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

Published date18 September 2020
Citation85 FR 58362
Record Number2020-20621
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 85 Issue 182 (Friday, September 18, 2020)
[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]
                -----------------------------------------------------------------------
                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.
                -----------------------------------------------------------------------
                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,
                [email protected].
                 For copies of the questionnaire, contact: Office of Prescription
                Drug Promotion (OPDP) Research Team, [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.
                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
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT