Document ID: FDA-2019-N-4763-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Assessment of
Terms and Phrases Commonly Used in Prescription Drug Promotion
Posted Date: 2020-09-18T04:00Z

[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58362-58366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20621]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4763]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Assessment of Terms 
and Phrases Commonly Used in Prescription Drug Promotion

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: Submit written comments (including recommendations) on the 
collection of information by October 19, 2020.

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 ``Assessment of Terms and Phrases Commonly 
Used in Prescription Drug Promotion.'' 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, 
PRAStaff@fda.hhs.gov.
    For copies of the questionnaire, contact: Office of Prescription 
Drug Promotion (OPDP) Research Team, DTCresearch@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.

Assessment of Terms and Phrases Commonly Used in Prescription Drug 
Promotion

OMB Control Number 0910-New

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to 
protect the public health, in part, by helping to ensure that 
prescription drug promotional material is truthful, balanced, and 
accurately communicated, so that patients and health care providers can 
make informed decisions about treatment options. 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: Advertising features, including content and 
format; target populations; and research quality. Through the 
evaluation of advertising features, we assess how elements such as 
graphics, format, and disease and product characteristics impact the 
communication and understanding of prescription drug risks and 
benefits. Focusing on target populations allows us to evaluate how 
understanding of prescription drug risks and benefits may vary as a 
function of audience, and our focus on research quality aims at 
maximizing the quality of our research data through analytical 
methodology development and investigation of sampling and response 
issues. This study will inform all three topic areas.
    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.
    The present research involves assessment of how consumers and 
primary care physicians (PCPs) interpret terms and phrases commonly 
used in prescription drug promotion, as well as those used to describe 
prescription drugs and prescription drug promotion more generally. This 
includes both what these terms and phrases mean to each population 
(e.g., definitions) and what these terms and phrases imply (e.g., about 
efficacy and safety). Some examples of interest include: ``natural'' or 
``naturally-occurring,'' and ``targeted'' or ``targeted therapy.'' The 
full list for assessment will include approximately 30 terms and 
phrases for each population. To accommodate such a large number, 
presented terms and phrases will be accompanied by only limited context 
(terms within sentences and phrases within paragraphs, as opposed to 
full promotional materials). Understanding the most prevalent 
interpretations of these terms and phrases can help OPDP determine the 
impact of specific language in prescription drug promotion. For 
example, certain terms and phrases, when used without additional 
contextual information, might overstate the efficacy or minimize the 
risk of a product. Additionally, from a health literacy perspective, it 
is helpful to ascertain general understanding of such terms and phrases 
as this may aid in the development of best practices around 
communicating these concepts.

[[Page 58363]]

