[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14440-14445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5666]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Empirical Study of 
Promotional Implications of Proprietary Prescription Drug Names

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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by April 15, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is ``Empirical Study of Promotional Implications 
of Proprietary Prescription Drug Names.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Empirical Study of Promotional Implications of Proprietary Prescription 
Drug Names

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 (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 Office of Prescription Drug Promotion's (OPDP) mission is to 
protect the public health by helping to ensure that prescription drug 
promotion is truthful, balanced, and accurately communicated. OPDP's 
research program provides scientific evidence to help ensure that our 
policies related to prescription drug promotion will have the greatest 
benefit to public health. Toward that end, we have consistently 
conducted research to evaluate the aspects of prescription drug 
promotion that are most central to our mission. Our research focuses in 
particular on three main topic areas: (1) Advertising features, 
including content and format; (2) target populations; and (3) research 
quality. Through the evaluation of advertising features we assess how 
elements such as graphics, format, and disease and product 
characteristics impact the communication and understanding of 
prescription drug risks and benefits; focusing on target populations 
allows us to evaluate how understanding of prescription drug risks and 
benefits may vary as a function of audience; and our focus on research 
quality aims at maximizing the quality of our research data through 
analytical methodology development and investigation of sampling and 
response issues. This study will inform the first two topic areas, 
advertising features and target populations.
    Because we recognize that the strength of data and the confidence 
in the robust nature of the findings is improved by utilizing the 
results of multiple converging studies, we continue to develop evidence 
to inform our thinking. We evaluate the results from our studies within 
the broader context of research and findings from other sources, and 
this larger body of knowledge collectively informs our policies as well 
as our research program. Our research is documented on our homepage, 
which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website 
includes links to the latest Federal Register notices and peer-reviewed 
publications produced by our office. The website maintains information 
on studies we have conducted, dating back to a survey on direct-to-
consumer advertisements conducted in 1999.
    During the prescription drug approval process, sponsors propose 
proprietary names for their products. These names undergo a proprietary 
name review that involves the Office of Drug Safety, the relevant 
medical office, and OPDP. OPDP reviews names to assess for alignment 
with the FD&C Act, which, among other things, provides that labeling 
can misbrand a product if false or misleading representations are made 
(see 21 U.S.C. 321(n), 352(a)). A proprietary name, which appears in 
labeling, could result in such misbranding if it is false or 
misleading. OPDP focuses its review on identifying names that overstate 
the efficacy or safety of the drug, suggest drug indications that are 
not accurate, suggest superiority without substantiation, or are of a 
fanciful nature that misleadingly implies unique effectiveness or 
composition. This research will focus on the effect on consumers' and/
or healthcare providers' perceptions of a drug product of names that 
overstate the efficacy of the drug product. An overstatement of 
efficacy can occur, for example, in terms of level of efficacy, in 
which the degree of relief is overstated, or in terms of the type of 
effect, in which case there is a mismatch with the indication of the 
drug. The drug products that are studied will be fictitious, and 
whether the names overstate the drug products' efficacy will be 
determined with regard to the products' fictitious degree of efficacy.
    The proposed study is designed to provide systematic, empirical 
evidence to answer two research questions:
     Primary research question: How, if at all, do names that 
suggest the medical condition for which a drug is indicated affect 
consumers' and/or healthcare providers' perceptions of prescription 
drugs?
     Secondary research question: How, if at all, do names that 
suggest an overstatement of the degree of efficacy of the drug affect 
consumers' and/or healthcare providers' perceptions of prescription 
drugs?
    The ideas generated in the Prescription Drug User Fee Amendments 
pilot project proprietary name review concept paper of 2008 \1\ 
provided a starting point for the study.

