Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion, 23821-23823 [2011-10253]
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Federal Register / Vol. 76, No. 82 / Thursday, April 28, 2011 / Notices
The information collection provisions
in §§ 314.70, 601.12, 807.81, and 814.39
have been approved under OMB control
numbers 0910–0001, 0910–0338, 0910–
0120, and 0910–0231, respectively.
Dated: April 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10254 Filed 4–27–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0230]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Examination of
Online Direct-to-Consumer
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a series of studies, Examination of
Online Direct-to-Consumer Prescription
Drug Promotion. These studies are
designed to test different ways of
presenting benefit and risk information
in online direct-to-consumer (DTC)
prescription drug Web sites.
DATES: Submit either electronic or
written comments on the collection of
information by June 27, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, e-mail: Ila.Mizrachi@fda.hhs.gov.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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17:01 Apr 27, 2011
Jkt 223001
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Examination of Online Direct-toConsumer Prescription Drug
Promotion—(OMB Control Number
0910—New)
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
banner ads, 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, pop up
windows, linking to more information,
and embedding 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 ads that make
claims about a product must, therefore,
also include risk information in a
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
23821
‘‘balanced’’ manner. Currently, there are
a number of questions surrounding how
to achieve ‘‘fair balance’’ in online 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 original regulations
that presently determine FDA’s position
on DTC promotion were written at a
time when the available media for DTC
promotion were print and broadcast,
and the primary audience was health
care professionals. This dynamic is
shifting, and evidence is needed to
support guidance development. The
series of studies described in this notice
will provide data that, along with other
input and considerations, will inform
the development of future guidance.
Design Overview: This research will
be conducted in three concurrent
studies. The first three studies are
experimental and the fourth is
qualitative.
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
E:\FR\FM\28APN1.SGM
28APN1
23822
Federal Register / Vol. 76, No. 82 / Thursday, April 28, 2011 / Notices
visibility (i.e., the risk information can
be seen without scrolling down versus
the risk information cannot be seen
without scrolling down) of risk
information on the homepage of a
prescription drug Web site. Participants
will be randomly assigned to
experimental conditions in a factorial
design as follows:
TABLE 1—STUDY 1 PROPOSED DESIGN (2×5)
Format
Visibility
Paragraph
Bullet list
Checklist
Highlighted box
Animated spokesperson
Scrolling Needed
No Scrolling Needed
The purpose of study 2 is to
investigate how special features such as
personal testimonial videos and
interactive visuals on branded drug Web
sites influence perceptions and
understanding of the risks and benefits
of the product. Examples of special
features we may examine include
personal testimonial video and
interactive mechanism of action visuals.
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 (2×2+1)
Special features
Risk presentation
Personal testimonial
Interactive visual
Control group
Prominent
Less Prominent
The purpose of study 3 is to
investigate whether links to and
citations from external organizations
referenced on the homepage of branded
drug Web sites influence consumer
perceptions and understanding of the
risks and benefits of the product. We
will examine two types of information:
Hyperlinks to the external
organization’s Web site (e.g., a link to
the American Heart Association) and
citations from an external organization
(e.g., a citation to American Heart
Association guidelines). We will also
examine the type of organization (e.g.,
nonprofit or online health community).
Participants will be randomly assigned
to experimental conditions in a factorial
design as follows:
TABLE 3—STUDY 3 PROPOSED DESIGN (8×2+1)
Information type
Organization type
Hyperlink to organization Web site
Citation
srobinson on DSKHWCL6B1PROD with NOTICES
Government
Nonprofit
Health Care
Health Professions Associations
Academic
Commercial
Online Health Community
Pharmaceutical Company-Sponsored Community
Control Group
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
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17:01 Apr 27, 2011
Jkt 223001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
study 1, depression and acid reflux
disease for study 2, and high blood
pressure for study 3.
For studies 1 to 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.
E:\FR\FM\28APN1.SGM
28APN1
23823
Federal Register / Vol. 76, No. 82 / Thursday, April 28, 2011 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Screener ...............................................................................
Pretests ................................................................................
Study 1 .................................................................................
Study 2 .................................................................................
Study 3 .................................................................................
Total ..............................................................................
20,000
1,200
4,000
2,000
3,600
........................
1
1
1
1
1
........................
20,000
1,200
4,000
2,000
3,600
........................
2/60
20/60
25/60
25/60
25/60
........................
1 There
Total hours
667
400
1,667
834
1,500
5,068
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
I. References
srobinson on DSKHWCL6B1PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
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-toConsumer 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.
Dated: April 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10253 Filed 4–27–11; 8:45 am]
BILLING CODE 4160–01–P
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17:01 Apr 27, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0287]
Guidance for Industry on Fish and
Fishery Products Hazards and
Controls, Fourth Edition; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Fish and Fishery Products
Hazards and Controls Guidance, Fourth
Edition.’’ The updated guidance
supports and complements FDA’s
regulations for the safe and sanitary
processing and importing of fish and
fishery products using hazard analysis
and critical control point (HACCP)
methods.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Contact the Florida Sea
Grant, IFAS–Extension Bookstore,
University of Florida, P.O. Box 110011,
Gainesville, FL 32611–0011, 1–800–
226–1764, for single copies of this
guidance. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Bruce F. Wilson, Center for Food Safety
and Applied Nutrition (HFS–325), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2300.
