[Federal Register Volume 86, Number 134 (Friday, July 16, 2021)]
[Rules and Regulations]
[Pages 37677-37679]
[FR Doc No: 2021-15177]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0470]
RIN 1625-AA00

Safety Zone; Upper Mississippi River, Mile Marker 579.7
Approximately 1,000 Feet Northwest of the Ulysses S. Grant Memorial
Hwy., Dubuque, IA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Upper Mississippi River at mile marker
579.7 extending 500 feet from the left decending bank approximately
1,000 feet northwest of the Ulysses S. Grant Memorial Hwy. The safety
zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a fireworks display.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector Upper
Mississippi River or a designated representative.

DATES: This rule is effective on July 17, 2021, from 9 p.m. through
10:30 p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0470 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Stephanie Moore, Sector Upper
Mississippi River Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because because it is impracticable. We must
establish this safety zone by July 17, 2021, and lack sufficient time
to provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper
Mississippi River (COTP) has determined that potential hazards
associated with a fireworks display on July 17, 2021, will be a safety
concern for anyone on the Upper Mississippi River at Mile Marker (MM)
579.7. This rule resulted from a marine event notification stating that
there will be a fireworks display to celebrate a wedding on the Upper
Mississippi River. This rule is needed to protect personnel, vessels,
and the marine environment in the navigable waters within the safety
zone before, during, and after the fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone on Upper Mississippi River at 9
p.m. through 10:30 p.m. The safety zone will cover all navigable waters
of the Upper Mississippi River at mile marker 579.7 approximately 1,000
feet northwest of the Ulysses S. Grant Memorial Hwy. The duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters before, during, and after a
fireworks display. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard (USCG) assigned to units under
the operational control of USCG Sector Upper Mississippi River.
    The COTP or a designated representative will inform the public of
the enforcement date and times for this safety zone, as well as any
emergent safety concerns that may delay the enforcement of the zone.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, and duration of the temporary safety zone. This action
involves a fireworks display that impacts a one half mile stretch of
the Upper Mississippi River on July 17, 2021, from 9 p.m. through 10:30
p.m. Moreover, the Coast Guard will issue a Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the safety zone, mariners
may seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian

tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting one hour and thirty minutes that will prohibit
entry on the Upper Mississippi River at MM 579.7, extending 500 feet
from the left decending bank. It is categorically excluded from further
review under paragraph L60 in Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0470 to read as follows:

Sec.  165.T08-0470  Safety Zone; Upper Mississippi River, Mile Marker
579.7, Dubuque, IA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Upper Mississippi River at mile marker 579.7 extending
500 feet from the left decending bank approximately 1,000 feet
northwest of the Ulysses S. Grant Memorial Hwy.
    (b) Enforcement period. This section will be enforced on July 17,
2021, from 9 p.m. through 10:30 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, persons and vessels are prohibited from entering the
safety zone unless authorized by the Captain of the Port Sector Upper
Mississippi River (COTP) or a designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard (USCG) assigned to units under the operational control of
USCG Sector Upper Mississippi River.
    (2) Persons or vessels desiring to enter into or pass through the
zone must request permission from the COTP or a designated
representative. They may be contacted on VHF radio Channel 16 or by
telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP or designated representative while
navigating in the regulated area.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement date and times
for this safety zone, as well as any emergent safety concerns that may
delay the enforcement of the zone through Broadcast Notice to Mariners
(BNM) and or Local Notices to Mariners (LNMs).

    Dated: July 13, 2021.
C.J. Barger,
Commander, Acting Captain of the Port, U.S. Coast Guard.
[FR Doc. 2021-15177 Filed 7-15-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78663-78667]
[FR Doc No: 2011-32275]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0230]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Examination of Online
Direct-to-Consumer Prescription Drug Promotion

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 January
18, 2012.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title, Examination of Online Direct-to-Consumer Prescription Drug
Promotion. Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Examination of Online Direct-to-Consumer Prescription Drug Promotion--
(OMB Control Number 0910--New)

