouri, natural frequencies 
(1 out of 10) may be more useful than percentages. Research suggests 
that less literate readers may interpret numbers as more risky when in 
frequency form (1 out of 10) versus percentage form (10 percent).
    (Response) We have worked with an expert reviewer in OPDP to 
product efficacy claims that are realistic for this drug product class.
    (Comment 27) From Merck: We suggest adding the following screener 
question to increase the odds of recruiting limited-literacy 
respondents: ``How confident are you in filling out medical forms by 
yourself?''
    (Response) We acknowledge that internet panels underrepresent 
individuals with very low literacy. Thus, it is important to 
acknowledge that our findings may not apply to very low literacy 
individuals. It would be prohibitively expensive for us to screen for 
literacy up front in order to establish quotas. We will measure health 
literacy and included it in analyses.
    The first two pretests and main study are expected to last no more 
than 30 minutes. The third pretest and followup study are expected to 
last no more than 15 minutes. This will be a one-time (rather than 
annual) collection of information. FDA estimates the burden of this 
collection of information as follows:

[[Page 26811]]

                                                              Table 2--Estimated Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per       Total             Average burden per response           Total hours
                                                 respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample Outgo (Pretests and Main Survey)......          16,384  ..............  ..............  .........................................  ..............
Screener Completes...........................           1,638               1           1,638  0.03 (2 minutes).........................            49.1
Eligible.....................................           1,556  ..............  ..............  .........................................  ..............
Completes, Pretest 1.........................             252               1             252  0.5 (30 minutes).........................             126
Completes, Pretest 2.........................             252               1             252  0.5 (30 minutes).........................             126
Completes, Main Study........................             495               1             495  0.5 (30 minutes).........................           247.5
Completes, Pretest 3.........................             108               1             108  0.25 (15 minutes)........................              27
Completes, Followup Study....................             216               1             216  0.25 (15 minutes)........................              54
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           629.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.
1. Lee, M. and Y-C. Lou, ``Consumer Reliance on Intrinsic and 
Extrinsic Cues in Product Evaluations: A Conjoint Approach,'' 
Journal of Applied Business Research, 12(1):21-29, 2011.
2. Teas, R.K. and S. Agarwal, ``The Effects of Extrinsic Product 
Cues on Consumers' Perceptions of Quality, Sacrifice, and Value,'' 
Journal of the Academy of Marketing Science, 28(2):278-290, 2000.
3. Rao, A.R. and K.B. Monroe, ``The Effect of Price, Brand Name, and 
Store Name on Buyers' Perceptions of Product Quality: An Integrative 
Review,'' Journal of Marketing Research, 26(3):351-357, 1989.
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ``How Do Consumers 
Interpret Market Leadership Claims in Direct-to-Consumer Advertising 
of Prescription Drugs?'' Advances in Consumer Research, 33:381-387, 
2006.
5. O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al., ``Presenting 
Efficacy Information in Direct-to-Consumer Prescription Drug 
Advertisements,'' Patient Education and Counseling, 95(2):271-280, 
2014.
6. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts 
Box to Communicate Drug Benefits and Harms: Two Randomized Trials,'' 
Annals of Internal Medicine, 150(8):516-527, 2009.
7. Sullivan, H.W., A.C. O'Donoghue, and K.J. Aikin, ``Presenting 
Quantitative Information About Placebo Rates to Patients,'' JAMA 
Internal Medicine, 173(2):2006-2007, 2013.
8. Train, K.E., Discrete Choice Methods With Simulation, Cambridge 
University Press, 2009.
9. Boudewyns, V., A.C. O'Donoghue, B. Kelly, et al., ``Influence of 
Patient Medication Information Format on Comprehension and 
Application of Medication Information: A Randomized, Controlled 
Experiment,'' Patient Education and Counseling, 98(12):1592-1599, 
2015.

    Dated: April 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10396 Filed 5-3-16; 8:45 am]
BILLING CODE 4164-01-P