Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer Print Advertisements, 53312-53314 [2010-21629]
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53312
Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices
Center for Environmental Health
(NCEH). Information was collected from
adult smokers of full-flavor, light and
ultralight cigarettes, however, the target
number of respondents was not
achieved during the initial project
period.
CDC requests OMB approval to
reinstate the information collection in
order to meet recruitment goals and
complete the data analysis as planned.
Changes include a reduction in the
number of respondents and a
corresponding reduction in the total
estimated burden hours. In addition,
minor changes will be made to account
for changes in cigarette labels, which no
longer use descriptors such as fullflavor, light or ultralight. There are no
changes to the data collection
instruments or the estimated burden per
response.
Respondents will be asked to
participate in a descriptive study of
smoking behavior that involves two
laboratory visits. Established smokers
who are interested in participating will
be screened for eligibility during a brief
five-minute computer-assisted
telephone interview (CATI). We
estimate screening approximately 150
individuals annually to yield complete
data collection on the annualized goal of
61 respondents. After completing the
CATI, individuals who express
continued interest in study participation
will undergo five additional minutes of
eligibility screening at the first
laboratory visit.
Each respondent who enrolls in the
study will make two one-hour visits to
an assessment laboratory. The visits will
occur on two consecutive days: Visit 1
will be scheduled in the morning of the
first day, and Visit 2 will be scheduled
in the afternoon of the second day.
Samples, measurements, and behavioral
information will be collected at each
visit. Visit 1 will include biologic
sample collection (urine, saliva, breath
carbon monoxide), smoking behavior of
smoking one cigarette, ventilation hole
blocking procedure and breath
measurements. Visit 2 will include
discussion of quit opportunities if
requested, biologic sample collection
(urine, saliva, breath carbon monoxide),
smoking behavior of smoking one
cigarette, ventilation hole blocking
procedure and breath measurements. In
addition, at Visit 2, each respondent
will submit the cigarette butts of all
cigarettes smoked since Visit 1 and a
completed Smoking Diary Form. The
estimated burden for the Smoking Diary
Form is ten minutes.
The goals of this project are to
characterize the range of human
smoking behavior for a variety of
cigarette categories and machinesmoked yields, and to estimate the
levels of biomarkers of exposure with
the various cigarette styles.
OMB approval is requested for two
years. Participation in the study is
voluntary. There are no costs to
respondents other than their time. The
total estimated burden hours are 151.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Adult Smokers .........................................................................
CATI Screener .......................
Visit 1 Screener ......................
Smoking Diary ........................
Laboratory Visit ......................
Dated: August 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–21723 Filed 8–30–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0417]
srobinson on DSKHWCL6B1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Format Variations in the Brief
Summary of Direct-to-Consumer Print
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
SUMMARY:
VerDate Mar<15>2010
16:33 Aug 30, 2010
Jkt 220001
Paperwork Reduction Act of 1995 (the
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
the Experimental Study of Format
Variations in the Brief Summary of
Direct-to-Consumer (DTC) Print
Advertisements (ads). This study is
designed to test different ways of
presenting benefit and risk information
in the brief summary in DTC print ads.
DATES: Submit either electronic or
written comments on the collection of
information by November 1, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
150
70
61
61
Number of
responses
per
respondent
Average
burden per
response
(in hours)
1
1
1
2
5/60
5/60
10/60
1
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), 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 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
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.
Experimental Study of Format
Variations in the Brief Summary of
Direct-to-Consumer Print
Advertisements—New
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act specifies that
ads for prescription drugs and biological
products must provide a true statement
of information ‘‘in brief summary’’ about
the advertised product’s ‘‘side effects,
contraindications, and effectiveness.’’