    We plan to conduct this research in two phases. First, we will 
conduct formative semi-structured interviews with 30 members of each 
population (general population consumers and PCPs). Second, we will 
conduct nationally representative, probability-based surveys of more 
than 1,000 members of each population on the same topic.
    Phase 1: Semistructured Interviews. In Phase 1 of the research, 
semistructured interviews will be conducted by web conferencing using 
the itracks platform, an online and mobile market research service 
provider. This approach allows for the participant and interviewer to 
see each other and includes a whiteboard feature that can be used to 
show the terms, statements, or passages for participants to read and 
follow along as the interviewer reads them aloud. This may be helpful 
in cases where the statements or passages are long, which may make them 
difficult to understand when read aloud. In addition, the written 
information may be helpful as a reference as the discussion progresses.
    Participation is estimated to take 1 hour. Participants will be 
recruited by email through itracks and its partner panels. All 
participants will be 18 years of age or older and must not have 
participated in a focus group or interview during the previous 3 
months. Additionally, for the consumer sample, we will exclude 
individuals who work in healthcare or marketing settings because their 
knowledge and experiences may not reflect those of the average 
consumer. For the PCP sample, we will exclude individuals who spend 
less than 50 percent of their time on patient care. Department of 
Health and Human Services employees and RTI International employees 
will be excluded from both respondent groups.
    We will start data collection with a soft launch of three 
interviews per segment (10 percent) to ensure that all processes are 
working well. Although we do not intend on making major changes to the 
interview guides as a result of these soft launch interviews, they will 
provide an opportunity to make minor changes (e.g., adding interviewer 
notes). Measurement for this phase will consist of a thematic analysis 
using a matrix approach to identify themes and mental models common 
across participants.
    Phase 2: Nationally Representative Surveys. In Phase 2 of the 
research, primarily closed-ended survey questions will be administered 
to each population. The closed-ended survey format will allow the team 
to quantify the frequency or prevalence of certain interpretations or 
meanings among a nationally representative sample of the general U.S. 
consumer and physician populations. Final questions and response 
options will be informed by key interpretations discovered during the 
Phase 1 interviews. For the consumer survey, we will use a probability 
sample selected from an address-based sampling frame and conduct the 
survey using a web-based platform. For the PCP survey, we will obtain a 
probability sample from the American Medical Association Masterfile and 
will conduct the survey via mail. For each population, we chose the 
sampling frame and survey mode that has been shown to produce the 
highest quality results for that population with respect to coverage, 
response rates, and nonresponse bias. The same exclusion criteria as 
specified for Phase 1 will be maintained for Phase 2. Participation is 
estimated at 20 minutes.
    We also plan to embed an experiment in the PCP mail survey. 
Research has shown that including a pen in the survey package can help 
to increase response rates and time to response, even potentially 
reducing the number of reminders required (Refs. 1 and 2). However, the 
shipping of pens can be costly and often pens are damaged in the mail 
(e.g., ink can leak, etc.). To determine whether another token 
incentive might be as effective at increasing response rates, we will 
randomize half of the sample to receive a pen and half to receive a 
packet of sticky notes or other token incentive. We will compare 
response rates between the two groups to help inform methods for future 
studies.
    We set our sample requirements to a 95 percent confidence interval 
and a 3 percent margin of error assuming an underlying proportion of 
0.50 in the population (which is the most conservative estimate and 
overestimates the sample size relative to alternate proportions). These 
parameters are commonly used in quantitative survey research (Refs. 3 
to 6) and offer balance between precision and cost. Thus, assuming a 
total U.S. population of roughly 250 million adults aged 18 or older 
(Ref. 7), we estimate the number of completed surveys to be 1,067 for 
the general population survey. Assuming a total population of 209,000 
PCPs (Ref. 8), with the same 95 percent confidence interval and  3 percent margin of error, we estimate the number of completed 
surveys for the provider survey to be 1,062. These sample sizes would 
also allow us to detect a mean difference between  0.15 and 
0.30 points (Ref. 6).
    In the Federal Register of November 6, 2019 (84 FR 59833), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received eight comments, but only five 
submissions were PRA-related. Within those submissions, FDA received 
multiple comments that the Agency has addressed.
    (Comment 1) Some comments supported the proposed research as an 
important step towards addressing current issues with U.S. prescription 
drug advertisement practices.
    (Response) FDA agrees with these comments to the extent they relate 
to this study.
    (Comment 2) A few comments suggested the proposed research 
methodology could be improved by providing the general population with 
the option to complete the survey in writing or over the phone. These 
comments asserted that elderly consumers are highly susceptible to 
false and misleading advertisements of prescription drugs, and that 
elderly consumers use prescription drugs at rates higher than any other 
age group. The comments also indicated that elderly populations may 
face barriers to accessing a web-based platform to complete the survey.
    (Response) While we agree that web panel surveys can sometimes have 
less than ideal coverage of populations like older adults, the survey 
proposed here would not be sampling from a web panel, but would instead 
use a probability sample selected from an address-based sample frame to 
ensure a nationally-representative sample. This helps to ensure better 
coverage of older adults, who may be less likely to be part of an 
existing opt-in survey panel or less likely to answer a web-based ad to 
complete a survey than to respond to a mailed survey invitation. Pew 
research finds that 73 percent of people aged 65+ have access to the 
internet in their home compared to 90 percent for the overall U.S. 
population (Ref. 9). To address this coverage concern, responses from 
older adults will be weighted to the full U.S. population.
    Our recent experience suggests we will be able to adequately 
represent this group. As an example, in a survey conducted by RTI on 
the Residential Energy Consumption Survey National Pilot, an analysis 
of representativeness among survey protocols found that for the older 
age group, web was less representative than a mixed mode survey 
allowing for either web-based or paper survey, but was still considered 
to have ``good'' agreement with the American Community Survey 
(considered the gold standard for U.S. demographic data).

