[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58362-58366]
[FR Doc No: 2020-20621]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4763]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Assessment of Terms
and Phrases Commonly Used in Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by October 19, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Assessment of Terms and Phrases Commonly
Used in Prescription Drug Promotion.'' Also, include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    For copies of the questionnaire, contact: Office of Prescription
Drug Promotion (OPDP) Research Team<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Assessment of Terms and Phrases Commonly Used in Prescription Drug
Promotion

OMB Control Number 0910-New

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health, in part, by helping to ensure that
prescription drug promotional material is truthful, balanced, and
accurately communicated, so that patients and health care providers can
make informed decisions about treatment options. OPDP's research
program provides scientific evidence to help ensure that our policies
related to prescription drug promotion will have the greatest benefit
to public health. Toward that end, we have consistently conducted
research to evaluate the aspects of prescription drug promotion that
are most central to our mission. Our research focuses in particular on
three main topic areas: Advertising features, including content and
format; target populations; and research quality. Through the
evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform all three topic areas.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing the
results of multiple converging studies, we continue to develop evidence
to inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our homepage,
which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey on direct-to-
consumer advertisements conducted in 1999.
    The present research involves assessment of how consumers and
primary care physicians (PCPs) interpret terms and phrases commonly
used in prescription drug promotion, as well as those used to describe
prescription drugs and prescription drug promotion more generally. This
includes both what these terms and phrases mean to each population
(e.g., definitions) and what these terms and phrases imply (e.g., about
efficacy and safety). Some examples of interest include: ``natural'' or
``naturally-occurring,'' and ``targeted'' or ``targeted therapy.'' The
full list for assessment will include approximately 30 terms and
phrases for each population. To accommodate such a large number,
presented terms and phrases will be accompanied by only limited context
(terms within sentences and phrases within paragraphs, as opposed to
full promotional materials). Understanding the most prevalent
interpretations of these terms and phrases can help OPDP determine the
impact of specific language in prescription drug promotion. For
example, certain terms and phrases, when used without additional
contextual information, might overstate the efficacy or minimize the
risk of a product. Additionally, from a health literacy perspective, it
is helpful to ascertain general understanding of such terms and phrases
as this may aid in the development of best practices around
communicating these concepts.

