[Federal Register Volume 84, Number 139 (Friday, July 19, 2019)]
[Notices]
[Pages 34897-34902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3163]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Physician 
Interpretation of Information About Prescription Drugs in Scientific 
Publications Versus Promotional Pieces

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 
19, 2019.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Physician Interpretation of Information About Prescription 
Drugs in Scientific Publications vs. Promotional Pieces.'' Also include 
the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Physician Interpretation of Information About Prescription Drugs in 
Scientific Publications vs. Promotional Pieces

OMB Control Number 0910-New

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA-regulated products in 
carrying out the provisions of the FD&C Act.
    The FD&C Act prohibits the dissemination of false or misleading 
information about medications in consumer-directed and professional 
prescription drug promotion. As part of its Federal mandate, FDA 
regulates whether advertising of prescription drug products is 
truthful, balanced, and accurately communicated (see 21 U.S.C. 352(n)). 
FDA's regulatory policies are aligned with the principles of free 
speech and due process in the U.S. Constitution. To inform current and 
future policies, and to seek to enhance

[[Page 34898]]

audience comprehension, FDA's Office of Prescription Drug Promotion 
(OPDP) conducts research focusing on: (1) Advertising features 
including content and format, (2) target populations, and (3) research 
quality. This proposed research focuses on healthcare professionals 
(HCPs). The proposed collection of information will investigate how 
physician perception of prescription drug information is influenced by 
variations in information context (presence of graphical elements and 
information delivery vehicle--medical journal abstract or sales aid), 
methodologic rigor of the underlying clinical study (high or low), and 
time pressure (present versus absent).

A. Ways in Which Information Context and Study Quality May Influence 
Perceptions

    Physicians gain knowledge about medical product uses from a variety 
of information vehicles including peer-reviewed journal articles, 
compendia, continuing medical education, and physician-directed 
promotion by or on behalf of manufacturers. Peer-reviewed scientific 
publications may report the results of a variety of studies, employing 
a wide range of methodologies with varying levels of rigor. As a 
result, information of varying quality is disseminated to the field. 
Physician detailing sometimes includes information derived from peer-
reviewed research that, in this context, serves a dual purpose: To both 
inform and market a particular product (Ref. 1).
    Prior research has examined some impacts of study quality and 
funding source on physician perception. For example, research by 
Kesselheim et al. (Ref. 2) on study abstracts examined how methodologic 
rigor (high, medium, low) and information about the source of funding 
(industry, National Institutes of Health, none) affected physician 
perceptions of study quality, prescribing intentions, and interest in 
reading the full article. Results indicated physician participants were 
able to distinguish between levels of methodologic rigor. Physicians 
also used information about the funding source to distinguish 
materials. They reported less willingness to prescribe the drugs or 
read the full study from trials funded by industry, regardless of study 
rigor. Thus, funding source was a contextual factor that impacted 
physicians' perceptions of the information.
    Research has also shown that physician prescribing behavior can be 
influenced by the context in which the information is delivered. 
Spurling et al. (Ref. 3) examined the way in which information from a 
pharmaceutical company was delivered (using conventional promotional 
techniques such as sales rep visits, journal advertisements, or 
attendance at pharmaceutical-sponsored meetings versus not using 
conventional promotional techniques such as participation in company 
sponsored trials and representatives' visits for nonpromotional 
purposes) and prescribing outcome across 58 studies. They found 
conventional promotional techniques were associated with an increase in 
prescribing and a decrease in prescribing quality. We are proposing to 
test a different type of contextual factor in this study: Whether the 
drug information appears in a medical journal abstract or a sales aid.