[[Page 14441]]

Based on ideas from that document, a review of the linguistics and 
social sciences literature, and an environmental scan of existing 
proprietary names, FDA developed and pretested an extreme, explicitly 
suggestive name (e.g., CuresFlux) and a neutral name (e.g., Zerpexin) 
for two medical conditions, high cholesterol and gastroesophageal 
reflux disease (GERD) (pretesting approved under OMB control number 
0910-0695). In the proposed main study, approximately 500 consumers 
from the general population and 500 healthcare providers (including 
physicians, nurse practitioners, and physician assistants) will see 
these pretested extreme and neutral names plus five target names per 
indication (names that may suggest the medical condition and vary in 
terms of promise of effect) and answer questions about the names, 
before and after they have been told what each drug's indication is. 
Target names will vary such that some efficacy implications are more 
apparent than others, and some will more clearly imply the medical 
condition for which a drug is indicated than others. Dependent 
variables will include identification of the medical condition for 
which a drug is indicated, efficacy, and perceptions.
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    \1\ https://www.regulations.gov/docket?D=FDA-2008-N-0281.
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    To our knowledge, this study is the first to provide a systemic 
investigation of a variety of proprietary prescription drug names.
    In the Federal Register of January 21, 2020 (85 FR 3392), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received seven submissions that were 
PRA-related. One submission was outside the scope of the research and 
is not addressed further. Within the remaining six submissions, FDA 
received multiple comments that the Agency has addressed below. For 
brevity, some public comments are paraphrased and therefore may not 
include the exact language used by the commenter. We assure commenters 
that the entirety of their comments was considered even if not fully 
captured by our paraphrasing in this document. The following acronyms 
are used here: HCP = healthcare provider; FDA and Agency = Food and 
Drug Administration; OPDP = FDA's Office of Prescription Drug 
Promotion.
    (Comment 1) Two comments recommended that the study should exclude 
consumers who work in the healthcare, marketing, or branding 
industries; primary care providers that spend less than 50 percent of 
their time on patient care; and the Department of Health and Human 
Services employees.
    (Response 1) We agree and currently have those exclusions included 
in the screener.
    (Comment 2) Two comments recommended the screener should include 
additional inclusion/exclusion criteria, such as number of years in 
practice and in what size facility they work (HCPs), and whether 
consumers have any of five diagnoses and how many HCPs they see 
(consumers).
    (Response 2) We plan to include most of the screening criteria and 
demographic data mentioned, including years in practice (HCPs); amount 
of time treating patients (HCPs); size of facility (HCPs); age 
(consumers); and diagnosis with one of the two illnesses which the 
hypothetical drugs in this study are indicated to treat--GERD and high 
cholesterol (consumers). Some of the other suggested questions for the 
screener are beyond the scope of this study. For this study, we have 
chosen to focus on primary care providers, as drugs for these two 
specific medical conditions are prescribed by primary care providers 
and should thus be salient for them. Additionally, we will ask relevant 
background questions of all participants, both HCPs and consumers, to 