    We plan to conduct this research in two phases. First, we will
conduct formative semi-structured interviews with 30 members of each
population (general population consumers and PCPs). Second, we will
conduct nationally representative, probability-based surveys of more
than 1,000 members of each population on the same topic.
    Phase 1: Semistructured Interviews. In Phase 1 of the research,
semistructured interviews will be conducted by web conferencing using
the itracks platform, an online and mobile market research service
provider. This approach allows for the participant and interviewer to
see each other and includes a whiteboard feature that can be used to
show the terms, statements, or passages for participants to read and
follow along as the interviewer reads them aloud. This may be helpful
in cases where the statements or passages are long, which may make them
difficult to understand when read aloud. In addition, the written
information may be helpful as a reference as the discussion progresses.
    Participation is estimated to take 1 hour. Participants will be
recruited by email through itracks and its partner panels. All
participants will be 18 years of age or older and must not have
participated in a focus group or interview during the previous 3
months. Additionally, for the consumer sample, we will exclude
individuals who work in healthcare or marketing settings because their
knowledge and experiences may not reflect those of the average
consumer. For the PCP sample, we will exclude individuals who spend
less than 50 percent of their time on patient care. Department of
Health and Human Services employees and RTI International employees
will be excluded from both respondent groups.
    We will start data collection with a soft launch of three
interviews per segment (10 percent) to ensure that all processes are
working well. Although we do not intend on making major changes to the
interview guides as a result of these soft launch interviews, they will
provide an opportunity to make minor changes (e.g., adding interviewer
notes). Measurement for this phase will consist of a thematic analysis
using a matrix approach to identify themes and mental models common
across participants.
    Phase 2: Nationally Representative Surveys. In Phase 2 of the
research, primarily closed-ended survey questions will be administered
to each population. The closed-ended survey format will allow the team
to quantify the frequency or prevalence of certain interpretations or
meanings among a nationally representative sample of the general U.S.
consumer and physician populations. Final questions and response
options will be informed by key interpretations discovered during the
Phase 1 interviews. For the consumer survey, we will use a probability
sample selected from an address-based sampling frame and conduct the
survey using a web-based platform. For the PCP survey, we will obtain a
probability sample from the American Medical Association Masterfile and
will conduct the survey via mail. For each population, we chose the
sampling frame and survey mode that has been shown to produce the
highest quality results for that population with respect to coverage,
response rates, and nonresponse bias. The same exclusion criteria as
specified for Phase 1 will be maintained for Phase 2. Participation is
estimated at 20 minutes.
    We also plan to embed an experiment in the PCP mail survey.
Research has shown that including a pen in the survey package can help
to increase response rates and time to response, even potentially
reducing the number of reminders required (Refs. 1 and 2). However, the
shipping of pens can be costly and often pens are damaged in the mail
(e.g., ink can leak, etc.). To determine whether another token
incentive might be as effective at increasing response rates, we will
randomize half of the sample to receive a pen and half to receive a
packet of sticky notes or other token incentive. We will compare
response rates between the two groups to help inform methods for future
studies.
    We set our sample requirements to a 95 percent confidence interval
and a 3 percent margin of error assuming an underlying proportion of
0.50 in the population (which is the most conservative estimate and
overestimates the sample size relative to alternate proportions). These
parameters are commonly used in quantitative survey research (Refs. 3
to 6) and offer balance between precision and cost. Thus, assuming a
total U.S. population of roughly 250 million adults aged 18 or older
(Ref. 7), we estimate the number of completed surveys to be 1,067 for
the general population survey. Assuming a total population of 209,000
PCPs (Ref. 8), with the same 95 percent confidence interval and  3 percent margin of error, we estimate the number of completed
surveys for the provider survey to be 1,062. These sample sizes would
also allow us to detect a mean difference between  0.15 and
0.30 points (Ref. 6).
    In the Federal Register of November 6, 2019 (84 FR 59833), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received eight comments, but only five
submissions were PRA-related. Within those submissions, FDA received
multiple comments that the Agency has addressed.
    (Comment 1) Some comments supported the proposed research as an
important step towards addressing current issues with U.S. prescription
drug advertisement practices.
    (Response) FDA agrees with these comments to the extent they relate
to this study.
    (Comment 2) A few comments suggested the proposed research
methodology could be improved by providing the general population with
the option to complete the survey in writing or over the phone. These
comments asserted that elderly consumers are highly susceptible to
false and misleading advertisements of prescription drugs, and that
elderly consumers use prescription drugs at rates higher than any other
age group. The comments also indicated that elderly populations may
face barriers to accessing a web-based platform to complete the survey.
    (Response) While we agree that web panel surveys can sometimes have
less than ideal coverage of populations like older adults, the survey
proposed here would not be sampling from a web panel, but would instead
use a probability sample selected from an address-based sample frame to
ensure a nationally-representative sample. This helps to ensure better
coverage of older adults, who may be less likely to be part of an
existing opt-in survey panel or less likely to answer a web-based ad to
complete a survey than to respond to a mailed survey invitation. Pew
research finds that 73 percent of people aged 65+ have access to the
internet in their home compared to 90 percent for the overall U.S.
population (Ref. 9). To address this coverage concern, responses from
older adults will be weighted to the full U.S. population.
    Our recent experience suggests we will be able to adequately
represent this group. As an example, in a survey conducted by RTI on
the Residential Energy Consumption Survey National Pilot, an analysis
of representativeness among survey protocols found that for the older
age group, web was less representative than a mixed mode survey
allowing for either web-based or paper survey, but was still considered
to have ``good'' agreement with the American Community Survey
(considered the gold standard for U.S. demographic data).

