[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58011-58018]
[FR Doc No: 2011-23926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0465]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study:
Effect of Promotional Offers in Direct-to-Consumer Prescription Drug
Print Advertisements on Consumer Product Perceptions

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 October
19, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Experimental Study: Effect of Promotional Offers in Direct-to-
Consumer Prescription Drug Print Advertisements on Consumer Product
Perceptions.'' 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:

I. Background

    In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.

Experimental Study: Effect of Promotional Offers in Direct-to-Consumer
Prescription Drug Print Advertisements on Consumer Product
Perceptions--(OMB Control Number 0910-New)

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 352(n)) requires advertisements for prescription
drugs to include, among other things, ``such information in brief
summary relating to side effects, contraindications, and effectiveness
as shall be required in regulations.'' Under this authority, FDA has
issued regulations to require most prescription drug advertisements to
provide a ``true statement of information in brief summary relating to
side effects, contraindications, and effectiveness.'' (Sec.  202.1(e)
(1) (21 CFR 202.1(e)(1)). To satisfy this requirement, an advertisement
that makes claims about a prescription drug must also include a ``fair
balance'' of information about the benefits and risks of the advertised
product, in terms of both content and presentation (Sec.
202.1(e)(5)(ii)). In part, Sec.  202.1(e)(6)(i) states that [a]n
advertisement for a prescription drug is false, lacking in fair
balance, or otherwise misleading, or otherwise violative of section
502(n) of the act, among other reasons, if it [c]ontains a
representation or suggestion, not approved or permitted for use in the
labeling, that a drug is better, more effective, useful in a broader
range of conditions or patients (as used in Sec.  202.1 ''patients''
means humans and in the case of veterinary drugs, other animals) safer,
has fewer, or less incidence of, or less serious side effects or
contraindications than has been demonstrated by substantial evidence or
substantial clinical experience (as described in paragraphs
(e)(4)(ii)(b) and (e)(4)(ii)(c) of Sec.  202.1) whether or not such
representations are made by comparison with other drugs or treatments,
and whether or not such a representation or suggestion is made directly
or through use of published or unpublished literature, quotations, or
other references.
    FDA's current regulations provide a limited exception to the
requirement in Sec.  202.1(e)(1), of presenting a true statement of
information in brief summary, for ``reminder advertisements''
(``reminder ads'')--advertisements that draw attention to the name of
the product but do not make representations about the product's
indication(s) or dosage recommendations (Sec.  202.1(e)(2)(i)).
(Certain drugs are not permitted to qualify for the reminder
advertisement exemption.) To meet the terms of this exemption,
reminders ads must in general be limited to the proprietary and
established name of the product and the established name of each active
ingredient in the drug product. Reminder ads may also (optionally)
contain information about the product's quantitative ingredients,
dosage form, quantity, price, and manufacturer, as well as other
written, printed, or graphic matter containing no representation or
suggestion relating to the product. Further, reminder ads that are
intended to provide consumers with information concerning the price
charged for a prescription drug product need not meet the terms of
Sec.  202.1(e)(2)(i) in order to be exempt from Sec.  202.1(e)(1) if
they meet all of the conditions in Sec.  200.200 (21 CFR 200.200). That
regulation, in turn, applies to prescription drug reminders ads that
are intended solely to provide consumers with information concerning
the price charged for a prescription for a particular drug product, and
the reminder ad contains no representation or suggestion concerning the
drug product's safety, effectiveness, or indications for use (Sec.
200.200(a)(1) and (b)).
    A topic of ongoing interest for consumer product manufacturers and
retailers is the use of consumer-oriented sales promotions such as free
trial offers, discounts, money-back guarantees, and rebates. Such
promotions are widely used in many product categories, including
prescription drugs.
    Prior research has demonstrated that the type of promotion offered
can affect how consumers respond to the promotion (Refs. 1, 2, and 3).
Price incentives \1\ may act as cues about product quality. For
example, a price incentive may not only act as an economic incentive to
buy the product, it may also artificially enhance consumers'
perceptions of the product's quality (Ref. 4). In the case that

consumers can readily test the performance of some products (termed
``experience'' goods; Ref. 5), this misperception is quickly corrected
through the consumer's use of the product. In situations where little
information about the product is available or when consumers are
unmotivated to seek further information, consumers may use price as a
heuristic cue to ascertain the quality of a product. Rao (2005; Ref. 6)
has referred to the use of price as a cue to quality as the ``price-
quality heuristic,'' where heuristics are conceptualized as mental
shortcuts that minimize cognitive effort to process information and are
used when individuals are unable or unwilling to engage in more
analytical processing of information (Ref. 7). For example, if length
of warranty is strongly believed to be a good predictor of quality,
then consumers may perceive a product as higher quality when a long
warranty is present than when one is not present (Ref. 8). Thus, price
incentives may have the potential to act as an ``inference rule'' (or
heuristic; Refs. 7 and 9) and, when present, they may preempt consumers
from thinking carefully about the product information contained in the
advertisement (i.e., fully elaborating on the information). This could
result in either favorable or unfavorable beliefs about the product
(Refs. 10 and 11). If a price incentive offer acts as a mental
heuristic in such a way as to result in an unbalanced or misleading
impression of the product's safety or efficacy, however, this would
raise concerns for FDA.
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    \1\ In this document, we use the terms ``price incentive'' and
``coupon'' interchangeably to refer to the types of promotional
offers to be addressed in our study.
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    Consumers vary in their reactions to price incentive promotions,
and researchers and economists have proposed a number of explanations
for why some consumers are sensitive to these tactics. Two such traits
are ``price consciousness'' and ``belief in the price-quality
relationship.'' Price consciousness is defined as the degree to which
the consumer focuses exclusively on paying low prices. Belief in the
price-quality relationship is defined as the degree to which one
believes a higher price indicates superior quality (Ref. 12). A broader
trait of ``value consciousness'' has also been used. This trait
involves assumptions about the construct of perceived value and its
relationship (a ratio) with the constructs of perceived quality and
perceived price.
    While price incentive promotions have been extensively studied in
the context of package goods, information on their effects in direct-
to-consumer (DTC) prescription drug ads is limited. One relevant study
(Ref. 13) found that a free-trial offer in a DTC ad for a high
cholesterol drug resulted in more favorable perceptions of the product
and the ad (both rated as good/bad, favorable/unfavorable, and
pleasant/unpleasant), and greater intentions to ask about the product.
No differences were found in terms of perceived product risk. However,
the study did not measure perceptions of product risk and benefit
separately, or comprehension of risk and benefit information.
Additionally, no attempt was made to control for factors that may
predispose individuals toward coupon use nor was the study conducted
with the target population (high cholesterol sufferers). We propose to
expand on this initial study by measuring perceived product risk and
benefit separately, measuring risk and benefit comprehension,
investigating a variety of price incentive offers, recruiting a wider
range of the target audience from malls and online, and by measuring
traits that may predispose individuals to be susceptible to coupon
influence.
    The current study will examine what effect, if any, the presence of
promotional offers in DTC prescription drug ads have on the following:
(1) Consumers' perceptions of product risks and benefits, (2) recall of
product risks and benefits, and (3) strongly held beliefs that may act
as potential moderators.
    Design Overview: Study 1: This study will examine types of
promotional offers (for example, free trial offer; money off cost;
money back guarantee; buy one, get one free; and no offer) in three
types of drug advertisements (prescription drug full product, over-the-
counter (OTC), and prescription drug reminder). The fictitious test
product will treat insomnia and will be modeled on an actual drug used
to treat this condition. Participants will be consumers who have
insomnia or who self-identify as having met the diagnostic criteria for
insomnia. Prescription drug full product advertisements contain
information about both benefits and risks, OTC drug advertisements
contain benefit information but not risk information, and prescription
drug reminder advertisements do not contain either benefit or risk
information.
    Study 1 will be administered in two modes, online and mall-
intercept, in order to assess the effects of mode on study results.
Table 1 of this document illustrates the design; the specific
promotional offers examined will be determined through pretesting.
Offers that demonstrate the most effect on perceptions of product
efficacy and risk will be selected for the main study.
    Study 1 is experimental in method: participants will be randomly
assigned to read one ad version. After reading the ad, participants
will answer a series of questions about the drug. We will test how the
offer type affects their recall of the benefit and risk information,
their perceptions of the benefits and risks of the drug, their
perceptions of the incentive, and their behavioral intention to look
for more information about the product and try the product. We will
also test how mode of administration (online versus mall intercept)
affects these variables.

