[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38658-38663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16552]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0417]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
1, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title, ``Experimental Study of Format Variations in the Brief Summary
of Direct-to-Consumer Print Advertisements.'' Also include the FDA
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Experimental Study of Format Variations in the Brief Summary of Direct-
to-Consumer Print Advertisements--(OMB Control Number 0910-New)
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(n)) specifies that ads for prescription drugs and biological
products must provide a true statement of information ``in brief
summary''
[[Page 38659]]
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 direct-to-consumer (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 (Ref.
1). Health practitioners themselves have indicated they often have
difficulty finding information they actively seek in package inserts
(see 65 FR 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
labels (Refs. 2 and 3), the nutrition facts label (Ref. 4), and other
information formats (Refs. 5 to 7) 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 (Ref. 8). 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.
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:
Table 1--Proposed Design (4x5 + 2)
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Efficacy level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
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Absolute Frequency................. 81% vs. 82%........... 61% vs. 82%........... 41% vs. 82%.......... 21% vs. 82%.......... 1% vs. 82%.
Absolute Frequency + Qualitative Fewer 81% vs. 82%..... Fewer 61% vs. 82%..... Fewer 41% vs. 82%.... Fewer 21% vs. 82%.... Fewer 1% vs. 82%.
Label.
Absolute Difference + Qualitative Fewer (1%)............ Fewer (21%)........... Fewer (41%).......... Fewer (61%).......... Fewer (81%).
Label.
Absolute Frequency + Absolute Fewer (1%) 81% vs. 82% Fewer (21%) 61% vs. Fewer (41%) 41% vs. Fewer (61%) 21% vs. Fewer (81%) 1% vs.
Difference + Qualitative Label. 82%. 82%. 82%. 82%.
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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 a 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
[[Page 38660]]
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.
In the Federal Register of August 31, 2010 (75 FR 53312), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four responses were received, each of which
included several comments.
I. Study Design
(Comment 1) Several suggestions related to participant
demographics, measuring health literacy, and determining what our
primary research questions are. One question related to the test DTC
advertisements to be used in the study.
(Response) We agree that the study design should include the
variables of age, education, ethnicity, and race; these are included in
the questionnaire. We will ask whether participants can read,
understand, and speak English.
We will measure subjective health literacy and the related concept
of numeracy, which is relevant for this research as we are studying the
comprehension of quantitative information. To clarify, we will not
limit our sample to those who are currently being treated with a
prescription drug for the condition being assessed; however, the
questionnaire includes questions about prescription drug use.
Regarding the primary research questions, as stated in the 60-day
notice, the current study will add to previous research by
systematically examining the different elements in the drug facts box
tested in previous research (Ref. 8) to determine whether and how to
add qualitative and quantitative benefit and risk information to the
brief summary. Specifically, we will test whether the inclusion of a
qualitative label and/or the inclusion of quantitative information
affects consumers' understanding of the information and their
perceptions of the product.
We have contracted with an organization that produces realistic ads
and stimuli to ensure that we will show respondents realistic
materials.
(Comment 2) This comment states that there was not enough detail in
the 60-day Federal Register notice, such as no description of the
criteria for determining the amount and type of risk and benefit
information to provide in the box format. Another question noted that
qualitative terms depend on many factors. This comment also recommends
that we consider implementing a cross-over study design to address
interpatient variability. This comment suggested considering caregivers
and consumers who do not have the medical condition treated by the
drug. The final question in this comment asked how the tools were
qualified or validated for their intended use.
(Response) The questionnaire, which has information about how
questions will be asked and how behavioral intention will be assessed,
was available upon request during the first comment period and will
continue to be available during the second comment period. Information
about how risk information will be portrayed, what statistical analyses
will be performed, subject recruitment, and pretest content is
addressed in this document.
We agree that a major challenge of the drug facts box format is
deciding the amount and content of risk information to include;
however, this type of study cannot address this issue. To replicate and
extend past research, we will use the drug facts box from a previous
study (Ref. 8) with slight modifications to the risk information (e.g.,
the addition of a serious risk, different rates of side effects in the
placebo and active drug groups).
