[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78859-78865]
[FR Doc No: 2020-26799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5900]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Endorser Status and
Explicitness of Payment in Direct-to-Consumer Promotion

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.

DATES: Submit written comments (including recommendations) on the
collection of information by January 6, 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
Comment'' or by using the search function. The title of this
information collection is ``Endorser Status and Explicitness of Payment
in Direct-to-Consumer Promotion.'' Also include the FDA docket number
found in brackets in the heading of this document.

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

Endorser Status and Explicitness of Payment in Direct-to-Consumer
Promotion

OMB Control Number 0910--NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health 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 topic area,
advertising features.
    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 (DTC) advertisements conducted in 1999.
    Advertisers have used celebrity endorsers for years, and DTC
pharmaceutical promotion is no different. As researchers studied the
influence of celebrity endorsers, they theorized that a correspondence
bias occurs in which people believe that endorsers truly believe what
they are saying. LaTour and Smith (Ref. 1) examined whether a
pharmacist, physician, celebrity, or consumer would be most persuasive
in advertisements for four different types of OTC products. They found
that endorsements by expert physicians and pharmacists were the most
likely to lead to purchase intentions, followed by endorsements by
consumers, and lastly, by celebrities. The type of OTC product did not
affect the persuasiveness of an endorsement.
    Bhutada and Rollins (Ref. 2) recently completed a study examining
the role of endorser type (i.e., celebrity vs. expert vs. non-
celebrity), and endorser and consumer gender in product DTC ads. They
found, like LaTour and Smith (Ref. 1), that expert endorsers were
thought of as higher in credibility and generally resulted in the same
amount of attention as celebrities. The authors did not find that
endorsement by experts resulted in greater consumer intention to pursue
the drug product.
    We propose to extend previous research by examining four types of
endorsers in two separate studies (celebrity, physician, patient, non-
celebrity influencer) \1\ and examining whether the presence of a
disclosure of their payment status influences participant reactions. We
propose to also test two different types of disclosure language--one
direct and more consumer-friendly, and one less direct.
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    \1\ A ``non-celebrity influencer'' is a person who has gained a
following on a blog, a Twitter feed, or other social media outlet.
In the 60-day notice, the term ``influencer'' was used; we have
added language to specify influencers who were not previously
celebrities before their social media activities.
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    To complete this research, we propose the following concurrent
studies.\2\
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    \2\ For case allocation, the literature suggests that some
proportion of consumers may not recall seeing the disclosure
statement in the advertisement (see, for example, Boerman et al.;
Ref. 3). Rather than allotting equal numbers of cases to each
condition, we will assign more cases to the disclosure present
condition to increase power in these cells.
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Study 1

                                        Table 1a--Study 1 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                     Endorser
               Payment disclosure                ------------------------------------------------      Total
                                                     Celebrity       Physician        Patient
----------------------------------------------------------------------------------------------------------------
Present.........................................              50              50              50             150
Absent..........................................              33              33              33              99
                                                 ---------------------------------------------------------------
    Total.......................................              83              83              83             249
----------------------------------------------------------------------------------------------------------------

                                      Table 1b--Study 1 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                     Endorser
               Payment disclosure                ------------------------------------------------      Total
                                                     Celebrity       Physician        Patient
----------------------------------------------------------------------------------------------------------------
Present.........................................              81              81              81             243
Absent..........................................              54              54              54             162
                                                 ---------------------------------------------------------------
    Total.......................................             135             135             135             405
----------------------------------------------------------------------------------------------------------------

    Study 1 will manipulate endorser type (three levels: Celebrity,
physician, patient) and payment disclosure (two levels: Present,
absent) within a print DTC ad for a fictitious acne product. For this
study, we will recruit 654 general population individuals (249 pretest;
405 main study) from the Kantar Lightspeed national nonprobability
internet panel. All participants must report familiarity with the
celebrity to be included in our study. The celebrity will be one who
has publicly spoken out about acne. We are not divulging the identity
of the celebrity in this public forum to maintain the integrity of our
research process. Stock photos will be used to depict a physician and a
patient in the other experimental conditions. Participants will be
randomly assigned to see one of the endorsers and to see the ad either
with or without a payment disclosure. The payment disclosure in Study 1
will be determined in cognitive

testing but will be similar to: ``[Endorser] has been paid to appear in
this ad for Drug X.''

Study 2

                                        Table 2a--Study 2 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                             Endorser
                       Payment disclosure                        --------------------------------      Total
                                                                    Influencer        Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct..................................................              50              50             100
Present-Indirect................................................              50              50             100
Absent..........................................................              33              33              66
                                                                 -----------------------------------------------
    Total.......................................................             133             133             266
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                                      Table 2b--Study 2 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                             Endorser
                       Payment disclosure                        --------------------------------      Total
                                                                    Influencer        Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct..................................................              81              81             162
Present-Indirect................................................              81              81             162
Absent..........................................................              54              54             108
                                                                 -----------------------------------------------
    Total.......................................................             216             216             432
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    In Study 2, we will also manipulate endorser type, examining a
patient and an internet influencer, one who provides online content to
a number of followers. We will also manipulate the explicitness of the
payment disclosure, resulting in a 2 (endorser: Influencer, patient) by
3 (payment disclosure: Present-direct, present-indirect, absent)
between-subjects design. The disclosure will be direct (e.g., ``Paid
ad. . .''), indirect (e.g., #sp for ``sponsored''), or absent. The
setting for this study will be an Instagram post for a fictitious
endometriosis product. This study partially replicates Study 1 and
extends it by further examining the explicitness of payment as another
manipulated variable and using a different set of endorser types and in
a different promotional setting.
    For Study 2, we will recruit 698 (266 pretest; 432 main study)
followers of an internet influencer who maintains an Instagram page
with more than 500,000 followers and has posted about endometriosis. As
in the first study, we are not revealing the influencer's identity in
this public forum to maintain the integrity of the study.
    In both studies, we are interested in the role of endorsement and
disclosure of payment status on participants' recall, benefit and risk
perceptions, and behavioral intentions. Participants will view one
promotional piece and answer questions via the internet. The study is
expected to take less than 20 minutes to complete. Dependent variables
will include attention to disclosure statement and risk/benefit
information; retention of risk/benefit information; recognition of
piece as promotion and endorser as paid; perceived benefits and risks,
attitudes toward the product, endorser, and ad; and behavioral
intentions, such as asking a doctor about the drug.
    In the Federal Register of January 28, 2020 (85 FR 4994), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six submissions that were PRA-
related. One submission (https://www.regulations.gov/docketBrowser?rpp=25&po=0&dct=PS&D=FDA-2019-N-5900&refD=FDA-2019-N-5900-0001) was a brief statement of support for the research and is not
addressed further. Within the remaining five submissions, FDA received
multiple comments that the Agency has addressed below. For brevity,
some public comments are paraphrased and, therefore, may not reflect
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: DTC = direct-to-consumer; FDA and ``The Agency'' = Food and Drug
Administration; OPDP = FDA's Office of Prescription Drug Promotion; and
FTC = Federal Trade Commission.
    (Comment 1) One comment suggested that the proposed research, at
least in part, is duplicative of information otherwise reasonably
available to FDA. The comment pointed out that the Notice cites three
scientific references, and it does not address the other literature
that exists on the subject of endorsers in advertising. The comment
recommended that FDA assemble and review the relevant literature on
endorsement to ensure the research questions have not already been
answered.
    (Response) A literature review was conducted as part of this
project that identified relevant literature. We identified a
significant gap in the literature regarding the impact of social media
influencers in prescription drug DTC advertisements, as well as a lack
of information about the impact of explicit payment disclosure. The
research questions outlined in our proposed research were designed to
address this gap.
    (Comment 2) One comment suggested that, although the studies
contain clear variables, they appear to lack clearly defined primary
outcomes and prespecified hypotheses for testing. The comment also
noted that the studies do not appear to be designed to account for Type
I error; thus, the results may be uninterpretable. The comment
recommended that FDA propose a primary endpoint for each study and
power each study to test it.
    (Response) Specific hypotheses have been developed for each of the
outcome variables, as described earlier in the notice. We will adjust
for multiple comparisons using the Bonferroni correction.