determine age, sex, and race, as well as familiarity with the target 
conditions.
    (Comment 3) One comment recommended that the complexity of the 
target names should be equivalent across indications.
    (Response 3) We have attempted to make these as similar as 
possible, including having them reviewed by a linguist and checking the 
number of syllables across conditions.
    (Comment 4) Three comments recommend better clarity around what the 
definitions of ``typical'' and ``standard'' and ``extreme'' and 
``neutral'' mean when describing the fictitious drug name and how these 
categories were identified and validated.
    (Response 4) The list of names was developed by our multimedia and 
creative services team who are well-versed in the practice of 
proprietary name development. The list was reviewed by the study team 
and also by a consultant with a Ph.D. in linguistics, who helped to 
screen for any overlap between categories.
    In July 2019, we conducted a pretest of 120 healthcare providers 
and 121 consumers to establish the categories for these names. We 
combined results of four measures to determine the most extreme and 
most neutral amongst a list of names. These measures included ability 
to identify the medical condition for which the drug is indicated; 
perceived benefit and perceived balance of benefit and risk; and, 
finally, a ranking of most obvious benefit. Names with the lowest joint 
rank across the four measures were considered most extreme and those 
with highest were considered most neutral. The results were consistent 
between HCPs and consumers.
    (Comment 5) One comment recommended excluding ``extreme, explicitly 
suggestive'' proprietary names that FDA would never permit or names 
that suggest the drug indication. The comment suggested instead that 
FDA use data that could assist the Agency in determining impressions 
produced by permissible proprietary names and names that would 
marginally fail FDA's misbranding review.
    (Response 5) The purpose of including ``extreme'' names in this 
study is not to have data on names that do not mimic real-world 
conditions, but to have something against which to compare the target 
names, which are similar to the kind of names that would be submitted 
to FDA for approval. Our findings may suggest that ``extreme'' and 
target names are very different and that target names are similar to 
more neutral names in their effects on perceptions.
    (Comment 6) One comment inquired if FDA will be providing sound 
files with the intended pronunciation of each of the test names.
    (Response 6) In consideration of this comment, and after hearing 
from our cognitive interview participants, we will introduce sound 
files at the beginning of the survey.
    (Comment 7) One comment expressed concerns about how the selection 
of target names will represent the current landscape--that is, it 
questioned how FDA will generalize these study results across 
therapeutic areas not tested if only representing one or two 
therapeutic areas.
    (Response 7) We recognize that our study is making use of only two 
therapeutic areas. As one research study, it cannot examine all 
possible therapeutic areas. Although our two divergent medical 
conditions will not provide us with unlimited information, they will 
provide limited generalizability and provide important information that 
may help inform the proprietary name review process.
    (Comment 8) Two comments were concerned that the questionnaire 
would take longer than the estimated 20 minutes.
    (Response 8) See our response to Comment 4 concerning the pretest 
that we conducted in July 2019. In the pretest, we successfully tested 
a total of 16 names across two indications in this time frame. During 
cognitive testing, we