B. Ways in Which Graphics May Influence Perceptions

    Promotional materials about prescription drugs that are directed 
toward physicians often include a variety of visual elements beyond 
simple text. In a study of professionally directed prescription drug 
brochures left for physicians by pharmaceutical representatives, 
researchers found 95 percent contained a visual graphic (including bar 
charts, line graphs, pie charts, arrows) accompanying the presentation 
of data (Ref. 4). An analysis of professionally directed prescription 
drug print advertisements in medical journals found 80 percent of the 
ads contained some type of image, and 21 percent contained data-related 
graphics. A group of two physicians and one pharmacist judged these 
ads. This group found that of those ads that contained images, 58 
percent contained images that minimized the risks of the product and 24 
percent of the images in the ads misled about product efficacy (Ref. 
5).

C. Ways in Which Time Pressure May Influence Perceptions

    We are also interested in how time pressure may impact physician 
perceptions. Time pressure can impact processing of information (e.g., 
accuracy and speed) as well as decision making. Physicians are often 
under pressure to split their work time between myriad duties that may 
include clinical care, research, mentoring, teaching, and 
administrative duties (Ref. 6). Individuals under time pressure tend to 
rely on previously formed attitudes for decision making and have less 
cognitive capacity to process information (Refs. 7 and 8). This results 
in different decisions depending on the amount of time available (Ref. 
9). Research suggests that in situations with high time pressure or 
increased ambiguity, experts use intuitive decision-making strategies 
rather than structured approaches (Refs. 10 and 11). Physicians may 
therefore tend to rely on intuitive processes rather than evidence-
based information under time pressure.
    Research has also found that under time pressure, physician 
adherence to clinical practice guidelines concerning history taking and 
advice giving can be compromised (Ref. 12). One study that assessed the 
reading habits of physicians found that with limited time available for 
critical reading, practitioners relied heavily on abstracts and 
prescreening of articles by editors (Ref. 13). Thus, time pressure is 
an element of physicians' practice environment that can impact 
information gathering and, consequently, decision making, and the 
quality of health care delivered.

II. Proposed Study

    We propose to investigate how physician perception of professional 
prescription drug communications is influenced by variations in 
information context, methodologic rigor of the underlying clinical 
study, and time pressure. We propose to test three different contextual 
presentations of drug information (medical journal abstract, sales aid 
without graphic design elements, and sales aid with graphic design 
elements), and two types of study methodological rigor used by 
Kesselheim et al. (classified as high or low; Ref. 2). We have chosen 
to test a mock sales aid presentation and a medical journal abstract to 
examine the potential differences in perception that may arise by 
presenting the same information in different vehicles. Mirroring the 
time constraints of practicing physicians, we will examine the role of 
time pressure by randomly assigning half of the study participants to a 
limited amount of available time to read the materials. Table 1 
describes the study design.

[[Page 34899]]



                                                                  Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Information context
                                      ------------------------------------------------------------------------------------------------------------------
                                                                                              Medical journal            Sales aid       Sales aid with
                                                                                                     abstract      without graphic       graphic design
                                                                                                                   design elements         elements \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limited Time to Read.................  Methodological Rigor \1\  High.
                                                                 Low.....................
--------------------------------------                          ----------------------------------------------------------------------------------------
Unlimited Time to Read.                                          High.
                                                                 Low.....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As defined by Kesselheim et al. (Ref. 2).
\2\ For example, colors and background images.