[[Page 58364]]

    (Comment 3) The comment indicated the proposed research methodology 
could be improved by including behavior-based questions in the surveys.
    (Response) We agree about the value of measuring behavioral 
intentions in general. However, in this particular study, in which we 
are asking about a variety of terms and phrases used in prescription 
drug advertising that may or may not be relevant to all members of the 
sample, behavioral intention questions would not be appropriate. The 
drugs in question would not be relevant or salient for all consumers in 
the study. For example, a respondent will be able to answer questions 
about language used to describe migraine medication (e.g., #1 
prescribed medication) even if they do not suffer from migraines. 
However, it would not make sense to ask them about their behavioral 
intentions related to taking that migraine medicine if they do not 
suffer from migraines. Given the limitations of space and scope, we do 
not plan to add more behavioral intentions measures into this study.
    (Comment 4) The comment suggested that some of the longer 
contextual-based passages interviewees are presented with should 
include situations in which viewers/listeners are presented with 
previously seldom-used or new-to-the-public terms and phrases and an 
attempt at definition or generation of emotional valence by marketers.
    (Response) The purpose of this study is for FDA to test 
understanding of terms ``commonly used in prescription drug 
promotion.'' Thus, those that have been ``previously seldom-used'' or 
are ``new-to the-public'' are outside the scope of the study and are 
not included in the survey materials.
    The idea to study emotional valence is very interesting, but also 
beyond the scope of the current research.
    (Comment 5) The comment included a note on the PCP mail surveys: 
Rather than focusing on incentivizing response via an object included 
with the PCP mail surveys, the comment suggested that research funds 
would be better spent ensuring the surveys are engaging, easily 
understood by the two target audiences, short to complete, and 
presented with a clear deadline.
    (Response) We believe we have the capacity both to incentivize the 
response and to ensure the surveys are engaging. For example, we 
specifically designed the advance mailings (letters that will go to 
potential participants) to follow best practices for ensuring the study 
is engaging, such as stating the purpose and likely outcomes of the 
research in the letter and including a graphic to identify the study on 
the postcard or envelope.
    Token incentives have been shown in the literature to have a real 
impact on response rates (Refs. 1 and 2), and increased response rates 
can save costs and potentially reduce nonresponse bias (if reluctant 
respondents are different from non-reluctant respondents). In fact, the 
literature has shown that even with short, engaging surveys, these 
types of token incentives can substantially boost response rates (Refs. 
10-12).
    (Comment 6) The comment suggested that the study population of 
healthcare providers should be expanded to include specialists.
    (Response) While we understand that some of the topics may be 
relevant for specialists, and we do often include specialists in our 
research, our focus in the present research is on PCPs. Specialists are 
not as numerous as PCPs, which makes them harder to recruit. In 2018, 
for example, the proportion of specialists representing each specialty 
area ranged from 2 percent (endocrinologists) to 11 percent 
(psychiatrists and emergency medicine specialists) (Ref. 13). These 
data demonstrate that the pool of potentially eligible specialists is 
