[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31318-31323]
[FR Doc No: 2021-12265]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1261]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Disclosures
to Healthcare Providers Regarding Data That Do Not Support Unapproved
Use of an Approved Prescription Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.

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 ``Study of Disclosures to Healthcare
Providers Regarding Data That Do Not Support Unapproved Use of an
Approved Prescription Drug.'' 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>
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.

Study of Disclosures to Healthcare Providers Regarding Data That Do Not
Support Unapproved Use of an Approved Prescription Drug

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's) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. 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 the first two topic areas: Advertising
features and target populations.
    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 revised draft guidance entitled ``Distributing Scientific and
Medical Publications on Unapproved New Uses--Recommended Practices''
(2014; Ref. 1),\1\ recommends that scientific and medical journal
articles that discuss unapproved uses of approved drug products be
disseminated with a representative publication that reaches contrary or
different conclusions, when such information exists. Similarly, the
draft guidance entitled ``Responding to Unsolicited Requests for Off-
Label Information About Prescription Drugs and Medical Devices'' (2011;
Ref. 2) \1\ recommends that when conclusions of articles or texts that
are disseminated in response to an unsolicited request have been
specifically called into question by other articles or texts, a firm
should disseminate representative publications that reach contrary or
different conclusions regarding the use at issue.
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    \1\ When final, this guidance will represent the FDA's current
thinking on this topic.
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    Pharmaceutical firms sometimes choose to disseminate publications
to healthcare providers (HCPs) that include data that appear to support
an unapproved use of an approved product. At the same time, published
data that are not supportive of that unapproved use may also exist. For
example, unsupportive published information could describe an increased
risk of negative outcomes (e.g., death, relapse) from the unapproved
use of the approved product, suggesting that the unapproved use does
not have a positive benefit-risk ratio. The purpose of this research is
to examine physicians' perceptions and behavioral intentions about an
unapproved new use of an approved prescription drug when made aware of
other data that are not supportive of the unapproved use. This research
will also evaluate the effectiveness of various disclosure approaches
for communicating the unsupportive information. We will use the results
of this research to better understand: (1) Physicians' perceptions of
an unapproved use of a prescription drug; (2) physicians' perceptions
about an unapproved use of an approved prescription drug when they are
aware of the existence of unsupportive information about it; (3)
physicians' perceptions of disclosures referencing the existence of
unsupportive information about that particular use; and (4) to examine
the utility and effectiveness of various approaches to the
communication of this information. In particular, we plan to examine
how different approaches to the communication of unsupportive
information affect physicians' thoughts and attitudes about the
unapproved use. Five approaches will be examined: (1) The provision of
the unsupportive data in the form of a representative publication; (2)
a disclosure that summarizes, rather than provides, the unsupportive
data and includes a citation to the representative publication; (3) a
disclosure that does not provide or include a summary of the
unsupportive data but does acknowledge that unsupportive data exist and
includes a citation to the representative publication; (4) a general
disclosure that does not provide or include a summary of the
unsupportive data but acknowledges unsupportive data may exist, without
conceding that such data do exist; or (5) nothing--the absence of any
presentation of unsupportive data or any disclosure about such data
(control condition). We have four research questions:
    RQ1: When considering a presentation of data about an unapproved
use of an approved drug product, how does the existence of unsupportive
data impact physicians'

perceptions and intentions with regard to that unapproved use?
    RQ2: How does the way in which the existence of unsupportive data
is communicated, when the specific data is not presented, impact
physicians' perceptions and intentions with regard to an unapproved use
of an approved drug product?
    RQ3: How are physicians' perceptions of and intentions toward an
unapproved use of an approved drug product affected by the disclosure
of specific unsupportive data versus disclosure statements about data
that is not presented?
    RQ4: Do other variables (e.g., demographics) have an impact on
these effects? These research questions will be examined in two medical
conditions.
    We plan to conduct one pretest with 180 voluntary adult
participants and one main study with 1,600 voluntary adult
participants. Participants in the main study will be 510 oncologists in
the oncology medical condition and 1,090 primary care physicians in the
insomnia \2\ medical condition. All participants will be physicians who
engage in patient care at least 50 percent of the time and do not work
for a pharmaceutical company, marketing firm, or the Department of
Health and Human Services. The gender, race/ethnicity, and ages of the
participating physicians will be self-identified by participants. We
will aim to include a mix of demographic segments to ensure a diversity
of viewpoints and backgrounds. Power analyses were conducted to ensure
adequate sample sizes to detect small to medium effects.
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    \2\ This medical condition was changed from diabetes to insomnia
based on cognitive testing.
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    The studies will be conducted online. The pretest and main studies
will have the same design and will follow the same procedure. The base
stimulus in both the pretest and main studies will consist of a sample
publication supporting an unapproved use of an approved drug product.
Within each medical condition, participants will be randomly assigned
to one of five test conditions (see figure 1). Following exposure to
the stimuli, they will be asked to complete a questionnaire that
assesses comprehension, perceptions, prescribing intentions, and
demographics. In the pretest, participants will also answer questions
about the study design and questionnaire.

