Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Information in Direct-to-Consumer Television Advertisements, 61433-61435 [2015-25958]
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
further assume that the 1,518 cosmetic
product establishments may not
maintain all of the records
recommended by the draft guidance.
Thus, for purposes of this analysis, we
assume that 1,518 establishments will
keep the records recommended by the
draft guidance, when it is finalized, as
reported in table 2, column 2. We
further assume that if multiple products
are produced in the same facility, the
written procedures and recordkeeping
will be shared among the multiple
products.
We base our estimates of the number
of records per recordkeeper and the
average burden per recordkeeping
reported in columns 3 and 5 of tables 1
and 2 on our experience with good
manufacturing practices used to control
the identity and composition of food
and dietary supplements and to limit
contaminants and prevent adulteration,
as well as our estimate of the burden of
similar recordkeeping activities
described in the dietary supplement
final rule published in the Federal
Register of June 25, 2007 (72 FR 34752
at 34916) (the June 25, 2007, final rule),
that established, in part 111 (21 CFR
part 111), the minimum good
manufacturing practices necessary for
dietary supplements. For the
recordkeeping recommendations listed
in table 2, the recordkeeping occasions
consist of frequent brief entries of dates,
temperatures, monitoring results, or
documentation that specific actions
were taken. Information might be
recorded a few times a day, week, or
month. Because the records burden
involves frequent brief entries, we did
not attempt to estimate the actual
number of recordkeeping occasions for
these activities. We entered one as the
default for the number of records per
recordkeeper and we calculated the
average burden per recordkeeping in
column 5 based on the reported burden
of similar provisions estimated in the
June 25, 2007, final rule, averaged
across the 1,460 firms covered by that
final rule.
The estimates for the recordkeeping
burdens presented here are averages. We
anticipate that the time spent to develop
written procedures and recordkeeping
would vary based on the type of
cosmetic product manufactured. The
estimated burdens for developing
recordkeeping includes record
maintenance, periodically reviewing
records to determine if they may be
discarded, and any associated
documentation for that activity.
This draft guidance also refers to
previously approved collections of
information found in our regulations.
These collections of information are
VerDate Sep<11>2014
21:23 Oct 09, 2015
Jkt 238001
subject to review by the Office of
Management and Budget (OMB) under
the PRA (44 U.S.C. 3501–3521). The
collections of information in our recall
regulations in 21 CFR part 7 have been
approved under OMB control number
0910–0249. The collection of
information in 21 CFR 70.25, which
requires that color additives subject to
certification be labeled with the lot
number assigned by the Color
Certification Branch, has been approved
under OMB control number 0910–0016.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25957 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3543]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Quantitative
Information in Direct-to-Consumer
Television Advertisements
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
research entitled ‘‘Quantitative
Information in Direct-to-Consumer
Television Advertisements.’’ The
objective of this research is to test
consumers’ understanding of
quantitative information about
prescription drugs in DTC television
advertisements (ads).
DATES: Submit either electronic or
written comments on the collection of
information by December 14, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
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61433
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–3543 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Quantitative Information in Direct-toConsumer Television Advertisements.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
E:\FR\FM\13OCN1.SGM
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mstockstill on DSK4VPTVN1PROD with NOTICES
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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
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21:23 Oct 09, 2015
Jkt 238001
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.
Quantitative Information in Direct-toConsumer Television Advertisements
OMB Control Number 0910–NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(b)(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.
A previous FDA study found that
simple quantitative information could
be conveyed in direct-to-consumer
(DTC) television ads in ways that
increased consumer’s knowledge about
the drug (OMB control number 0910–
0663, ‘‘Experimental Study:
Presentation of Quantitative
Effectiveness Information to Consumers
in Direct-to-Consumer (DTC) Television
and Print Advertisements for
Prescription Drugs’’).1 However, this
research only tested simple information
(e.g., one clinical trial, comparison to
placebo). Drug information can be much
more complicated (e.g., complicated
endpoints, multiple study arms). The
following studies are designed to
address the question of whether
consumers can use more complicated
information when assessing prescription
drug information in television DTC ads.
These studies will build on previous
research by: (1) Examining more
complicated quantitative information,
(2) examining quantitative information
for both benefits and risks, and (3)
examining how visuals designed to
represent efficacy interact with
quantitative information.
The objective of this project is to test
consumers’ understanding of
quantitative information about
1 O’Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et
al. ‘‘Presenting efficacy information in direct-toconsumer prescription drug advertisements.’’
Patient Education and Counseling, vol. 95(2), pp.
271–280, 2014.