[[Page 14442]]

examined burden and decided to eliminate Q[uestion]7, which will speed 
response. We will also conduct a soft launch of the survey with 
approximately 10 percent of the sample and can look at actual length at 
that time. This gives us the ability to pause fielding of the survey 
and make further cuts if the soft launch data suggest it is necessary.
    (Comment 9) Five comments recommended that we add ``none of the 
above,'' ``no impression,'' ``no opinion'' or ``do not know'' response 
options to some questions.
    (Response 9) The rationale usually given for including ``don't 
know''/``no opinion''/``none'' options is to allow participants who 
cannot form a relevant judgment (e.g., due to insufficient information) 
a way to indicate as much. However, an unintended consequence of 
including these options is that they can facilitate satisficing, where 
participants who have enough information to form a relevant judgment 
nonetheless choose ``don't know''/``no opinion''/``none'' because it 
takes less effort. As a result, ``don't know''/``no opinion''/``none'' 
options do not tend to improve measurement and tend to increase item 
nonresponse (i.e., missing data) (Ref. 1). For these reasons, we will 
not add these options.
    (Comment 10) Seven comments suggested adding more open-ended 
responses to explain why respondents answered questions in certain 
ways.
    (Response 10) As noted by two comments the survey may be longer 
than an average of 20 minutes, which will cause us to remove questions 
after cognitive testing. Unfortunately, it is impractical to include 
many open-ended questions in this particular research because of time 
constraints. Qualitative research on this topic may be a good idea for 
a future study.
    (Comment 11) One comment recommended checks to ensure that 
respondents are not being careless in their responses (e.g., just 
guessing, providing random answers, straight-lining).
    (Response 11) We intend to check for inattentive respondents by 
testing for straight-lining and examining the distribution of time to 
complete the study for outliers. Participants who complete the study 
plus or minus three standard deviations from the sample mean will be 
excluded from the main analysis. We agree with the recommendation to 
include speed traps/attention checks in the questionnaire and will add 
one to the study.
    (Comment 12) Three comments requested access to the screener or 
study target names.
    (Response 12) We have described the purpose of the study, the 
design, the population of interest, and have provided the questionnaire 
to numerous individuals upon request. Our full stimuli are under 
development during the PRA process. We do not make draft stimuli public 
during this time because of concerns that this may contaminate our 
participant pool and compromise the research. We strive to publish the 
results of our research in peer-reviewed journals and all stimuli will 
be available at that time.
    (Comment 13) One comment recommended a specific approach for 
addressing the issue of broadening the indication that included an 
unaided ``fit to category'' question and an open-ended ``does the brand 
name tell you anything about the product?'' OR ``what does this name 
mean to you?''--type question for each name.
    (Response 13) The approach described in this comment is one method 
to approach the issue of broadening the indication and may be useful 
for future research. However, in the current study we aim to collect 
information about multiple names, which precludes open-ended questions 
for each name in a single participant session. Moreover, our initial 
examination is focused on overstatement of efficacy. Broadening of the 
indication is another topic that researchers could pursue.
    (Comment 14) One comment mentioned that we had no particular items 
on the issue of unique composition and suggested adding an open-ended 
question regarding general associations to determine whether a 
particular ingredient or dosage formulation is implied by a proprietary 
name.
    (Response 14) Our current research is focused on the issue of 
overstatement of efficacy in proposed proprietary drug names. Future 
research could examine issues related to composition and dosage 
formulation, but that is beyond the scope of the current research.
    (Comment 15) One comment suggested FDA should conduct two survey 
pretests: One to assess whether the survey answers the research 
questions, and one that allows respondents to complete the survey under 
the supervision of a moderator, who is able to converse with 
respondents and gather feedback on how participants interpret the 
questions. Further, the comment suggests FDA should consider conducting 
qualitative followup interviews with survey respondents to gain deeper 
insight into how the sample proprietary names affected their 
impressions of safety, efficacy and indication.
    (Response 15) We have accomplished the goals recommended in this 
comment by conducting cognitive interviewing. During these cognitive 
interviews, participants were encouraged to think aloud as they 
reviewed and answered the survey with prompts from a trained moderator. 
These interviews enabled us to capture deeper, more qualitative 
responses from a small nonrepresentative sample of individuals in order 
to improve the questionnaire.
    (Comment 16) One comment suggested FDA consider the inverse 
approach of our design by setting up the research to examine how, if at 
all, names that do suggest the drug's indication increase the chance 
for proper usage, reduce the potential for medication errors, do not 
mislead HCPs or patients regarding non-approved use of the drug, and 
increase the chance that if a patient does ask an HCP about a certain 
medication then that medication would be one approved to treat a 
condition with which the patient has been diagnosed.
    (Response 16) The purpose of the current study is to provide 
evidence about whether certain types of names influence consumers' 
perceptions, as well as benefit and risk perceptions so that FDA 
reviewers may better assess names during premarket review. Other 
effects of names are beyond the scope of the current study but may be 
considered in future research.
    (Comment 17) One comment suggested the ability of HCPs who 
prescribe drug products to determine whether a proprietary name 
overstates the efficacy of that product without the ability to review 
the respective package insert labeling fails to meet the intent of 21 
U.S.C. 321(n). The comment further stated that OPDP and the sponsor of 
the product are in the best position to determine the relationship 
between the proprietary name and the material facts in the labeling of 
the product, which sometimes is not available at the investigational 
new drug (IND) application stage when proprietary names are developed 
and tested with consumers and HCPs.
    (Response 17) The purpose of the current study is to determine 
whether a proprietary name itself could play a role in influencing 
consumer and HCP perceptions of drug risks or benefits by suggesting 
the medical condition for which the drug is indicated or by suggesting 
an overstatement of the efficacy of the drug. Including the package 
insert would confound any potential results of this study, as it would 
not be possible to tease apart