I. Background

    Pharmaceutical products are launched and marketed in a number of
new modalities and venues that did not exist a short time ago.
Increasingly, prescription products are promoted to consumers online in
such formats as banners, Web sites, and videos. The interactive nature
of the Internet allows for features not possible with traditional media
(i.e., print, radio, and television), such as scrolling information,
popup windows, linking to additional information, and embedded videos.
FDA regulations require that prescription drug advertisements include a
``fair balance'' of information about the benefits and risks of
advertised products, both in terms of the content and presentation of
the information (21 CFR 202.1(e)(5)(ii)). All prescription drug
promotion that makes claims about a product must, therefore, also
include risk information in a ``balanced'' manner. Currently, there are
a number of questions surrounding how to achieve ``fair balance'' in
online direct-to-consumer (DTC) promotion.
    A few studies have examined how well online DTC Web sites
communicate benefit and risk information. Although content analyses
demonstrate that most Web sites include information on side effects and
contraindications (Ref. 1), risk information is often presented less
prominently and in fewer locations on the Web site (Refs. 2, 3, and 4).
Content analyses also suggest that risk information on DTC prescription
drug Web sites is often incomplete (Ref. 5) and written at very high
literacy levels (Ref. 6).
    One study examined how users interact with prescription drug Web
sites (Ref. 7). This study found that the placement of risk and benefit
information on a Web site is an important factor in whether it achieves
``fair balance.'' Specifically, participants' ability to find and
accurately recall risk information was enhanced when risk and benefit
information were presented separately and when risk information was
presented on a higher order page (i.e., on a second-level page clearly
linked from the homepage, or on the homepage).
    This project is designed to test different ways of presenting
prescription drug risk and benefit information on branded drug Web
sites. This research is relevant to current policy questions and debate
and will complement qualitative research we plan to conduct on issues
surrounding social media. The series of studies described in this
document will provide data that, along with other input and
considerations, will inform the development of future guidance.