    For this proposed study, voluntary participants will be board-
certified internists. To examine differences between experimental 
conditions, we will conduct inferential statistical tests such as 
analysis of variance (ANOVA). With the sample size described, we will 
have sufficient power to detect small-to-medium sized effects in the 
main study.
    We plan to conduct one pretest with 158 voluntary participants and 
one main study with 566 voluntary participants. The purpose of the 
pretest is to ensure the manipulations are working as intended, and to 
examine the effectiveness of question wording. In the pretest, 
participants will answer questions about the study design and 
questionnaire. The studies will be conducted online. The pretest and 
main studies will have the same design and will follow the same 
procedure. Participants will be randomly assigned to one of 12 test 
conditions (see table 1). Following exposure to the stimuli, they will 
be asked to complete a questionnaire that assesses comprehension, 
perceptions, prescribing intentions, and demographics. We anticipate 
analyzing the data as a full factorial design (main effects and 
interactions) with two primary comparisons for the information context 
independent variable: Journal abstract versus sales aid without 
graphics and sales aid without graphics versus sales aid with graphics. 
We will also do an exploratory comparison of journal abstract versus 
sales aid with graphics.
    This study will be conducted as part of the research program of the 
OPDP. OPDP's mission is to protect the public health by helping to 
ensure that prescription drug information is truthful, balanced, and 
accurately communicated, so that patients and health care providers can 
make informed decisions about treatment options. OPDP's research 
program supports this mission by providing scientific evidence to help 
ensure that our policies related to prescription drug promotion will 
have the greatest benefit to public health. Toward that end, we have 
consistently conducted research to evaluate the aspects of prescription 
drug promotion that we believe are most central to our mission, 
focusing on three main topic areas: Advertising features, including 
content and format; target populations; and research quality. Through 
the evaluation of advertising features we assess how elements such as 
graphics, format, and disease and product characteristics impact the 
communication and understanding of prescription drug risks and 
benefits; focusing on target populations allows us to evaluate how 
understanding of prescription drug risks and benefits may vary as a 
function of audience; and our focus on research quality aims at 
maximizing the quality of research data through analytical methodology 
development and investigation of sampling and response issues. This 
study falls under the topic of both target populations and advertising 
features.
    In the Federal Register of October 17, 2018 (83 FR 52490), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments that were PRA 
related. Within those submissions, FDA received multiple comments that 
the Agency has addressed.
    (Comment) Two comments asked for clarity about the research 
objectives and hypotheses. One comment asked how FDA will use such 
knowledge to inform the regulation of prescription drug promotion in 
the future, particularly the variable of time.
    (Response) As described in the 60-day Federal Register notice, we 
propose to investigate how physician perception of professional 
prescription drug communications is influenced by variations in 
information context, methodologic rigor of the underlying clinical 
study, and time pressure. We propose to test three different contextual 
presentations of drug information (medical journal abstract, sales aid 
without graphic design elements, sales aid with graphic design 
elements), and two types of study methodological rigor used by 
Kesselheim et al. (classified as high or low; Ref. 2). We have chosen 
to test a mock sales aid presentation and a medical journal abstract to 
examine the potential differences in perception that may arise by 
presenting the same information in different vehicles. Mirroring the 
time constraints of practicing physicians, we will examine the role of 
time pressure by randomly assigning half of the study participants to a 
limited amount of available time to read the materials. Our research 
questions (RQs) are:

    RQ 1: Does the information context in which the information 
appears affect processing of the information?
    RQ 2: Does methodological rigor of the study affect processing 
of the information?
    RQ2a: Do physicians correctly interpret the methodological rigor 
of the study?
    RQ3: Does the time available to read the information affect 
processing of the information?
    RQ4: What are the potential interactions between these factors?

    Thus, the goal of our study is to understand the ways in which the 
presentation of information, methodological rigor, and time affect how 
physicians interpret information about drugs when it comes from 
different sources. Although we cannot speculate on any future action 
because of our research studies, the Agency is committed to examining 
and conducting research that will ensure that any changes are grounded 
in science and will have the greatest benefit to public health. For 
this reason, FDA consistently conducts research to evaluate the aspects 
of prescription drug promotion that we believe are most central to our 
mission, focusing on three main topic areas: Advertising features, 
including content and format; target populations; and research quality. 
Results from studies we conduct are evaluated within the broader 
context of research and findings from other