                                                                 Figure 1--Study Design
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                                                                                Accompanied by
                                                                  Accompanied by        disclosure that
                                           Accompanied by        disclosure with       unsupportive data        Accompanied by
                                           representative           summary of       exist and including a    general disclosure      No disclosure or
                                          publication with    unsupportive data and    citation for that      that unsupportive        material about
                                         unsupportive data     including a citation   data, but without a   data may exist and no    unsupportive data
                                                                  for that data          summary of the            citation
                                                                                unsupportive data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Condition 1
Medical Condition 2
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    In the Federal Register of July 6, 2020 (85 FR 40300), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two submissions that were PRA-
related. Within these submissions FDA received multiple comments that
the Agency has addressed below. For brevity, some public comments are
paraphrased and, therefore, may not include the exact language used by
the commenter. We assure commenters that the entirety of their comments
was considered even if not fully captured by our paraphrasing in this
document. The following acronyms are used here: HCP = healthcare
provider; FDA and ``The Agency'' = Food and Drug Administration; OPDP =
FDA's Office of Prescription Drug Promotion.
    (Comment 1) One comment asserted that FDA has not made the stimuli
available for public comment and requested FDA publish a new 60-day
notice after these comments have been addressed to give the public
another opportunity to review and comment.
    (Response 1) We have provided the purpose of the study, the design,
the population of interest, and the questionnaire to individuals upon
request. These materials have proven sufficient for public comment and
for academic experts to peer review the study successfully. Our full
stimuli are under development during the PRA process. We do not make
draft stimuli public during this time because of concerns that this may
contaminate our participant pool and compromise the research.
    (Comment 2) One comment suggested that due to the task of reading
the ``scientific publication'' stimuli and length of the questionnaire,
FDA's estimation of the time it will take to complete the study is too
low, and thus the burden of the information collection is inaccurate.
    (Response 2) The scientific ``publications'' in this study are each
formatted as a one-page brief report. The text is presented in two
columns and has the following headings: Introduction, Methods, Results,
Discussion, and Limitations. The survey contains primarily closed-ended
questions with Likert scales, and there are five open-ended questions.
The expected time for the study is based on our prior experience
conducting studies using similar protocols. We will also test the time
during the pretest to ensure we stay within 20 minutes. If we determine
the average time for completing the survey is greater than 20 minutes,
we will revise the survey prior to fielding the main study.
    (Comment 3) One comment asserts this proposed study overlaps with
other OPDP research currently in progress and references several
studies.
    (Response 3) OPDP may conduct concurrent or overlapping studies on
similar topics. While the studies referenced by the comment contribute
to the evidence base for prescription drug promotion, prior studies had
a different focus than the current study. Prior disclosure studies
examined the effectiveness of disclosures in increasing understanding
of efficacy claims (``Disclosures in Professional and Consumer
Prescription Drug Promotion'') and the role of disclosures in
mitigating potentially misleading presentations of preliminary or
descriptive data about oncology drugs (``Disclosures of Descriptive

Presentations in Professional Oncology Prescription Drug Promotion'').
The third study mentioned by the comment (``Physician Interpretation of
Information About Prescription Drugs in Scientific Publications vs.
Promotional Pieces'') investigates how physician perception of
professional prescription drug communications is influenced by
variations in information context, methodologic rigor of the clinical
study, and time pressure.
    The current study uses an experimental design to compare various
disclosure approaches for communicating unsupportive information about
an unapproved new use. The findings of this study will help inform
FDA's understanding about when disclosures about unsupportive data
might be useful and what types of information should be included.
    (Comment 4) One comment expressed concern that the way in which the
proposed research is described in the notice suggests that
pharmaceutical firms disseminate supportive data but do not adequately
disclose unsupportive data and that this ``implied bias'' may taint the
collection and interpretation of the data.
    (Response 4) The sentences referred to in this comment appear in
the Federal Register notices for the study to provide background and do
not suggest that any firms are not following the recommendations in the
two guidance documents referenced in that same background section.
Rather, the background outlines the current FDA recommendations around
disclosure of unsupportive data with these types of communications and
the intent of the study to evaluate alternative approaches to the
disclosure of unsupportive data. These background statements are not
part of the materials that will be provided to study participants.
Rather, study instructions tell participants only that they will be
reviewing informational material about a prescription drug. No
instructional materials provided to participants mention a
pharmaceutical manufacturer. Therefore, we do not believe the
collection and interpretation of study findings will be tainted or
biased.
    (Comment 5) One comment suggested deleting or amending all
questions about HCPs' prescribing decisions (Questions 4, 5, 10, 11, 14
to 23) because these decisions are likely to be influenced by many
factors and are outside of FDA's jurisdiction. This comment also
asserted Question 10 is biased and worded to suggest that
pharmaceutical firms disseminate supportive data but do not adequately
disclose unsupportive data and suggests deleting or amending the
question.
    (Response 5) As explained earlier, the Public Health Service Act
authorizes FDA to conduct research relating to health information, and
the FD&C Act authorizes FDA to conduct research relating to drugs and
other FDA-regulated products in carrying out the provisions of the FD&C
Act. The purpose of the current experimental study is to examine
physicians' perceptions and behavioral intentions about an unapproved
new use of an approved prescription drug when made aware of other data
that are not supportive of the unapproved use and to evaluate the
effectiveness of various disclosure approaches for communicating the
unsupportive information. The study is within FDA's authority, and it
will help to inform OPDP's work to help ensure that prescription drug
information is truthful, balanced, and accurately communicated so that
HCPs and consumers can make informed decisions.
    Questions 4 and 5 were intended to assess the impact of various
disclosure manipulations on hypothetical prescribing decisions.
Measuring behavioral intention is a common method of assessing
knowledge and attitudes. There is substantial theoretical and empirical
support for our approach, and strong behavioral intention has been
shown to be predictive across a wide range of behaviors, including
prescribing (Refs. 3 to 5). Based on the results of cognitive
interviews, we have revised the measurement of behavioral intention to
the following: ``If you were considering prescribing [DRUG] to a
patient with [DISEASE], how important would the information in the
[DISPLAY FILL] be in your decision making?''
    Questions 14 to 23 provide important information to address the
research questions for this study, including sources of information for
studies that do not support an off-label use as well as what aspects of
the study would be most important to prescribers.
    Questions 10 and 11 are intended to evaluate whether there is
enough information for the participants to make a prescribing decision
based on the information in the brief study report and disclosure
condition, not to assess the adequacy of pharmaceutical firms'
disclosure of unsupportive data generally. Pharmaceutical firms are not
referenced in any study materials, and these questions do not imply
anything about their dissemination activities.
    (Comment 6) One comment recommended that the stimuli used to
represent publications that reach contrary or different conclusions
regarding the unapproved use be held to the same standards as the
publication about the unapproved use. The comment suggests that this
should include being considered scientifically sound by experts with
scientific training and expertise to evaluate the safety or
effectiveness of the drug or device.
    (Response 6) Both the supportive and unsupportive data provided to
study participants either in the form of publications or summary
information were reviewed by FDA experts with the requisite scientific
training and experience to ensure they are appropriate, realistic, and
of similar quality.
    (Comment 7) One comment recommended that the disclosure summary
include specific information about the study design (i.e., study
population and control group, key clinical endpoints (patient
outcomes)), statistical significance (i.e., 95 percent confidence
interval (CI), hazard ratio (HR) and p value) and other key data needed
to determine benefit-risk ratio, and to include the product
manufacturer and study sponsor.
    (Response 7) The proposed experimental study design includes five
conditions to examine disclosure approaches for communicating
unsupportive information. One of the five conditions provides study
details as recommended by the comment. The other conditions have
varying levels of detail about the unsupportive information about the
unapproved new use of the prescription drug. There is also a control
condition. We have purposely omitted the product manufacturer and study
sponsor, as we know from other research this may unduly influence
physicians' beliefs about the quality of the study (Ref. 6).
    (Comment 8) One comment suggested the disclosure correlate with the
unapproved use described in the brief study report.
    (Response 8) We agree with this point. The disclosure and
unsupportive data provided to participants are relevant to the
unapproved use information participants initially review.
    (Comment 9) One comment suggested including hyperlinks to a
citation for the data and including a representative publication with
unsupportive data. This comment also suggested keeping track of how
many study participants utilize the hyperlink.
    (Response 9) We developed the stimuli for this study using
information from multiple scientific publications. Thus, the content
does not represent one particular study, and we are unable