    (Comment 3) The comment indicated the proposed research methodology
could be improved by including behavior-based questions in the surveys.
    (Response) We agree about the value of measuring behavioral
intentions in general. However, in this particular study, in which we
are asking about a variety of terms and phrases used in prescription
drug advertising that may or may not be relevant to all members of the
sample, behavioral intention questions would not be appropriate. The
drugs in question would not be relevant or salient for all consumers in
the study. For example, a respondent will be able to answer questions
about language used to describe migraine medication (e.g., #1
prescribed medication) even if they do not suffer from migraines.
However, it would not make sense to ask them about their behavioral
intentions related to taking that migraine medicine if they do not
suffer from migraines. Given the limitations of space and scope, we do
not plan to add more behavioral intentions measures into this study.
    (Comment 4) The comment suggested that some of the longer
contextual-based passages interviewees are presented with should
include situations in which viewers/listeners are presented with
previously seldom-used or new-to-the-public terms and phrases and an
attempt at definition or generation of emotional valence by marketers.
    (Response) The purpose of this study is for FDA to test
understanding of terms ``commonly used in prescription drug
promotion.'' Thus, those that have been ``previously seldom-used'' or
are ``new-to the-public'' are outside the scope of the study and are
not included in the survey materials.
    The idea to study emotional valence is very interesting, but also
beyond the scope of the current research.
    (Comment 5) The comment included a note on the PCP mail surveys:
Rather than focusing on incentivizing response via an object included
with the PCP mail surveys, the comment suggested that research funds
would be better spent ensuring the surveys are engaging, easily
understood by the two target audiences, short to complete, and
presented with a clear deadline.
    (Response) We believe we have the capacity both to incentivize the
response and to ensure the surveys are engaging. For example, we
specifically designed the advance mailings (letters that will go to
potential participants) to follow best practices for ensuring the study
is engaging, such as stating the purpose and likely outcomes of the
research in the letter and including a graphic to identify the study on
the postcard or envelope.
    Token incentives have been shown in the literature to have a real
impact on response rates (Refs. 1 and 2), and increased response rates
can save costs and potentially reduce nonresponse bias (if reluctant
respondents are different from non-reluctant respondents). In fact, the
literature has shown that even with short, engaging surveys, these
types of token incentives can substantially boost response rates (Refs.
10-12).
    (Comment 6) The comment suggested that the study population of
healthcare providers should be expanded to include specialists.
    (Response) While we understand that some of the topics may be
relevant for specialists, and we do often include specialists in our
research, our focus in the present research is on PCPs. Specialists are
not as numerous as PCPs, which makes them harder to recruit. In 2018,
for example, the proportion of specialists representing each specialty
area ranged from 2 percent (endocrinologists) to 11 percent
(psychiatrists and emergency medicine specialists) (Ref. 13). These
data demonstrate that the pool of potentially eligible specialists is
limited. Given the large required sample size for this study, we chose
to limit the population to PCPs.
    (Comment 7) The comment suggested that FDA should use additional
context for certain terms to more accurately represent the way in which
these terms are conveyed in promotion. Specifically, the comment
requested that FDA add context for the following terms:
    1. HCP assessment term of ``significant (as in statistically
significant)'': The comment stated that this term should be accompanied
by a 95 percent confidence interval, hazard ratio, and p-value as
additional data points.
    2. HCP and consumer assessment phrases ``manageable safety profile;
established safety profile; well-studied safety profile; ``well-
tolerated'': The comment stated that these phrases should be
accompanied by an example, such as a table showing most common adverse
events.
    (Response) Regarding the term ``significant (as in statistically
significant)'' and the suggestion to add additional data points:
Although references to statistical significance in the prescription
drug promotion marketplace are sometimes accompanied by other
statistical information, at other times they are not. In this
assessment, we wish to assess understanding of this phrase on its own.
    Regarding ``manageable safety profile'' and related phrases and the
suggestion to add an example such as a table showing most common
adverse events: Given the length of the current instruments, we are
limited in what can be included. The scope of this study includes terms
and phrases and not graphics or numbers. However, we recognize the
importance of studying those features as well. Examples of research
involving these features can be found on the OPDP research website,
linked earlier in this document.
    (Comment 8) The comment suggests that the following commonly used
terms should be added to the assessment to increase the utility,
quality and clarity of the information collected.
    For consumers and HCP, the comment suggested adding:
    1. ``Potent'' to assessment term ``powerful;'' and
    2. New assessment term ``convenient/straightforward/simple/easy/
easy to use.''
    For HCPs only, the comment suggested adding ``high affinity.''
    (Response) Thank you for these suggestions. We added ``potent,''
``convenient,'' ``straightforward,'' ``simple,'' ``easy'', and ``easy
to use'' to the surveys. For ``high affinity,'' we have conducted
several informal searches, but have not found sufficient examples of
the use of this term in promotional materials.
    (Comment 9) The comment noted that the surveys take terms and
phrases out of context and suggests that FDA should study how consumers
and PCPs interpret representative promotional pieces that include
appropriate accompanying context.
    (Response) This study is one in a program of related research
conducted by OPDP. In several related studies, we examine how consumers
and PCPs interpret the terms and phrases in representative promotional
pieces that include accompanying context. In contrast to this prior
research, the proposed research allows for assessment of a large number
of terms and phrases--effectively emphasizing breadth over depth, and
involving data collection from a nationally representative sample. We
believe these various approaches to studying language commonly used in
prescription drug promotion complement one another and together
contribute to a more comprehensive understanding of the research
questions.
    (Comment 10) The comment suggested that questions in the surveys
may be leading. In describing the proposed research, the 60-day notice
stated, ``For example, certain terms and