[[Page 34900]]

sources. The broader body of knowledge is used to inform both policy 
and regulatory approaches.
    (Comment) Six comments focused on various aspects of the study 
design. Comments asked for: (1) Clarity about the reasoning behind 
inclusion of the aspects of time pressure; (2) how time pressure 
reflects the reality of the HCP experience; (3) how time pressure will 
be operationalized; (4) justification for comparison of a sales aid to 
an abstract; (5) a suggestion to remove one of the sales aid conditions 
to simplify the design; and (6) more detail about how methodologic 
rigor will be defined and represented in a sales aid or an abstract. 
One comment (7) asserted graphics in promotional materials are tested 
by pharmaceutical companies through market research to ensure correct 
interpretation and so the presence or absence of graphics cannot 
predict how HCPs will interpret information in promotional materials. 
This comment also asserted the 1992 supporting reference in the 60-day 
Federal Register notice was outdated.
    (Response to 1-3) Prior research has found that many physicians 
have limited time to spend reading drug information (Refs. 6-11). To 
imitate physicians' real-world experiences in this study, half of the 
participants will be randomly assigned to a condition in which time 
pressure is present; the other half will experience no time pressure. 
Those in the time pressure present condition will receive instructions 
explaining they will have two minutes to review the study description, 
which will be reevaluated after pretesting. Those without time pressure 
will be told they have as much time as they need to review the study 
description.
    (Response to 4-5) As described in the 60-day Federal Register 
notice, we have two primary comparisons for the information context 
independent variable: Journal abstract versus sales aid without 
graphics, and sales aid without graphics versus sales aid with 
graphics. We will also do an exploratory comparison of journal abstract 
versus sales aid with graphics. As further described in the 60-day 
Federal Register notice, we are examining the potential differences in 
perception that may arise by presenting the same information in 
different vehicles. The same information will be presented in the 
context of an abstract and the context of a sales aid. Described 
another way, we are controlling the text of the information and varying 
its ``wrapper'' to explore whether the context in which the information 
appears influences how the information is perceived. A comparison of 
abstract to sales aid without graphics, and sales aid without graphics 
to sales aid with graphics will enable us to examine perceptual 
differences that may arise from the context in which the information 
occurs. To control for extraneous effects, we are not presenting any 
other information in the sales aid.
    (Response to 6) In addition to studying the presentation of 
information in different information vehicles (sales aid versus 
abstract), we will also examine two different levels of methodological 
rigor, either high or low quality (Ref. 2). Some key differences 
between the levels of rigor are: Blinding, representative population, 
and drug safety reported (Ref. 2). For example, the high rigor study 
that half of the participants will view was a randomized double-blind 
study that had a representative patient population, and the drug was 
reported to be safe (Ref. 2). The low rigor study that the other half 
of the participants will view was open-label (no blinding), was not 
representative of the patient population, and there was no report of 
the safety of the drug (Ref. 2). We used the same criteria to develop 
our stimuli as did Kesselheim et al. (Ref. 2). For example, variables 
in the high rigor condition included double-blind, active comparator, 
and representative patient population. Variables in the low rigor 
condition included open-label, usual care comparator, and a non-
representative patient population.
    (Response to 7) It is possible that the presence of graphics 
affects the impressions of the product, which we are assessing in this 
study. To address the comment about the date of the referenced 
research, we conducted an additional search of the literature. In a 
study by Othman et al. (Ref. 14), 28 percent of claims made in 
pharmaceutical advertisements were judged clear and not misleading. 
This suggests that 72 percent were misleading or unclear. We welcome 
the opportunity to review unpublished market research or other 
available data to inform this study.
    (Comment) One comment questioned the sufficiency of the proposed 
analysis plan based on the information provided in the notice and asked 
for clarity about the main dependent variables.
    (Response) Our primary dependent variables are: Likelihood to 
prescribe, confidence in study results, interpret data cautiously, 
would use data in prescribing, credibility of data, bias of data, and 
trust in promotion. We will conduct ANOVAs (for continuous variables) 
and logistic regressions (for dichotomous variables) with interaction 
terms and planned comparisons to test the research questions. We have 
outlined our research questions above.
    (Comment) Three comments requested FDA disseminate the study 
stimuli, and one comment requested disseminating the questionnaire 
prior to requesting comments.
    (Response) We have described the purpose of the study, the design, 
the population of interest, and the estimated burden. The 60-day notice 
published on October 17, 2018, provided an email address to obtain 
copies of the questionnaire (83 FR 52490 at 52491, column 3) and we 
provided the questionnaire to individuals upon request. The content of 
the stimuli is taken from Kesselheim et al. (Ref. 2). Our full stimuli 
are under development during the PRA process. We do not make draft 
stimuli public during this time because of concerns that this may 
contaminate our participant pool and compromise the research.
    (Comment) Two comments questioned limiting the sample to board-
certified internists and not including specialists, particularly those 
who specialize in diabetes treatment and endocrinologists. Relatedly, 
one comment suggested a sample size of at least 200 physicians.
    (Response) Our study is a partial replication of the Kesselheim et 
al. (Ref. 2) study. In that study, internists were used as the target 
population and in keeping with the replication, we chose to evaluate 
internists as well. We encourage future research to expand to other 
physician specialties. The sample will provide us enough power to 
detect a medium-sized effect between the study variables.
    (Comment) Two comments suggested changing the scale range of the 
questions so that all of the questions use a consistent scale range.
    (Response) We are using several questions that have been validated 
in previous studies. Therefore, some of the scales have various 
lengths. We chose to maintain scale range to maintain validation rather 
than editing scales for consistency.
    (Comment) Seven comments suggested changes to the questionnaire. 
These suggested changes included: (1) Adjusting the wording of the 
question that asks about the importance of the target study ``to ensure 
more consistent interpretation by respondents, such as importance of 
study findings on respondent decision making, etc.''; (2) revising the 
question about perceptions of bias to avoid the respondent making the 
assumption that the data presentation is biased; (3) deletion of 
questions about perceptions of risk; (4) deletion of the question about 
places