[[Page 14443]]

whether perceptions were influenced by the name itself or the 
accompanying materials. We note that this is a large-scale study 
examining multiple names and that our purpose in conducting it differs 
from that of a pharmaceutical company engaged in developing and testing 
the proprietary name of one of its products.
    (Comment 18) One comment suggested that the proposed primary 
research question, which is designed to determine how, if at all, a 
proprietary name that suggests the medical condition for which it is 
indicated affects perceptions of the drug, does not determine whether a 
name overstates the efficacy of the product.
    (Response 18) We agree that whether a name suggests the medical 
condition for which a drug is indicated is a separate question from 
whether the name overstates the drug's efficacy. However, we aim, in 
part, to investigate how individuals perceive the efficacy of products 
when the names do suggest the medical condition they are indicated to 
treat. The purpose of this study is to compare names that: (1) With 
varying degrees of specificity, may suggest the medical condition for 
which a drug is indicated, with or without varied promises of effect 
(target names); (2) we know through pretesting overstate the efficacy 
(extreme names); and (3) we know to be neutral through pretesting. 
Perceptions of consumers and HCPs are important to consider when 
reviewing proprietary names and thus, important to test empirically.
    (Comment 19) One comment suggested that research is not necessary 
because names should be evaluated by those who have medical and 
regulatory experience.
    (Response 19) We agree that people who are knowledgeable about the 
relevant fields should make decisions about proprietary names based on 
the best information in their fields. Determining how names are 
processed and understood by consumers and HCPs is important information 
to be considered in the review of these names. Therefore, this research 
is being conducted to increase the body of evidence upon which experts 
can rely when assessing proposed proprietary names for misbranding 
concerns.
    (Comment 20) Three comments mentioned the study sample size. One 
comment stated that the reason for selecting approximately 1000 
respondents was not provided, and it suggested that the size of such a 
study on a proposed drug product would not be reasonable or cost 
effective for the pharmaceutical industry. One comment recommended that 
an appropriate sample size be used, and another comment remarked that 
the sample size seemed appropriate.
    (Response 20) The sample size was selected based on power analysis. 
We have set statistical power for the main study to test five proposed 
names against both the neutral control name and the extreme control 
name, using a 7 x 7 Latin squares design. With a Bonferroni correction 
for up to 10 pairwise comparisons, the study is powered to detect 
conventionally small effects (f >= 0.06, dz >= 0.21, or 0.14 difference 
in proportions) assuming a family-wise alpha level of 0.005 and 90 
percent power for all tests.
    This is a large-scale study examining multiple names, whose purpose 
differs from that of one pharmaceutical company assessing their chosen 
names.
    (Comment 21) One comment concurred that an automated online survey 
would be the most efficient means to conduct the research.
    (Response 21) Thank you for this comment.
    (Comment 22) One comment asked that we clarify what specific 
statistical tests will be performed to determine whether a particular 
target name has an improper (biasing) impact on perceptions of drug 
efficacy and/or safety--and (possibly) on other perceptions.
    (Response 22) To compare names based on the categorical name 
recognition and perceived indication questions, we will apply 
nonparametric tests of dependent proportions. First, we plan to conduct 
Cochran's Q test separately for each list of names, testing whether the 
proportions of at least two names per list are significantly different 
from one another. We will follow up significant Cochran's Q tests with 
McNemar's pairwise tests, comparing each target name against the 
neutral and extreme names in each list.
    To test for evidence of mean differences by drug name on interval-
level outcomes (e.g., perceived efficacy magnitude, perceived severity 
of risks, and perceived balance of risks and benefits), we will use 
repeated-measures analyses of variance or mixed model analysis. We will 
run separate models for each list of names and study cohort. We will 
follow-up significant omnibus tests by conducting pairwise comparisons 
between each of the target names versus the neutral and extreme names.
    See information about the study's statistical power assumptions 
above.
    (Comment 23) One comment asked for clarity regarding what decision 
rule or norm/standard will be used to conclude that there is or is not 
improper suggestiveness.
    (Response 23) There is an important distinction between 
investigating the effect of a prescription drug name on perceptions and 
establishing that the name is improperly suggestive. This study is 
focused on the effect on perceptions of: (1) Names that suggest the 
medical condition for which a drug is indicated with varying degrees of 
explicitness and (2) names that suggest an overstatement of the 
efficacy of the drug with varying degrees of explicitness. Determining 
whether what a prescription drug name suggests or the name's degree of 
suggestiveness is ``improper,'' or could contribute to misbranding the 
drug or to other violation(s) of the FD&C Act and Agency regulations, 
falls beyond the scope of the current project.
    (Comment 24) One comment suggested clarifying the purpose and 
intended use of the data and further suggests that regardless of the 
purpose of the proposed information collection, in addressing use of 
the survey data, FDA should account for the First Amendment protection 
provided to proprietary names.
    (Response 24) As stated in the 60-day notice, the purpose of this 
study is to expand the body of knowledge by answering questions about 
whether names alone impact consumer and provider perceptions of a drug. 
This information will help inform the proprietary name review process. 
FDA's review of proprietary names is conducted to help ensure that 
proposed proprietary names do not contribute to misbranding a drug or 
to other violation(s) of the FD&C Act and Agency regulations, 
particularly when that proprietary name appears in labeling (see, e.g., 
21 U.S.C. 321(n) and 352(a)). We conduct our review of proprietary 
names in accordance with applicable legal authorities, including the 
First Amendment.
    (Comment 25) One comment suggested Q1 should have a timer element 
(i.e., 15-20 seconds) for each set of seven names that will help to 
standardize the time spent by viewers on both sets and mitigate viewers 
who would quickly scan Set 1, only to spend more time on Set 2 after 
realizing they will be asked to recognize the names.
    (Response 25) In addition to counterbalancing the sets of names, we 
will institute a time limit for each viewing.
    (Comment 26) Another comment suggested that for Q1, we use names 
that were found unacceptable due to promotional reasons for foils.