We agree that qualitative terms depend on many factors; however,
this study does not address the feasibility of creating qualitative
terms but rather tests whether qualitative terms affect consumer
comprehension. As requested, we will note this in our conclusions.
Conducting a cross-over design would significantly increase study
length, and repeated exposure to the same stimuli with minor changes
may affect participants' responses. We have conducted power analyses
and believe we can find interpretable results without conducting a
cross-over design.
To ensure that our participants are motivated to consider the
information presented in the study and to conserve resources, we will
limit our sample to people who have the medical condition of interest.
Cognitive testing will be used to test questionnaire items prior to
their use, and similar items have been used in our previous studies.
The items have face validity, and several are drawn from well-tested
items used in the psychology literature (for example, behavioral
intentions; Ref. 9). Finally, we will pretest the study manipulations.
(Comment 3) This comment included three statements about the
details of the proposed study. First, the comment questioned why we
chose to test percents and frequencies and not relative differences in
this study. Second, this comment pointed out that the differences in
the stimuli should be stated as percentage points, not as percentages.
Third, the comment asks whether the risk and benefit information will
be presented in the same mathematical expression and whether they will
be presented independently.
(Response) We focus on percents and frequencies because we are
replicating and extending previous research on a drug facts box (Ref.
8), which included percents and frequencies but not relative
differences. The study found that the drug facts box outperformed a
traditional brief summary. The drug facts box tested had several
elements that differed from the traditional brief summary, including
percents, frequencies (i.e., XX/100), and qualitative labels. From
these results, it is not possible to tell which elements of the drug
facts box were responsible for the effects found. This study aims to
test systematically the elements of the drug facts box to determine
which, if any, improves consumer comprehension.
We will change percentages to percentage points in our stimuli.
To clarify, when participants see benefit information in a certain
information type (or mathematical expression, for example, percents),
they will also see risk information in that same information type (for
example, percents). However, the efficacy level (from smallest to
largest effect) will be manipulated in one design, and the risk level
(from smallest to largest effect) will be manipulated in a separate
design.
(Comment 4) The comment suggested that we redesign the study such
that participants would view the study materials and then answer
questions about the materials only after consulting with a physician.
This comment lists a number of practical issues surrounding how to
create drug facts boxes and notes that this study will provide limited
practical information on how to format the brief summary for drugs with
multiple indication, multiple studies, or multiple outcomes. Another
recommendation from the comment is to include conditions that test
relative difference. The comment suggests eliminating the ``largest
effect'' cells.
(Response) We cannot ask participants to incur the financial and
personal (time) cost of visiting a doctor to discuss a treatment for
the purposes of research. This is not feasible or ethical. We cannot
ethically ask them to go to their doctor to discuss a fictitious drug
(nor would the doctor be able to discuss a fictitious drug with them),
and
[[Page 38661]]
we cannot ethically recommend a real product for them to discuss with
their doctor. Aside from the feasibility and ethical issues, this is an
unnecessary step to answer our research questions about participants'
comprehension of a widely disseminated written form of information.
Moreover, the assumption behind this recommendation, that physician
consultations are the ``context in which prescription drug
advertisements are actually used,'' is questionable. DTC advertising
does not exist solely in the confines of a doctor's office; rather, DTC
advertising targets consumers outside of a doctor's office, with the
goal of prompting consumers to ask their physicians about the product.
Therefore, clear communication of risks and benefits is needed for
consumers before a consultation with a physician.
We agree that there are several practical issues surrounding the
utility of the drug facts box; however, these issues are outside the
scope of the proposed study. This study does not address how
information would be chosen for inclusion in drug facts boxes but
rather whether and how consumers can understand the information
presented. As stated in the response to comment 7, our first step will
be to study a simple version of the drug facts box, with one
indication.
We agree that relative difference is an interesting way to present
quantitative information and are currently studying this presentation
in another study (Refs. 10 and 11). However, as noted in the response
to comment 3, in this study we are systematically testing the elements
of the drug facts box presented in past research (Ref. 8) to determine
which, if any, improves consumer comprehension.
We agree that these ``largest effect'' cells may be unrealistic and
plan to use pretests to determine the number of levels and the content
of the levels (e.g., the differences used) to be included in the main
study.
II. Publication of the Study
(Comment 5) This comment requested that FDA provide clarity on the
timing and strategy for the conduct of this study with respect to other
planned studies.
