[Federal Register: June 22, 2009 (Volume 74, Number 118)]
[Notices]
[Page 29490-29493]
[DOCID:fr22jn09-65]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0263]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Presentation of Quantitative
Effectiveness Information to Consumers in Direct-to-Consumer Television
and Print Advertisements for Prescription Drugs

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 Presentation of
Quantitative Effectiveness Information to Consumers in Direct-to-
Consumer (DTC) Television and Print Advertisements for Prescription
Drugs. This study is designed to communicate quantitative information
about product benefits in DTC print and television ads.

DATES: Submit written or electronic comments on the collection of
information by [August 21, 2009

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: Liz Berbakos, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

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 Presentation of Quantitative Effectiveness
Information to Consumers in Direct-to-Consumer (DTC) Television and
Print Advertisements for Prescription Drugs--New

    The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for
humans, disclose in advertisements certain information about the
advertised product's uses and risks.\1\ By its nature, the presentation
of

this information is likely to evoke active trade-offs by consumers,
i.e., comparisons with the perceived risks of not taking treatment, and
comparisons with the perceived benefits of taking a treatment.\2\ FDA
has an interest in fostering safe and proper use of prescription drugs,
an activity that engages both risks and benefits. Therefore, an
examination of ways to improve consumers' understanding of this
information is central to this regulatory task.
---------------------------------------------------------------------------

    \1\ For prescription drugs and biologics, section 502 of the act
requires advertisements to contain ``information in brief summary
relating to side effects, contraindications, and effectiveness'' (21
U.S.C. 352(n)).
    \2\ See Swartz, L., S. Woloshin, W. Black, et al., The Role of
Numeracy in Understanding the Benefit of Screening Mammography,
Annals of Internal Medicine, 127(11), 966-72, 1997.
---------------------------------------------------------------------------

    Under the act, FDA engages in a variety of communication activities
to ensure that patients and health care providers have the information
they need to make informed decisions about treatment options, including
the use of prescription drugs. FDA regulations (21 CFR 201.57) describe
the content of required product labeling, and FDA reviewers ensure that
labeling contains accurate and complete information about the known
risks and benefits of each drug.
    FDA regulations require that prescription drug advertisements that
make (promotional) claims about a product also include risk information
in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. This balance applies to
both the front, display page of an advertisement, as well as including
the brief summary page. However, beyond the ``balance'' requirement
there is limited guidance and research to direct or encourage sponsors
to present benefit claims that are informative, specific, and reflect
clinical effectiveness data.
    Research and guidance to sponsors on how to present benefit and
efficacy information in prescription drug advertisements is limited.
For example, ``benefit claims,'' broadly defined, appearing in
advertisements are often presented in general language that does not
inform patients of the likelihood of efficacy and are often simply
variants of an ``intended use'' statement. One content analysis of DTC
advertising by Woloshin and Schwartz (2001)\3\ found that information
about product benefits and risks is often presented in an unbalanced
fashion. The researchers classified the ``promotional techniques'' used
in the advertisements. Emotional appeals were observed in 67 percent of
the ads while vague and qualitative benefit terminology was found in 87
percent of the ads. Only 9 percent contained data. However, for risk
information, half the advertisements used data to describe side-
effects, typically with lists of side-effects that generally occurred
infrequently. Similarly, a content analysis by Frosch et al. (2007)\4\
found that only a small proportion of product-claim ads gave specific
information about the population prevalence of the medical condition
being advertised. The authors criticize DTC for presenting ``best-case
scenarios that can distort and inflate consumers' expectations about
what prescription drugs can accomplish'' (Froch et al., 2007, p. 12)
without disclosing how many consumers are likely to experience that
benefit.
---------------------------------------------------------------------------

    \3\ Woloshin, S. and L. Schwartz, Direct to Consumer
Advertisements for Prescription Drugs: What Are Americans Being
Told, Lancet, 358, 1141-46, 2001.
    \4\ Frosch, D.L., P.M. Krueger, R.C. Hornik, et al., Creating
Demand for Prescription Drugs: A Content Analysis of Television
Direct-to-Consumer Advertising, Annals of Family Medicine, 5(1), 6-
13, 2007.
---------------------------------------------------------------------------

    Some research has proposed that providing quantitative information
about product efficacy enables consumers to make better choices about
potential therapy. One possible format (termed the ``drug facts'' box
by its creators) for this information has recently received
attention.\5\ In these studies, the drug facts box format contained
information about the product's efficacy and safety in terms of rate
(how many people in the clinical trial experienced a benefit or side
effect compared to placebo). As expected, this study showed that
consumers who were provided efficacy information used it. Participants
receiving efficacy information (without other potentially valuable
information about the drug) were more likely to correctly choose the
product with the higher efficacy than consumers who saw the brief
summary that did not contain this information.
---------------------------------------------------------------------------