SUMMARY:
PO 00000
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Fmt 4703
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SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the guidance for industry entitled ‘‘Fish
and Fishery Products Hazards and
Controls Guidance, Fourth Edition.’’
This guidance is being issued consistent
with FDA’s good guidance practices
(GGP) regulation (§ 10.115 (21 CFR
10.115)). This guidance is being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
updated information in this guidance
will significantly enhance the seafood
industry’s ability to protect the public
health and will provide important
recommendations for conducting a
hazard analysis and implementing a
HACCP plan. Although this guidance
document is immediately in effect, it
remains subject to comment in
accordance with the Agency’s GGP
regulation.
This guidance provides industry with
information that will assist processors of
seafood products in identifying the
likelihood that a food safety hazard may
occur in their product and will guide
them in the preparation of appropriate
HACCP plans for those hazards that are
reasonably likely to occur. A summary
of the changes from the third edition is
included in the discussion section of the
guidance.
Under FDA’s fish and fishery
products regulations (part 123 (21 CFR
part 123)), processors of fish and fishery
products are required to operate
preventive control systems under the
principles of HACCP. Fish and fishery
products are adulterated under section
402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342(a)(4)) if a
processor fails to have and implement a
HACCP plan when one is necessary
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23821-23823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10253]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0230]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Examination of Online Direct-to-Consumer Prescription
Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a series of studies, Examination of Online
Direct-to-Consumer Prescription Drug Promotion. These studies are
designed to test different ways of presenting benefit and risk
information in online direct-to-consumer (DTC) prescription drug Web
sites.
DATES: Submit either electronic or written comments on the collection
of information by June 27, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7726, e-mail:
Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Examination of Online Direct-to-Consumer Prescription Drug Promotion--
(OMB Control Number 0910--New)
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 banner ads, 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, pop up windows, linking to more information, and
embedding 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 ads that make 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 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 original regulations that presently
determine FDA's position on DTC promotion were written at a time when
the available media for DTC promotion were print and broadcast, and the
primary audience was health care professionals. This dynamic is
shifting, and evidence is needed to support guidance development. The
series of studies described in this notice will provide data that,
along with other input and considerations, will inform the development
of future guidance.
Design Overview: This research will be conducted in three
concurrent studies. The first three studies are experimental and the
fourth is qualitative.
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
[[Page 23822]]
visibility (i.e., the risk information can be seen without scrolling
down versus the risk information cannot be seen without scrolling down)
of risk information on the homepage of a prescription drug Web site.
Participants will be randomly assigned to experimental conditions in a
factorial design as follows:
Table 1--Study 1 Proposed Design (2x5)
----------------------------------------------------------------------------------------------------------------
Format
----------------------------------------------------------------------------------------------
Visibility Animated
Paragraph Bullet list Checklist Highlighted box spokesperson
----------------------------------------------------------------------------------------------------------------
Scrolling Needed ................. ................. ................. ................. .................
No Scrolling ................. ................. ................. ................. .................
Needed
----------------------------------------------------------------------------------------------------------------
The purpose of study 2 is to investigate how special features such
as personal testimonial videos and interactive visuals on branded drug
Web sites influence perceptions and understanding of the risks and
benefits of the product. Examples of special features we may examine
include personal testimonial video and interactive mechanism of action
visuals. 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 (2x2+1)
------------------------------------------------------------------------
Special features
------------------------------------------------------
Risk presentation Personal Interactive
testimonial visual Control group
------------------------------------------------------------------------
Prominent ................. ................
Less Prominent ................. ................
------------------------------------------------------------------------
The purpose of study 3 is to investigate whether links to and
citations from external organizations referenced on the homepage of
branded drug Web sites influence consumer perceptions and understanding
of the risks and benefits of the product. We will examine two types of
information: Hyperlinks to the external organization's Web site (e.g.,
a link to the American Heart Association) and citations from an
external organization (e.g., a citation to American Heart Association
guidelines). We will also examine the type of organization (e.g.,
nonprofit or online health community). Participants will be randomly
assigned to experimental conditions in a factorial design as follows:
Table 3--Study 3 Proposed Design (8x2+1)
----------------------------------------------------------------------------------------------------------------
Information type
Organization type ---------------------------------------------------------------------------
Hyperlink to organization Web site Citation
----------------------------------------------------------------------------------------------------------------
Government .................................... ....................................
Nonprofit .................................... ....................................
Health Care .................................... ....................................
Health Professions Associations .................................... ....................................
Academic .................................... ....................................
Commercial .................................... ....................................
Online Health Community .................................... ....................................
Pharmaceutical Company-Sponsored .................................... ....................................
Community
Control Group ....................................
----------------------------------------------------------------------------------------------------------------
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, depression and acid reflux disease for study 2, and high blood
pressure for study 3.
For studies 1 to 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.
[[Page 23823]]
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........................ 20,000 1 20,000 2/60 667
Pretests........................ 1,200 1 1,200 20/60 400
Study 1......................... 4,000 1 4,000 25/60 1,667
Study 2......................... 2,000 1 2,000 25/60 834
Study 3......................... 3,600 1 3,600 25/60 1,500
Total....................... .............. .............. .............. .............. 5,068
----------------------------------------------------------------------------------------------------------------
\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''.
I. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) 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'
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Dated: April 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10253 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P