II. Comments

    In the Federal Register of April 28, 2011 (76 FR 23821), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Seven statements were received, some of
which included several comments.
    (Comment 1) One comment expressed the opinion that DTC advertising
will never present risk and benefit information in a balanced manner
and therefore the government should take a stronger stand against DTC
advertising.
    (Response) This is outside the scope of this project, but we note
that the overall purpose of the research is to improve consumer
understanding of prescription drug advertising.
    (Comment 2) The comment describes Web archiving technology and how
it can be used to capture information from Web sites. They recommended
we use their company's Web archiving services for regulatory activities
and to conduct the study.
    (Response) The sections of this comment that relate to how the
company's services can be used for regulatory activities are beyond the
scope of this project. The sections that relate to the research suggest
that we could use Web archiving technology to create Web sites for the
study; however, we plan to create new, unique, fictitious Web sites for
the study to ensure familiarity with a particular Web site or brand
does not have any influence on our findings.
    (Comment 3) Two statements suggested additional information should
be collected from participants. One statement suggested we use some of
this additional information (prescription drug use) as a covariate.
    (Response) Some of the additional information suggested is already
included in the questionnaire (e.g., age, ethnicity, education level,
and prescription drug use for the medical condition of interest).
Although native language and whether participants are hearing or vision
impaired are not directly assessed, participants must be capable of
completing an intake questionnaire and core adult profile survey, both
of which are written at an eighth grade reading level. Other additional
information suggested will be included. Specifically, we will include
level of Internet use and length of time from diagnosis with the
medical condition of interest. In addition, we will use prescription
drug use for the medical condition of interest as a covariate in our
analyses.
    (Comment 4) One comment addressed the recruitment process,
requesting that we disclose how participants will be recruited and
recommending online recruitment.
    (Response) We plan to recruit and conduct the study online.
    (Comment 5) One comment recommended that caregivers also be
included as participants.
    (Response) 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.
    (Comment 6) One comment requested that we not apply the results of
these studies to social media and mobile technology, as Web sites
differ in a number of ways from other online contexts.
    (Response) These studies are designed to address questions
surrounding branded prescription drug Web sites and therefore the
results will not be applied to social media and mobile technology.
    (Comment 7) One comment requested that FDA publish the study design
for the qualitative study mentioned in the Federal Register notice.
    (Response) FDA plans to conduct 10 focus groups to investigate how
consumers, patients, and caregivers use online health communities and
social media sites to make health decisions, especially regarding
prescription drugs. These focus groups received OMB approval on April
28, 2011 (``Examination of Online Direct-to-Consumer Prescription Drug
Promotion,'' OMB control number 0910-0677). FDA will share the results
of these focus groups when they become available.
    (Comment 8) One comment suggested that the proposed samples sizes
may not result in adequate statistical power.
    (Response) We have conducted power analyses and will have
sufficient sample to detect small to medium size effects with an alpha
level of 0.05 and power of 0.90.
    (Comment 9) One statement suggested that the proposed 2 x 2 + 1
design in Study 2 may limit an objective assessment of the effect of
the variables in the control group. Another questioned the presence of
the control group in Study 2, suggesting that it may confound the
interpretation of results regarding the ``prominence'' manipulation.
This statement suggested evaluating prominence in a separate part of
the study.
    (Response) Study 2 is designed to test two research questions: (1)
To what extent does the presence of special features (e.g., personal
testimonials, animated visuals) on a branded drug Web site influence
consumer perceptions of a prescription drug and (2) to what extent does
the prominence of risk information in special features on a branded
drug Web site influence consumer perceptions of a prescription drug?
Both research questions can be addressed within the same design without
having to evaluate prominence in a separate design. The first research
question will be tested by comparing responses of participants exposed
to a Web site with a special feature to those who were not (the control
group). The second research question will be tested by comparing
responses of participants exposed to more prominently displayed risk
information to those exposed to less prominently displayed risk
information (i.e., the control condition would not be included in these
analyses).
    (Comment 10) One comment stated that the study outcome measures
were not clear and recommended using validated measures.
    (Response) The key outcome measures are risk comprehension, benefit
comprehension, risk perceptions, and benefit perceptions. Where
validated measures exist we will use them. Because the comprehension
measures by necessity will be based on the information particular to
each fictitious drug, these will be new measures; however, they will
take the form of similar comprehension measures used by FDA and others
in past research.
    (Comment 11) One comment noted that we planned to conduct the
studies with participants diagnosed with medical conditions like high
cholesterol, seasonal allergies, depression, acid reflux, and high
blood pressure, but suggested we also include participants with other
medical conditions such as HIV and cancer and replicate the studies
across different therapeutic areas.
    (Response) As noted in the comment, we plan to conduct the studies
with patients diagnosed with a range of medical conditions that differ
in diagnosis, symptomatology, patient population, and treatment
options. Because it is difficult to recruit participants from low-
incidence samples such as those recommended, we do not plan to include
these other medical conditions in the study. However, we will consider
this for future studies and encourage replication across medical
conditions by other researchers.
    (Comment 12) One comment recommended that FDA not delay issuing
draft Internet guidance until the results of the studies are known.