                            Table 1--Study 1 Design, Mode 1 (Online, Internet Panel)
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                                                                Type of advertisement
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   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
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Free trial offer..................                   Online                    Online                    Online
Buy one, get one free.............                   Online                    Online                    Online
Money off cost....................                   Online                    Online                    Online
Money back guarantee..............                   Online                    Online                    Online
Control: No offer.................                   Online                    Online                    Online
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                                Table 2--Study 1 Design, Mode 2 (Mall Intercept)
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                                                                Type of advertisement
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   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
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Free trial offer..................                     Mall                      Mall                      Mall
Buy one, get one free.............                     Mall                      Mall                      Mall
Money off cost....................                     Mall                      Mall                      Mall
Money back guarantee..............                     Mall                      Mall                      Mall
Control: No offer.................                     Mall                      Mall                      Mall
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    Study 2: We propose to replicate the online mode from Study 1 in a
second medical condition, high blood pressure.

                                Table 3--Study 2 Design (Online, Internet Panel)
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                                                                Type of advertisement
                                   -----------------------------------------------------------------------------
   Promotional offer  (examples)        Efficacy and risk                                  None (prescription
                                       (prescription full)       Efficacy only (OTC)            reminder)
----------------------------------------------------------------------------------------------------------------
Free trial offer..................                   Online                    Online                    Online
Buy one, get one free.............                   Online                    Online                    Online
Money off cost....................                   Online                    Online                    Online
Money back guarantee..............                   Online                    Online                    Online
Control: No offer.................                   Online                    Online                    Online
----------------------------------------------------------------------------------------------------------------

    The test product in Study 2 will be for the treatment of high blood
pressure. Participants will be consumers who have been told by a health
care professional that they have high blood pressure. As with Study 1,
this study is experimental in method: participants will be randomly
assigned to read one ad version. After reading the ad, participants
will answer a series of questions about the drug. We will test how the
offer type affects perceived efficacy, perceived risk, behavioral
intention, and recall of the benefit and risk information.
    Data will be collected using an Internet protocol (Studies 1 and 2)
and mall intercept (Study 1). Consumers who have insomnia or self-
identify as meeting the criteria for insomnia will be recruited for
Study 1 and consumers who have been told by a health care professional
that they have high blood pressure will be recruited for Study 2.
Because the task presumes basic reading abilities, all selected
participants must speak and read English fluently. Participants must be
18 years or older. We will use analysis of variance and regressions to
test hypotheses. Interviews are expected to last no more than 20
minutes. A total of 5,850 participants will be involved in the studies.
This will be a one-time (rather than annual) collection of information.
    In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice
for public comment in the Federal Register of September 22, 2010 (75 FR
57798) Docket No FDA-2010-N-0465). FDA received five comments. In the
following section, we outline the observations and suggestions raised
in the comments and provide our responses.
    Two comments wrote in support of the study. We thank those who
commented for their support of this research.
    (Comment 1) One comment spoke against FDA conducting the research,
saying (in part), ``[T]his survey is so unnecessary and such a waste of
tax dollars * * * [W]e all know already how consumers take this
information * * * [Y]ou can see from teh (sic) way the ads are
presented what the big money big pharma con men are up to.''
    (Response) We thank the citizen that took the time to comment on
this study. The purpose of this study is to examine the potential
impact on perceptions of product safety and efficacy of price
incentives included in the body of a prescription drug advertisement.
We disagree that the field has definitively answered the question of
how consumers will ``take this information.'' As described in the
background section of the study in Ref. 13 (Bhutada), one study that
examined the impact of a price incentive in a prescription drug print
advertisement found that consumers who saw an ad with a price incentive
had favorable perceptions of the product and the ad, perceptions of the
product and greater intentions to ask about the product. No differences
were found in terms of perceived product risk. However, the study did
not measure perceptions of product risk and benefit separately, or
comprehension of risk and benefit information. In addition, we note
that the findings of other academic studies in this field point in two
different directions; research shows the presence of price incentives
can foster beliefs about product quality or diminish beliefs about
product quality. Therefore, the lack of information about the potential
influence of price incentive offers on risk and benefit comprehension
and the conflicting findings in the current literature make this is an
opportune area in which to conduct an empirical study.
    Two comments included multiple points about the study justification
and design. We thank those who provided the comments for taking the
time to provide detailed comments on our study and respond to their
points in the paragraphs that follow.
    (Comment 2) This comment suggested that the proposed study is not
necessary for the proper performance of FDA's functions because no
evidence of a serious or widespread problem with price incentives has
been identified.
    (Response) FDA disagrees with this assertion. While no ``serious or
widespread problem'' has been previously identified, the Agency has
observed increasing use of a variety of price incentive promotional
offers in DTC print advertisements for