phrases, when used without additional contextual information, might
overstate the efficacy and minimize the risk of a product.'' The
comment stated that this statement shows bias that manifests in the
proposed questions and suggests that because the evident bias is deeply
rooted in this proposed study and its surveys, FDA should fundamentally
reformulate the proposed collection of information in its entirety.
    (Response) We agree that some of the probes proposed for use in the
Phase 1 research may appear to be leading, so we have rewritten these
probes. For example, where it said ``safer,'' we have altered language
to ``more'' or ``less'' safe.
    In the Phase 2 surveys, the safety and efficacy questions are not
leading or one-sided. The questions use bipolar response scales
allowing respondents to indicate that the products using that term are
less safe/effective, equally as safe/effective, or more safe/effective.
    (Comment 11) The comment suggested that the proposed answers in the
closed-ended surveys are unbalanced.
    (Response) We have reviewed the Phase 2 questions and made some
edits to ensure more balance.
    It is important to note that the response options shown for many of
the questions are just examples. The full list of response options used
in the Phase 2 surveys will be developed based on responses to the
Phase 1 interviews. As a result, the Phase 2 response options may skew
slightly negative or positive depending on what interview respondents
say in the Phase 1 interviews. However, we will ensure that there is
balance with both negative and positive response options.
    (Comment 12) The comment suggested that by asking respondents to
compare closely related terms and phrases, the survey may force
artificial findings of difference. The comment stated that even if the
measured differences are real (and not due to biases in the surveys),
it is unclear how the results would have any practical utility because
there may not be any objective definitions of the terms with which to
compare the results.
    (Response) We describe below the process to mitigate the effects of
this concern.
     If participants in the Phase 1 research do not articulate
differences between certain terms, we will exclude those terms from
Phase 2. This will reduce the chance to find artificial differences
between terms.
     We can also split question sets into multiple individual
questions. We will make decisions surrounding this solution following
completion of the Phase 1 interviews.
     For the consumer survey, which will be conducted online
only, we will randomize the order in which the terms are presented.
This will not eliminate context effects but will randomly distribute
any error across terms rather than significantly biasing an individual
term.
    (Comment 13) The comment opined that the surveys, at least in the
past, are unnecessarily duplicative of information otherwise reasonably
accessible to FDA (e.g., focus groups conducted by FDA in 2014; and
information available from third-party sources regarding the terms
``many,'' ``most,'' ``majority,'' ``some,'' and ``few'').
    (Response) We believe the research is not duplicative of that
conducted in 2014 by FDA, but instead builds on that research. It is
being conducted by the same research team and is part of a coherent
program of research that includes formative focus groups, in-depth
interviews, a survey, and an experimental study. We used those focus
group reports to inform the development of answer options for this
study. The very few terms that are repeated in the current survey have
been included in the current study because researchers wanted to follow
up on previous findings with a larger, nationally representative
sample. Furthermore, that study did not collect any quantitative data
on the terms.
    Literature searches in multiple medical, social science, and
linguistics databases, including Pubmed, Web of Science, EBSCO
Discovery Service, and Linguistics Database for research on how people
quantify or interpret terms like ``few'' and ``many'' as we do in the
present research did not reveal significant literature on these terms.
It is important for FDA to understand how these terms are interpreted
in the context of prescription drug promotion, thus we plan to keep
them in the current study.
    (Comment 14) A comment recommended that FDA remove questions about
the terms ``off-label'' and ``prescription drug promotion'' as they are
not terms used in promotion.
    (Response) While ``off label'' and ``prescription drug promotion''
are not terms that are typically used in promotion, it is important for
FDA to understand how healthcare providers perceive these terms in
general. We have revised the description of the scope in the Federal
Register notice to clarify this broader purpose. We now state: ``The
present research involves assessment of how consumers and primary care
physicians (PCPs) interpret terms and phrases commonly used in
prescription drug promotion, as well as those used to describe
prescription drugs and prescription drug promotion more generally.''
    (Comment 15) A comment recommended that FDA change the framing for
the survey from a focus on ``words or phrases that are commonly used in
prescription drug advertising'' to ``words or phrases that are commonly
used to describe prescription drugs.'' The comment suggested that if
the survey keeps the former, respondents will view the surveys through
whatever biases they have for drug advertising.
    (Response) Because it is our intention to examine what participants
think in the context of prescription drug advertising, we have retained
our original approach to framing the research, while also expanding
that framing to reference terms or phrases that are commonly used to
describe prescription drug promotion.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
          Activity               Number of     responses per    Total annual     Average  burden    Total hours
                                respondents     respondent        responses       per  response
----------------------------------------------------------------------------------------------------------------
                                               General Population
----------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes               85               1  85..............  0.083 (5                       7
 (assumes 35% eligible).                                                         minutes).
Phase 1: Number of completes              30               1  30..............  1...............              30
Phase 2: Screener completes            1,185               1  1,185...........  0.083 (5                      98
 (assumes 90% eligible).                                                         minutes).