    (Response) FDA does not intend to delay issuing draft guidance
because of this research.
    (Comment 13) One comment suggested that FDA policy should not
categorically prohibit the use of hyperlinks to provide risk
information.
    (Response) Because this comment addresses issues of policy and not
the current research, this comment is outside the scope of this
project.
    (Comment 14) One comment suggested that, rather than focus on a
single branded drug Web site, the studies should take into account the
multiple executional elements of Internet drug promotion and how online
promotional executions are affected by the broader health information
environment. The comment argues that this is necessary because risk and
benefit comprehension is affected not only by the specifics of one
branded drug Web site but also by other health information found online
and elsewhere.
    (Response) The regulations these studies address do not apply to
the broader online health information environment; rather, each
individual branded drug Web site needs to achieve fair balance. The
fictitious branded drug Web sites used in the studies will include
multiple executional elements; however, only one variable will be
manipulated at a time in order to maintain experimental control.
    (Comment 15) One comment recommended we take advantage of other
researchers who can help revise the study design.
    (Response) We obtained comments from peer reviewers and
incorporated their suggestions in the new design.
    (Comment 16) One comment noted that there are numerous issues that
this research does not address, including online data mining by
pharmaceutical companies, techniques of personalization for targeted
digital pharmaceutical and health marketing, and pharmaceutical
marketing's ``exploitative'' approach to social media. The comment
criticized the focus on branded drug Web sites, as the online marketing
environment encompasses newer technology.
    (Response) Although there are several other issues surrounding
prescription drug advertising online, such as privacy concerns, this is
not the purview of the current research. This research is not designed
to ``assess the full impact of digital drug marketing'' or document
pharmaceutical marketing practices but rather to address specific
issues regarding implementation of ``fair balance'' regulations for
branded prescription drug Web sites. We note that no one study can
address all relevant questions and encourage others to pursue research
in this area to supplement the proposed research.
    Although the online landscape is much broader than Web sites, Web
sites continue to be a major source of information for consumers (e.g.,
a recent survey found that 49 percent of respondents who went online
for prescription drug information reported seeking this information on
a specific brand's Web site (Ref. 8)) and, as noted previously in this
document, there is not much relevant research on branded prescription
drug Web sites.
    (Comment 17) One comment suggested that the study use eye tracking
and neuromarketing methods.
    (Response) Because the comment does not specify why eye tracking
and neuromarketing should be used in this research beyond noting that
the pharmaceutical industry employs these methods, it is difficult to
understand how the current research would benefit from these methods.
Neuromarketing, for instance, may tell us that participants prefer one
Web site over another. While this is relevant information from a
marketing perspective, from a regulatory perspective it is
comprehension, and not preference, that is the important outcome to
assess.
    (Comment 18) One comment requested additional information on the
study. Issues not already addressed previously in this document include
hypotheses, how the risk information will be portrayed, whether the Web
site will be viewed under controlled conditions, how the participants'
perceptions and understanding of the risks and benefits will be
assessed, and the statistical analyses to be performed.
    (Response) As noted in the 60-day Federal Register notice, the
questionnaire is available upon request; this demonstrates how
participants' perceptions and understanding will be assessed. We intend
to manipulate how the risk information will be portrayed; please see
the study design. Participant will complete the study online, not under
controlled conditions. We will ask about the type of device they are
using to view the Web site and can control for this if necessary.
Hypotheses and statistical analyses are included in this document.
    (Comment 19) One comment recommends testing the use of hyperlinks
to risk information in the first study. The comment states that this
would be useful in developing guidance for social media as well.
    (Response) We have revised the design in Study 1 so that the risk
visibility manipulation now tests the use of hyperlinks to risk
information. We note that this study focuses on prescription drug Web
sites aimed at consumers. As discussed in a previous comment, the
results of these studies will be applied in this context only and not
to social media.
    (Comment 20) One comment asks for more detail regarding the
checklist and animated spokesperson to be used in the first study.
    (Response) The Study 1 risk formats were chosen based on the risk
communication literature. Risk communication studies have found that
making risk information less dense (e.g., bulleted lists), more visual
(e.g., checklists), and audible (e.g., spokesperson) might increase
comprehension. Thus, we want to test formats that are consistent with
risk communication best practices. The checklist will be more visual
and pronounced than a typical bulleted list. The animated spokesperson
will include an audio component.
    (Comment 21) One comment recommended that FDA follow FDA's 2009
Draft Guidance on Presenting Risk Information when deciding which risk
information should be included in the special features in Study 2.
    (Response) FDA will consider this guidance when designing the study
stimuli.
    (Comment 22) One comment questioned the usefulness of the Study 3
design.
    (Response) We have redesigned the third study to ensure it
addresses relevant questions in online prescription drug promotion.
Please see the revised study design in this document.