limited. Given the large required sample size for this study, we chose 
to limit the population to PCPs.
    (Comment 7) The comment suggested that FDA should use additional 
context for certain terms to more accurately represent the way in which 
these terms are conveyed in promotion. Specifically, the comment 
requested that FDA add context for the following terms:
    1. HCP assessment term of ``significant (as in statistically 
significant)'': The comment stated that this term should be accompanied 
by a 95 percent confidence interval, hazard ratio, and p-value as 
additional data points.
    2. HCP and consumer assessment phrases ``manageable safety profile; 
established safety profile; well-studied safety profile; ``well-
tolerated'': The comment stated that these phrases should be 
accompanied by an example, such as a table showing most common adverse 
events.
    (Response) Regarding the term ``significant (as in statistically 
significant)'' and the suggestion to add additional data points: 
Although references to statistical significance in the prescription 
drug promotion marketplace are sometimes accompanied by other 
statistical information, at other times they are not. In this 
assessment, we wish to assess understanding of this phrase on its own.
    Regarding ``manageable safety profile'' and related phrases and the 
suggestion to add an example such as a table showing most common 
adverse events: Given the length of the current instruments, we are 
limited in what can be included. The scope of this study includes terms 
and phrases and not graphics or numbers. However, we recognize the 
importance of studying those features as well. Examples of research 
involving these features can be found on the OPDP research website, 
linked earlier in this document.
    (Comment 8) The comment suggests that the following commonly used 
terms should be added to the assessment to increase the utility, 
quality and clarity of the information collected.
    For consumers and HCP, the comment suggested adding:
    1. ``Potent'' to assessment term ``powerful;'' and
    2. New assessment term ``convenient/straightforward/simple/easy/
easy to use.''
    For HCPs only, the comment suggested adding ``high affinity.''
    (Response) Thank you for these suggestions. We added ``potent,'' 
``convenient,'' ``straightforward,'' ``simple,'' ``easy'', and ``easy 
to use'' to the surveys. For ``high affinity,'' we have conducted 
several informal searches, but have not found sufficient examples of 
the use of this term in promotional materials.
    (Comment 9) The comment noted that the surveys take terms and 
phrases out of context and suggests that FDA should study how consumers 
and PCPs interpret representative promotional pieces that include 
appropriate accompanying context.
    (Response) This study is one in a program of related research 
conducted by OPDP. In several related studies, we examine how consumers 
and PCPs interpret the terms and phrases in representative promotional 
pieces that include accompanying context. In contrast to this prior 
research, the proposed research allows for assessment of a large number 
of terms and phrases--effectively emphasizing breadth over depth, and 
involving data collection from a nationally representative sample. We 
believe these various approaches to studying language commonly used in 
prescription drug promotion complement one another and together 
contribute to a more comprehensive understanding of the research 
questions.
    (Comment 10) The comment suggested that questions in the surveys 
may be leading. In describing the proposed research, the 60-day notice 
stated, ``For example, certain terms and