The comment recommends that FDA publish findings from this study
and previous studies on the Division of Drug Marketing, Advertising,
and Communications (DDMAC) Web page (Ref. 12).
(Response) To clarify, this study will begin after two related
studies (Refs. 10 and 11) have been conducted. The results from these
studies may inform the execution of this study. The study will not be
superseded by related research results, as none of the other research
examines the drug facts box format for the brief summary.
We agree and have taken steps to publish reports from our previous
research on the DDMAC Web page (Ref. 12). When the current project is
concluded, we will post the findings on the DDMAC Web page as well.
(Comment 6) Much of this comment focused on previous research.
First, this comment requests that we disclose the results of previous
research. Second, this comment recommends that we wait to begin new
studies until results of previous research have been publicly reported.
(Response) As stated in the response to comment 5, we agree and
have taken steps to publish findings from our previous research on the
DDMAC Web page (ref. 12). Unfortunately, the lengthy research process
does not allow us to comply with the second request. To continue having
an active research program, we must submit new proposals while previous
projects are ongoing. As stated in response to comment 5, as research
projects develop, we will take results of previous research in account.
III. Product Labeling
(Comment 7) A comment noted that product labeling is multifaceted
and recommended that conclusions should be flexible to address these
wide variations in product attributes. Another suggestion was to
consider a label format that includes multiple endpoints.
(Response) We agree that product labeling is multifaceted and will
tailor our conclusions to acknowledge that we tested one simple version
of the drug facts box.
As a first step, we plan to study a simple version of the drug
facts box, with one indication. If consumers cannot understand the
information in a drug facts box with one indication, they are not
likely to understand the information in the drug facts box with
multiple indications. In addition, testing an ad with one endpoint is
realistic as drug ads often promote only one indication even if a drug
has multiple indications.
(Comment 8) Another comment suggested that, along with testing the
qualitative label, ``fewer people taking Drug X had symptom Y,'' we
should also test the qualitative label, ``more people taking Drug X
received effective relief from symptom Y.''
(Response) Unfortunately, we do not have the resources to test
multiple qualitative labels in this study; however, we will test the
qualitative label suggested by the comment in place of our original
language.
IV. Revised Study Design
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. We plan to use pretests
to determine the number of levels and the content of the levels (e.g.,
the differences used) to be included in the main study. We will also
pretest whether participants should have access to the ad while
completing the questionnaire. The following design includes the maximum
number of levels we would include. These factors will be combined in a
factorial design as follows:
Table 2--Benefit Design (4 x 5 + 2)
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Efficacy level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
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(1) Absolute Frequency............. 19% vs. 18%........... 39% vs. 18%........... 59% vs. 18%.......... 79% vs. 18%.......... 99% vs. 18%.
(2) Absolute Frequency + More 19% vs. 18%...... More 39% vs. 18%...... More 59% vs. 18%..... More 79% vs. 18%..... More 99% vs. 18%.
Qualitative Label.
[[Page 38662]]
(3) Absolute Difference + More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Qualitative Label. point). points). points). points). points).
(4) Absolute Frequency + Absolute More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Difference + Qualitative Label. point) 19% vs. 18%. points) 39% vs. 18%. points) 59% vs. 18%. points) 79% vs. 18%. points) 99% vs. 18%.
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Note: Qualitative label example: ``More people taking drug X had heartburn relief.'' There are two additional conditions: a no information condition and
a qualitative label only (More) condition.
Table 3--Risk Design (4 x 5 + 2)
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Risk level
Information type --------------------------------------------------------------------------------------------------------------------
Smallest effect Smaller effect Mid-size effect Larger effect Largest effect
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(1) Absolute Frequency............. 3% vs. 2%............. 23% vs. 2%............ 43% vs. 2%........... 63% vs. 2%........... 83% vs. 2%.
(2) Absolute Frequency + More 3% vs. 2%........ More 23% vs. 2%....... More 43% vs. 2%...... More 63% vs. 2%...... More 83% vs. 2%.
Qualitative Label.
(3) Absolute Difference + More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Qualitative Label. point). points). points). points). points).