[[Page 14444]]

    (Response 26) The purpose of Q1 is to determine how well 
participants recall the names they viewed. The foils are used to help 
determine whether participants are merely checking off the complete 
list of names or marking ones they truly saw on the previous screen. 
Thus, we do not believe using actual names as foils would add value.
    (Comment 27) One comment mentioned that Q3-Q7 introduce an aided 
portion of the survey (by grouping names into two specific medical 
conditions and identifying those names with each medical condition to 
the respondents) and suggested that, without seeing the product 
profile, ``it will be difficult to get responsible data on efficacy 
perceptions of the respondents.'' Another comment suggested that Q3 
should ask a more specific question, perhaps on unique effectiveness or 
overstatement of efficacy.
    (Response 27) Our research questions focus on whether the names 
alone result in perceptions of risk or efficacy, thus, Q3-Q7 are 
directly relevant to the research questions. Regarding Q3, we do not 
want to lead participants into answers or confuse them by asking them 
about regulatory terms with which they are unfamiliar. We will delete 
Q7.
    (Comment 28) Regarding Q2, one comment suggested caution in terms 
of handling responses in which respondents presented with a particular 
target name (e.g., ``AltAFlux'') fail to identify the indication that 
the name is hypothesized to be suggestive of (e.g., ``Acid Reflux''), 
checking another indication instead (e.g., ``Asthma''). In such cases, 
it would be inappropriate to interpret any observed effects on drug 
perceptions to the name being overly suggestive of a particular 
indication. A conservative course of action would therefore be to 
remove from subsequent analyses all instances in which a target name is 
not attributed to its hypothesized indication.
    (Response 28) The target names are representative of the types of 
names that are frequently submitted to FDA for review. They may include 
information about the medical condition for which the drug is 
indicated, or both the medical condition and efficacy. We do not 
presuppose that a name's effect on perceptions of drug effectiveness 
are dependent on recognition of the medical condition for which the 
drug is indicated, though we will consider this mediation effect as we 
refine the analysis plan for this project.
    (Comment 29) One comment suggested that Q4 does not seem relevant 
since serious side effects of the drug would normally be evaluated in 
the context of the clinical studies or post-marketing studies and would 
be presented in the package insert labeling.
    (Response 29) The question is whether the name alone influences 
perception of risk and benefit; thus, Q4 is directly relevant to 
answering those questions.
    (Comment 30) Three comments suggested deleting Q5. For example, one 
comment discussed that perceived balance of risks and benefits is 
usually communicated in advertising by utilizing the approved labeling 
in presenting fair balance and, thus, a proprietary name would not 
normally present risks and benefits. The comment stated that names that 
do present benefits within the name without context to its risk would 
not be considered misleading since the approved labeling would 
represent balance of risks and benefits.
    (Response 30) Our research questions focus on whether the 
proprietary name alone affects consumer and HCP perceptions of risk or 
efficacy of the drug. Q5 helps to answer those research questions by 
asking participants to opine on whether the proprietary name alone 
indicates to them that the benefits of a product outweigh the risks. 
Our research will not answer the question whether a given name is 
misleading or whether labeling or advertising incorporating the name 
would violate the FD&C Act and its implementing regulations.
    (Comment 31) One comment suggested that measuring attitudes toward 
each name (Q6) does not seem to add anything toward measuring the 
efficacy claims of a name and another comment recommends changing 