to provide hyperlinks. The revised design suggested in the comment may
be a good suggestion for future research.
    Several comments suggested changes to the proposed questionnaire.
    (Comment 10) One comment suggested the instructions and lack of a
``don't know'' response option may lead to forced guessing, which may
undermine the utility of the study.
    (Response 10) We have deleted Question 10 and revised Question 11
to read, ``What additional information, if any, did you need in order
to consider prescribing [DRUG] for [DISEASE]?'' and deleted the
instructions to ``give us your best guess on answers you do not know.''
    (Comment 11) One comment recommends FDA focus on HCPs'
understanding of the data rather than asking about HCPs' preference for
receiving information (Q19 and Q20).
    (Response 11) In response to the comment, we have removed Questions
19 and 20 from the survey. Question 3 (now Q4) assesses physician
understanding of the disclosure.
    (Comment 12) One comment suggested deleting or revising Questions 6
and 9 because outside influences could skew the results.
    (Response 12) We are examining the impact of the various levels of
information disclosure on participants' ratings of how informative they
find the information and how likely they would be to search for
additional information about the drug. Participants will be randomly
assigned to a condition, and any individual differences or potential
biases should be spread across experimental conditions. Thus, if we
find differences between and among conditions, we can be reasonably
certain that the study manipulations caused the differences. In
consideration of this comment and feedback from peer reviewers, we have
revised Question 6 (now Q7) to read, ``If you were considering
prescribing [DRUG] for [DISEASE], how useful would the information
[DISPLAY FILL] be?''
    (Comment 13) One comment suggested deleting or revising Question 8
because it is unclear what it means for information to be ``credible''
in this context, and assessing credibility is very subjective.
    (Response 13) To clarify, this question reads, ``How credible is
the information presented [DISPLAY FILL]?'' where [DISPLAY FILL] in
Condition 1 is ``on page 2,'' in Conditions 2, 3, and 4 is the text of
the disclosure condition to which they have been assigned, and in
Condition 5 is ``the material.'' Thus, the information on which
participants are being asked to give their opinion is specified. This
question has been used in other studies without difficulty. Cognitive
testing did not identify any difficulty with respondents' understanding
of ``credible'' in this context.
    (Comment 14) One comment suggested amending questions that are
worded ``contradict or do not support'' because physicians may view a
lack of support (inconclusive findings) as different from contradictory
findings.
    (Response 14) We did not intend for ``do not support'' to mean that
the findings are inconclusive, although we acknowledge that it could be
interpreted in such a way. Our intention was to refer to any findings
that do not support the off-label use, such as findings that the drug
is not effective for the off-label use or had increased risks. We
explored potential confusion by asking separate questions on the
concepts of ``contradict'' and ``inconclusive'' in cognitive testing.
Cognitive testing suggested that respondents generally considered
``findings that contradict'' and ``findings that have inconclusive
support'' to be very similar concepts. While respondents agreed that
the two were technically distinct, they tended to assess the two
similarly in this context. To gather additional empirical data, we will
retain these as separate items in the pretest.
    (Comment 15) One comment suggests many of the questions use
unbalanced answer scales and recommends the answer scales should be
balanced. For example, it may be difficult for participants to
distinguish between ``A little'' and ``Somewhat'' or ``Very'' and
``Extremely.'' Relatedly, the positive and negative options are not
necessarily opposites (e.g., ``Agree'' or ``Disagree'') or parallel in
intensity (e.g., ``Strongly Agree'' or ``Strongly Disagree'').
    (Response 15) We are not using a bipolar scale measuring opposites.
Bipolar scales are typically used when there are two opposing
possibilities (e.g., ``Strongly Agree'' or ``Strongly Disagree''). We
chose a unipolar scale (e.g., ``not at all important'' to ``extremely
important'') because the questions are asking about the relative
presence or absence of a quality. In the case of usefulness, for
instance, it makes more sense for the scale to begin with the absence
of usefulness (``not at all useful'') rather than the opposite of
usefulness (``extremely useless''). By beginning with ``Not at all,''
the order of the scale balances out the unidimensional nature of the
question (Ref. 7). In fact, a key advantage of a unipolar scale is that
it does not depend on defining opposites. The scale labels (i.e., ``Not
at all,'' ``A little,'' ``Somewhat,'' ``Very,'' and ``Extremely'') have
been tested in multiple studies, and evidence shows that participants
are able to distinguish between the response options (see, for example,
Ref. 8).
    (Comment 16) One comment expressed a lack of clarity on how
Question 3 could yield interpretable responses and recommended
replacing this open-ended question with closed-ended questions.
    (Response 16) Open-ended items are often used when the intention is
to understand respondents' comprehension (Ref. 9). By asking
respondents to rephrase the disclosure in their own words (as if
explaining to a colleague), we can assess whether respondents
understand the disclosure language as intended (Ref. 10). The responses
to open-ended items are qualitative data and will be analyzed to assess
what respondents feel to be key information (information included in
their summary), what they feel is extraneous information (information
not included in their summary), and any information that is confusing
or unclear (information summarized incorrectly in the summary).
    (Comment 17) One comment suggested adding the following questions
to the questionnaire:
    1. How often do you research and study off-label uses of approved
drugs in a given week? With possible answer choices being ``never,
rarely, occasionally, frequently.''
    2. How often are drug products used off-label in your practice?
With possible answer choices being ``never, rarely, occasionally,
frequently.''
    3. Would you prescribe this drug for (unapproved use of an approved
drug product)? With possible answer choices being: ``yes, no, need more
information.''
    (Response 17) For the first suggested question, we currently assess
frequency of prescribing a drug off label (Q14) and the sources used to
learn about off-label uses (old Q15 and old Q16, now Q17, Q18, and
Q19). We think this combination of questions adequately covers the
concept of how often participants prescribe and look for information
about off-label uses. Regarding the response choices, the timeframe of
a week is very narrow, and would be difficult to answer for those who
prescribe off-label infrequently (e.g., a few times a year). In
response to the comment and external peer review comment, we have
revised response options for Q14 to be more specific (once a week or
more often, several times each month, several times each