    (Comment 3) One comment suggested that it is unclear how FDA came
up with the proposed sample sizes for the two related studies. For
example, the comment stated that the chart for pretest 1 contains the
following notation: ``(0.80 power, 0.10 alpha, small effect size
f=.2),'' but it is unclear what f=.2 means in this context. The comment
requested that FDA explain what statistical model it used to estimate
the study size and how it determined that the relevant effect size is
.2.
    (Response) f=.2 is a common standard used to calculate small effect
size in experimental studies (Ref. 4). We used G*Power to estimate
study size (Ref. 5).
    (Comment 4) One comment suggested that the proposed research is
unnecessary to the proper performance of FDA's functions because the
FTC takes the lead on regulating endorsement. The comment stated that
FDA has not addressed the extensive framework and guidance available
from the FTC on this topic. The comment further stated that, although
use of an endorser might conceivably inform an assessment of whether
advertising or promotion is false or misleading, it is not clear how
FDA views this new research on endorser status as fitting into its core
regulatory jurisdiction or activities.
    (Response) FDA and the FTC have a long history of working
collaboratively to protect American consumers. While the FTC does
regulate endorsement in many types of commercial advertisements, FDA
has authority to regulate prescription drug advertising with respect to
the safety and effectiveness of such drugs. In line with FDA's
responsibility to ensure that prescription drug advertising and other
promotional communications are truthful and non-misleading, the present
research will provide data on how elements related to endorsement
presentations in prescription drug promotion impact audience perception
and comprehension. Collecting this data is critical to FDA's science-
based approach to assessing prescription drug promotion to determine
whether it communicates information about prescription drugs to
consumers in a truthful, non-misleading way. We note that as part of
the process of developing the present research, FDA carefully evaluated
the FTC guidance on endorser issues.
    (Comment 5) One comment recommended that alignment and input should
be obtained from the FTC regarding the design of the study and
usability of the results.
    (Response) We evaluated the current FTC guidance on endorsement
disclosure when developing this study and all relevant elements of its
design, including our hypotheses, test stimuli, etc.
    (Comment 6) One comment suggested that the research may be skewed
by the influence of a particular celebrity. The comment recommended
that the study be amended so it is not subject to bias by the influence
of one particular well-known celebrity.
    (Response) Familiarity with an endorser has shown to be an
important factor in attention to DTC advertisements, but the evidence
is less strong that familiarity uniquely affects other outcomes such as
behavioral intention (see, for example, Refs. 2 and 6). The celebrity
used in Study 1 will have high levels of public recognition, so we
anticipate few participants will be filtered out due to low levels of
familiarity with endorser. We recognize that the individual
characteristics of the celebrity may drive responses. This possibility
is an unavoidable limitation of the study design, and we will be
transparent when reporting results.
    (Comment 7) One comment recommended that FDA use #ad instead of
#sp. The comment noted that FTC has stated that #ad is an effective
disclosure of sponsorship.
    (Response) Our review of current practices shows that vendors
continue to indicate endorsement by #sp online. An indirect disclosure
such as #sp serves as a useful comparator to a direct disclosure such
as ``Paid ad. . .'', helping us answer the research question of whether
direct and indirect acknowledgements of endorsement vary in their
influence on attitudes and perceptions.
    (Comment 8) One comment recommended that FDA incorporate some type
of control into each study.
    (Response) We have designed these studies to include a control. The
control, in both studies, is a duplicate version of the promotion
featuring endorsement by a patient, as opposed to a celebrity or
influencer, without inclusion of a payment disclosure.
    (Comment 9) One comment suggested that FDA should ensure that the
hypothetical products used in the proposed surveys do not too closely
resemble real products. For example, the conditions of use and the risk
of the hypothetical products should not mirror FDA-approved labeling
language for any marketed products. In addition, FDA should only
present hypothetical drug advertisements for diseases with many
treatment options from multiple sponsors. Otherwise, the comment states
that FDA's research could inadvertently harm one particular sponsor.
    (Response) The prescription drugs used in this study, while based
on existing prescription treatments, are fictitious with names and
branding that do not mirror any marketed products. Although we have
created the pieces to be as realistic as possible, FDA does not intend
to single out any real product on the basis of our fictional promotion.
We specifically use fictitious products and materials to avoid the
confound of prior knowledge of actual products. Moreover, it is the
endorser type and messaging around the endorsement disclosure that are
being investigated. The fictional drug is not a study variable and
therefore is held constant.
    (Comment 10) One comment suggested that the route of drug
administration may influence the participants' responses, as oral
administration and inhaled medication is preferable compared to
injections. Therefore, the comment suggested that the study use
fictitious drugs with routes of administration that are similar to top
advertised DTC prescription drugs.
    (Response) This is outside the scope of study objectives. The goal
of the studies is to understand the effect of endorsement and payment
disclosure on perceived risks and benefits of DTC promotion. Because
the same drug is being presented in each experimental condition, the
effects of mode of administration are being held constant in each
study; therefore, any observed effects are not related to the route of
administration chosen.
    (Comment 11) One comment suggested that in order to increase
internal validity, the location of the disclosures in the promotional
pieces should be consistent across endorser and/or disclosure type.
    (Response) FDA will ensure that for each study, disclosures will
appear in the same area of the promotional piece, using similar font
and style treatment.
    (Comment 12) One comment suggested that acne and endometriosis
drugs are not representative of the top advertised prescription drugs
and that the current proposed study design, therefore, may not
represent the most advertised DTC drugs in the market.
    (Response) The purpose of the studies is to understand the effect
of endorsement and payment disclosure on perceived risks and benefits
of DTC promotion. The value of our approach is random assignment to
experimental conditions and control of extraneous variables. Choice of
drug is not a study variable and therefore held constant. Although the
type of drug may play a