The prescription drug advertising
regulations (§ 202.1(e)(3)(iii) (21 CFR
202.1(e)(3)(iii))) specify that the
information about risks must include
each specific side effect and
contraindication from the advertised
drug’s FDA-approved labeling,
including the Warnings, Precautions,
Adverse Reactions, and other relevant
sections. Some of the current
approaches to fulfilling the brief
summary requirement, while adequate
from a regulatory perspective, result in
ads that may be difficult to read and
understand when used in consumerdirected promotion.
In recent years, FDA has become
concerned about the adequacy of the
brief summary in DTC print
advertisements for prescription drugs.
Because the regulations do not specify
how to address each risk, sponsors can
use discretion in fulfilling the brief
summary requirement under
§ 202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the riskrelated sections of the approved product
labeling (also called the package insert,
professional labeling, prescribing
information, and direction circular).
This labeling is written for health
professionals, using medical
terminology. While adequate to fulfill
the brief summary requirement for print
advertisements, this method may not be
VerDate Mar<15>2010
18:53 Aug 30, 2010
Jkt 220001
the most ideal. Research has shown that
while many consumers will make the
effort to read the brief summary in
prescription drug print advertisements
if they are especially interested in the
drug, as a general rule consumers
typically read little or none of the brief
summary information.1 Health
practitioners themselves have indicated
they often have difficulty finding
information they actively seek in
package inserts (see 65 FR 80733 at
81082, December 22, 2000, for a
discussion of studies supporting the use
of a highlights section in physician
labeling). There may be other ways to
fulfill this requirement that improve
consumers’ ability to find and
comprehend the information in this
important document.
There is evidence suggesting that both
information content and the format in
which it is presented will impact
comprehension. For instance, research
with the format of over-the-counter
(OTC) drug
(OTC) drug labels,2 the nutrition facts
label,3 and other information formats4
demonstrates that information presented
with section headings, graphics (such as
bullets), and other design elements is
more easily read than information
presented in paragraph format.
Research conducted by FDA and
others has examined the content and
format of the brief summary specifically.
For instance, FDA conducted a series of
relevant studies (OMB control numbers
0910–0591 and 0910–0611). Schwartz,
Woloshin, and Welch have compared
one format for adding quantitative and
qualitative benefit and risk information
to the brief summary.5 Specifically,
1 Aikin, K.J., Swasy, J.L. and Braman, A.C. (2004).
Patient and Physician Attitudes and Behaviors
Associated with DTC Promotion of Prescription
Drugs: Summary of FDA Survey Research Results,
Final Report. Available at https://www.fda.gov/cder/
ddmac/Final%20Report/FRfinal111904.pdf. Last
accessed March 26, 2009.
2 Aikin, K.J. (1998). Consumer Comprehension
and Preference for Variations in the Proposed OverThe-Counter Drug Labeling Format, Final Report;
Vigilante, W.J. & Wogalter, M.S. (1997). The
preferred order of overt-the-counter (OTC)
pharmaceutical label components. Drug
Information Journal, 31, 973–988.
3 Levy, A.S., Fein, S.B. & Schucker, R.E. (1992).
More effective nutrition label formats are not
necessarily more preferred. Journal of the American
Dietetic Association, 92(10), 1230–1234.
4 Lorch, R. & Lorch, E. (1995). Effects of
organizational signals on text-processing strategies.
Journal of Educational Psychology, 87(4), 537–544;
Lorch, R. & Lorch, E. (1996). Effects of
organizational signals on free recall of expository
text. Journal of Educational Psychology, 88(1), 38–
48; Lorch, R., Lorch, E. & Inman, W. (1993). Effects
of signaling topic structure on text recall. Journal
of Educational Psychology, 85(2), 281–290.