year, less than once a year, have never prescribed a drug for an off-
label use).
    For the second suggestion, we agree that the frequency of
prescribing within the practice would be useful to capture and have
added a question to measure this. No difficulties were identified with
this question during cognitive testing.
    For the third suggestion, we agree that this would be a useful
measure. In response to this comment and peer review, we have revised
the questionnaire to ask about prescribing likelihood for the specific
off-label use.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
                   Activity                        Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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Pretest screener..............................             290               1             290  0.08 (5 minutes)........................              23
Pretest completes.............................             180               1             180  0.33 (20 minutes).......................              59
Main study screener...........................           2,526               1           2,526  0.08 (5 minutes)........................             202
Main study completes, Medical Condition 1.....             510               1             510  0.33 (20 minutes).......................             168
Main study completes, Medical Condition 2.....           1,090               1           1,090  0.33 (20 minutes).......................             360
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................           1,600  ..............  ..............  ........................................             812
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500 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. ``Distributing Scientific and Medical Publications on Unapproved
New Uses--Recommended Practices--Revised Draft Guidance,'' 2014.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf.
*2. ``Responding to Unsolicited Requests for Off-Label Information
About Prescription Drugs and Medical Devices Draft Guidance,'' 2011.
https://www.fda.gov/media/82660/download.
3. Ajzen, I. 1985. ``From Intentions to Actions: A Theory of Planned
Behavior.'' In: Action Control: From Cognition to Behavior, edited
by J. Kuhl and J. Beckmann, pp. 11-39. Berlin, Heidelber, New York:
Springer-Verlag.
4. Murshid, M.A. and Z. Mohaidin. 2017. ``Models and Theories of
Prescribing Decisions: A Review and Suggested a New Model.''
Pharmacy Practice, 15(2), 990.
*5. Sable M.R., L.R. Schwartz, P.J. Kelly, et al. 2006. ``Using the
Theory of Reasoned Action to Explain Physician Intention to
Prescribe Emergency Contraception.'' Perspectives on Sexual and
Reproductive Health, 38(1), pp. 20-27. https://www.guttmacher.org/journals/psrh/2006/using-theory-reasoned-action-explain-physician-intention-prescribe.
6. Kesselheim, A.S., C.T. Robertson, J.A. Myers, et al. 2012. ``A
Randomized Study of How Physicians Interpret Research Funding
Disclosures.'' New England Journal of Medicine, 367(12), pp. 1119-
1127.
7. Schaeffer, N.C. and S. Presser. 2003. ``The Science of Asking
Questions.'' Annual Review of Sociology, 29.
8. Fox, J., M. Earp, and R. Kaplan. 2020. ``Item Scale
Performance.'' 75th Annual American Association for Public Opinion
Research Virtual Conference.
9. Ozuru, Y., S. Briner, C.A. Kurby, et al. 2013. ``Comparing
Comprehension Measured by Multiple-Choice and Open-Ended Questions.
Canadian Journal of Experimental Psychology = Revue canadienne de
psychologie experimentale, 67(3), pp. 215-227.
10. Tanur, J.M. (Ed.). 1992. Questions About Questions: Inquiries
Into the Cognitive Bases of Surveys. Russell Sage Foundation.