[[Page 58365]]

phrases, when used without additional contextual information, might 
overstate the efficacy and minimize the risk of a product.'' The 
comment stated that this statement shows bias that manifests in the 
proposed questions and suggests that because the evident bias is deeply 
rooted in this proposed study and its surveys, FDA should fundamentally 
reformulate the proposed collection of information in its entirety.
    (Response) We agree that some of the probes proposed for use in the 
Phase 1 research may appear to be leading, so we have rewritten these 
probes. For example, where it said ``safer,'' we have altered language 
to ``more'' or ``less'' safe.
    In the Phase 2 surveys, the safety and efficacy questions are not 
leading or one-sided. The questions use bipolar response scales 
allowing respondents to indicate that the products using that term are 
less safe/effective, equally as safe/effective, or more safe/effective.
    (Comment 11) The comment suggested that the proposed answers in the 
closed-ended surveys are unbalanced.
    (Response) We have reviewed the Phase 2 questions and made some 
edits to ensure more balance.
    It is important to note that the response options shown for many of 
the questions are just examples. The full list of response options used 
in the Phase 2 surveys will be developed based on responses to the 
Phase 1 interviews. As a result, the Phase 2 response options may skew 
slightly negative or positive depending on what interview respondents 
say in the Phase 1 interviews. However, we will ensure that there is 
balance with both negative and positive response options.
    (Comment 12) The comment suggested that by asking respondents to 
compare closely related terms and phrases, the survey may force 
artificial findings of difference. The comment stated that even if the 
measured differences are real (and not due to biases in the surveys), 
it is unclear how the results would have any practical utility because 
there may not be any objective definitions of the terms with which to 
compare the results.
    (Response) We describe below the process to mitigate the effects of 
this concern.
     If participants in the Phase 1 research do not articulate 
differences between certain terms, we will exclude those terms from 
Phase 2. This will reduce the chance to find artificial differences 
between terms.
     We can also split question sets into multiple individual 
questions. We will make decisions surrounding this solution following 
completion of the Phase 1 interviews.
     For the consumer survey, which will be conducted online 
only, we will randomize the order in which the terms are presented. 
This will not eliminate context effects but will randomly distribute 
any error across terms rather than significantly biasing an individual 
term.
    (Comment 13) The comment opined that the surveys, at least in the 
past, are unnecessarily duplicative of information otherwise reasonably 
accessible to FDA (e.g., focus groups conducted by FDA in 2014; and 
information available from third-party sources regarding the terms 
``many,'' ``most,'' ``majority,'' ``some,'' and ``few'').
    (Response) We believe the research is not duplicative of that 
conducted in 2014 by FDA, but instead builds on that research. It is 
being conducted by the same research team and is part of a coherent 
program of research that includes formative focus groups, in-depth 
interviews, a survey, and an experimental study. We used those focus 
group reports to inform the development of answer options for this 
study. The very few terms that are repeated in the current survey have 
been included in the current study because researchers wanted to follow 
up on previous findings with a larger, nationally representative 
sample. Furthermore, that study did not collect any quantitative data 
on the terms.
    Literature searches in multiple medical, social science, and 
linguistics databases, including Pubmed, Web of Science, EBSCO 
Discovery Service, and Linguistics Database for research on how people 
quantify or interpret terms like ``few'' and ``many'' as we do in the 
present research did not reveal significant literature on these terms. 
It is important for FDA to understand how these terms are interpreted 
in the context of prescription drug promotion, thus we plan to keep 
them in the current study.
    (Comment 14) A comment recommended that FDA remove questions about 
the terms ``off-label'' and ``prescription drug promotion'' as they are 
not terms used in promotion.
    (Response) While ``off label'' and ``prescription drug promotion'' 
are not terms that are typically used in promotion, it is important for 
FDA to understand how healthcare providers perceive these terms in 
general. We have revised the description of the scope in the Federal 
Register notice to clarify this broader purpose. We now state: ``The 
present research involves assessment of how consumers and primary care 
physicians (PCPs) interpret terms and phrases commonly used in 
prescription drug promotion, as well as those used to describe 
prescription drugs and prescription drug promotion more generally.''
    (Comment 15) A comment recommended that FDA change the framing for 
the survey from a focus on ``words or phrases that are commonly used in 
prescription drug advertising'' to ``words or phrases that are commonly 
used to describe prescription drugs.'' The comment suggested that if 
the survey keeps the former, respondents will view the surveys through 
whatever biases they have for drug advertising.
    (Response) Because it is our intention to examine what participants 
think in the context of prescription drug advertising, we have retained 
our original approach to framing the research, while also expanding 
that framing to reference terms or phrases that are commonly used to 
describe prescription drug promotion.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
          Activity               Number of     responses per    Total annual     Average  burden    Total hours
                                respondents     respondent        responses       per  response
----------------------------------------------------------------------------------------------------------------
                                               General Population
----------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes               85               1  85..............  0.083 (5                       7
 (assumes 35% eligible).                                                         minutes).
Phase 1: Number of completes              30               1  30..............  1...............              30
Phase 2: Screener completes            1,185               1  1,185...........  0.083 (5                      98
 (assumes 90% eligible).                                                         minutes).