role in the perceptions of risks and benefits, the value of our study
is the comparisons between experimental conditions.
    (Comment 13) Two comments suggested that participants'
unfamiliarity with the proposed conditions may bias their responses, so
it may be more useful to include only patients with the condition as
participants in each study.
    (Response) The study population is those who are exposed to
prescription drug advertisements. For Study 1, we chose a high
incidence condition (acne) so that it would be relatable to a large
segment of the population. Regardless of whether or not the condition
is personally salient, the public is still exposed to these
advertisements.
    For Study 2, we chose a condition that is important to the
influencer in the study--and this information would be known to many of
her followers, who are the research audience for Study 2. Engagement
and e-Word of Mouth have been shown to be important behavioral outcomes
from social media promotion (Ref. 3). Thus, in a real-world setting,
audience members may choose to comment on or share the advertised
content with family or friends, regardless of whether or not they have
the health condition themselves.
    For both studies, we ask about personal experience and involvement
with the health condition, and we will assess whether these variables
have any effects.
    (Comment 14) One comment suggested ensuring that neutral language
is used when recruiting for Study 1's general population, so as not to
select for participants that are more susceptible to the celebrity's
influence. For example, the comment suggested that the study ask
participants if they ``recognize'' the celebrity vs. if they are a
``fan'' of the celebrity.
    (Response) In screeners for both studies, we ask if participants
are ``familiar'' with celebrities/influencers, thus maintaining neutral
language.
    (Comment 15) Two comments suggested participants' familiarity with
the endorser may bias responses and limit participant demographics. One
comment suggested that recruiting participants from the follower list
of an Instagram influencer, as proposed in Study 2, may skew the
average age of the participants to be younger, especially if the
influencer chosen for this study is a ``handheld name'' versus a
``household name.'' The comment also suggested that the participants
may have a female skew. Another comment suggested that the current
inclusion criteria should be expanded to also include followers of
influencers with similar content, recognition, and follower
demographics as the endorser being tested, which will increase external
validity by encompassing viewers that would likely see the post through
suggestions via Instagram's algorithm.
    (Response) Familiarity with an endorser has been shown to be an
important factor in attention given to DTC advertisements (Ref. 2), and
that is one driver of an influencer's value as an endorser. By
including endorser type as an experimental condition, we seek to
isolate these effects. Thus, the biases inherent in these relationships
are a necessary aspect of this topic area.
    The study design is a between-subjects design. Because participants
are only exposed to one promotional piece, the specific effects from
behavioral bias can be isolated.
    We agree with the commenter that Study 2 will have a younger,
female skew. This is consistent with Instagram's audience more
generally (Ref. 7). Advertisers who use Instagram influencers as
endorsers will access the same audience (i.e., Instagram followers) as
in our study. To minimize confounds, we will limit the sample to the
influencer's followers, who are likely to be the most influenced by
her. Future research can be conducted on whether our findings
extrapolate to men and older audiences.
    (Comment 16) One comment suggested that to account for the
potential bias in these studies, it would be useful to include
questions relating to participant demographics in the surveys, such as
age, gender, and attitude toward the celebrity or influencer, if they
are not already included.
    (Response) The survey includes questions about participant
demographics and attitude toward endorser.
    (Comment 17) One comment suggested that in order to prevent bias,
the study should exclude consumers who work in healthcare or marketing
settings, primary care providers that spend less than 50 percent of
their time on patient care, and Department of Health and Human Service
employees.
    (Response) The studies in this research do not include physician
participants. Consumers will be excluded if they work for a
pharmaceutical company, an advertising agency, a market research firm,
or the U.S. Department of Health and Human Services. They will also be
screened out if they are not familiar with the celebrity/influencer,
and, for Study 2, if they are biologically male, as men cannot have
endometriosis.
    (Comment 18) One comment suggested that the questionnaire is too
long and recommended deleting questions or rewording.
    (Response) We have had individuals unfamiliar with the study test
the survey for length, and we found it takes less than 20 minutes to
complete. Moreover, we will also conduct pretesting to check timing and
make adjustments, if necessary, based on the data from those pretests.
    (Comment 19) One comment suggested we should consistently use
balanced Likert scales with a neutral midpoint.
    (Response) This is a matter of debate in the literature and has
never been resolved. Many of our measures derive from previously
validated scales, and we prefer to maintain the scales on which they
were validated. However, where appropriate, we do use 5-point Likert
scales with a neutral midpoint.
    (Comment 20) One comment recommended rewording Q17 (in both study
questionnaires) to state ``What do you remember about the safety
information presented?''
    (Response) Q17 is a validated (OMB control number 0910-0861)
closed-ended item asking how much risk information was read (with a
thumbnail image highlighting the important safety information). In
order to increase quality of response, we will keep the closed-ended
item. Moreover, open-ended questions take longer to answer, and we want
to maintain an appropriate length of time to complete the survey.
    (Comment 21) One comment suggested that the adjectives that the
respondent is asked to rank in Q18a-Q18e (Study 1) are redundant with
only nuanced differences that may not be distinguishable to
respondents, and therefore suggested these items be deleted. If they
are retained, the comment suggested labeling answer choice #3 with
``Neither unimportant nor important.''
    (Response) These items were adapted from Zaichowsky's Disease State
Involvement scale (Ref. 8). The original validated items used a 7-point
scale without a labeled midpoint. To be consistent with most of the
items and with previous comments, we reduced the scale to 5 points.
However, we did not include a labeled midpoint because it could result
in under-response for values 2 and 4. This response applies to Q20
(Study 2) as well, where we want to ensure that individuals taking
Study 2 on their mobile devices are not overwhelmed.