    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12265 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Rules and Regulations]
[Pages 38617-38620]
[FR Doc No: 2015-16181]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-2434; Directorate Identifier 2015-CE-023-AD;
Amendment 39-18196; AD 2015-13-09]
RIN 2120-AA64

Airworthiness Directives; Piper Aircraft, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Piper Aircraft, Inc. Models PA-46-350P and PA-46-500TP airplanes. This
AD requires installing cable ties around the cabin altitude encoder and
the supporting structure, adding thread-locking compound to the threads
of the existing single fastener; and repetitively inspecting the cable
ties and the fastener to ensure security and proper condition. This AD
was prompted by a report that a cabin altitude encoder came free from
its mounting bracket, which interfered with motion of the elevator
flight control. We are issuing this AD to correct the unsafe condition
on these products.

DATES: This AD is effective July 13, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 13,
2015.
    We must receive comments on this AD by August 21, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-

30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    For service information identified in this AD, contact Piper
Aircraft, Inc., 2926 Piper Drive, Vero Beach, Florida 32960; telephone:
(877) 879-0275; email<EMAIL_ADDRESS>Internet:
www.piper.com. You may review this referenced service information at
the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
2434.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
2434; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gregory ``Keith'' Noles, Aerospace
Engineer, FAA, Atlanta Aircraft Certification Office (ACO), 1701
Columbia Avenue, College Park, Georgia 30337; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received a report that a Piper Aircraft, Inc. (Piper) Model PA-
46-500TP airplane experienced a pitch control system problem that
resulted in a limited ability to control the elevator. The pilot was
able to land the aircraft safely with a combination of primary pitch
control and pitch trim. Initial speculation was that this was an
installation error.
    Follow-on investigation revealed that a Garmin avionics box
installed behind the instrument panel had fallen down on the elevator
control sector adjacent to the column and jammed the primary pitch
control. The box is the cabin altitude encoder and is installed upside
down above the elevator control sector. This configuration was
introduced in December 2014 as part of a type design change to Piper
Model PA-46-500TP airplanes. A similar configuration was also
introduced on the PA-46-350P through a type design change. The box is
installed with one fastener with no locking features. The one fastener
uses a knurled nut that is also installed upside down. Vibration and
low installation torque could easily cause the nut to come loose. The
reported airplane had only 12 hours time in service.
    This condition, if not corrected, could result in loss of control.
We are issuing this AD to correct the unsafe condition on these
products.

Related Service Information Under 1 CFR Part 51

    We reviewed Piper Aircraft, Inc. Mandatory Service Bulletin No.
1283, dated June 12, 2015. The service bulletin describes procedures
for installing cable ties around the avionics box and the supporting
structure; repetitively inspecting the cable ties and the knurled nut
to ensure security and proper condition; and applying thread-locking
compound to the knurled nut to ensure proper security. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this AD.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information described previously.

Differences Between the AD and the Service Information

    Piper Aircraft, Inc. Mandatory Service Bulletin No. 1283, dated
June 12, 2015, includes more airplane serial numbers than we have
included in this AD. The cabin altitude encoders on the airplanes for
the additional serial numbers affected in the service bulletin use a
similar installation, but are located and oriented differently so that
they do not create the unsafe condition. Piper is working on a
permanent modification to incorporate on all airplanes affected by the
service bulletin.

Interim Action

    We consider this AD interim action. The design approval holder is
currently developing a modification to correct the unsafe condition
identified in this AD. Once this modification is developed, approved,
and available, we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because if
the cabin altitude encoder mouting becomes loose and intereferes with
the elevator control system, this could result in loss of control.
Therefore, we find that notice and opportunity for prior public comment
are impracticable and that good cause exists for making this amendment
effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2015-2434 and
Directorate Identifier 2015-CE-023-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 28 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                    Labor cost             Parts cost             product        operators
----------------------------------------------------------------------------------------------------------------
Modify the encoder mounting        1 work-hour x $85    $10.....................             $95          $2,660
 installation by installing 2       per hour = $85.
 cable ties and thread-locking
 compound.
Inspect the encoder mounting       1 work-hour x $85    Not applicable..........              85           2,389
 installation to verify proper      per hour = $85
 condition and security of the      (per inspection
 cable ties and security of the     cycle).
 knurled nut.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements/
repairs that will be required based on the results of the inspection.
We have no way of determining the number of aircraft that might need
these replacements/repairs:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace cable ties and/or apply thread-locking  1 work-hour x $85 per hour = $85             $10             $95
 compound.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-13-09 Piper Aircraft, Inc.: Amendment 39-18196; Docket No. FAA-
2015-2434; Directorate Identifier 2015-CE-023-AD.

(a) Effective Date

    This AD is effective July 13, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Piper Aircraft, Inc. airplanes,
certificated in any category, as identified in table 1 of paragraph
(c) of this AD:

           Table 1 of Paragraph (c) of This AD--Applicability
------------------------------------------------------------------------
                 Model                             Serial No.
------------------------------------------------------------------------
PA-46-350P............................  4636652 through 4636662.
PA-46-500TP...........................  4697549, 4697569, 4697582
                                         through 4697591, 4697593
                                         through 4697595, 4697597, and
                                         4697598.
------------------------------------------------------------------------

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2130, Cabin Pressure Control System.

(e) Unsafe Condition

    This AD was prompted by a report that a cabin altitude encoder
came free from its mounting bracket, which interfered with motion of
the elevator flight control. This condition, if not prevented, could
result in loss of control. We are issuing this AD to correct the
unsafe condition on these products.

(f) Compliance

    Comply with this AD as specified in paragraphs (g) and (h) of
this AD, including all subparagraphs, unless already done.