    \5\ Schwartz, L.M., S. Woloshin, H.G. Welch, The Drug Facts Box:
Providing Consumers With Simple Tabular Data on Drug Benefit and
Harm, Medical Decision Making, 27, 655-692, 2007; Schwartz, L.M., S.
Woloshin, H.G. Welch, Communicating Drug Benefits and Harms With a
Drug Facts Box: Two Randomized Trials, Annals of Internal Medicine,
150, 516-527, 2009; Woloshin, S., L.M. Schwartz, H.G. Welch, The
Value of Benefit Data in Direct-to-Consumer Drug Ads, Health
Affairs, Suppl Web Exclusives, W4-234-245, 2004.
---------------------------------------------------------------------------

    Although these results are intriguing, additional research is
necessary to uncover important information about how consumers
understand effectiveness information about prescription drug products
from DTC advertisements. For example, the research to date does not
address whether simply adding efficacy rate information and qualitative
summations to a consumer-friendly brief summary would enable consumers
to find and report the correct answer, or if the presentation of
information in a chart format itself increases comprehension.
    Further, these data cannot address the best way in which to convey
numerical information; percents were used but another format, such as
frequencies, may be more effective at communicating quantitative
information. Previous research shows that individuals have great
difficulty processing numerical concepts (e.g., Beyth-Marom, 1982;
Bowman, 2002; Cohen, Ferrell, and Johnson, 2002).\6\ A few studies have
attempted to determine what different formats make these concepts least
troublesome (e.g., Fagerlin, Wang, and Ubel, 2005; Lipkus, 2007),\7\
however, most research into the communication of numerical concepts
concentrates on risk information. We are not aware of research looking
into the integration of quantitative information about effectiveness or
benefits into the body of the advertisement itself. The addition of
this information may help consumers make better healthcare decisions,
provided they can understand it.
---------------------------------------------------------------------------

    \6\ Beyth-Marom, R., How Probable is Probable? A Numerical
Translation of Verbal Probability Expressions, Journal of
Forecasting, 1, 257-269, 1982; Bowman, M.L., The Perfidity of
Percentiles, Archives of Clinical Neuropsychology, 17, 295-303,
2002; Cohen, D.J., J.M. Ferrell, N. Johnson, What Very Small Numbers
Mean, Journal of Experimental Psychology: General, 131, 424-442,
2002.
    \7\ Fagerlin, A., C. Wang, P.A. Ubel, Reducing the Influence of
Anecdotal Reasoning on People's Health Care Decisions: Is a Picture
Worth a Thousand Statistics? Medical Decision Making, 25, 398-405,
2005; Lipkus, I., Numeric, Verbal, and Visual Formats of Conveying
Health Risks: Suggested Best Practices and Future Recommendations,
Medical Decision Making, 27, 697-713, 2007.
---------------------------------------------------------------------------

    It is also not known if ways of communicating product efficacy work
equally well across print and television DTC media. To our knowledge,
research on presenting quantitative information in risk communication
has been conducted exclusively with static modalities. The ideal format
for presenting quantitative information may vary as a function of
presentation. The amount of mental processing capacity each individual
can devote to understanding a message varies depending on how long
individuals have to look at the material and whether the material is
self-paced or presented at an uncontrollable speed. As a result, some
forms of quantitative information may lend themselves to print, rather
than broadcast. This particular understanding is crucial to the risk-
benefit tradeoff that patients must make with the consultation of a
health care professional in order to achieve the best health outcomes.
    The proposed study will examine: (1) Various ways of communicating

quantitative efficacy in DTC print ads and (2) whether the findings
translate to DTC television ads.
    Design Overview: This study will be conducted in two concurrent
parts; one examining quantitative information in DTC print
advertisements and the other examining such information in DTC
television advertisements. Three factors will be examined: Drug
efficacy, visual format, and type of statistic. Drug efficacy (low
versus high) is defined by a quantifiable, objective metric that can be
conveyed in graphical representations of the drug versus the comparator
reference drug (in this case, placebo). ``High'' efficacy is noticeably
better than the placebo, whereas ``low'' efficacy is minimally better
than the placebo. Visual format is defined as various methods through
which efficacy can be visually represented. We have chosen to
investigate three different formats: Bar graph, pictograph, and pie
chart. Type of statistic is defined as the type of statistical
information conveyed: Frequency, relative frequency, or percentage.
These factors will be combined in a partially crossed factorial design
as follows:

                  Table 1.--Type of Visual Format x Type of Statistic Conveyed x Efficacy Level
----------------------------------------------------------------------------------------------------------------
                                                                           Type of Visual Format
----------------------------------------------------------------------------------------------------------------
       Type of Statistic              Efficacy Level          None        Pie Chart     Bar Chart    Pictograph
----------------------------------------------------------------------------------------------------------------
Frequency                       High Efficacy                 [check]       [check]       [check]       [check]
                               ---------------------------------------------------------------------------------
                                Low Efficacy                  [check]       [check]       [check]       [check]
----------------------------------------------------------------------------------------------------------------
Percentage                      High Efficacy                 [check]       [check]       [check]           N/A
                               ---------------------------------------------------------------------------------
                                Low Efficacy                  [check]       [check]       [check]           N/A
----------------------------------------------------------------------------------------------------------------
Combination Frequency +         High Efficacy                 [check]           N/A           N/A           N/A
 Percentage
                               ---------------------------------------------------------------------------------
                                Low Efficacy                  [check]           N/A           N/A           N/A
----------------------------------------------------------------------------------------------------------------
Relative Frequency              High Efficacy                 [check]           N/A           N/A           N/A
                               ---------------------------------------------------------------------------------
                                Low Efficacy                  [check]           N/A           N/A           N/A
----------------------------------------------------------------------------------------------------------------
Relative Frequency + Absolute   High Efficacy                 [check]           N/A           N/A           N/A
 Rate
                               ---------------------------------------------------------------------------------
                                Low Efficacy                  [check]           N/A           N/A           N/A
----------------------------------------------------------------------------------------------------------------
None                            N/A                           [check]           N/A           N/A           N/A
----------------------------------------------------------------------------------------------------------------