PO 00000
Frm 00101
Fmt 4703
Sfmt 4703
prescription drugs in DTC television
ads. In study 1, we plan to examine
experimentally the presence and
complexity of quantitative benefit and
risk information in DTC television ads
(table 1). We hypothesize that,
replicating past studies, adding simple
quantitative information about benefits
and risks will lead to increased
understanding among consumers. We
will test whether adding complex
quantitative information results in the
same outcomes as simple quantitative
information or whether it is too much
quantitative information for consumers
to process. In study 2, we plan to
examine experimentally the presence of
quantitative benefit information and
how the ad visually represents efficacy
(by having no images, images that
accurately reflect the improvement in
health that could be expected with
treatment, or images that overstate the
improvement in health that could be
expected with treatment (table 2). We
hypothesize that overstated images of
improvement will lead consumers to
overestimate the drug’s efficacy;
however, adding a quantitative claim
may moderate this effect. To test these
hypotheses, we will conduct inferential
statistical tests such as analysis of
variance (ANOVA). With the sample
sizes described below, we will have
sufficient power to detect small- to
medium-sized effects in each study.
All participants will be 60 years of age
or older. We will exclude individuals
who work in healthcare or marketing.
We selected a sample of participants 60
years and older to increase the
likelihood that participants will be
interested in the fictitious study drug
and therefore motivated to pay attention
to the ad during the study. The studies
will be conducted with an Internet
panel.
In both studies, participants will be
randomly assigned to one experimental
condition and view the corresponding
television ad. The ad will be for a
fictitious drug to treat cataracts. The ads
will be created and pretested to ensure
that consumers perceive different levels
of complexity across the ads in study 1,
and different levels of image accuracy in
study 2. ‘‘Pretests for a Study on
Quantitative Information in Direct-toConsumer Television Advertisements’’
will be submitted under OMB control
number 0910–0695. After viewing the
ad twice, participants will complete a
questionnaire that assesses consumers’
understanding of the drug information,
their retention of the information, and
their perceptions of the drug. We will
also measure covariates such as
demographics and numeracy. The
E:\FR\FM\13OCN1.SGM
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61435
Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
questionnaires are available upon
request.
TABLE 1—STUDY 1 DESIGN
Quantitative risk claim
No ...
Quantitative Efficacy Claim ................
Yes: General Statement (e.g., seen
in less than 1% of patients).
Yes: Frequencies
for Each Risk
No.
Yes: simple (e.g., reduced pain in
83% of patients).
Yes: complex (e.g., reduced pain by
30% in 83% of patients).
TABLE 2—STUDY 2 DESIGN
Images of improvement
None ....................
Quantitative Benefit Claim ..................
Accurate improvement in health conveyed in images.
Overstated improvement in health
conveyed in images.
No.
Yes.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—STUDY 1
No. of
respondents
Activity
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Sample outgo .......................................................................
Number to complete the screener (10%) ............................
Number eligible for survey (70%) ........................................
Number to complete the survey (85%) ................................
15,130
1,513
1,059
900
........................
1
........................
1
........................
1,513
........................
900
........................
.05 (3 min.)
........................
.33 (20 min.)
........................
76
........................
297
Total ..............................................................................
........................
........................
2,413
........................
373
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1—STUDY 2
No. of
respondents
Activity
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Sample outgo .......................................................................
Number to complete the screener (10%) ............................
Number eligible for survey (70%) ........................................
Number to complete the survey (85%) ................................
15,130
1,513
1,059
900
........................
1
........................
1
........................
1,513
........................
900
........................
.05 (3 min.)
........................
.33 (20 min.)
........................
76
........................
297
Total ..............................................................................
........................
........................
2,413
........................
373
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25958 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61433-61435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3543]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Quantitative Information in Direct-to-Consumer
Television Advertisements
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 research entitled ``Quantitative
Information in Direct-to-Consumer Television Advertisements.'' The
objective of this research is to test consumers' understanding of
quantitative information about prescription drugs in DTC television
advertisements (ads).
DATES: Submit either electronic or written comments on the collection
of information by December 14, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-3543 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Quantitative Information in
Direct-to-Consumer Television Advertisements.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including
[[Page 61434]]
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Quantitative Information in Direct-to-Consumer Television
Advertisements OMB Control Number 0910-NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(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.
A previous FDA study found that simple quantitative information
could be conveyed in direct-to-consumer (DTC) television ads in ways
that increased consumer's knowledge about the drug (OMB control number
0910-0663, ``Experimental Study: Presentation of Quantitative
Effectiveness Information to Consumers in Direct-to-Consumer (DTC)
Television and Print Advertisements for Prescription Drugs'').\1\
However, this research only tested simple information (e.g., one
clinical trial, comparison to placebo). Drug information can be much
more complicated (e.g., complicated endpoints, multiple study arms).