5 Schwartz, L.M., Woloshin, S., & Welch, H.G.
(2009). Communicating drug benefits and harms
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
53313
Schwartz et al. designed a prescription
drug facts box similar in format to the
Nutrition Facts panel and OTC Drug
Facts panel. The box contains a number
of elements, including qualitative and
quantitative (both absolute frequency
and absolute difference) information
about benefits and risks. This study
showed that consumers who were
provided efficacy information in a
prescription drug facts box were more
likely to correctly choose the product
with the higher efficacy than consumers
who saw the brief summary using
medical language from the prescribing
information. However, it is unclear
which elements of the drug facts box are
necessary to improve consumer
understanding. For instance, it is not
known whether simply adding efficacy
rate information to a consumer-friendly
brief summary would be sufficient to
enable consumers to understand a
product’s efficacy, or whether
qualitative summations are necessary as
well.
The current study will add to
previous research by systematically
examining these different elements to
determine whether and how to add
qualitative and quantitative benefit and
risk information to the brief summary.
The results of this study will inform
FDA of the usefulness and parameters of
various format and content options for
the brief summary.
Design Overview: This study will be
conducted in two concurrent parts; one
examining variations on the benefit
information presented in DTC print
advertisements and the other examining
variations on the risk information
presented in DTC print advertisements.
The factors studied will be the type of
information (i.e., the addition of
quantitative and qualitative information
in a box format) and the level of efficacy
or risk. We will vary the level of efficacy
and risk such that the largest effect is
noticeably different from the placebo,
whereas the smallest effect is minimally
different from the placebo. These factors
will be combined in a factorial design as
follows:
with a drug facts box: Two randomized trials.
Annals of Internal Medicine, 150(8). Available
online at https://www.annals.org/cgi/content/full/
0000605-200904210-00106v1. Last accessed March
26, 2009.
E:\FR\FM\31AUN1.SGM
31AUN1
53314
Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices
TABLE 1.—PROPOSED DESIGN (4 X 5 + 2)
Efficacy Level
Information Type
Smallest Effect
Smaller Effect
Mid-Size Effect
Larger Effect
Largest Effect
Absolute Frequency
81% vs. 82%
61% vs. 82%
41% vs. 82%
21% vs. 82%
1% vs. 82%
Absolute Frequency +
Qualitative Label
Fewer
81% vs. 82%
Fewer
61% vs. 82%
Fewer
41% vs. 82%
Fewer
21% vs. 82%
Fewer
1% vs. 82%
Absolute Difference +
Qualitative Label
Fewer (1%)
Fewer (21%)
Fewer (41%)
Fewer (61%)
Fewer (81%)
Absolute Frequency +
Absolute Difference +
Qualitative Label
Fewer (1%)
81% vs. 82%
Fewer (21%)
61% vs. 82%
Fewer (41%)
41% vs. 82%
Fewer (61%)
21% vs. 82%
Fewer (81%)
1% vs. 82%
Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk
information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ‘‘fewer people taking drug
X had disease/symptom Y.’’
The test product will be for the
treatment of high prevalence medical
condition and modeled on an actual
drug used to treat that condition.
Participants will be consumers who
have been diagnosed with the medical
condition of interest. They will be
randomly assigned to read one ad
version. After reading the ad,
participants will answer a series of
questions about the drug. We will test
how the information type affects
perceived efficacy, perceived risk,
behavioral intention, and accurate
understanding of the benefit and risk
information.
Interviews are expected to last no
more than 20 minutes. A total of 11,750
participants will be involved in the
study. This will be a one-time (rather
than annual) collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
750
1
750
20 minutes
250
11,000
Main Study
1
11,000
20 minutes
3,667
Total
3,917
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–21629 Filed 8–30–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0084]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PRISTIQ
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with NOTICES
HHS.
ACTION:
Total Hours
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
PRISTIQ and is publishing this notice of
that determination as required by law.
FDA has made the determination
because of the submission of
SUMMARY:
VerDate Mar<15>2010
16:33 Aug 30, 2010
Jkt 220001
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53312-53314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21629]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0417]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Format Variations in the Brief
Summary of Direct-to-Consumer Print Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 the Experimental Study of Format Variations
in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements
(ads). This study is designed to test different ways of presenting
benefit and risk information in the brief summary in DTC print ads.