III. Revised Study Design

    This research will be conducted in three concurrent studies. The
design and hypotheses for each study are outlined as follows. We will
use ANOVAs, planned comparisons, and regressions to test hypotheses.
    The purpose of Study 1 is to investigate whether the presentation
of risk information on branded drug Web sites influences consumers'
perceptions and understanding of the risks and benefits of the product.
In Study 1, we will examine the format (e.g., whether the risk
information is presented in a paragraph or as a bulleted list) and
visibility of risk information on a prescription drug Web site. Risk
visibility will be manipulated by having the risk information on the
homepage; having the risk information on the homepage with a signal to
scroll; or having a hyperlink, with a signal to

click on the link, on the homepage that leads to a secondary page with
the risk information. The signal will direct participants to the
important safety information. Participants will be randomly assigned to
experimental conditions in a factorial design as follows:

                                                            Table 1--Study 1 Proposed Design
                                                                         [3 x 5]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Format
---------------------------------------------------------------------------------------------------------------------------------------------------------
   Risk visibility             Paragraph                 Bullet list                Checklist              Highlighted box        Animated spokesperson
--------------------------------------------------------------------------------------------------------------------------------------------------------
On Homepage            .........................  ........................  ........................  ........................  ........................
On Homepage with       .........................  ........................  ........................  ........................  ........................
 Signal
On Secondary Page      .........................  ........................  ........................  ........................  ........................
 with Signal
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A. Study 1 Hypotheses

    1. Locating risk information on the homepage (with or without a
signal) will lead consumers to have greater perceived risk and greater
risk comprehension than locating this information on a secondary page
with a hyperlink. Locating risk information on the homepage with a
signal will lead consumers to have greater perceived risk and greater
risk comprehension than locating this information on the homepage
without a signal.
    2. Presenting risk information in a bulleted list or checklist
format will lead consumers to have greater perceived risk and greater
risk comprehension than presenting this information in paragraph
format.
    3. Presenting risk information in a highlighted box format will
lead consumers to have greater perceived risk and greater risk
comprehension than presenting this information in bulleted list,
checklist, or paragraph format.
    4. We have competing hypotheses for the animated spokesperson. If
the use of audio increases attention to the animated spokesperson, then
presenting risk information via an animated spokesperson will lead
consumers to have greater perceived risk and greater risk comprehension
than presenting this information in any other format. If the animated
spokesperson distracts consumers and/or the preset pace of the audio
presentation is difficult for consumers to follow, then presenting risk
information via an animated spokesperson will lead consumers to have
lower perceived risk and lower risk comprehension than presenting this
information in any other format.
    The purpose of Study 2 is to investigate how special visual
features on branded drug Web sites influence perceptions and
understanding of the risks and benefits of the product. The special
features we will examine are a personal testimonial video and an
animated mechanism of action visual. Benefit information will be
presented in either a personal testimonial video, an animated mechanism
of action visual, or in text (the control). We will examine these
special features in the context of the prominence of the presentation
of risk information in two levels; more prominent and less prominent.
An example of a more prominent display of risk information might
involve including the risks as part of the spoken testimonial, whereas
a less prominent display may involve a scrolling text of the risks
after the animated video. We will include a control condition in which
participants view a Web page with no special features. Participants
will be randomly assigned to experimental conditions in a factorial
design as follows:

                    Table 2--Study 2 Proposed Design
                               [2 x 2 + 1]
------------------------------------------------------------------------
                            Special features
-------------------------------------------------------------------------
                        Personal
Risk presentation     testimonial      Animated visual    Control group
------------------------------------------------------------------------
Prominent          .................  ................  ................
Less Prominent     .................  ................  ................
------------------------------------------------------------------------

B. Study 2 Hypotheses

    1. The presence of any special feature will lead consumers to have
lower perceived risk, greater perceived efficacy, greater benefit
comprehension, and greater intentions to ask their doctor about the
drug than the absence of these features.
    2. More prominently displayed risk information will lead consumers
to have greater perceived risk and greater risk comprehension than less
prominently displayed risk information.
    The revised Study 3 design tests whether participants are misled by
a link from a branded prescription drug Web site to a disease awareness
Web site with off-label information, and whether the presence of
context attenuates this potential effect. Participants will be randomly
assigned to experimental conditions in a factorial design as follows:

                     Table 3--Study 3 Revised Design
                                 [4 x 1]
------------------------------------------------------------------------
                                 Context
-------------------------------------------------------------------------
                                                        External and not
No Link (control)         None          External only       sponsored
------------------------------------------------------------------------
                   .................  ................  ................
------------------------------------------------------------------------