The following studies are designed to address the question of whether
consumers can use more complicated information when assessing
prescription drug information in television DTC ads. These studies will
build on previous research by: (1) Examining more complicated
quantitative information, (2) examining quantitative information for
both benefits and risks, and (3) examining how visuals designed to
represent efficacy interact with quantitative information.
---------------------------------------------------------------------------
\1\ O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al.
``Presenting efficacy information in direct-to-consumer prescription
drug advertisements.'' Patient Education and Counseling, vol. 95(2),
pp. 271-280, 2014.
---------------------------------------------------------------------------
The objective of this project is to test consumers' understanding
of quantitative information about prescription drugs in DTC television
ads. In study 1, we plan to examine experimentally the presence and
complexity of quantitative benefit and risk information in DTC
television ads (table 1). We hypothesize that, replicating past
studies, adding simple quantitative information about benefits and
risks will lead to increased understanding among consumers. We will
test whether adding complex quantitative information results in the
same outcomes as simple quantitative information or whether it is too
much quantitative information for consumers to process. In study 2, we
plan to examine experimentally the presence of quantitative benefit
information and how the ad visually represents efficacy (by having no
images, images that accurately reflect the improvement in health that
could be expected with treatment, or images that overstate the
improvement in health that could be expected with treatment (table 2).
We hypothesize that overstated images of improvement will lead
consumers to overestimate the drug's efficacy; however, adding a
quantitative claim may moderate this effect. To test these hypotheses,
we will conduct inferential statistical tests such as analysis of
variance (ANOVA). With the sample sizes described below, we will have
sufficient power to detect small- to medium-sized effects in each
study.
All participants will be 60 years of age or older. We will exclude
individuals who work in healthcare or marketing. We selected a sample
of participants 60 years and older to increase the likelihood that
participants will be interested in the fictitious study drug and
therefore motivated to pay attention to the ad during the study. The
studies will be conducted with an Internet panel.
In both studies, participants will be randomly assigned to one
experimental condition and view the corresponding television ad. The ad
will be for a fictitious drug to treat cataracts. The ads will be
created and pretested to ensure that consumers perceive different
levels of complexity across the ads in study 1, and different levels of
image accuracy in study 2. ``Pretests for a Study on Quantitative
Information in Direct-to-Consumer Television Advertisements'' will be
submitted under OMB control number 0910-0695. After viewing the ad
twice, participants will complete a questionnaire that assesses
consumers' understanding of the drug information, their retention of
the information, and their perceptions of the drug. We will also
measure covariates such as demographics and numeracy. The
[[Page 61435]]
questionnaires are available upon request.
Table 1--Study 1 Design
----------------------------------------------------------------------------------------------------------------
Quantitative risk claim
----------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
No.............. Yes: General Yes: Frequencies
Statement (e.g., for Each Risk
seen in less than 1%
of patients).
Quantitative Efficacy Claim... No...................
Yes: simple (e.g.,
reduced pain in 83%
of patients).
Yes: complex (e.g.,
reduced pain by 30%
in 83% of patients).
----------------------------------------------------------------------------------------------------------------
Table 2--Study 2 Design
----------------------------------------------------------------------------------------------------------------
Images of improvement
---------------------------------------------
----------------------------------------------------------------------------------------------------------------
None............ Accurate improvement Overstated
in health conveyed improvement in
in images. health conveyed in
images.
Quantitative Benefit Claim.... No..............
Yes.............
----------------------------------------------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden \1\--Study 1
----------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sample outgo.................... 15,130 .............. .............. .............. ..............
Number to complete the screener 1,513 1 1,513 .05 (3 min.) 76
(10%)..........................
Number eligible for survey (70%) 1,059 .............. .............. .............. ..............
Number to complete the survey 900 1 900 .33 (20 min.) 297
(85%)..........................
-------------------------------------------------------------------------------
Total....................... .............. .............. 2,413 .............. 373
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Reporting Burden \1\--Study 2
----------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sample outgo.................... 15,130 .............. .............. .............. ..............
Number to complete the screener 1,513 1 1,513 .05 (3 min.) 76
(10%)..........................
Number eligible for survey (70%) 1,059 .............. .............. .............. ..............
Number to complete the survey 900 1 900 .33 (20 min.) 297
(85%)..........................
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Total....................... .............. .............. 2,413 .............. 373
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25958 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P