DATES: Submit either electronic or written comments on the collection
of information by November 1, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.
[[Page 53313]]
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.
Experimental Study of Format Variations in the Brief Summary of Direct-
to-Consumer Print Advertisements--New
Section 502(n) of the Federal Food, Drug, and Cosmetic Act
specifies that ads for prescription drugs and biological products must
provide a true statement of information ``in brief summary'' about the
advertised product's ``side effects, contraindications, and
effectiveness.'' The prescription drug advertising regulations (Sec.
202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the
information about risks must include each specific side effect and
contraindication from the advertised drug's FDA-approved labeling,
including the Warnings, Precautions, Adverse Reactions, and other
relevant sections. Some of the current approaches to fulfilling the
brief summary requirement, while adequate from a regulatory
perspective, result in ads that may be difficult to read and understand
when used in consumer-directed promotion.
In recent years, FDA has become concerned about the adequacy of the
brief summary in DTC print advertisements for prescription drugs.
Because the regulations do not specify how to address each risk,
sponsors can use discretion in fulfilling the brief summary requirement
under Sec. 202.1(e)(3)(iii). Frequently, sponsors print in small type,
verbatim, the risk-related sections of the approved product labeling
(also called the package insert, professional labeling, prescribing
information, and direction circular). This labeling is written for
health professionals, using medical terminology. While adequate to
fulfill the brief summary requirement for print advertisements, this
method may not be the most ideal. Research has shown that while many
consumers will make the effort to read the brief summary in
prescription drug print advertisements if they are especially
interested in the drug, as a general rule consumers typically read
little or none of the brief summary information.\1\ Health
practitioners themselves have indicated they often have difficulty
finding information they actively seek in package inserts (see 65 FR
80733 at 81082, December 22, 2000, for a discussion of studies
supporting the use of a highlights section in physician labeling).
There may be other ways to fulfill this requirement that improve
consumers' ability to find and comprehend the information in this
important document.
---------------------------------------------------------------------------
\1\ Aikin, K.J., Swasy, J.L. and Braman, A.C. (2004). Patient
and Physician Attitudes and Behaviors Associated with DTC Promotion
of Prescription Drugs: Summary of FDA Survey Research Results, Final
Report. Available at https://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf. Last accessed March 26, 2009.
---------------------------------------------------------------------------
There is evidence suggesting that both information content and the
format in which it is presented will impact comprehension. For
instance, research with the format of over-the-counter (OTC) drug
(OTC) drug labels,\2\ the nutrition facts label,\3\ and other
information formats\4\ demonstrates that information presented with
section headings, graphics (such as bullets), and other design elements
is more easily read than information presented in paragraph format.
---------------------------------------------------------------------------
\2\ Aikin, K.J. (1998). Consumer Comprehension and Preference
for Variations in the Proposed Over-The-Counter Drug Labeling
Format, Final Report; Vigilante, W.J. & Wogalter, M.S. (1997). The
preferred order of overt-the-counter (OTC) pharmaceutical label
components. Drug Information Journal, 31, 973-988.
\3\ Levy, A.S., Fein, S.B. & Schucker, R.E. (1992). More
effective nutrition label formats are not necessarily more
preferred. Journal of the American Dietetic Association, 92(10),
1230-1234.
\4\ Lorch, R. & Lorch, E. (1995). Effects of organizational
signals on text-processing strategies. Journal of Educational
Psychology, 87(4), 537-544; Lorch, R. & Lorch, E. (1996). Effects of
organizational signals on free recall of expository text. Journal of
Educational Psychology, 88(1), 38-48; Lorch, R., Lorch, E. & Inman,
W. (1993). Effects of signaling topic structure on text recall.
Journal of Educational Psychology, 85(2), 281-290.