(g) Modification

    Do one of the following in paragraphs (g)(1) or (g)(2) of this
AD:
    (1) Before further flight after July 13, 2015 (the effective
date of this AD), modify the encoder mounting installation by
installing two cable ties and adding thread-locking compound to the
knurled holddown nut. Do the modification following Part I of Piper
Aircraft, Inc. Mandatory Service Bulletin No. 1283, dated June 12,
2015.
    (2) Before each flight after July 13, 2015 (the effective date
of this AD) do a pre-flight security check by grasping the knurled
holddown nut with a bare hand and verifying that the nut is tight
and secure. Within the next 10 hours time-in-service after July 13,
2015 (the effective date of this AD), you must do the modification
required in paragraph (g)(1) of this AD.

    (i) The pre-flight security check required in paragraph (g)(2)
of this AD may be performed by the owner/operator holding at least a
private pilot certificate as authorized by section 43.7 of the
Federal Aviation Regulations (14 CFR 43.7), and must be entered into
the aircraft records showing compliance with this AD in accordance
with section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).

    Note 1 to paragraph (g)(2)(i):  Piper Aircraft, Inc. Mandatory
Service Bulletin No. 1283, dated June 12, 2015, which is
incorporated by reference in this AD, includes pictures for
accessing and locating the cabin altitude encoder and can be used as
guidance for performing this preflight check. See paragraphs (l)(3)
and (l)(4) for the availability of this service information.

    (ii) The pre-flight security check required in paragraph (g)(2)
of this AD is no longer necessary after the modification required by
either paragraph (g)(1) or (g)(2) of this AD.

(h) Inspection

    Within 50 hours TIS after doing the modification required in
paragraph (g)(1) or (g)(2) of this AD and repetitively thereafter
not to exceed 50 hours TIS, inspect the encoder mounting
installation to verify the proper condition and security of the
cable ties and the security of the knurled holddown nut. Do the
inspection following Part II of Piper Aircraft, Inc. Mandatory
Service Bulletin No. 1283, dated June 12, 2015.
    (1) If the cable ties are found to not be properly secure or are
not in proper condition during the inspection required in paragraph
(h) of this AD, before further flight, replace with new cable ties
following Part I of Piper Aircraft, Inc. Mandatory Service Bulletin
No. 1283, dated June 12, 2015.
    (2) If the knurled holddown nut is found to not be properly
secure during the inspection required in paragraph (h) of this AD,
before further flight, apply thread-locking compound following Part
I of Piper Aircraft, Inc. Mandatory Service Bulletin No. 1283, dated
June 12, 2015.

(i) Special Flight Permit

    Special flight permits are permitted with the following
limitation: The pre-flight security check required in paragraph
(g)(2) of this AD must be done.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Gregory ``Keith''
Noles, Aerospace Engineer, FAA, Atlanta ACO, 1701 Columbia Avenue,
College Park, Georgia 30337; phone:<PHONE_NUMBER>; fax: (404) 474-
5606; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Piper Aircraft, Inc. Mandatory Service Bulletin No. 1283,
dated June 12, 2015.
    (ii) Reserved.
    (3) For Piper Aircraft, Inc. service information identified in
this AD, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach,
Florida 32960; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: www.piper.com.
    (4) You may view this service information at FAA, FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on June 24, 2015.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2015-16181 Filed 7-6-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Rules and Regulations]
[Pages 20461-20466]
[FR Doc No: 2013-07980]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0139; FRL-9381-7]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flumioxazin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 5, 2013. Objections and
requests for hearings must be received on or before June 4, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0139, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0139 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 4, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0139, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 2E7982)
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.568 be amended by establishing
tolerances for residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-
dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-
tetrahydro-1H-isoindole-1,3(2H)-dione, in or on artichoke at 0.02 parts
per million (ppm); cabbage and Chinese cabbage (tight-headed varieties
only) at 0.02 ppm; olives, and olive oil at 0.02 ppm; pomegranate at
0.02 ppm; cactus fruit at 0.1 ppm, and cactus pads at 0.05 ppm. That
document referenced a summary of the petition prepared by Valent U.S.A.
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established for some
commodities. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.* *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flumioxazin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flumioxazin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity,