    The three context conditions will include a link. For example,
``For more information about Disease X, please visit [link].'' An
example of the ``none'' context condition is, ``if the link is clicked,
there is an interim page that says `Loading.' '' An example of the
``external only'' context is, ``if the link is clicked, there is an
interim page that says `You are leaving the Drug X Web site and
entering an external Web site.' '' An example of the ``external and not
sponsored'' context is ``if the link is clicked, there is an interim
page that says `You are leaving the Drug X Web site and entering an
external Web site not controlled or endorsed by Pharmaceutical Company
Y.' ''

C. Study 3 Hypotheses

    1. Participants who view the link to external information, compared
to those who do not, will have greater perceived efficacy and lower
correct benefit comprehension.
    2. This effect may be attenuated by context, such that participants
who view the link without context, compared to those who view the link
with either type of context, will have greater perceived efficacy and
lower correct benefit comprehension. We will explore whether the type
of context (external only vs. external and not sponsored) affects
perceived efficacy and benefit comprehension.
    In these three studies, participants will be randomly assigned to
view one version of a (fictitious) prescription drug Web site. After
viewing the Web site, participants will answer a series of questions
about the drug. We will test how the manipulations affect outcomes such
as perceived efficacy, perceived risk, behavioral intention, and
accurate understanding of the benefit and risk information. In each
study, the fictitious prescription drug 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. For instance, the
medical conditions may be high cholesterol and seasonal allergies for
Study 1, high blood pressure and acid reflux disease for Study 2, and
depression for Study 3. Interviews are expected to last no more than 25
minutes (the questionnaire is available upon request). This will be a
one-time (rather than annual) collection of information.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener....................................          16,000               1          16,000  0.03 (2 minutes)..........................             533
Pretests....................................           1,200               1           1,200  0.33 (20 minutes).........................             400
Study 1.....................................           6,000               1           6,000  0.42 (25 minutes).........................           2,500
Study 2.....................................           2,000               1           2,000  0.42 (25 minutes).........................             833
Study 3.....................................           1,000               1           1,000  0.42 (25 minutes).........................             417
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           4,683
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Macias, W. and L. Stavchansky Lewis, ``How Well Do Direct-to-
Consumer (DTC) Prescription Drug Web Sites Meet FDA Guidelines and
Public Policy Concerns?'' Health Marketing Quarterly, vol. 22, pp.
45-71, 2005.
    2. Hicks, K.E., M.S. Wogalter, and W.J. Vigilante, Jr.,
``Placement of Benefits and Risks in Prescription Drug
Manufacturers' Web Sites and Information Source Expectations,'' Drug
Information Journal, vol. 39, pp. 267-278, 2005.
    3. Huh, J. and B.J. Cude, ``Is the Information 'Fair and
Balanced' in Direct-to-Consumer Prescription Drug Web Sites?''
Journal of Health Communication, vol. 9, pp. 529-540, 2004.
    4. Sheehan, K.B., ``Direct-to-Consumer (DTC) Branded Drug Web
Sites Risk Presentation and Implications for Public Policy,''
Journal of Advertising, vol. 36, pp. 123-135, 2007.
    5. Davis, J.J., E. Cross, and J. Crowley, ``Pharmaceutical Web
Sites and the Communication of Risk Information,'' Journal of Health
Communication, vol. 12, pp. 29-39, 2007.
    6. Naik, S. and S.P. Desselle, ``An Evaluation of Cues,
Inducements, and Readability of Information on Drug-Specific Web
Sites,'' Journal of Pharmaceutical Marketing and Management, vol.
17, pp. 61-81, 2007.
    7. Vigilante, Jr., W.J., and M.S. Wogalter, ``Assessing Risk and
Benefit Communication in Direct-to-Consumer Medication Web Site
Advertising,'' Drug Information Journal, vol. 39, pp. 3-12, 2005.
    8. Prevention Magazine. 14th Annual Survey of Consumer Reactions
to DTC Advertising of Prescription Medicines, Emmaus, PA: Rodale,
Inc., 2011.

    Dated: December 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32275 Filed 12-16-11; 8:45 a.m.]
BILLING CODE 4160-01-P