prescription drugs. The proposed study is intended to help the Agency
better understand what effect, if any, these price incentive promotions
have on consumer perceptions of risk and benefit information about the
advertised prescription drugs. Improving FDA's understanding of these
effects will assist the Agency in proactively meeting its
responsibility to implement the FD&C Act. As already noted, both the
FD&C Act and existing regulations issued to implement it are concerned
with ensuring that prescription drug advertisements, including DTC
print ads, provide appropriate risk and benefit information and are not
otherwise misleading. (See, e.g., 21 U.S.C. 352(n) and 321(n);
202.1(e);) The study will provide information to help the Agency assess
how these mandates can be met where price incentives are employed, and
is therefore ``necessary for the proper performance of FDA's functions
* * *'' (44 U.S.C. 3508).
    (Comment 3) This comment suggested that the inclusion of a truthful
price incentive in an otherwise compliant DTC advertisement cannot
render the advertisement false, misleading or lacking fair balance
under the FD&C Act regardless of the psychological theories implicated.
The comment further asserted that the inclusion of a truthful price
incentive into an otherwise compliant DTC ad cannot serve as the basis
for FDA to initiate regulatory action against the ad under the FD&C
Act.
    (Response) FDA believes that if the inclusion of a ``truthful''
price incentive in promotional material results in an unbalanced net
impression of the drug product, that this would create a misleading
impression of risk and benefit. As explained in FDA's draft guidance
for industry entitled ``Presenting Risk Information in Prescription
Drug and Medical Device Promotion,'' it is important to emphasize that
when FDA evaluates the risk communication in a promotional piece, FDA
looks not just at specific risk-related statements, but at the net
impression--i.e., the message communicated by all elements of the piece
as a whole. The purpose of the evaluation is to determine whether the
piece as a whole conveys an accurate and non-misleading impression of
the benefits and risks of the promoted product. Manufacturers should
therefore focus not just on individual claims or presentations, but on
the promotional piece as a whole. A promotional communication that
conveys a deceptive net impression of the product could be misleading,
even if specific individual claims or presentations are not misleading
(Ref. 14).
    Thus, even if a price incentive included in an advertisement is in
fact ``truthful,'' the net impression of the promotional piece as a
whole can be unbalanced or misleading, which may in turn violate
existing regulations. FDA proposes this study to help determine whether
or not including a price incentive in a DTC print advertisement for a
prescription drug can result in an unbalanced or otherwise misleading
net impression of the drug product.
    (Comment 4) This comment stated that the study may provide
interesting information about the effect of price incentives on
consumer attitudes toward a brand and useful information on optimal
advertising practices, but it cannot provide information relevant to
the statutory and regulatory requirements applicable to DTC
advertising.
    (Response) FDA disagrees that the study cannot provide information
relevant to the statutory and regulatory requirements applicable to DTC
advertising. As noted previously, this study will examine issues that
are well within FDA's regulatory authority--whether the inclusion of
price incentives in prescription drug ads impacts a consumer's
understanding of the risk and benefit information of the drug. In
particular, we are interested to learn whether the inclusion of price
incentives can interfere with the fair balance of information and cause
a misleading net impression. Knowing whether or not misleading
impressions result is a prerequisite to considering how any such
misleading effects should be addressed.
    (Comment 5) One comment contends that the citation to Sec.
202.1(e)(6)(i) included in the 60-day notice (75 FR 57798) is
inaccurately truncated, and further asserts that the only indirect
claims and representations subject to this regulation are those made
through use of literature, quotations, or other references. The comment
argues that because price incentives do not involve the use of
published or unpublished literature, quotations or other references,
this provision does not provide a legal basis for the proposed study or
for the Agency to regulate the heuristic effects (if any) of price
incentives.
    (Response) In response to the comment's concern that FDA
inaccurately truncated the regulation, and to avoid misunderstanding,
FDA has included a longer excerpt of Sec.  202.1(e)(6) in this notice
than was included in the prior notice. However, FDA disagrees with the
comment's conclusion about the justification for the proposed study.
    As an initial matter, as noted, FDA has authority under section
502(n) of the FD&C Act to specify by regulation how to present the
brief summary of risk and benefit information required in prescription
drug advertisements. This authority, together with FDA's authority to
conduct research relating to drugs (21 U.S.C. 393(d)(2)(c)), amply
supports the proposed study. FDA need not establish that it would bring
enforcement actions under Sec.  202.1(e)(6)(i) or any other specific
provisions of the present regulations in order to justify conducting a
study that is intended to provide a better empirical understanding of
the impact, if any, on risk and benefit information communication where
price incentives are included in DTC print advertisements for
prescription drugs. The results of this study will help to inform FDA's
review of, and regulatory policies for, prescription drug advertising
subject to section 502(n) of the FD&C Act.
    Turning specifically to Sec.  202.1(e)(6), we disagree with the
comment's construction of that regulation. As indicated in the
prefatory text of Sec.  202.1(e)(6), the specifics that follow are
``among other reasons'' that an advertisement for a prescription drug
is false, lacking in fair balance, or otherwise misleading, indicating
that these are examples and not an exclusive list as the comment
assumes. In the same vein, Sec.  202.1(e)(6)(i) states that an
advertisement may not contain: A representation or suggestion, not
approved or permitted for use in the labeling, that a drug is better,
more effective, useful in a broader range of conditions or patients (as
used in Sec.  202.1 ``patients'' means humans and in the case of
veterinary drugs, other animals) safer, has fewer, or less incidence
of, or less serious side effects or contraindications than has been
demonstrated by substantial evidence or substantial clinical experience
(as described in paragraphs (e)(4)(ii)(b) and (e)(4)(ii)(c) of Sec.
202.1) whether or not such representations are made by comparison with
other drugs or treatments, and whether or not such a representation or
suggestion is made directly or through use of published or unpublished
literature, quotations, or other references.
    This phrasing prohibits ``a representation or suggestion, not
approved or permitted for use in the labeling'' even if the
representation or suggestion is not made via the means given as
examples in the regulation. Thus, FDA has consistently, and