(4) Absolute Frequency + Absolute More (1 percentage More (21 percentage More (41 percentage More (61 percentage More (81 percentage
Difference + Qualitative Label. point) 3% vs. 2%. points) 23% vs. 2%. points) 43% vs. 2%. points) 63% vs. 2%. points) 83% vs. 2%.
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Note: Qualitative label example: ``More people taking drug X had side effect Y.'' There are two additional conditions: a no information condition and a
qualitative label only (More) condition.
In the benefit design, we will use the mid-size effect for the risk
information in all conditions and vary the information type to match
the benefit information type (e.g., participants who see absolute
frequency benefit information will also see absolute frequency risk
information). Similarly, in the risk design, we will use the mid-size
effect for the benefit information in all conditions and vary the
information type to match the risk information type.
The test product will be for the treatment of gastroesophageal
reflux disease and modeled on an actual drug used to treat this
condition. Participants will be consumers who have heartburn or acid
reflux disease. 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. The questionnaires
for the risk and benefit designs will have identical questions;
however, the order will differ. In the risk design, questions about
risk will appear before questions about benefits; in the benefit design
questions about benefits will appear before questions about risks.
Data will be collected using an Internet protocol. Consumers who
have heartburn or acid reflux disease will be recruited for the study.
Because the task presumes basic reading abilities, all selected
participants must speak and read English fluently. Participants must be
18 years or older. We will use Levene's test of homogeneity of
variances, analysis of variances, and regressions to test hypotheses.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden\1\
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Average
Number of Number of Total annual burden per
Activity respondents responses per responses response (in Total hours
respondent hours) \2\
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Screener........................ 30,000 1 30,000 2/60 1,000
Pretest......................... 750 1 750 20/60 250
Main Study...................... 11,000 1 11,000 20/60 3,667
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Total....................... .............. .............. .............. .............. 4,917
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60.''
V. References
FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.
1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs--
[[Page 38663]]
Summary of FDA Survey Research Results, Final Report, November 19,
2004,'' accessed online at http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf.
2. Aikin, K.J., ``Consumer Comprehension and Preference for
Variations in the Proposed Over-the-Counter Drug Labeling Format,
Final Report,'' 1998.
3. Vigilante, W.J. and M.S. Wogalter, ``The Preferred Order of Over-
the-Counter (OTC) Pharmaceutical Label Components,'' Drug
Information Journal, vol. 31, pp. 973-988, 1997.
4. Levy, A.S., S.B. Fein, and R.E. Schucker, ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred, ''
Journal of the American Dietetic Association, vol. 92, pp. 1230-
1234, 1992.
5. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Text-Processing Strategies,'' Journal of Educational Psychology,
vol. 87, pp. 537-544, 1995.
6. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Free Recall of Expository Text,'' Journal of Educational Psychology,
vol. 88, pp. 38-48, 1996.
7. Lorch, R., E. Lorch, and W. Inman, ``Effects of Signaling Topic
Structure on Text Recall,'' Journal of Educational Psychology, vol.
85, pp. 281-290, 1993.
8. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts
Box to Communicate Drug Benefits and Harms: Two Randomized Trials,''
Annals of Internal Medicine, vol. 150, pp. 516-527, 2009, accessed
online at http://www.annals.org/cgi/content/full/0000605-200904210-00106v1.
9. Webb, T.L. and P. Sheeran, ``Does Changing Behavioral Intentions
Engender Behavior Change? A Meta-Analysis of the Experimental
Evidence,'' Psychological Bulletin, vol. 132, pp. 249-268, 2006.
10. ``Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request;
Experimental Study: Presentation of Quantitative Effectiveness
Information to Consumers in Direct-to-Consumer (DTC) Television and
Print Advertisements for Prescription Drugs,'' Federal Register,
vol. 75, pp. 373-379, January 5, 2010.
11. ``Agency Information Collection Activities; Proposed Collection;
Comment Request; Study of Clinical Efficacy Information in
Professional Labeling and Direct-to-Consumer Print Advertisements
for Prescription Drugs,'' Federal Register, vol. 75, pp. 34142-
34146, June 16, 2010.
12. FDA, About the Center for Drug Evaluation and Research Page,
DDMAC Research, (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm).
Dated: June 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16552 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P