Phase 2: Number of completes           1,067               1  1,067 + 10% \2\.  0.333 (20                    391
                                                              = 1,174.........   minutes).
----------------------------------------------------------------------------------------------------------------
                                                 PCP Population
----------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes              104               1  104.............  0.083 (5                       9
 (assumes 30% eligible).                                                         minutes).
Phase 1: Number of completes              30               1  30..............  1...............              30
Phase 2: Screener completes            1,180               1  1,180...........  0.083 (5                      98
 (assumes 90% eligible).                                                         minutes).
Phase 2: Number of completes           1,062               1  1,062 + 10% \2\   0.333 (20                    389
                                                               = 1,168.          minutes).
----------------------------------------------------------------------------------------------------------------
    Total...................  ..............  ..............  ................  ................           1,052
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of
  completing the survey when the target number is reached and that those surveys will be completed and received
  before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
  both samples in the study.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Bell, K., L. Clark, C. Fairhurst, et al, ``Enclosing A Pen
Reduced Time to Response to Questionnaire Mailings.'' Journal of
Clinical Epidemiology, 74:144-150, 2016.
2. Sharp, L., C. Cochran, S.C. Cotton, et al., ``Enclosing a Pen
with a Postal Questionnaire Can Significantly Increase the Response
Rate.'' Journal of Clinical Epidemiology, 59:747-754, 2006.
3. Bartlett, J.E., J.W. Kotrlik, and C.C. Higgins, ``Organizational
Research: Determining Appropriate Sample Size in Survey Research.''
Information Technology, Learning, and Performance Journal, 19:43-50,
2001.
4. Cochran, W.G. (1997), Sampling Techniques (3rd ed.). New York:
John Wiley & Sons.
5. Dillman, D.A., J.D. Smyth, and L.M. Christian (2014), internet,
Phone, Mail, and Mixed-mode Surveys: The Tailored Design Method (4th
Ed.). Hoboken, NJ: John Wiley & Sons, Inc.
6. Krejcie, R.V. and D.W. Morgan, ``Determining Sample Size for
Research Activities.'' Educational and Psychological Measurement,
30: 607-610, 1970.
7. *U.S. Census Bureau (2017), ``National Population by
Characteristics: 2010-2017.'' Retrieved from https://www.census.gov.
8. *Agency for Healthcare Research and Quality (2011), ``The Number
of Practicing Primary Care Physicians in the United States.''
Retrieved from http://www.ahrq.gov/research/findings/factsheets/primary/pcwork1/index.html.
9. *internet/Broadband Fact Sheet (2019), Pew Research Center.
Retrieved from https://www.pewresearch.org/internet/fact-sheet/internet-broadband.
10. Sanchez, R., Powell, R., and M. Kurtz (2019), ``Oh Look, Another
Pen! Incentive Effects and the Influence of Varying Non-Monetary
Incentives on Response Rate and Survey Completion.'' Presented at
the American Association for Public Opinion Research Conference,
Toronto, Ontario.
11. Stanley, M.V., Geisen, E., Olmsted, M.G., and J. J. Murphy
(2016, October), ``The Effects of Incentive Type on Response Rates
in a Survey of Physicians.'' Presented at Southern Association for
Public Opinion Research Conference, Raleigh, NC.
12. Beatty, P., Jamoom, E., and J. Hsiao (2014), ``Continuing
Experiments on Non-Monetary Incentive in Physician Surveys.''
Presented at the meeting of the American Association for Public
Opinion Research, Anaheim, CA.
13. *Kaiser Family Foundation (2018), ``Professionally Active
Specialist Physicians by Field.'' Retrieved from https://www.kff.org/other/state-indicator/physicians-by-specialty-area.