appropriately, examined both direct and indirect representations and
suggestions when examining the net impression presented in a
prescription drug advertisement.
    (Comment 6) One comment asserts that the citation to Sec.
202.1(e)(6)(xviii) is inappropriate because this regulation concerns
only the presentation of heading and subheadings and FDA is studying
the mere fact that a price incentive has been made, not the way in
which headline, subheadline, or pictorial or other graphic matter are
used to communicate that price incentive.
    (Response) FDA does not need to rely on Sec.  202.1(e)(6)(xviii) to
justify the proposed study therefore we have removed the reference to
this regulation.
    (Comment 7) One comment contends that the scientific research
identified does not provide justification for conducting the study nor
does it provide support for the proposition that promotional offers
have the capacity to act as a cue or a heuristic with respect to
prescription drugs.
    (Response) We acknowledge that there is little research on the
impact of price incentive offers in prescription drug advertising. The
paucity of existing research is a primary motivation for the proposed
research. The question of whether or not a price incentive offer can
affect perceptions of and recall of prescription drug efficacy and risk
is an empirical one and will be tested in the proposed study.
    (Comment 8) One comment directly questioned the need to conduct
this study in light of the results found by Bhutada et al. (Ref. 13;
2009). Specifically, the comment asserts that the study found no effect
of a price incentive on consumer comprehension of risks or benefits of
the prescription drug.
    (Response) As noted previously, the Bhutada et al. study did not
measure perceptions of product risk and benefit separately. Perceptions
of product risk and benefit were measured on a scale with risk at one
end and benefits at the other, so it was not possible to assess the
effects of the price incentive on risks and benefits separately.
Further, comprehension of risk and benefit information was not measured
at all, so it is impossible to determine from this study if there was
an effect on comprehension. The current proposed study will extend this
initial study by measuring perceived product risk and benefit
separately, measuring risk and benefit comprehension, investigating a
variety of promotional offers, recruiting a wider range of the target
audience from malls and online, and by measuring traits that may
predispose individuals to be susceptible to influence in their
perceptions of risk or benefit by a price incentive.
    (Comment 9) One comment asserts that heuristic effects are not
claims, either expressed or implied, and since reminder ads do not
include any safety or effectiveness information, there is no basis even
to argue that they may preempt consumers from thinking carefully about
the product information contained in the reminder ad.
    (Response) It is an empirical question whether price incentives
operate as a heuristic cue and further, whether those cues impact
perceptions of product characteristics (in this case, the product's
efficacy and risk). As the literature on heuristic judgment
demonstrates, individuals are frequently faced with situations in which
they are required to make judgments using incomplete information and
are able to do so (Refs. 15 and 16). Therefore, it is reasonable to
test whether an incentive can influence this judgment in the context of
both a full-product and a reminder DTC prescription drug advertisement.
    (Comment 10) One comment asserts that the regulation explicitly
permits companies to include information about price within reminder
ads. The comment argues that because price incentives pertain to price,
this regulation provides no legal basis for the proposed study or for
the Agency to regulate price incentives contained in reminder ads.
    (Response) FDA acknowledges that current regulations permit
reminder ads to include price information under defined conditions,
while remaining exempt from the requirement for a ``true statement of
information in brief summary.'' FDA does not intend to use the results
of this study to regulate drug prices. In this study, FDA is only
seeking to assess the effects, if any, of the presence of various
offers in DTC advertisements on consumers' perceptions of product risks
and benefits. As stated previously, we will use ``reminder ads'' in
this study to understand the effect of offers on consumer perceptions
of safety and efficacy. Reminder ads present a useful tool in
determining this effect as broad safety and efficacy information is not
otherwise provided in such advertisements. Results of this preliminary
study will help FDA in its assessment of drug ads and in broader
assessment of its regulatory policy for effectuating section 502(n) of
the FD&C Act and other legal authorities governing drug promotion.
    (Comment 11) One comment said that FDA has not established
standards by which to judge the results of the study. This comment
asserted that even if consumers have a more positive view of the safety
or effectiveness of a product with a price incentive compared to one
that does not, this does not automatically deem the ad false, lacking
in fair balance, or otherwise misleading.
    (Response) To judge the results of our study, we take our cue from
the related field of research conducted on potentially misleading
claims and employed frequently by the Federal Trade Commission in their
investigations of advertising claims (Ref. 17). In this research, an ad
with the content at issue removed serves as an appropriate experimental
control. Based on this precedent, an ad without a price incentive is an
appropriate control in this study.
    (Comment 12) One comment stated that unless FDA can establish that
differences in perceptions of safety or efficacy are not due to
differences in price and/or the size of the price incentive, any
restrictions or requirements on price incentives will require FDA to
regulate prescription drug pricing.
    (Response) As previously acknowledged, the FD&C Act does not
provide FDA with authority to regulate prescription drug pricing and
that is not the purpose or intended outcome of this study. The purpose
of the currently proposed study is to investigate how different
purchase incentives, including ones that may affect the actual price of
the product, may operate in the context of a DTC ad. If we find that
some types or all types of offers do influence viewers' comprehension
and perceptions of safety or effectiveness, then, as suggested by this
comment, the next logical step may be to conduct further study to
disentangle the effects of the presence of the offer itself and the
magnitude of the price incentives. In one research study we do not have
the ability to examine all variables of interest, however, and we
believe the variables we have chosen for the proposed study are
reasonable.
    (Comment 13) One comment asserted that by equating cues and
inference rules with product claims, FDA risks imposing restrictions on
DTC advertising based on potential deception rather than actual
deception, which the comment argues is fraught with risk under the
First Amendment. This comment cites the following from Washington Legal
Foundation v. Henney (56 F. Supp. 2d 81, 85 (D.D.C. 1999)), ``FDA may
not restrict speech based on its perception that the speech

