Document ID: FDA-2010-N-0417-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer Print Advertisements
Posted Date: 2011-07-01T04:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        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     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%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Efficacy level
          Information type          --------------------------------------------------------------------------------------------------------------------
                                         Smallest effect         Smaller effect         Mid-size effect         Larger effect          Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
(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%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Risk level
          Information type          --------------------------------------------------------------------------------------------------------------------
                                         Smallest effect         Smaller effect         Mid-size effect         Larger effect          Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
(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%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,917
----------------------------------------------------------------------------------------------------------------
\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