---------------------------------------------------------------------------
Research conducted by FDA and others has examined the content and
format of the brief summary specifically. For instance, FDA conducted a
series of relevant studies (OMB control numbers 0910-0591 and 0910-
0611). Schwartz, Woloshin, and Welch have compared one format for
adding quantitative and qualitative benefit and risk information to the
brief summary.\5\ Specifically, Schwartz et al. designed a prescription
drug facts box similar in format to the Nutrition Facts panel and OTC
Drug Facts panel. The box contains a number of elements, including
qualitative and quantitative (both absolute frequency and absolute
difference) information about benefits and risks. This study showed
that consumers who were provided efficacy information in a prescription
drug facts box were more likely to correctly choose the product with
the higher efficacy than consumers who saw the brief summary using
medical language from the prescribing information. However, it is
unclear which elements of the drug facts box are necessary to improve
consumer understanding. For instance, it is not known whether simply
adding efficacy rate information to a consumer-friendly brief summary
would be sufficient to enable consumers to understand a product's
efficacy, or whether qualitative summations are necessary as well.
---------------------------------------------------------------------------
\5\ Schwartz, L.M., Woloshin, S., & Welch, H.G. (2009).
Communicating drug benefits and harms with a drug facts box: Two
randomized trials. Annals of Internal Medicine, 150(8). Available
online at https://www.annals.org/cgi/content/full/0000605-200904210-00106v1. Last accessed March 26, 2009.
---------------------------------------------------------------------------
The current study will add to previous research by systematically
examining these different elements to determine whether and how to add
qualitative and quantitative benefit and risk information to the brief
summary. The results of this study will inform FDA of the usefulness
and parameters of various format and content options for the brief
summary.
Design Overview: This study will be conducted in two concurrent
parts; one examining variations on the benefit information presented in
DTC print advertisements and the other examining variations on the risk
information presented in DTC print advertisements. The factors studied
will be the type of information (i.e., the addition of quantitative and
qualitative information in a box format) and the level of efficacy or
risk. We will vary the level of efficacy and risk such that the largest
effect is noticeably different from the placebo, whereas the smallest
effect is minimally different from the placebo. These factors will be
combined in a factorial design as follows:
[[Page 53314]]
Table 1.--Proposed Design (4 x 5 + 2)
----------------------------------------------------------------------------------------------------------------
Efficacy Level
Information Type -------------------------------------------------------------------------------------------
Smallest Effect Smaller Effect Mid-Size Effect Larger Effect Largest Effect
----------------------------------------------------------------------------------------------------------------
Absolute Frequency 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82%
----------------------------------------------------------------------------------------------------------------
Absolute Frequency + Fewer Fewer Fewer Fewer Fewer
Qualitative Label 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82%
----------------------------------------------------------------------------------------------------------------
Absolute Difference Fewer (1%) Fewer (21%) Fewer (41%) Fewer (61%) Fewer (81%)
+ Qualitative Label
----------------------------------------------------------------------------------------------------------------
Absolute Frequency + Fewer (1%) Fewer (21%) Fewer (41%) Fewer (61%) Fewer (81%)
Absolute Difference 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82%
+ Qualitative Label
----------------------------------------------------------------------------------------------------------------
Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22
cells) will also be used to test risk information (for a total of 44 cells). The specific numbers in the table
are placeholders only. Qualitative label example: ``fewer people taking drug X had disease/symptom Y.''
The test product will be for the treatment of high prevalence
medical condition and modeled on an actual drug used to treat that
condition. Participants will be consumers who have been diagnosed with
the medical condition of interest. They will be randomly assigned to
read one ad version. After reading the ad, participants will answer a
series of questions about the drug. We will test how the information
type affects perceived efficacy, perceived risk, behavioral intention,
and accurate understanding of the benefit and risk information.
Interviews are expected to last no more than 20 minutes. A total of
11,750 participants will be involved in the study. This will be a one-
time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 2.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 750 1 750 20 minutes 250
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Main Study 11,000 1 11,000 20 minutes 3,667
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 3,917
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21629 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-01-S