    (Comment 22) One comment suggested that Q20 and Q21 (Study 1) may
be redundant, and since Q20 uses more consumer-friendly language to
seek respondent opinion on effectiveness of drug, the comment
recommended removing Q21. This comment also applies to Q22 and Q23 of
Study 2.
    (Response) We will remove Q21 (Study 1) and Q23 (Study 2).
    (Comment 23) One comment recommended that Q22 (Study 1) be framed
differently to help understand how endorsers influence the
understanding of safety and risk and that the answer choice should have
an option for respondents who do not know.
    (Response) We decline to make the recommended change because this
is a validated item that FDA has used in past survey experiments to
measure perceived risk likelihood.
    (Comment 24) One comment questioned the utility of asking whether
an endorser is ``Attractive,'' ``Classy,'' and ``Elegant'' (Q30, Study
1); whether a drug name and endorser name ``go together'' (Q31, Study
1); and how a subject feels about the life and values of the endorser
(Q32, Study 1). The comment recommended that FDA consider deleting
these questions.
    (Response) In the marketing literature on celebrity endorsements,
these three elements are well established as important moderators in
attitude toward advertisement and behavioral intention. ``Attractive,''
``Classy,'' and ``Elegant'' are elements in a 15-item scale validated
by Ohanian (1990) to measure endorser credibility (Ref. 9). The
literature refers to ``whether a drug name and endorser go together''
as ``product match-up'' (Ref. 10), and high match-up was recently shown
to be predictive of behavioral intention for e-cigarettes (Ref. 11).
The level of identification that consumers have with a celebrity
endorser has been shown to influence how consumers attend to and
process information in an advertisement (Refs. 12 and13). Thus, we will
maintain these questions.
    (Comment 25) One comment suggested that, if the research is
intended to assess the influence of endorsers or their payment status,
Q15-Q17 in both surveys and Q20-Q27 for Study 1 and Q22-Q29 for Study 2
appear to be outside of the scope. With these questions, subjects would
be asked to assess the risks and benefits of a drug based on an
advertisement. The comment recommended that FDA delete these questions
or revise them so they are focused instead on payment or endorsement.
    (Response) As part of the examination of the effect of the
endorser, one purpose of the study is to understand the effect of
endorsement and payment disclosure in DTC promotion on perceived risks
and benefits of a prescription drug. The questions mentioned in this
comment measure these dependent variables--consumer perceptions of risk
and benefit information presented in the promotion. We will maintain
these questions in order to assess if endorsement and the payment
disclosure have any effects on perceptions of risk and benefit
information.
    (Comment 26) One comment suggested that the structure of Q28 (Study
1) and Q30 (Study 2) should be consistent with other questions in this
survey. It recommended changing each question to include ``What is the
likelihood'' (e.g., What is the likelihood that you would ask your
doctor to prescribe) and presenting answer choices in a 5-point Likert
scale.
    (Response) We will assess how this item functions in pretesting and
make any change that is warranted.
    (Comment 27) One comment suggested moving Q28a (Study 1) and Q30a
(Study 2) up in the survey, after Q13, as this question could function
as a priming question after initial viewing of ad.
    (Response) Because this item is part of a validated scale (Ref.
14), we will maintain it at its current location in both surveys.
    (Comment 28) One comment suggested that Q31 (Study 1) and Q33
(Study 2) construct and answer choices should align with other
similarly constructed question and answer choices in this section of
the survey.
    (Response) This is a validated item (Ref. 15) to measure endorser-
product match-up. Therefore, we will maintain the current format.
    (Comment 29) One comment suggested that Q33 (Study 1) and Q35
(Study 2) could cause respondent confusion regarding what is meant by
``background,'' which could lead to uninterpretable results. It
recommended explicitly stating what is meant by ``background'' (e.g.,
``I prefer a product recommended by an endorser because of his/her
experience with this illness'').
    (Response) This is a validated item (Ref. 16) that measures
identification with endorser; thus, we will maintain its original form
in both studies.
    (Comment 30) One comment mentioned that Q43-Q45 (Study 1) and Q45-
Q47 (Study 2) probe the level of influence that endorsers have over
respondents and suggested adding a question asking if the respondent
has followed the advice of an endorser.
    (Response) Q36-Q48 (Study 1) and Q45-47 (Study 2) are validated
items in the celebrity-persona parasocial-involvement scale (Ref. 17);
thus, we will maintain the integrity of the scale and not add another
question in this series.
    (Comment 31) One comment suggested that the debriefing statements
in both questionnaires may serve the respondent better if placed
earlier in the document as a disclaimer and suggested placing the
disclaimer language prior to showing the promotional piece.
    (Response) To maximize the attention participants give to this
survey task, we do not wish to inform them of the information in the
debriefing statement until they have completed the survey.
    (Comment 32) One comment suggested that Q18 and Q19 (Study 2) are
redundant, although respondents may not define a paid endorser post as
advertising, and that the items seem irrelevant. It recommended
removing Q18 from the questionnaire.
    (Response) Previous experimental studies on social media promotion
have found that participants did not consistently notice a payment
disclosure or interpret a sponsored post as advertising (Ref. 1). These
issues are central to the question of whether consumers process payment
disclosures. Moreover, participants in cognitive testing distinguished
between the two items.
    (Comment 33) One comment noticed that Q20 in Study 2 is similar to
Q18 in Study 1; however, answer choices are not provided in a similar
construct. The comment recommended utilizing a 5-point Likert scale to
measure the outcome.
    (Response) We simplified the response scale for Study 2 items,
where possible, to account for anticipated higher usage of mobile
devices. Because we prefer a larger number of response options in
general, we plan to maintain the 5-point Likert scale for Study 1, but
use the 3-point scale in Study 2 to account for mobile devices.
    (Comment 34) One comment suggested that Q24 (Study 2) could be
framed differently to help understand how endorsers influence the
understanding of safety and risk. The comment recommended asking ``Do
you recall the risk associated with the medication?'' and suggested
that the answer choice should have an option for respondents who do not
know.
    (Response) Q24 and Q25 from Study 2 are closed-ended questions that
ask about recall of drug benefits and risks. To be balanced, the
question stem and