    Dated: September 14, 2020.
Lowell J. Schiller,

Principal Associate Commissioner for Policy.
[FR Doc. 2020-20621 Filed 9-17-20; 8:45 am]
BILLING CODE 4164-01-P


Elizabeth Kopits/DC/USEPA/US

03/06/2008 10:52 AM

To

Nathalie Simon/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS> cc

Al McGartland/DC/USEPA/US@EPA, Bryan Hubbell/RTP/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, <EMAIL_ADDRESS>Thomas Gillis/DC/USEPA/US@EPA

Subject

Re: NCEE comments on Ozone RIA (version submitted to OMB 2/29-3/5)

OK, thanks!

Nathalie Simon/DC/USEPA/US

03/06/2008 10:50 AM

To

Elizabeth Kopits/DC/USEPA/US@EPA

cc

Al McGartland/DC/USEPA/US@EPA, Bryan Hubbell/RTP/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, <EMAIL_ADDRESS>Thomas Gillis/DC/USEPA/US@EPA

Subject

Re: NCEE comments on Ozone RIA (version submitted to OMB 2/29-3/5)

Hi Elizabeth --

It is my understanding that given the concurrent nature of the review, we should share our comments with OMB as well.

Thanks.

Nathalie

***************************************************************

Nathalie B. Simon,  PhD

Associate Director

National Center for Environmental Economics

USEPA, Mail Code 1809T

1200 Pennsylvania Avenue, NW

Washington, DC  20460

ph:<PHONE_NUMBER>  fax:<PHONE_NUMBER>

**************************************************************

Elizabeth Kopits/DC/USEPA/US

03/06/2008 10:46 AM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Al McGartland/DC/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, <EMAIL_ADDRESS>Thomas Gillis/DC/USEPA/US@EPA, Bryan Hubbell/RTP/USEPA/US@EPA

Subject

NCEE comments on Ozone RIA (version submitted to OMB 2/29-3/5)

Hi Ron,

Here are NCEE's comments on the Ozone RIA (the most recent version of each chapter that has been sent to OMB).  The only chapter we have not read yet is Appendix 9B.  We will try to get our comments on that to you by early afternoon.  Also, our comments on the hybrid extrapolated cost methodology still reflect our views in yesterday's email exchange, since we have not had a chance to discuss your afternoon email yet.  We will get back to you on that shortly as well.