[[Page 34901]]

where information about unapproved drugs has been encountered because 
it appears unrelated to the study goals; (5) addition of a response 
choice to the question measuring decision to include colleagues as a 
source of information; (6) addition of screening questions about 
statistical training; and (7) addition of a question about how much 
time is typically spent reviewing materials such as this.
    (Responses) (1) The study importance question is taken from 
Kesselheim et al. (Ref. 2) and we did not encounter any issues with 
this question during cognitive interviews. (2) Perceptions of the 
amount of potential bias is one of our primary dependent measures. We 
will change the wording of this question to read ``How unbiased or 
biased is the study you saw?'' [1 = very unbiased; 5 = very biased]. 
(3) We acknowledge participants may have a difficult time answering 
questions about risk. We believe an overall risk-benefit assessment is 
possible based on the information provided. Thus, we have decided to 
retain these questions as variables of secondary interest. (4) The 
question about where participants may encounter information about 
unapproved drugs is taken from the Healthcare Professional Survey of 
Professional Prescription Drug Promotion (Docket No. FDA-2018-N-0215). 
We have included it here so that we may compare results across the two 
populations in an exploratory manner. (5) We will add a question about 
seeking information in response to the data participants see in the 
study that includes a response choice that captures desire to discuss 
drug information with a colleague prior to prescribing. (6) We will add 
a question about statistical training to the demographic section of the 
questionnaire. (7) We will add a question about how long participants 
typically spend reading materials of this type.
    (Comment) One comment suggested moving the non-terminating 
demographic screener questions to the end of the survey.
    (Response) We appreciate this suggestion. We have moved these 
questions to the end of the survey.
    (Comment) One comment asked that the results be broadly and 
systematically disseminated.
    (Response) The Agency anticipates disseminating the results of the 
study after the final analyses of the data are completed, reviewed, and 
cleared. The exact timing and nature of any such dissemination has not 
been determined, but may include presentations at trade and academic 
conferences, submissions in publications, publishing articles, and 
internet postings.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
                 Activity                      Number of     responses per   Total annual           Average  burden per  response           Total hours
                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest screener..........................             197               1             197  0.03 (2 minutes)............................               6
Main Study screener.......................             700               1             700  0.03 (2 minutes)............................              21
Completes, Pretest........................             158               1             158  0.33 (20 minutes)...........................              53
Completes, Main Study.....................             566               1             566  0.33 (20 minutes)...........................             187
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................           1,621  ..............           1,621  ............................................             267
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
are available for viewing by interested persons between 9 a.m. and 4 
p.m., Monday through Friday; they also are available electronically at 
https://www.regulations.gov. References without asterisks are not on 
public display at https://www.regulations.gov because they have 
copyright restriction. Some may be available at the website address, if 
listed. References without asterisks are available for viewing only at 
the Dockets Management Staff. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