response options should be parallel between the two items. Moreover, we
cannot add additional open-ended questions to the survey without
increasing participant fatigue. Thus, we will maintain the closed-ended
nature of the question. We recognize that this will be a difficult
question for participants, and therefore, we prefer not to provide an
option for ``don't know.''
    FDA estimates the burden of this collection of information as
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Study 1 Screener..............             933               1             933  0.08 (5 minutes)           74.64
Study 1 Pretest...............             249               1             249  0.33 (20                   82.17
                                                                                minutes).
Study 1 Main Test.............             405               1             405  0.33 (20                  133.65
                                                                                minutes).
Study 2 Screener..............           1,417               1           1,417  0.08 (5 minutes)          113.36
Study 2 Pretest...............             266               1             266  0.33 (20                   87.78
                                                                                minutes).
Study 2 Main Test.............             432               1             432  0.33 (20                  142.56
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          634.16
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references are on display with the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
these are not available electronically at https://www.regulations.gov
as these references are copyright protected. Some may be available at
the website address, if listed. 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. LaTour, C. and M. Smith (1986). ``A Study of Expert Endorsement
of OTC Pharmaceutical Products.'' Journal of Pharmaceutical
Marketing & Management, vol. 1(2), pp. 117-128.
2. Bhutada, N.S. and B.L. Rollins (2015). ``Disease-Specific Direct-
to-Consumer Advertising of Pharmaceuticals: An Examination of
Endorser Type and Gender Effects on Consumers' Attitudes and
Behaviors.'' Research in Social Administrative Pharmacy, vol. 11(6),
pp. 891-900.
3. Boerman, S.C., L.M. Willemsen, and E.P. Van Der Aa (2017). ``
`This post is sponsored': Effects of Sponsorship Disclosure on
Persuasion Knowledge and Electronic Word of Mouth in the Context of
Facebook.'' Journal of Interactive Marketing, vol. 38, pp. 82-92.
4. Cohen, J. (1988), ``Statistical Power Analysis for the Behavioral
Sciences.'' Routledge. ISBN 978-1-134-74270-7.
5. Faul, F., E. Erdfelder, A.G. Lang, et al. (2007). ``G*Power 3: A
Flexible Statistical Power Analysis Program for the Social,
Behavioral, and Biomedical Sciences.'' Behavior Research Methods,
vol. 39, pp. 175-191.
6. Woods, C.B., S. Baxter, E. King, et al. (2017). ``Celebrity?
Doctor? Celebrity doctor? Which Spokesperson Is Most Effective for
Cancer Prevention?'' In E. Kendal and B. Diug (Eds.) Teaching
Medicine and Medical Ethics Using Popular Culture (pp. 71-98).
Palgrave Studies in Science and Popular Culture. Cham, Switzerland:
Palgrave Macmillan. doi:10.1007/978-3-319-65451-5_5.
7. https://www.statista.com/statistics/398166/us-instagram-user-age-distribution/.
8. Zaichkowsky, J.L. (1994). ``The Personal Involvement Inventory:
Reduction, Revision, and Application to Advertising.'' Journal of
Advertising, vol. 23(4), pp. 59-70.
9. Ohanian, R. (1990). ``Construction and Validation of a Scale to
Measure Celebrity Endorsers' Perceived Expertise, Trustworthiness,
and Attractiveness.'' Journal of Advertising, vol. 19(3), pp. 39-52.
10. Kamins, M.A. and K. Gupta (1994). ``Congruence Between
Spokesperson and Product Type: A Matchup Hypothesis Perspective.''
Psychology & Marketing, vol. 11(6), pp. 569-586.
11. Phua, J., J.S.E. Lin, and D.J. Lim (2018). ``Understanding
Consumer Engagement with Celebrity-Endorsed E-Cigarette Advertising
on Instagram.'' Computers in Human Behavior, vol. 84, pp. 93-102.
12. Brown, W.J. and M.C. Bocarnea (2007). ``Celebrity-Persona
Interaction Scale.'' In R.A. Reynolds, R. Woods, and J.D. Baker
(Eds.) Handbook of Research on Electronic Surveys and Measurements
(pp. 302-305). Hershey, PA: Idea Group Reference.
13. Brown, W.J. and M.A.C. De Matviuk (2010). ``Sports Celebrities
and Public Health: Diego Maradona's Influence on Drug Use
Prevention.'' Journal of Health Communication, vol. 15(4), pp. 358-
373.
14. Huh, J., D.E. DeLorme, and L.N. Reid (2005). ``Factors Affecting
Trust in On-Line Prescription Drug Information and Impact of Trust
on Behavior Following Exposure to DTC Advertising.'' Journal of
Health Communication, vol. 10(8), pp. 711-731.
15. Till, B.D. and M. Busler (2000). ``The Match-Up Hypothesis:
Physical Attractiveness, Expertise, and the Role of Fit on Brand
Attitude, Purchase Intent and Brand Beliefs.'' Journal of
Advertising, vol. 29(3), pp. 1-13.
16. Biswas, D., A. Biswas, and N. Das (2006). ``The Differential
Effects of Celebrity and Expert Endorsements on Consumer Risk
Perceptions: The Role of Consumer Knowledge, Perceived Congruency,
and Product Technology Orientation.'' Journal of Advertising, vol.
35(2), pp. 17-31.
17. Bocarnea, M.C. and W.J. Brown (2007). ``Celebrity-Persona
Parasocial Interaction Scale.'' In R.A. Reynolds, R. Woods, and J.D.
Baker (Eds.) Handbook of Research on Electronic Surveys and
Measurements (pp. 309-312). Hershey, PA: Idea Group Reference.

    Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26799 Filed 12-4-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Rules and Regulations]
[Pages 77382-77383]
[FR Doc No: 2011-31794]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1341; Directorate Identifier 2011-NE-41-AD;
Amendment 39-16891; AD 2011-25-51]
RIN 2120-AA64

Airworthiness Directives; Continental Motors, Inc. (CMI)
Reciprocating Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Continental Motors, Inc. (CMI) models TSIO-520, TSIO-550-K, TSIOF-550K,
and IO-550-N series reciprocating engines. This emergency AD was sent
previously to all known U.S. owners and operators of these engines.
This AD requires replacing affected CMI starter adapters with starter
adapters eligible for installation. This AD was prompted by 5 reports
received of fractures in starter adapter shaft gears in certain part
number (P/N) CMI starter adapters. We are issuing this AD to prevent
failure of the starter adapter gear shaft, leading to an inoperable oil
scavenge pump and engine in-flight shutdown.

DATES: This AD is effective December 28, 2011 to all persons except
those persons to whom it was made immediately effective by Emergency AD
2011-25-51, issued on November 29, 2011, which contained the
requirements of this amendment.
    We must receive comments on this AD by January 27, 2012.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Continental
Motors, Inc., P.O. Box 90, Mobile, AL 36601; phone:<PHONE_NUMBER>, or
go to:  http://tcmlink.com/servicebulletins.cfm.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations Office
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 Operations Office (phone:<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Anthony Holton, Aerospace Engineer,
Atlanta Certification Office, FAA, Small Airplane Directorate, 1701
Columbia Avenue, Atlanta, GA 30337; phone:<PHONE_NUMBER>; fax: (404)
474-5567; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On November 29, 2011, we issued Emergency AD 2011-25-51, which
requires replacing affected CMI starter adapters with starter adapters
eligible for installation. This action was prompted by 5 reports
received of fractures in starter adapter shaft gears in certain P/N CMI
starter adapters. This condition, if not corrected, could result in
failure of the starter adapter gear shaft, leading to an inoperable oil
scavenge pump and engine in-flight shutdown.