[[Page 58366]]

 
Phase 2: Number of completes           1,067               1  1,067 + 10% \2\.  0.333 (20                    391
                                                              = 1,174.........   minutes).
----------------------------------------------------------------------------------------------------------------
                                                 PCP Population
----------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes              104               1  104.............  0.083 (5                       9
 (assumes 30% eligible).                                                         minutes).
Phase 1: Number of completes              30               1  30..............  1...............              30
Phase 2: Screener completes            1,180               1  1,180...........  0.083 (5                      98
 (assumes 90% eligible).                                                         minutes).
Phase 2: Number of completes           1,062               1  1,062 + 10% \2\   0.333 (20                    389
                                                               = 1,168.          minutes).
----------------------------------------------------------------------------------------------------------------
    Total...................  ..............  ..............  ................  ................           1,052
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of
  completing the survey when the target number is reached and that those surveys will be completed and received
  before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
  both samples in the study.

II. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. Bell, K., L. Clark, C. Fairhurst, et al, ``Enclosing A Pen 
Reduced Time to Response to Questionnaire Mailings.'' Journal of 
Clinical Epidemiology, 74:144-150, 2016.
2. Sharp, L., C. Cochran, S.C. Cotton, et al., ``Enclosing a Pen 
with a Postal Questionnaire Can Significantly Increase the Response 
Rate.'' Journal of Clinical Epidemiology, 59:747-754, 2006.
3. Bartlett, J.E., J.W. Kotrlik, and C.C. Higgins, ``Organizational 
Research: Determining Appropriate Sample Size in Survey Research.'' 
Information Technology, Learning, and Performance Journal, 19:43-50, 
2001.
4. Cochran, W.G. (1997), Sampling Techniques (3rd ed.). New York: 
John Wiley & Sons.
5. Dillman, D.A., J.D. Smyth, and L.M. Christian (2014), internet, 
Phone, Mail, and Mixed-mode Surveys: The Tailored Design Method (4th 
Ed.). Hoboken, NJ: John Wiley & Sons, Inc.
6. Krejcie, R.V. and D.W. Morgan, ``Determining Sample Size for 
Research Activities.'' Educational and Psychological Measurement, 
30: 607-610, 1970.
7. *U.S. Census Bureau (2017), ``National Population by 
Characteristics: 2010-2017.'' Retrieved from https://www.census.gov.
8. *Agency for Healthcare Research and Quality (2011), ``The Number 
of Practicing Primary Care Physicians in the United States.'' 
Retrieved from http://www.ahrq.gov/research/findings/factsheets/primary/pcwork1/index.html.
9. *internet/Broadband Fact Sheet (2019), Pew Research Center. 
Retrieved from https://www.pewresearch.org/internet/fact-sheet/internet-broadband.
10. Sanchez, R., Powell, R., and M. Kurtz (2019), ``Oh Look, Another 
Pen! Incentive Effects and the Influence of Varying Non-Monetary 
Incentives on Response Rate and Survey Completion.'' Presented at 
the American Association for Public Opinion Research Conference, 
Toronto, Ontario.
11. Stanley, M.V., Geisen, E., Olmsted, M.G., and J. J. Murphy 
(2016, October), ``The Effects of Incentive Type on Response Rates 
in a Survey of Physicians.'' Presented at Southern Association for 
Public Opinion Research Conference, Raleigh, NC.
12. Beatty, P., Jamoom, E., and J. Hsiao (2014), ``Continuing 
Experiments on Non-Monetary Incentive in Physician Surveys.'' 
Presented at the meeting of the American Association for Public 
Opinion Research, Anaheim, CA.
13. *Kaiser Family Foundation (2018), ``Professionally Active 
Specialist Physicians by Field.'' Retrieved from https://www.kff.org/other/state-indicator/physicians-by-specialty-area.

    Dated: September 14, 2020.
Lowell J. Schiller,

Principal Associate Commissioner for Policy.
[FR Doc. 2020-20621 Filed 9-17-20; 8:45 am]
BILLING CODE 4164-01-P