Since we are reviewing concurrently with OMB at this point, I assume it is OK to send these to Heidi and Rob too?

Thanks,

Elizabeth and Cynthia.


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16279-16280]
[FR Doc No: 2015-07020]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0205]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Broadway Bridge across the
Willamette River, mile 11.7, at Portland, OR. The deviation is
necessary to accommodate the Portland Race for the Roses event. This
deviation allows the bridge to remain in the down, or closed, position
to facilitate the safe movement of event participants across the
bridge.

DATES: This deviation is effective from 4 a.m. to 9:30 a.m. on April
19, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0205] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Multnomah County requested that the Broadway
Bascule Bridge remain closed to vessel traffic to facilitate the safe,
uninterrupted roadway passage of participants in the Portland Race for
the Roses event. The Broadway Bridge crosses the Willamette River at
mile 11.7 and provides 90 feet of vertical clearance above Columbia
River Datum 0.0 while in the closed-to-navigation position.
    Under normal conditions, this bridge operates in accordance with 33
CFR 117.897, which allows for the bridge to remain closed between 7
a.m. and 9 a.m. and 4 p.m. and 6 p.m. Monday through Friday and also
requires advance notification when a bridge opening is needed. This
deviation allows the bascule span of the Broadway Bridge across the
Willamette River, mile 11.7, to remain in the closed-to-navigation
position and need not open for maritime traffic from 4:00 a.m. to 9:30
a.m. April 19, 2015. The bridge shall operate in accordance to 33 CFR
117.897 at all other times. Waterway usage on this stretch of the
Willamette River includes vessels ranging from commercial tug and barge
to small pleasure craft.
    Vessels able to pass through the bridge in the closed positions may
do so at any time. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 23, 2015.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2015-07020 Filed 3-26-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Notices]
[Pages 7601-7602]
[FR Doc No: 2011-2949]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63831; File No. SR-CBOE-2011-011]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Modify the Fees Schedule for the CBOE Stock
Exchange

February 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''), \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 27, 2011, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the Fees Schedule for its CBOE
Stock Exchange (``CBSX''). The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.org/legal), at
the Exchange's Office of the Secretary, and at the Commission.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its CBSX Fees Schedule to modify the
CBSX regulatory fees. Currently, CBOE charges a $2,500 fee to CBSX
Trading Permit Holders who apply for CBOE to act as their designated
examining authority as well as $2,500 per month to CBSX Trading Permit
Holders for whom CBOE acts as the designated examining authority. To
offset an increase in the cost associated with processing these
applications and acting as the regulatory authority, the Exchange
proposes to raise the $2,500 fees to $3,000. The Exchange believes the
regulatory fees are appropriate and reasonable in that they help offset
costs incurred in connection with regulation of CBSX.
    The fee changes will become effective on February 1, 2011.
2. Statutory Basis
    Because the filing increases certain regulatory-related fees to
offset regulatory costs, the proposed rule change is consistent with
Section 6(b) of Act,\3\ in general, and furthers the objectives of
Section 6(b)(4) of the Act \4\ in particular, in that it is designed to
provide for the equitable allocation of reasonable dues, fees, and
other charges among CBOE members and other persons using its
facilities.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change is designated by the Exchange as
establishing or changing a due, fee, or

other charge, thereby qualifying for effectiveness on filing pursuant
to Section 19(b)(3)(A)(ii) of the Act \5\ and subparagraph (f)(2) of
Rule 19b-4 \6\ thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \6\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2011-011 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2011-011. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the CBOE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2011-011 and should be
submitted on or before March 3, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-2949 Filed 2-9-11; 8:45 am]
BILLING CODE 8011-01-P