Relevant Service Information

    We reviewed CMI Mandatory Service Bulletin (MSB) No. MSB11-4, dated
November 23, 2011. The MSB describes the affected starter adapters, and
describes what starter adapters are eligible for installation.

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 replacing affected CMI starter adapters with
starter adapters eligible for installation.

Differences Between the AD and the Service Information

    The CMI MSB No. MSB11-4, dated November 23, 2011 requires
reporting. This emergency AD does not.

FAA's 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 of
the short compliance time required to remove the affected parts from
service. 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-2011-1341 and
Directorate Identifier 2011-NE-41-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 will affect 195 engines installed on
airplanes of U.S. registry. We also estimate that it will take about 4
work-hours per engine to perform the actions required by this AD, and
that the average labor rate is $85 per work-hour. Required parts will
cost about $500 per engine. Based on these figures, we estimate the
total cost of the AD to U.S. operators to be $163,800.

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):

2011-25-51 Continental Motors, Inc. (Formerly Teledyne Continental
Motors, Continental): Amendment 39-16891; Docket No. FAA-2011-1341;
Directorate Identifier 2011-NE-41-AD.

(a) Effective Date

    This AD is effective December 28, 2011 to all persons except
those persons to whom it was made immediately effective by Emergency
AD 2011-25-51, issued on November 29, 2011, which contained the
requirements of this amendment.

(b) Affected ADs

    None.

(c) Applicability

    This emergency AD applies to Continental Motors, Inc. (CMI)
TSIO-520-B, BB, D, DB, E, EB, J, JB, K, KB, N, NB, UB, VB; TSIO-550-
K; TSIOF-550-K; IO-550-N (Turbo-normalized only; STC SE10589SC);
with a starter adapter part number (P/N) 642085A17, 642085A19,
642085A20, 642085-1A1, and R-642085A17, installed, where the engine
was manufactured between January 1, 2011 and November 20, 2011, or,
where a replacement new or rebuilt starter adapter that was
purchased from Continental Motors, Inc. and installed between
January 1, 2011 and November 20, 2011.

(d) Unsafe Condition

    This AD was prompted by 5 reports received of fractures in
starter adapter shaft gears in certain P/N CMI starter adapters. We
are issuing this AD to prevent failure of the starter adapter gear
shaft, leading to an inoperable oil scavenge pump and engine in-
flight shutdown.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For starter adapters with less than 75 hours of total time-
in-service (TIS) on the effective date of this AD, before further
flight, replace the starter adapter with a starter adapter eligible
for installation.
    (2) For starter adapters with between 75 and 100 hours of total
TIS, inclusive on the effective date of this AD, within the next 10
hours of engine operation, or before exceeding 100 hours TIS,
whichever occurs first, replace the starter adapter with a starter
adapter eligible for installation.
    (3) For starter adapters with more than 100 hours of total TIS
on the effective date of this AD, no further action is required.

(f) Definition

    For the purpose of this AD, a starter adapter eligible for
installation is:
    (1) A starter adapter with one of the P/Ns listed in this AD
that has a vibro-peened manufacturer code below the ink stamped P/N
on the starter adapter, or
    (2) A starter adapter with one of the P/Ns listed in this AD
that has more than 100 hours total TIS.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Atlanta Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(h) Related Information

    (1) For further information about this AD, contact: Anthony
Holton, Aerospace Engineer, Atlanta Certification Office, FAA, Small
Airplane Directorate, 1701 Columbia Avenue, Atlanta, GA 30337;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) CMI Mandatory Service Bulletin No. MSB11-4, dated November
23, 2011, pertains to this AD.
    (3) For copies of the service information referenced in this AD,
contact: Continental Motors, Inc., PO Box 90, Mobile, AL 36601;
phone:<PHONE_NUMBER>, or go to: http://tcmlink.com/servicebulletins.cfm. You may review copies of the referenced
service information at the FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on December 5, 2011.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-31794 Filed 12-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Proposed Rules]
[Pages 79934-79936]
[FR Doc No: 2020-27207]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0727; Airspace Docket No. 20-ACE-18]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Cambridge NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace, extending
upward from 700 feet above the surface. This action also proposes
several administrative corrections to the airspace's legal description.
This action would ensure the safety and management of instrument flight
rules (IFR) operations at the airport.

DATES: Comments must be received on or before January 25, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0727; Airspace Docket No. 20-ACE-18, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would amend the Class E airspace at Cambridge Municipal Airport,
Cambridge NE, to support IFR operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2020-0727;
Airspace Docket No. 20-ACE-18''. The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ``ADDRESSES'' section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by amending the Class E airspace extending
upward from 700 feet above the surface. To properly contain IFR
departures to 700 feet above the surface the 6.4-mile radius should be
increased to a 7.5-mile radius of the airport. This area would be
described as follows: That airspace extending upward from 700 feet
above the surface within a 7.5-mile radius of Cambridge Municipal
Airport.
    Further, this action proposes to remove Harry Strunk NDB from the
airspace text header and the airspace description. The FAA proposes the
removal of the navigation aid (NAVAID) because it is being
decommissioned. Also, the NAVAID is not needed to describe the
airspace.
    Lastly, this action proposes an administrative correction to the
airspace legal description. The airport's geographic coordinates do not
match the FAA database and should be updated to lat. 40[deg]18'24'' N,
long. 100[deg]09'43'' W.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (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); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE NE E5 Cambridge, NE

Cambridge Municipal Airport, NE
    (Lat. 40[deg]18'24'' N, long. 100[deg]09'43'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.5-mile radius of Cambridge Municipal Airport.