    The test product will be for the treatment of high cholesterol and
modeled on an actual drug used to treat that condition (such as
Lipitor[sscopy]). The product labeling will be used as the reference
for defining the high- and low-efficacy levels and the objective
metrics for clinical performances. Because both parts of the study will
run concurrently, experimental conditions will be identical in both the
print and television portions.
    Participants will read or view one ad version. After reading the
ad, participants will make a series of judgments about the drug. The
mean difference between the low- and high-efficacy condition will serve
as the baseline for testing whether this difference varies across
various graphical presentations, with the exception of the No
Information (control) condition. In other words, our analyses will
involve two steps. In step 1, within each format, we will test whether
participants were able to distinguish between low- and high-efficacy
drugs. In step 2, within each efficacy level, we will test whether
participants' estimates of efficacy differ across formats and examine
the accuracy of these estimates.
    Interviews are expected to last no more than 20 minutes. A total of
4,500 participants will be involved in the 2 parts of the study. This
will be a one time (rather than annual) collection of information.
    FDA estimates the burden of this collection of information as
follows:
    The total respondent sample for this data collection is 4,500
(2,225 in each part). We estimate the response burden to be 20 minutes,
for a burden of 1,485 hours.
    The response burden chart is listed in table 2 of this document.

                                 Table 2.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
                               4,500                  1              4,500                .33              1,485
----------------------------------------------------------------------------------------------------------------
Total                          4,500                  1              4,500                .33              1,485
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.

[FR Doc. E9-14501 Filed 6-19-09; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 21, 2011

	On June 21st, 2011 we held a conference call with Cummins to discuss
concerns raised by Cummins regarding heavy-duty onboard diagnostic (OBD)
requirements and timing.  Cummins raised concerns during the comment
period for the heavy-duty greenhouse gas notice of proposed rulemaking
that heavy-duty hybrid applications may not be able to meet the 2013
heavy-duty OBD regulations that were published in the 2009 OBD Final
Rulemaking.,  Specifically, their comments include a request for a delay
of the application of HD OBD requirements for hybrid applications until
2020.  Attendees from this meeting are shown in the table below.

 Attendee 	Affiliation

Cleophas Jackson 	EPA – Compliance and Innovative Strategies Division

Anthony Neam 	EPA – Assessment and Standards Division

Amy Kopin 	EPA – Assessment and Standards Division

Mark Stepper	Cummins

Morgan Andreae	Cummins

Thomas A. Dollmeyer	Cummins

Benjamin J. Zwissler	Cummins

Bill Ellison	Cummins

Greg M. Pataky	Cummins

Hwei Jen Kachler	Cummins

 U.S. EPA, NHTSA, and DOT, “Greenhouse Gas Emission Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,”
republished December 29, 2010.  Available here:
http://origin.www.gpo.gov/fdsys/pkg/FR-2010-12-29/html/2010-32726.htm

 U.S. EPA, “Control of Air Pollution from New Motor Vehicles and New
Motor Vehicles Engines; Final Rule Regulations Requiring Onboard
Diagnostic Systems on 2010 and Later Heavy-Duty Engines Used in Highway
Applications Over 14,000 Pounds; Revisions to Onboard Diagnostic
Requirements for Diesel Highway Heavy-Duty Vehicles Under 14,000
Pounds,” published February 24, 2009.  Available here:
http://www.epa.gov/otaq/regs/im/obd/regtech/hd-obd-frm-02-24-09-notice-7
4-fr-8310.pdf


Conference Call with Institute of Scrap Recycling Industries for Docket

December 15, 2005

On Thursday December 15, 2005, Environmental Protection Agency (EPA)
team members from the Office of Solid Waste (OSW) had a conference call
with David Wagger and Scott Horne of the Institute of Scrap Recycling
Industries (ISRI) from 9:30 am to 10:30 am. The purpose of the call was
to learn about recycling practices among ISRI’s members to facilitate
an analysis of overall good hazardous waste recycling practices for a
DSW rulemaking. The call focused on the information ISRI provides its
members on environmental insurance as well as ISRI’s Recycling
Industry Operating Standard (RIOS), a management standard developed
especially for the scrap industry that covers environment, health and
safety, and quality.

Kathy Blanton	Environmental Protection Agency

Scott Horne	Institute of Scrap Recycling Industries

Amy Lile 	Environmental Protection Agency

David Wagger	Institute of Scrap Recycling Industries