[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59833-59836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on research entitled ``Assessment of Terms and 
Phrases Commonly Used in Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection 
of information by January 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 6, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-4763 for ``Assessment of Terms and Phrases Commonly Used in 
Prescription Drug Promotion.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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:

I. Background

    Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in

[[Page 59834]]

the Federal Register concerning each proposed collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Assessment of Terms and Phrases Commonly Used in Prescription Drug 
Promotion

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 
promotional material is truthful, balanced, and accurately 
communicated, so that patients and healthcare 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, focusing 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 research data through analytical methodology development and 
investigation of sampling and response issues. This study will inform 
all three topic areas.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is improved through 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 direct-to-consumer 
survey 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. 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.
    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: Semi-Structured Interviews. In Phase 1 of the research, 
semi-structured 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 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

[[Page 59835]]

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 completes 
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).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                      Number of
             Activity                 Number of     responses per       Total annual respondents               Hours per response           Total hours
                                     respondents     respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   General Population
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Phase 1: Screener completes                    85               1  85................................  0.08 (5 minutes).................               7
 (assumes 35% eligible).
Phase 1: Number of completes.....              30               1  30................................  1................................              30
Phase 2: Screener completes                 1,185               1  1,185.............................  0.08 (5 minutes).................              95
 (assumes 90% eligible).
Phase 2: Number of completes.....           1,067               1  1,067 + 10% \2\ = 1,174...........  0.34 (20 minutes)................             399
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                                                                     PCP Population
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Phase 1: Screener completes                   104               1  104...............................  0.08 (5 minutes).................               8
 (assumes 30% eligible).
Phase 1: Number of completes.....              30               1  30................................  1................................              30
Phase 2: Screener completes                 1,180               1  1,180.............................  0.08 (5 minutes).................              94
 (assumes 90% eligible).
Phase 2: Number of completes.....           1,062               1  1,062 + 10% \2\ = 1,168...........  0.34 (20 minutes)................             397
                                  ----------------------------------------------------------------------------------------------------------------------
    Total........................  ..............  ..............  ..................................  .................................           1,060
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\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.'' (Available at: 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/

[[Page 59836]]

factsheets/primary/pcwork1/index.html.

    Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24229 Filed 11-5-19; 8:45 am]
BILLING CODE 4164-01-P