could, may, or might mislead.'' The comment urges FDA to carefully
consider First Amendment issues before proceeding with the study.
    (Response) We have carefully considered First Amendment issues in
designing this study. The Washington Legal Foundation v. Henney case
cited by the comment notes that ``the government must demonstrate that
the restricted speech, by nature, is more likely to mislead than to
inform'' (Id. at 85). It is the goal of the proposed study to
investigate whether a price incentive may or may not be ``more likely
to mislead than to inform.''] Our participants will view a fictitious
but realistic DTC print ad and answer questions about that ad. From
their answers we will be able to determine their responses to the
information in the ad. Thus, we will measure whether the ad is actually
misleading and not potentially misleading. The experimental control
afforded by participants' random assignment to different experimental
conditions ensures that we will be able to pinpoint the source of any
differences in responses to ad variations by comparing responses of
participants who see the variables of interest (in this case, the
offer) versus those who do not.
    (Comment 14) One comment stated that the proposed study appears to
be designed more to assess the effect of coupons on brand attitudes and
consumer impressions and does not appear to be tailored to assess the
effect of price incentives on statutory and regulatory requirements. In
other words, the comment argues that FDA has no regulatory authority to
manage or regulate consumer attitudes or impressions toward a brand.
    (Response) As noted previously, the study is designed to determine
whether price incentive offers embedded in prescription drug ads can
result in a misleading net impression of risk and benefit, which may in
turn violate existing regulations under the FD&C Act. We will measure
the effect of the offer on consumer's understanding of the product's
efficacy and safety and the net impression of the product created by a
promotional piece in regards to that piece alone, which will inform our
review of DTC prescription drug advertising generally. FDA does not
intend to regulate or manage consumer attitudes or impressions towards
a particular brand.
    (Comment 15) One comment questioned the utility of including the
reminder and OTC test arms in the study as these advertisements do not
include both safety and effectiveness information.
    (Response) As stated previously, individuals are frequently faced
with situations in which they are required and able to make judgments
using incomplete information. As detailed previously, the inclusion of
a prescription reminder ad and an OTC ad provides experimental control.
We will compare perceptions of the product attributes among
participants who see: (1) Full risk and efficacy information (full ad),
(2) only efficacy information (OTC ad), and (3) neither risk nor
efficacy information (prescription reminder ad). The question of
whether an incentive can influence this judgment in the context of a
DTC prescription drug advertisement is the empirical question we are
addressing in the proposed study.
    (Comment 16) Two comments requested FDA provide more information on
the study population and study design including the primary research
questions, stimuli, endpoints, and action standards.
    (Response) The proposed questionnaire has been and continues to be
available upon request. We refer to pages 57800 and 57801 of the 60-day
notice (75 FR 57798) where the study design was described. We have
described the primary research questions in more detail in this 30-day
notice. Specific hypotheses and the analysis plan are included in this
document.
    (Comment 17) One comment requested that FDA specify the types of
advertisements to be used in the study (i.e., spread, gatefold, \1/3\
page ad). Another comment requested that FDA engage the services of an
advertising agency that specializes in the development of DTC print
advertisements. Further, the comment asserted that the location of the
promotional offer may have an impact on consumer perceptions of product
risks and benefits and requested FDA define the location of the offer
and clarify if it will be varied in the test ads.
    (Response) The full product DTC ad will be two pages, including a
brief summary. The OTC ad and reminder ad will each be one page. We
have contracted with an organization that produces realistic ads and
stimuli to ensure that we will show respondents realistic materials.
The location of the promotional offer will be standardized as much as
possible across all test conditions and will be incorporated in such a
way as to not obscure the description of either the risks or benefits
in the full product ad.
    (Comment 18) One comment requested FDA identify and study more
general disclosures that are not directly related to safety or
effectiveness info, such as ``consult with a physician to discuss
whether this drug is right for you.''
    (Response) We appreciate the comment about widening the scope of
the disclosures to be studied. Based upon the suggestion of our peer
reviewers, we have changed the focus of the second study to examine a
second medical condition and will not be investigating disclosures as
part of this initial study. We encourage other interested entities to
engage in research on disclosures.
    (Comment 19) One comment requested that the study population be
limited to individuals who have been diagnosed with the medical
condition of interest and exclude those merely `at risk' of developing
the condition because those who do not have the medical condition may
be much less attentive to the information in the ad and thus skew the
study results. In another paragraph, the same comment questioned the
need to conduct the proposed study in the target population since doing
so would not yield different results from Bhutada et al. (2009) who did
not use diagnosed individuals.
    (Response) As these two suggestions are contradictory, we offer our
reasoning behind selecting participants in Study 1 who are either
diagnosed or fit the criteria for diagnosis of insomnia (formerly
referred to as ``at risk''). One purpose of a purchase incentive is to
encourage new users to try a product (Ref. 18). Similarly, the first of
the Pharmaceutical Research and Manufacturers of America's (PhRMA)
guiding principles on direct to consumer advertising (Ref. 19) states
that ``* * * DTC advertising of prescription medicines can benefit the
public health by * * * motivating patients to contact their physicians
and engage in a dialogue about health concerns * * *'' Inclusion of an
incentive might encourage a consumer who recognizes the symptoms
described in the advertisement to discuss the condition with a doctor
or other health care professional. Thus, we conclude that both
diagnosed patients and those individuals who self-report meeting the
diagnostic criteria for the advertised medical condition but have not
yet been diagnosed are a valid sample for Study 1. We are limiting our
Study 2 sample to individuals who have been diagnosed with high blood
pressure by a health care professional.
    (Comment 20) One comment requested that demographic information
such as age, education, income, ethnicity, race, a baseline assessment
of health literacy, and whether the