completeness, and reliability as well as the relationship of the
results of the studies to human risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.
    In general, flumioxazin has mild or low acute toxicity. Also, the
subchronic and chronic toxicity studies demonstrated that toxic effects
associated with flumioxazin include anemia as well as effects on the
liver and the cardiovascular system. Developmental effects were
observed in developmental rat studies but not in developmental rabbit
studies. Hematologic (hematopoietic) effects of anemia were noted in
rats, consisting of alterations in hemoglobin parameters. Increased
renal toxicity in male rats was also reported following chronic
exposure. There is no evidence of neurotoxicity or immunotoxicity in
the recently submitted guideline studies. Increased quantitative
susceptibility was seen in the rat developmental toxicity studies.
Fetal effects were observed in the absence of maternal toxicity. In
addition, both increased qualitative and quantitative susceptibility
were observed in the rat reproduction study. Severe fetal effects were
observed at lower doses than milder parental effects. In most of the
available mutagenicity studies, flumioxazin was negative for
mutagenicity; however, aberrations were seen in a chromosomal
aberration assay (CHO cells). Based on the lack of evidence of
carcinogenicity in mice and rats, flumioxazin is classified as ``not
likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0139 on pages
43-48 of the document titled ``Flumioxazin. Human Health Risk
Assessment for the Proposed Uses on Artichoke, Cabbage, Olive,
Pomegranate, and Prickly Pear Cactus''.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flumioxazin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 21, 2012 (77 FR 58493)
(FRL-9358-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR
180.568. EPA assessed dietary exposures from flumioxazin in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for flumioxazin. In estimating acute
dietary exposure, EPA used food consumption information from the U.S.
Department of Agriculture's National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA) from 2003-2008. As to
residue levels in food, EPA assumed tolerance level residues and 100
percent crop treated (PCT) for all proposed and registered commodities.
In addition, EPA used default concentration factors to estimate
residues of flumioxazin in processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA from 2003-2008. As to residue levels in food, EPA assumed
tolerance level residues and 100 PCT for all proposed and registered
commodities. In addition, EPA used default concentration factors to
estimate residues of flumioxazin in processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flumioxazin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flumioxazin. Tolerance level residues and 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. In the environment
flumioxazin photodegrades very rapidly in water and on soil.
Concentrations of flumioxazin and its major degradates (482-HA, APF,
and THPA) are expected to be found in water; however, flumioxazin and
the metabolites 482-HA and APF have been identified as the residues of
concern in drinking water.
    To estimate concentrations of flumioxazin including its major
degradates of concern (482-HA and APF) in ground water, the Agency used
a screening level water exposure model in the dietary exposure analysis
and risk assessment. This simulation model took into account data on
the physical, chemical, and fate/transport characteristics of
flumioxazin. Since this chemical is currently registered for direct
applications to water, surface water estimates are based on the use of
flumioxazin as an aquatic herbicide where a maximum 400 parts per
billion (ppb) concentration is maintained. Hydrolysis is considered the
major route of dissipation for flumioxazin in the environment and the
levels of degradates (482-HA and APF) increase continuously with time.
    Based on the Screening Concentration in Ground Water (SCI-GROW)
model the estimated drinking water concentrations (EDWCs) for both
acute and chronic exposures of 482-HA and APF are estimated to be 45.27
ppb and 2.66 ppb, respectively, in ground water. EDWCs of parent
flumioxazin are estimated to be negligible in ground water for both
acute and chronic exposures. For surface water, the EDWCs for
flumioxazin are estimated to be 400 ppb for acute exposures and no 482-
HA and APF is expected to be present. For chronic exposures, EDWCs of
flumioxazin and its major degradates

(482-HA and APF) are estimated to be 9.4, 21.6, and 110.1 ppb,
respectively, for surface water resulting in an EDWC of 142 ppb
(total).
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 400 ppb was used to assess
the contribution to drinking water of flumioxazin. For chronic dietary
risk assessment, the water concentration of value 142 ppb (the total
EDWC for flumioxazin, 482-HA and APF in surface water) was used to
assess the contribution to drinking water of flumioxazin and its major
degradates (482-HA and APF).
    Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flumioxazin is currently registered for uses that could result in
residential exposures, including aquatic areas, ornamental gardens,
ornamental trees, turf, and golf courses. EPA assessed residential
exposure with the assumption that homeowner handlers wear shorts,
short-sleeved shirts, socks, and shoes, and that they complete all
tasks associated with the use of a pesticide product including mixing/
loading, if needed, as well as the application. Residential handler
exposure scenarios for both dermal and inhalation are considered to be
short-term only, due to the infrequent use patterns associated with
homeowner products.
    EPA uses the term ``postapplication'' to describe exposure to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide. Flumioxazin is registered for
use in many areas that can be frequented by the general population
including residential areas, golf courses, lakes, and ponds. As a
result, individuals can be exposed by entering these areas if they have
been previously treated. Therefore, short-term and intermediate dermal
postapplication exposures and risks were assessed for adults and
children. In addition, oral post-application exposures and risks were
assessed for children to be protective of possible hand-to-mouth,
object-to-mouth, and soil ingestion activities that may occur on
treated turf areas. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flumioxazin to share a common mechanism of
toxicity with any other substances, and flumioxazin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flumioxazin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Evidence of increased
susceptibility to fetuses was observed in the oral and dermal
developmental rat studies i.e. cardiovascular anomalies (ventricular
septal defect) that occurred in the absence of maternal toxicity.
Additionally, the rat reproduction study demonstrated evidence of
qualitative and quantitative post-natal susceptibility because
reproductive effects in offspring were observed at doses lower than
those that caused parental/systemic toxicity, and because the
reproductive effects in offspring were considered to be more severe
than the parental/systemic effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for oral and dermal exposures, but be
retained at 10X for inhalation exposures. That decision is based on the
following findings:
    i. The toxicity database for flumioxazin is largely complete with
the exception of an inhalation developmental study, which was recently
determined necessary, in order to better assess route-specific
inhalation risks. In the absence of this study, a 10X FQPA safety
factor to account for database uncertainty is needed to protect the
safety of infants and children to assess risks for all inhalation
exposure scenarios. The toxicity profile can be characterized for all
effects, including potential developmental and reproductive toxicity,
immunotoxicity and neurotoxicity with the current database.
    ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although increased susceptibility was seen in the rat
developmental and reproductive studies, EPA's concern for these effects
is low, and there are no residual uncertainties for pre- and/or
postnatal toxicity because:
    a. The developmental toxicity NOAELs/LOAELs are well characterized
after oral and dermal exposure;
    b. The offspring toxicity NOAEL and LOAEL are well characterized in
the reproduction study and
    c. The points of departure for assessing risk to developing
fetuses, infants, and children have been selected either from the
developmental and reproductive toxicity studies from the chronic study
which established a lower point of departure for chronic effects than
the studies in pre- and postnatal animals. Thus, the regulatory
endpoints for flumioxazin are protective of the increased
susceptibility seen in the developmental and reproduction studies, and
there are no residual concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary analyses were based on
tolerance-level residues and 100 PCT assumptions for all commodities.
The dietary drinking water assessment utilized water concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water