1. Yi, J.C., G. Anandalingam, and L.A. Sorrell, ``An Expert System 
to Physician-Detailing Planning,'' Expert Systems with Applications, 
25:533-544, 2003.
2. Kesselheim, A.S., C.T. Robertson, J.A. Myers, et al., ``A 
Randomized Study of How Physicians Interpret Research Funding 
Disclosures,'' New England Journal of Medicine, 367:1119-1127, 2012.
3.*Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al., 
``Information from Pharmaceutical Companies and the Quality, 
Quantity, and Cost of Physicians' Prescribing: A Systematic 
Review,'' PLoS Medicine, 7:e1000352, 2010.
4. Cardarelli, R., J.C. Licciardone, and L.G. Taylor, ``A Cross-
Sectional Evidence-Based Review of Pharmaceutical Promotional 
Marketing Brochures and Their Underlying Studies: Is What They Tell 
Us Important and True?'' BMC Family Practice, 7:13, 2006.
5. Wilkes, M.S., B.H. Doblin, and M.F. Shapiro, ``Pharmaceutical 
Advertisements in Leading Medical Journals: Experts' Assessments,'' 
Annals of Internal Medicine, 116:912-919, 1992.
6. Fassiotto, M., C. Simard, C. Sandborg, et. al, ``An Integrated 
Career Coaching and Time-Banking System Promoting Flexibility, 
Wellness, and Success: A Pilot Program at Stanford University School 
of Medicine,'' Academic Medicine, 93:881-887, 2018.
7. Alison, L., B. Doran, M.L. Long, et. al, ``The Effects of 
Subjective Time Pressure and Individual Differences on Hypotheses 
Generation and Action Prioritization in Police Investigations,'' 
Journal of Experimental Psychology. 19:83-93, 2013.
8. Ratneshwar, S. and S. Chaiken, ``Comprehension's Role in 
Persuasion: The Case of Its Moderating Effect on the Persuasive 
Impact of Source Cues,'' Journal of Consumer Research, 18:52-62, 
1991.
9. Moore, D.L., D. Hausknecht, and K. Thamodaran, ``Time 
Compression, Response Opportunity, and Persuasion,'' Journal of 
Consumer Research, 13:85-99, 1986.
10. Dror, I.E., B. Basola, and J.R. Busemeyer, ``Decision Making 
Under Time Pressure: An Independent Test of Sequential Sampling 
Models,'' Memory & Cognition, 27:713-725, 1999.
11. Croskerry, P., ``The Cognitive Imperative Thinking About How We 
Think,'' Academic Emergency Medicine, 7:1223-1231, 2000.
12. Tsiga, E., E. Panagopoulou, N. Sevdalis, et. al, ``The Influence 
of Time Pressure on Adherence to Guidelines in Primary Care: An 
Experimental Study,'' BMJ Open, 3:e002700, 2013.
13. Saint, S., D.A. Christakis, S. Saha, et. al, ``Journal Reading 
Habits of Internists,'' Journal of General Internal Medicine, 
15:881-884, 2000.
14. *Othman, N., A. Vitry, and E.E.

[[Page 34902]]

Roughead, ``Quality of Pharmaceutical Advertisements in Medical 
Journals: A Systematic Review,'' PLoS Medicine, 4:e6350, https://doi.org/10.1371/journal.pone.0006350, 2009.

    Dated: July 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15350 Filed 7-18-19; 8:45 am]
BILLING CODE 4164-01-P