consumer is currently being treated with a prescription drug for the
condition being studied be included in the information collection.
    (Response) Demographic and health literacy information will be
collected.
    (Comment 21) One comment requested that FDA use prudence when
broadly interpreting the results from this study and developing
subsequent guidance based on these study results, and requested that
the results of the study not be applied beyond print ads or,
alternatively, to expand the study to include Internet promotion.
    (Response) At this time we cannot expand the study to encompass
Internet promotion. We concur that there are media-specific factors
that influence information processing between static (e.g., print) and
dynamic (e.g., video) platforms, and will note that our study was
conducted with print ads in our interpretation of the results. However,
we contend that the cognitive processes used in understanding and
interpreting incentive information are likely to apply across
promotional platforms.
    (Comment 22) Two comments mentioned that the study does not assess
how consumer perceptions of product risks and benefits are translated
into a discussion with their health care provider. One comment stated
that because these products can only be purchased after a discussion
with a health care provider, the study be redesigned so that consumer
perceptions are measured after a discussion with a health care
provider.
    (Response) We concur that this study does not address behaviors,
such as how ad perceptions are translated into a discussion with a
health care provider. As noted previously, one purpose of DTC
advertising is to motivate consumers to engage in a discussion with
their health care provider about health concerns. Another purpose,
supported by research findings (Refs. 20 and 21), is to increase
awareness of available treatments. DTC advertising does not exist
solely in the confines of a doctor's office; rather, DTC advertising
targets consumers outside of a doctor's office, with the goal of
prompting consumers to ask their physicians about the product. In
deciding whether or not to discuss a particular product with their
health care provider, consumers presumably are engaging in some sort of
judgment about the product being promoted. Therefore, clear
communication of risks and benefits is needed for consumers before a
consultation with a physician, and it is valid to measure these
impressions.
    (Comment 23) One commenter requested that FDA provide clarity on
the timing of this study vis-a-vis other FDA DTC studies and make
available the results of previous DTC studies on the Division of Drug
Marketing Advertising and Communications (DDMAC) Research Web page.
    (Response) The timing of this study is not dependent on other
research currently underway. We have taken steps to publish reports
from our previous research on the DDMAC Web page (see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm). When the
current project is concluded, we will report on the study.
    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.......................................           8,500               1           8,500  .03 (2 minutes)........................             283
Pretests.......................................           1,000               1           1,000  .33 (20 minutes).......................             333
Study 1: Online................................           1,950               1           1,950  .33 (20 minutes).......................             650
Study 1: Mall intercept........................           1,950               1           1,950  .33 (20 minutes).......................             650
Study 2........................................           1,950               1           1,950  .33 (20 minutes).......................             650
                                                --------------------------------------------------------------------------------------------------------
    Total......................................          15,350  ..............  ..............  .......................................           2,566
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. 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. 4 p.m., Monday through Friday. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. deGroot, I.M., G. Antonides, and D. Read, et al., ``The Effects
of Direct Experience on Consumer Product Evaluation,'' Journal of
Socio-Economics, vol. 38, pp. 509-519, 2009.
2. DelVecchio, D., D.H. Henard, and T.H. Freling. ``The Effect of
Sales Promotion on Post-Promotion Brand Preference: A Meta-
Analysis,'' Journal of Retailing, vol. 82, pp. 203-213, 2006.
3. Mico, C.C. and T.G. Chowdhury. ``The Effect of Message's
Regulatory Focus and Product Type on Persuasion,'' Journal of
Marketing Theory and Practice, vol. 18, pp. 181-190, 2010.
4. LeClerc, F. and J.D.C. Little, ``Can Advertising Copy Make FSI
Coupons More Effective?'' Journal of Marketing Research, vol. 34,
pp. 473-484, 1997.
5. Wolk, A. and C. Ebling, ``Multi-Channel Price Differentiation: An
Empirical Investigation of Existence and Causes,'' International
Journal of Research in Marketing, vol. 27, pp. 142-150, 2010.
6. Rao, A. R., ``The Quality of Price as a Quality Cue,'' Journal of
Marketing Research, vol. 42, pp. 401-405, 2005.
7. Chaiken, S., A. Liberman, and A.H. Eagly, ``Heuristic and
Systematic Information Processing Within and Beyond the Persuasion
Context,'' J.S. Uleman and J.A. Bargh (Eds.), Unintended Thought,
pp. 212-252, New York: Guilford Press, 1989.
8. Johar, G.V. and C.J. Simmons, ``The Use of Concurrent Disclosures
to Correct Invalid Inferences,'' Journal of Consumer Research, vol.
26, p. 307, 2000.
9. Luce, M.F. and J.W. Payne, ``Constructive Consumer Choice
Processes,'' Journal of Consumer Research, vol. 25, pp. 187-217,
1998.
10. Alba, J.W. and H. Marmorstein, ``The Effects of Frequency
Knowledge on Consumer Decision Making,'' Journal of Consumer
Research, vol. 14, pp. 14-25, 1987.
11. Inman, J.J., L. McAlister, and W.D. Hoyer, ``Promotion Signal:
Proxy for a Price Cut?'' Journal of Consumer Research, vol. 17, pp.
74-81, 1990.
12. Garretson, J.A. and S. Burton, ``Highly Coupon and Sale Prone
Consumers: Benefits Beyond Price Savings,'' Journal of Advertising
Research, vol. 43, pp. 162-172, 2003.
13. Bhutada, N.S., C.L. Cook and M. Perri, ``Consumer Responses to
Coupons in Direct-to-Consumer Advertising of Prescription Drugs,''
Health Marketing Quarterly, vol. 26, pp. 333-346, 2009.
14. ``Guidance for Industry: Presenting Risk

Information in Prescription Drug and Medical Device Promotion,''
2009, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf,
last accessed May 26, 2011.
15. Kivetz, R. and I. Simonson, ``The Effects of Incomplete
Information on Consumer Choice,'' Journal of Marketing Research,
vol. 37, pp. 427-448, 2000.
16. Kardes, F.R., S.S. Posavac and M.L. Cronley, ``Consumer
Inference: A Review of Processes, Bases, and Judgment Contexts,''
Journal of Consumer Psychology, vol. 14, pp. 230-256, 2004.
17. Murphy, D., T.H. Hoppock, and M.K. Rusk, ``Generic Copy Test of
Food Claims in Advertising. Joint Staff Report of the Bureaus of
Economics and Consumer Protection, Federal Trade Commission,'' 1998,
available at http://www.ftc.gov/os/1998/11/netfood.pdf, last
accessed January 14, 2011.
18. RxMarketMetrics Series, ``Savings Offers: Effectively Reaching
the Right Audience?'' DTC Perspectives, vol. 10, pp. 14-16, 2011.
19. PhRMA Guiding Principles: Direct to Consumer Advertising About
Prescription Medicines (2005), available at http://www.phrma.org/sites/default/files/631/phrmaguidingprinciplesdec08final.pdf, last
accessed January 5, 2011.
20. Aikin, K.J., J.S.,Swasy, and A.C. Braman, ``Patient and
Physician Attitudes and Behaviors Associated With Direct-to-Consumer
Promotion of Prescription Drugs: Summary of FDA Survey Research
Results, Final Report,'' 2004, available at http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf
(last accessed May 26, 2011).
21. ``13th Annual Survey of Consumer Reactions to DTC Advertising of
Prescription Medicines,'' Prevention Magazine, Emmaus, PA: Rodale,
Inc, 2010.

    Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23926 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12892-12893]
[FR Doc No: 2016-05501]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD16-8-000]

White River Electric Association; Notice of Preliminary
Determination of a Qualifying Conduit Hydropower Facility and
Soliciting Comments and Motions To Intervene

    On February 24, 2016, White River Electric Association filed a
notice of intent to construct a qualifying conduit hydropower facility,
pursuant to section 30 of the Federal Power Act (FPA), as amended by
section 4 of the Hydropower Regulatory Efficiency Act of 2013
(HREA).\1\ The proposed Miller Creek Ditch Hydropower Project would
have an installed capacity of 180 kilowatts (kW), and would be located
along the Miller Creek Ditch. The project would be located near the
Town of Meeker, in Rio Blanco County, Colorado.
---------------------------------------------------------------------------

    \1\ Hydropower Regulatory Efficiency Act of 2013, Public Law
113-23, Sec.  4, 27 Stat. 493 (2013); 79 FR 2164 (2014).
---------------------------------------------------------------------------

    Applicant Contact: Alan Michalewicz, P.O. Box 958, 233 6th Street,
Meeker, CO 81641, Phone No.<PHONE_NUMBER>.
    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A new powerhouse, approximately 20 feet
by 23 feet, adjacent to the downstream end of an existing 30-inch-
diameter by approximately 680-foot-long steel pipe used to convey
Miller Creek Ditch across County Road 13; (2) an underground tailrace
returning flows to the existing 30-inch-diameter steel pipe; (3) a new
450-foot-long, 30-inch-diameter penstock, fed by a new diversion and
intake structure adjacent to an existing diversion and intake
structure; (4) a cross flow turbine/generating unit with an installed
capacity of 180 kW; and (5) appurtenant facilities.
    The proposed project would have a total installed capacity of 180
kW.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
                                                                                Satisfies
               Statutory provision                                   Description                        (Y/N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by HREA.............  The conduit the facility uses is a tunnel, canal,           Y
                                                   pipeline, aqueduct, flume, ditch, or similar
                                                   manmade water conveyance that is operated for
                                                   the distribution of water for agricultural,
                                                   municipal, or industrial consumption and not
                                                   primarily for the generation of electricity.
FPA 30(a)(3)(C)(i), as amended by HREA..........  The facility is constructed, operated, or                   Y
                                                   maintained for the generation of electric power
                                                   and uses for such generation only the
                                                   hydroelectric potential of a non-federally owned
                                                   conduit.
FPA 30(a)(3)(C)(ii), as amended by HREA.........  The facility has an installed capacity that does            Y
                                                   not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii), as amended by HREA........  On or before August 9, 2013, the facility is not            Y
                                                   licensed, or exempted from the licensing
                                                   requirements of Part I of the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: The proposed addition of the
hydroelectric project along the Miller Creek Ditch will not alter its
primary purpose of distributing water for irrigation. Therefore, based
upon the above criteria, Commission staff preliminarily determines that
the proposal satisfies the requirements for a qualifying conduit
hydropower facility, which is not required to be licensed or exempted
from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\2\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \2\ 18 CFR 385.2001-2005 (2015).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior

registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the Web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (i.e., CD16-8) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY, call
(202) 502-8659.

    Dated: March 7, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05501 Filed 3-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Pages 19603-19604]
[FR Doc No: 2016-07802]

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ENVIRONMENTAL PROTECTION AGENCY

[9944-65-Region 6]

Notice of Proposed Administrative Settlement Pursuant to the
Comprehensive Environmental Response, Compensation, and Liability Act

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for public comment.

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

SUMMARY: In accordance with Section 122(h)(1) of the Comprehensive
Environmental Response, Compensation, and Liability Act, as amended
(``CERCLA''), 42 U.S.C. 9622(h)(1), notice is hereby given of a
proposed administrative settlement concerning the Rab Valley Wood
Preserving Superfund Site, located in Panama, LeFlore County, Oklahoma.
    The settlement requires Joslyn Manufacturing Company, settling
party,

to pay a total of $280,000 as payment of past response costs to the
Hazardous Substances Superfund. The settlement includes a covenant not
to sue pursuant to Sections 106 and 107(a) of CERCLA, 42, U.S.C. 9606
and 9607(a).
    For thirty (30) days following the date of publication of this
notice, the Agency will receive written comments relating to this
notice and will receive written comments relating to the settlement.
The Agency will consider all comments received and may modify or
withdraw its consent to the settlement if comments received disclose
facts or considerations which indicate that the settlement is
inappropriate, improper, or inadequate. The Agency's response to any
comments received will be available for public inspection at 1445 Ross
Avenue, Dallas, Texas 75202-2733.

DATES: Comments must be submitted on or before May 5, 2016.

ADDRESSES: The proposed settlement and additional background
information relating to the settlement are available for public
inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733. A copy of the
proposed settlement may be obtained from Kenneth Talton, 1445 Ross
Avenue, Dallas, Texas 75202-2733 or by calling<PHONE_NUMBER>. Comments
should reference the Rab Valley Wood Preserving Superfund Site, Panama,
LeFlore County, Oklahoma, and EPA Docket Number 6-02-16, and should be
addressed to Kenneth Talton at the address listed above.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pletan, 1445 Ross Avenue,
Dallas, Texas 75202-2733 or call<PHONE_NUMBER>.

    Dated: March 28, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-07802 Filed 4-4-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Page 36812]
[FR Doc No: 2017-16505]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0124]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0057

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting a Reinstatement,
without change, of a previously approved collection for which approval
has expired for the following collection of information: 1625-0057,
Small Passenger Vessels--Title 46 Subchapters K and T without change.
Our ICR describes the information we seek to collect from the public.
Before submitting this ICR to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before October 6,
2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0124] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2017-0124], and
must be received by October 6, 2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Small Passenger Vessels--Title 46 Subchapters K and T.
    OMB Control Number: 1625-0057.
    Summary: The information requirements are necessary for the proper
administration and enforcement of the program on safety of commercial
vessels as it affects small passenger vessels. The requirements affect
small passenger vessels (under 100 gross tons) that carry more than 6
passengers.
    Need: Under the authority of 46 U.S.C. 3305 and 3306, the Coast
Guard prescribed regulations for the design, construction, alteration,
repair and operation of small passenger vessels to secure the safety of
individuals and property on board. The Coast Guard uses the information
in this collection to ensure compliance with the requirements.
    Forms: CG-841, Certificate of Inspection; CG-854, Temporary
Certificate of Inspection; CG-948, Permit to Proceed to Another Port
for Repairs; CG-949, Permit to Carry Excursion Party; CG-3752,
Application for Inspection of U.S. Vessel; CG-5256, U.S. Coast Guard
Inspected Small Passenger Vessel.
    Respondents: Owners and operators of small passenger vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from
399,420 hours to 397,124 hours a year due to a decrease in the
estimated annual number of respondents.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: August 1, 2017.
Marilyn L. Scott-Perez,
U.S. Coast Guard, Chief, Office of Information Management.
[FR Doc. 2017-16505 Filed 8-4-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: February 22, 2010 (Volume 75, Number 34)]
[Notices]
[Page 7604-7606]
[DOCID:fr22fe10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0079]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Graphic Cigarette Warning Labels

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 the Experimental Study of Graphic Cigarette
Warning Labels that is being conducted in support of the graphic label
statement provision of the Family Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act).

DATES: Submit written or electronic comments on the collection of
information by April 23, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://

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: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Experimental Study of Graphic Cigarette Warning Labels