semantic differential endpoints for this item.
    (Response 31) Measuring attitudes adds to our knowledge of how 
individuals interpret particular drug names. The semantic differential 
endpoints used in the original attitude question, as well as the 
proposed replacements, are among those recommended by prominent 
attitude theorists (Ref. 2). We have used these items in several 
studies without any issues, including studies measuring consumer and 
physician attitudes toward prescription drugs. Nevertheless, we will 
replace the negative-positive item with an item using worthless-
valuable as endpoints.
    (Comment 32) Five comments suggested reducing or eliminating Q7, 
which questions participants about their attitudes toward the drug 
names.
    (Response 32) As noted in Response 17, in the interest of reducing 
time burden for participants, we will delete this question.
    (Comment 33) Two comments questioned the utility of or recommended 
deleting Q8.
    (Response 33) We agree and will delete this item.
    (Comment 34) Two comments suggested that Q9 and two comments 
suggested that Q10 and Q11 are not applicable to the objectives of this 
survey.
    (Response 34) Similarity, typicality, and familiarity could 
reasonably influence perceptions of drug names independently of the 
experimental manipulation. These measures are being included in this 
study as potential covariates.
    (Comment 35) One comment suggested that Q11 is confusing, as 
respondents are asked to rate if they ``have heard of each of the 
following drug names before,'' after being previously told in the 
questionnaire introduction that the drugs ``have been recently 
developed'' and before being informed in the debriefing that the names 
are fictitious. Moreover, some respondents could interpret the present 
question as meaning ``Were the following names mentioned in this 
survey?'' which is presumably not the intent of the question.
    (Response 35) We agree that this item as written was confusing, and 
this was confirmed by cognitive testing. Thus, we will alter the 
question to clarify that we are interested in whether respondents had 
heard the drug name prior to the study. This question will be used as a 
covariate in the study design.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
                                   Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent      respondents     per response
----------------------------------------------------------------------------------------------------------------
Consumer Screener.............           1,233               1           1,233  .08 (5 minutes).           98.64

[[Page 14445]]

 
HCP Screener..................           1,233               1           1,233  .08 (5 minutes).           98.64
Consumer Study................             493               1             493  .33 (20 minutes)          162.69
HCP Study.....................             493               1             493  .33 (20 minutes)          162.69
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          522.66
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

References

    The following references are on display with the Dockets Management 
Staff, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 
1061, Rockville, MD 20852, 240-402-7500 and are available for viewing 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
these are not available electronically at https://www.regulations.gov 
as these references are copyright protected. Some may be available at 
the website address, if listed. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

1. Krosnick, J.A. and S. Presser, ``Question and Questionnaire 
Design.'' In P.V. Marsden and J.D. Wright (Eds.). Handbook of Survey 
Research (2nd Ed.). Emerald: Bingley, UK, 2010.
2. Fishbein, M. and I. Ajzen, Predicting and Changing Behavior: The 
Reasoned Action Approach. New York, NY: Psychology Press, 2010.

    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05330 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P