Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion, 59833-59836 [2019-24229]
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24233 Filed 11–5–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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.’’
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.
DATES:
17:43 Nov 05, 2019
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
SUMMARY:
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Electronic Submissions
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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
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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/201523389.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, PRAStaff@
fda.hhs.gov. For copies of the
questionnaire, contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
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
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
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
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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 ‘‘naturallyoccurring,’’ 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
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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, probabilitybased 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, 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 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
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
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
59835
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
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
respondents
Hours per
response
Total hours
General Population
Phase 1: Screener completes
ble).
Phase 1: Number of completes
Phase 2: Screener completes
ble).
Phase 2: Number of completes
(assumes 35% eligi-
85
1
85 ........................................
0.08 (5 minutes) .................
7
..................................
(assumes 90% eligi-
30
1,185
1
1
30 ........................................
1,185 ...................................
1 ..........................................
0.08 (5 minutes) .................
30
95
..................................
1,067
1
1,067 + 10% 2 = 1,174 .......
0.34 (20 minutes) ...............
399
PCP Population
Phase 1: Screener completes
ble).
Phase 1: Number of completes
Phase 2: Screener completes
ble).
Phase 2: Number of completes
(assumes 30% eligi-
104
1
104 ......................................
0.08 (5 minutes) .................
8
..................................
(assumes 90% eligi-
30
1,180
1
1
30 ........................................
1,180 ...................................
1 ..........................................
0.08 (5 minutes) .................
30
94
..................................
1,062
1
1,062 + 10% 2 = 1,168 .......
0.34 (20 minutes) ...............
397
Total .....................................................................
........................
........................
.............................................
.............................................
1,060
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
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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
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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
https://www.ahrq.gov/research/findings/
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factsheets/primary/pcwork1/.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Commission
on Childhood Vaccines
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice; correction.
AGENCY:
The original Federal Register
Notice announcing the December 2019
Advisory Commission on Childhood
Vaccines (ACCV) meeting indicated that
this meeting would be held December
5–6, 2019. This meeting is not being
conducted over two days, and instead
will only take place only on December
5, 2019.
The ACCV will hold a public meeting
on December 5, 2019, at 10:00 a.m.
Eastern Time via Adobe Connect and
telephone conference. This will not be
an in-person meeting. The public can
join the meeting by:
1. (Audio Portion) Calling the
conference phone number: 800–988–
0218 and providing the following
information:
Leader Name: Ms. Tamara Overby
Password: 9302948
(Visual Portion) Connecting to the
ACCV Adobe Connect Meeting using the
following URL: https://
hrsa.connectsolutions.com/accv/.
Participants should call and connect 15
minutes prior to the meeting in order for
logistics to be set up. If you have never
attended an Adobe Connect meeting,
please test your connection using the
following URL: https://hrsa.connect
solutions.com/common/help/en/
support/meeting_test.htm and get a
quick overview using URL: https://
www.adobe.com/go/connectpro_
overview.
Information about the ACCV and the
agenda for this public meeting can be
obtained at the following website:
https://www.hrsa.gov/advisory
committees/childhoodvaccines/index.
html.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Program Analyst,
Division of Injury Compensation
Programs (DICP), HRSA, in one of three
ways: (1) Send a request to the following
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address: Annie Herzog, Program
Analyst, DICP, HRSA, 5600 Fishers
Lane, 08N146B, Rockville, Maryland
20857; (2) call (301) 443–6593; or (3)
send an email to aherzog@hrsa.gov.
Meeting times could change. For the
latest information regarding the
meeting, including start time, please
check the ACCV website at: https://
www.hrsa.gov/advisorycommittees/
childhoodvaccines/.
This meeting will only take place on
December 5, 2019 and is not being
conducted over two days (December 5–
6, 2019) as stated previously in the
Federal Register (FR Doc. 2019–00439
Filed 1–30–19).
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–24166 Filed 11–5–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration will publish
periodic summaries of proposed
projects. To request more information
on the proposed projects or to obtain a
copy of the information collection
plans, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, through the use of
automated collection techniques or
other forms of information technology.
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Proposed Project: Protection and
Advocacy for Individuals With Mental
Illness (PAIMI) Annual Program
Performance Report (OMB No. 0930–
0169)—Extension
The Protection and Advocacy for
Individuals with Mental Illness (PAIMI)
Act at 42 U.S.C. 10801 et seq.,
authorized funds to the same protection
and advocacy (P&A) systems created
under the Developmental Disabilities
Assistance and Bill of Rights Act of
1975, known as the DD Act (as amended
in 2000, 42 U.S.C. 15001 et seq.]. The
DD Act supports the Protection and
Advocacy for Developmental
Disabilities (PADD) Program
administered by the Administration on
Intellectual and Developmental
Disabilities (AIDD) within the
Administration on Community Living.
AIDD is the lead federal P&A agency.
The PAIMI Program supports the same
governor-designated P&A systems
established under the DD Act by
providing legal-based individual and
systemic advocacy services to
individuals with significant (severe)
mental illness (adults) and significant
(severe) emotional impairment
(children/youth) who are at risk for
abuse, neglect and other rights
violations while residing in a care or
treatment facility.
In 2000, the PAIMI Act amendments
created a 57th P&A system—the
American Indian Consortium (the
Navajo and Hopi Tribes in the Four
Corners region of the Southwest). The
Act, at 42 U.S.C. 10804(d), states that a
P&A system may use its allotment to
provide representation to individuals
with mental illness, as defined by
section 42 U.S.C. 10802 (4)(B)(iii)
residing in the community, including
their own home, only, if the total
allotment under this title for any fiscal
year is $30 million or more, and in such
cases an eligible P&A system must give
priority to representing PAIMI-eligible
individuals, as defined by 42 U.S.C.
10802(4)(A) and (B)(i).
The Children’s Health Act of 2000
(CHA) also referenced the state P&A
system authority to obtain information
on incidents of seclusion, restraint and
related deaths [see, CHA, Part H at 42
U.S.C. 290ii–1]. PAIMI Program formula
grants awarded by SAMHSA go directly
to each of the 57 governor-designated
P&A systems. These systems are located
in each of the 50 states, the District of
Columbia, the American Indian
Consortium, American Samoa, Guam,
the Commonwealth of the Northern
Mariana Islands, the Commonwealth of
Puerto Rico, and the U.S. Virgin Islands.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 https://www.ahrq.gov/research/findings/
[[Page 59836]]
factsheets/primary/pcwork1/.
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