    Tobacco products are responsible for more than 440,000 deaths each
year. The Centers for Disease Control and Prevention report that
approximately 46 million U.S. adults smoke cigarettes in the United
States, even though this behavior will result in death or disability
for half of all regular users. Paralleling this enormous health burden
is the economic burden of tobacco use, which is estimated to total $193
billion annually in medical expenditures and lost productivity. Curbing
the significant adverse consequences of tobacco use is one of the most
important public health goals of our time. One way to do this is
through health warnings that describe and graphically depict the harm
caused by cigarette use.
    On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act granted FDA
important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors. Section 201 of the Tobacco Control
Act, which amends section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333), requires FDA to issue ``regulations
that require color graphics depicting the negative health consequences
of smoking to accompany the label statements specified in subsection
(a)(1).'' FDA conducts research relating to tobacco products under its
statutory authority in section 1103(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act, as amended by the Tobacco Control Act, to conduct
research ``relating to foods, drugs, cosmetics, devices, and tobacco
products in carrying out the act.'' The study proposed here is an
effort by FDA to collect data concerning graphic warnings on cigarette
packages and their impact on consumer perceptions, attitudes, and
behavior with respect to smoking.
    The study, the Experimental Study of Graphic Cigarette Warning
Labels, is a voluntary experimental survey of consumers. The purpose of
the study is to assess the effectiveness of various graphic warnings on
cigarette packs for achieving three communication goals: (1) Conveying
information about various health risks of smoking, (2) encouraging
cessation of smoking among current smokers, and (3) discouraging
initiation of smoking among youth and former smokers. The study will
collect data from various groups of consumers, including current
smokers aged 13 years and older, former smokers aged 13 years and
older, and non-smokers aged between 13 and 25 years who may be
susceptible to initiation of smoking. The study goals are to: (1)
Measure consumer attitudes, beliefs, and intended behaviors related to
cigarette smoking in response to graphic warning labels; (2) determine
whether consumer responses to graphic warning labels differ across
various groups based on smoking status, age, or other demographic
variables; and (3) evaluate the relative effectiveness of various
graphic images associated with each of the nine warning statements
specified in the Tobacco Control Act for achieving each of the
communication goals. The information collected from the study is
necessary to inform the agency's efforts to implement the mandatory
graphic warnings required by the Tobacco Control Act.
    The experimental study data will be collected from participants of
an Internet panel of approximately 43,000 people. Participation in the
experimental study is voluntary.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          No. of         Annual Frequency       Total Annual
                 Portion of Study                      Respondents         per Response          Responses       Hours per  Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-test                                                           60                     1                 60                  0.5                   30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener                                                       15,000                     1             15,000                  0.016                240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Experimental Survey                                             5,400                     1              5,400                  0.5                2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                               .................                     1             15,460  .....................              2,970
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here. Sixty panel
members will take part in a pre-test of the study, estimated to last 30
minutes (0.5 hours), for a total of 30 hours. Approximately 15,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.016 hours),
for a total of 125 hours. Fifty-four hundred (5,400) respondents will
complete the full study, estimated to last 30 minutes (0.5 hours), for
a total of 2,700 hours. The total estimated burden is 2,970 hours.

    Dated: February 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3320 Filed 2-19-10; 8:45 am]
BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 February 7, 2005 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: BEAD Review of Chlorsulfuron Comments FROM: Nicole Zinn, Biologist Herbicide and Insecticide Branch Jin Kim, Economist Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

THRU: Arnet Jones, Chief Herbicide and Insecticide Branch David Widawsky, Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Susan Jennings, Chemical Review Manager Special Review and Reregistration Division PEER REVIEW PANEL: February 2, 2005 The purpose of this memorandum is to respond to benefits related public comments received regarding chlorsulfuron's Phase 3: Public Release of Risk Assessments and Risk Management Options for Comment issued in the Federal Register on September 24, 2004. Of seven comments received by the Office of Pesticide Programs ( OPP), four had benefits related comments. A benefits assessment has not been done at this time. These comments will be considered in any benefits work conducted for chlorsulfuron. The following table contains a summary of each individual benefits related comment and BEAD's response to those comments. Only the portion of the comments relevant to BEAD are included in the table. 2 Table 1. Summary of Chlorsulfuron Comments Commenter Comment and BEAD Response ( if any)

Wheat Jane Thomas  Washington State Pest Management Resource Service Comment: Chlorsulfuron is usually applied in combination with metsulfuronmethyl and in conjunction with a phenoxy herbicide, on wheat on fields with a wheat/ fallow rotation. It is applied in the spring by air. Plant back restrictions have resulted in growers using either tribenuron or tribenuron + thifensulfuron. Reducing the application rate or removing aerial application will cause growers to switch to phenoxy herbicides or, more likely, other sulfonylurea ( SU) herbicides. A lower application rate may cause the herbicide to become ineffective. Aerial application is needed in the spring because often the ground is wet. Delays in application with ground equipment may result in the herbicide being less effective.

BEAD Response: BEAD believes that it is possible that growers will use a different SU herbicide if chlorsulfuron applications are no longer feasible due to the mitigation. The concerns raised about reducing the application rate and eliminating aerial application are valid. However, BEAD would need to review efficacy data and conduct further analysis to determine if the mitigation options are feasible. The information submitted in the comment will be considered if a benefits assessment is required.

Crop Not Specified/ Pasture and Rangeland John L. Baker, Supervisor, Fremont County ( WY) Weed and Pest Control District Comment: " Telar is the single most effective herbicide for the control of Perennial Pepperweed and Hoary Cress in Wyoming. The combination of relative low cost, residual, and soil activity make it an important part of our weed control activities. While nearly all of our application work with Telar is with low pressure, large droplet hand directed sprays, it only seems prudent to preserve aerial application as an option due to the extensive areas of infestation by these weeds in rangeland and pasture sites. Would it not be possible to detail the endangered species of concern and the areas in which they are found, than to prohibit aerial application all together? Drift control agents combined with low drift equipment and technique may be all that is needed to reduce drift associated non target impacts."

BEAD Response: Chlorsulfuron is registered for control of these weed species. BEAD has not completed a benefits assessment at this time but will consider this information if a benefits assessment is required. Additional information on the need for aerial application would be necessary for this application method to be assessed. Commenter Comment and BEAD Response ( if any)

3 Vegetation Management Ferry County Noxious Weed Control Board ( State not specified) Comment: " We have used Chlorsulfuron as part of our arsenal of vegetation control herbicides for several years. We have found it to be a very effective herbicide for the control of one of our toughest noxious weeds, Dalmatian toadflax."

BEAD Response: A number of herbicides are registered for use on Dalmatian toadflax. North Dakota State University Extension Service lists picloram, chlorsulfuron and imazapic as herbicides used to control Dalmatian toadflax ( ND Extension, Web address: http:// www. ext. nodak. edu/ extpubs/ plantsci/ weeds/ w1239w. htm. Additional information, such as use sites and comparative performance data, and an analysis of cost impacts would need to be reviewed if a benefits assessment is required.

Pasture, Rangeland, Public Lands Leon J. Wrage, South Dakota Extension Agronomist  Weeds; Darrell L. Deneke, South Dakota Extension IPM Coordinator Comment: Chlorsulfuron is used to control invasive weeds in pasture, range and public lands. Chlorsulfuron is not marketed on wheat in South Dakota. Target weeds are hoary cress ( perennial pepperweed), Canada thistle, biennial thistle, common mullein, dalmatian toadflax, and tansy. " Chlorsulfuron is the most effective herbicide option for hoary cress. It is also effective for perennial and biennial thistle species. 18% of the infestations involve environmental restrictions such as slope or trees that preclude use of more restrictive products. There is adequate grass selectivity and tolerance to adjacent deep rooted vegetation when used at current rates and application methods."

BEAD Response: Chlorsulfuron is registered for control of these weed species. BEAD has not completed a benefits assessment at this time but will consider this information if a benefits assessment is required.