[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
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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
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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