    Issued in Seattle, Washington, on December 7, 2020.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2020-27207 Filed 12-10-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]
[Page 54662-54664]
[DOCID:fr08se10-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62799; File No. SR-Phlx-2010-118]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by NASDAQ OMX PHLX, Inc. Relating to the $.50 Strike Price
Program

August 30, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 25, 2010, NASDAQ OMX PHLX, Inc. (the ``Exchange'' or
``Phlx'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, pursuant to Section 19(b)(1) of the Act \3\ and Rule
19b-4 thereunder,\4\ proposes to amend Commentary .05 to Exchange Rule
1012, Series of Options Open for Trading, specifically the Exchange's
$.50 Strike Price Program (the ``$.50 Strike Program'' or ``Program'')
\5\ to: (i) Expand the $.50 Strike Program for strike prices below
$1.00; (ii) extend the $.50 strike program to strike prices that are
$5.50 or less; (iii) extend the prices of the underlying security to at
or below $5.00; and (iv) extend the number of options classes overlying
20 individual stocks.
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    \3\ 15 U.S.C. 78s(b)(1).
    \4\ 17 CFR 240.19b-4.
    \5\ See Securities Exchange Act Release Nos. 60694 (September
18, 2009), 74 FR 49048 (September 25, 2009) (SR-Phlx-2009-65) (order
approving); and 61630 (March 2, 2010), 75 FR 11211 (March 10, 2010)
(SR-Phlx-2010-26) (notice of filing and immediate effectiveness
allowing concurrent listing of $3.50 and $4 strikes for classes that
participate in both the $0.50 Strike Program and the $1 Strike
Program).
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    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, on the Commission's Web site
at http://www.sec.gov, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to modify Commentary
.05 to Exchange Rule 1012 to expand the $.50 Strike Program in order to
provide investors with opportunities and strategies to minimize losses
associated with owning a stock declining in price.
    The Exchange is proposing to establish strike price intervals of
$.50, beginning at $.50 for certain options classes where the strike
price is $5.50 or less and whose underlying security closed at or below
$5.00 in its primary market on the previous trading day and which have
national average daily volume that equals or exceeds 1000 contracts per
day as determined by The Options Clearing Corporation (``OCC'') during
the preceding three calendar months. The Exchange also proposes to
limit the listing of $.50 strike prices to options classes overlying no
more than 20 individual stocks as specifically designated by the
Exchange.
    Currently, Exchange Rule 1012 at Commentary .05 permits strike
price intervals of $.50 or greater beginning at $1.00 where the strike
price is $3.50 or less, but only for option classes whose underlying
security closed at or below $3.00 in its primary market on the previous
trading day and which have national average daily volume that equals or
exceeds 1000 contracts per day as determined by The Options Clearing
Corporation during the preceding three calendar months. Further, the
listing of $.50 strike prices is limited to options classes overlying
no more than 5 individual stocks as specifically designated by the
Exchange. The Exchange is currently restricted from listing series with
$1 intervals within $0.50 of an existing strike price in the same
series, except that strike prices of $2, $3, and $4 shall be

permitted within $0.50 of an existing strike price for classes also
selected to participate in the $0.50 Strike Program.\6\
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    \6\ See Exchange Rule 1012, Commentary .05(a)(i)(B) referring to
the $1 Strike Program.
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    The number of $.50 strike options traded on the Exchange has
continued to increase since the inception of the Program. There are now
approximately 19 of the $.50 strike price option classes listed, and
traded, across all options exchanges including Phlx; 5 of which are
classes chosen by Phlx for the $0.50 Strike Program. The proposal would
expand $.50 strike offerings to market participants, such as traders
and retail investors, and thereby enhance their ability to tailor
investing and hedging strategies and opportunities in a volatile market
place.
    By way of example, if an investor wants to invest in 5,000 shares
of Sirius Satellite (``SIRI'') at $ 0.9678,\7\ the only choice the
investor would have today would be to buy out-of-the-money calls, at
the $1.00 strike, or to invest in the underlying stock with a total
outlay of $.96 per share or $4,800. However, if a $.50 strike series
were available, an investor may be able to invest in 5,000 shares by
purchasing an exercisable in-the-money $.50 strike call option. It is
reasonable to assume that with SIRI trading at $.96, the $.50 strike
call option would trade at an estimated price of $.46 to $.48 under
normal circumstances. This would allow the investor to manage 5,000
shares with the same upside potential return for a cost of only $2,350
(assuming $.47 as a call price).
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    \7\ SIRI was trading at $ 0.9678 on July 13, 2010.
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    Similarly, if an investor wanted to spend $4,800 for 5,000 shares
of SIRI, a $.50 put option that would trade for $.01 to $.05 would
provide protection against a declining stock price in the event that
SIRI dropped below $.50 per share. In a down market, where high volume
widely held shares drop below $1.00, investors deserve the opportunity
to hedge downside risk in the same manner as investors have with stocks
greater than $1.00.
    Increasing the threshold from $3.00 to $5.00 and expanding the
number of $0.50 strikes available for stocks under $5.00 further aids
investors by offering opportunities to manage risk and execute a
variety of option strategies to improve returns. For example, today an
investor can enhance their yield by selling an out-of-the-money call.
Using an example of an investor who wants to hedge Citigroup (``C'')
which is trading at $4.24,\8\ that investor would be able to choose the
$4.50 strike which is 6% out-of-the-money or they would be able to
choose the $5.00 strike which is 17.92% out-of-the-money, under this
proposal. Today, this investor only has the latter choice. Beyond that,
this investor today may choose the $6.00 strike which is 41% out-of-
the-money and offers significantly less premium. Pursuant to this
proposal if this investor had a choice to hedge with a $5.50 strike
option, the investor would have the opportunity to sell the option at
only 29% out-of-the-money and would improve their return by gaining
more premium, while also benefitting from 29% of upside return in the
underlying equity.
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    \8\ This was the price for C on July 14, 2010.
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    By increasing the number of securities from 5 individual stocks to
20 individual stocks would allow the Exchange to offer investors
additional opportunities to use the $0.50 strike program. The Exchange
notes that $0.50 strikes have had no impact on capacity. Further, the
Exchange has observed the popularity of $0.50 strikes. The open
interest in the $2.50 August strike series for Synovus Financial Corp.
(``SNV''), which closed at $2.71 on July 13, 2010, was 12,743 options;
whereas open interest in the $2 and $3 August strike series was a
combined 318 options. The open interest in the August $1.50 strike
series for Ambac Financial Group, Inc. (``ABK''), which closed at
$0.7490 on July 13, 2010, was 15,879 options compared to 8,174 options
for the $2 strike series. The August $2.50 strike series had open
interest of 22,280 options, also more than the traditional $2 strike
series.
    By expanding the $.50 Strike Program investors would be able to
better enhance returns and manage risk by providing investors with
significantly greater flexibility in the trading of equity options that
overlie lower price stocks by allowing investors to establish equity
options positions that are better tailored to meet their investment,
trading and risk.
    The Exchange also proposes making a corresponding amendment to
Commentary .05(a)(i)(B) of Exchange Rule 1012 to add $5 to $1 Strike
Program language that addresses listing series with $1 intervals within
$0.50 of an existing strike price in the same series. Currently, and to
account for the overlap with the $.50 Strike Program, the following
series are excluded from this prohibition: strike prices of $2, $3, and
$4. The Exchange proposes to add $5 to that list to account for the
proposal to expand the $.50 Strike Program to a strike price of $5.50.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest. The Exchange believes that amending the current $.50 Strike
Program will result in a continuing benefit to investors by giving them
more flexibility to closely tailor their investment decisions in a
greater number of securities. Investors would be provided with an
opportunity to minimize losses associated with declining stock prices
which do not exist today. With the increase in active, low-prices
securities, the Exchange believes that amending the $.50 Strike Program
to allow a $.50 strike interval below $1 for strike prices of $5.50 or
less is necessary to provide investor additional opportunity to
minimize and manage risk.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml;) or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2010-118 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2010-118. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2010-118 and should be
submitted on or before September 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-22287 Filed 9-7-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Rules and Regulations]
[Pages 57832-57834]
[FR Doc No: 2022-20424]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0947; FRL-9640-02-R4]