concentrations. The residential exposure assessment incorporates
similarly conservative assumptions in the assessment of post-
application exposure to children and in the incidental oral exposure
assessment for children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flumioxazin will occupy 75% of the aPAD for females 13-49 years old,
the only population group of concern for acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 44% of the cPAD for all
infants less than 1 year old, the population subgroup receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
flumioxazin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Flumioxazin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to flumioxazin.
    Different methodologies were used for the presentation of short-
term aggregate risk for adults and children. An aggregate risk estimate
(ARI) approach was required to estimate short-term adult aggregate risk
because there are different levels of concern (LOCs) for adult dermal
and inhalation exposures, 100 and 1,000, respectively. For short-term
child aggregate risk, the combined MOE approach was used because the
endpoint of concern (decreased pup weight) and the LOC are the same.
Using the exposure assumptions described in this unit for short-term
exposures, EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate ARI of 1.12 for adults and
aggregate MOE of 182 for children. Because EPA's level of concern for
flumioxazin is an ARI of 1 or below and a MOE of 100 or below, these
aggregate risk estimates are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Since the short- and intermediate-term toxicological endpoints
for flumioxazin are the same for each route of exposure, only short-
term exposures were assessed.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flumioxazin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method, Valent Method RM30-A-1) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for flumioxazin for any of the
commodities covered by this document.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the levels for prickly pear cactus fruit and
pads from 0.1 and 0.05 to 0.07 and 0.06, respectively. The
modifications were due to the Agency's use of the Organization for
Economic Co-operation and Development (OECD) calculation procedures to
determine the appropriate tolerance levels.
    Additionally, the petition proposed a tolerance for olive oil at
0.02 ppm. The Agency reviewed an olive oil processing study and found
that the residue levels found in olive oil were the same as those found
in olives. As such, the Agency has determined that a tolerance for
olive is appropriate, and a separate tolerance on olive oil is not
necessary.

V. Conclusion

    Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on artichoke,
globe at 0.02 ppm; cabbage at 0.02 ppm; cabbage, Chinese, napa at 0.02
ppm; olive at 0.02 ppm; pomegranate at 0.02 ppm; prickly pear, fruit at
0.07 ppm; and prickly pear, pads at 0.06 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections

subject to OMB approval under the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require any special considerations
under Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 28, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.568, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Artichoke, globe...........................................         0.02

                                * * * * *
Cabbage....................................................         0.02
Cabbage, Chinese, napa.....................................         0.02

                                * * * * *
Olive......................................................         0.02

                                * * * * *
Pomegranate................................................         0.02
Prickly pear, fruit........................................         0.07
Prickly pear, pads.........................................         0.06

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-07980 Filed 4-4-13; 8:45 am]
BILLING CODE 6560-50-P


Comments on EPA NPRM, Implementation of the 2008 NAAQS for Ozone

Page 8, in the second to last paragraph  -  The last sentence seems out of date since EPA has issued their 120 day letters already.

Page 11, in the paragraph at the top of the page  -  The last sentence reads as if EPA will not be considering any 2009-2011 monitoring data when it makes it final designations.  If some areas did submit 2009-2011 data prior to EPA's release of their 120 day letters, this should be clarified.

Page 11, in the last paragraph before D  -  If EPA has already issued their 120 day letters, suggest this paragraph be updated to reflect where EPA is currently in the designation process.  Also, the last sentence does not seems to be consistent with what is stated on page 20 regarding EPA's intent to complete designations no later than May 31, 2012.

Page 12, last sentence in the paragraph before Section III, suggest adding "including general conformity" after "... for other purposes"

Page 20-23   -  EPA proposed 2 options for establishing the maximum attainment dates.  The commenter suggests option 2 (attainment date specified as a certain number of years from the end of the calendar year in which an area's nonattainment designation is effective.) may provide greater certainty to transportation agencies in preparing for their conformity analysis, as the attainment year is one of the analysis years.  This option may eliminate the uncertainty and confusion of which 3 consecutive ozone seasons should be considered in determining the attainment year, especially if the effective date of the designations is in the middle of the ozone season.

Starting on Page 23  -  Section IV.  Revoking the 97 ozone NAAQS for transportation conformity.  One commenter suggested that EPA also provide more information regarding the transition from the 97 ozone NAAQS to the 2008 NAAQS, especially on issues related to how conformity applies for the 97 standard during the 1 year grace period and once the 97 standard is revoked.   It is appropriate to include this type of information in this rulemaking for  review/comment as opposed to future implementation rules mostly addressing other issues.

Page 23  -  Section IV.  Other commenters suggested it would be appropriate to expand on transition and implementation in the forthcoming implementation rule.

Page 24, The commenter recommend sto change the last sentence in the first paragraph (before Section A.) to something similar to the last sentence in the paragraph  before Section III on page 12, which is more definitive.

Page 28  -  In the second line on the page, suggest deleting the word "either" since the sentence does not present two options or ideas.


[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Page 29838]
[FR Doc No: 2018-13617]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83479; File No. SR-CboeBZX-2018-018

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade Shares of the Principal Morley Short Duration
Index ETF

June 20, 2018.
    On April 23, 2018, Cboe BZX Exchange, Inc. (``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'')\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares of the Principal Morley
Short Duration Index ETF pursuant to BZX Rule 14.11(c)(4), which
governs the listing and trading of Index Fund Shares based on fixed
income securities indexes. The proposed rule change was published for
comment in the Federal Register on May 8, 2018.\3\ The Commission has
received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83152 (May 2, 2018),
83 FR 20892.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is June 22, 2018. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
August 6, 2018 as the date by which the Commission shall either approve
or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-CboeBZX-2018-018).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13617 Filed 6-25-18; 8:45 am]
BILLING CODE 8011-01-P