Air Plan Approval; Mississippi; Infrastructure Requirements for
the 2015 8-Hour Ozone National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of a State Implementation Plan (SIP) submission provided by
the State of Mississippi, through the Mississippi Department of
Environmental Quality (MDEQ), through a letter dated January 25, 2021.
This approval pertains to certain infrastructure requirements of the
Clean Air Act (CAA or Act) for the 2015 8-hour ozone national ambient
air quality standards (NAAQS or standards). Whenever EPA promulgates a
new or revised NAAQS, the CAA requires that each state adopt and submit
a SIP for the implementation, maintenance, and enforcement of that
NAAQS. EPA is approving portions of Mississippi's January 25, 2021,
submittal as the state has certified that its SIP contains provisions
that ensure the 2015 8-hour ozone NAAQS is implemented, enforced, and
maintained in Mississippi. EPA has determined that Mississippi's
infrastructure SIP submission satisfies certain required infrastructure
elements for the 2015 8-hour ozone NAAQS.

DATES: This rule is effective October 24, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0947. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests, that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Ms. LaRocca can
also be reached via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On October 1, 2015, EPA promulgated a revised primary and secondary
NAAQS for ozone, revising the 8-hour ozone standards from 0.075 parts
per million (ppm) to a new more protective level of 0.070 ppm. See 80
FR 65292 (October 26, 2015). Pursuant to section 110(a)(1) of the CAA,
states are required to submit SIP revisions meeting the applicable
requirements of section 110(a)(2) within three years after promulgation
of a new or revised NAAQS or within such shorter period as EPA may
prescribe. Section 110(a)(2) requires states to address basic SIP
elements such as requirements for monitoring, basic program
requirements, and legal authority that are designed to assure
attainment and maintenance of the NAAQS. This particular type of SIP is
commonly referred to as an ``infrastructure SIP'' or ``iSIP.'' States
were required to submit such SIP revisions for the 2015 8-hour ozone
NAAQS to EPA no later than October 1, 2018.\1\
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    \1\ In infrastructure SIP submissions, states generally certify
evidence of compliance with sections 110(a)(1) and (2) of the CAA
through a combination of state regulations and statutes, some of
which have been incorporated into the SIP. In addition, certain
federally-approved, non-SIP regulations may also be appropriate for
demonstrating compliance with sections 110(a)(1) and (2).

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    This action is approving portions of Mississippi's January 25,
2021, SIP revision provided to EPA, through the MDEQ, for the
applicable infrastructure SIP requirements of the 2015 8-hour ozone
NAAQS, with the exception of the prevention of significant
deterioration (PSD) provisions related to major sources under sections
110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J); the air quality
modeling element of 110(a)(2)(K); \2\ and the visibility protection
provisions of section 110(a)(2)(D)(i)(II). EPA will consider the
portions of Mississippi's January 25, 2021, SIP revision that addresses
the PSD infrastructure elements, the air quality modeling element, and
the visibility protection provisions of section 110(a)(2)(D)(i)(II)
through separate rulemakings. EPA also notes that Mississippi's January
25, 2021, SIP submission addresses all infrastructure elements except
for those pertaining to the contribution to nonattainment or
interference with maintenance in other states.\3\
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    \2\ As part of the January 25, 2021, SIP submission, Mississippi
requested conditional approval of the PSD provisions related to
major sources under sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and
110(a)(2)(J), and the air quality modeling element under
110(a)(2)(K). Under CAA section 110(k)(4), EPA may conditionally
approve a SIP revision based on a commitment from a state to adopt
specific enforceable measures by a date certain, but not later than
one year from the date of approval. If the state fails to meet the
commitment within one year of the final conditional approval, the
conditional approval will be treated as a disapproval and EPA will
issue a finding of disapproval. In the July 15, 2022, NPRM, EPA
proposed to conditionally approve the PSD provisions related to
major sources under sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and
110(a)(2)(J), and the air quality modeling element under
110(a)(2)(K) in relation to Mississippi's January 25, 2021, SIP
revision. However, EPA is not finalizing that proposed conditional
approval through this final action and will address these provisions
through a separate rulemaking.
    \3\ On September 6, 2019, Mississippi provided a SIP submission
addressing the interstate transport provisions of section
110(a)(2)(D)(i)(I) pertaining to contribution to nonattainment or
interference with maintenance in other states. EPA is addressing the
interstate transport provisions of section 110(a)(2)(D)(i)(I)
through a separate rulemaking.
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    In a notice of proposed rulemaking (NPRM), published on July 15,
2022 (87 FR 42424), EPA proposed to approve in part and conditionally
approve in part a portion of Mississippi's January 25, 2021, SIP
revision addressing certain infrastructure requirements for the 2015 8-
hour ozone NAAQS.\4\ The details of Mississippi's submission and the
rationale for EPA's action are explained in the NPRM. Comments on the
July 15, 2022, NPRM were due on or before August 15, 2022. EPA did not
receive any comments on the July 15, 2022, NPRM.
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    \4\ As discussed in footnote 2, EPA is not finalizing the
proposed conditional approval through this final action.
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II. Final Action

    With the exception of the visibility provision of section
110(a)(2)(D)(i)(II) and the PSD provisions related to major sources
under sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3), and
110(a)(2)(J), and the modeling provision of 110(a)(2)(K), EPA is
approving Mississippi's January 25, 2021, SIP submission because it
satisfies certain required infrastructure elements for the 2015 8-hour
ozone NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this final action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 21, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2) of the CAA.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: September 15, 2022.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart Z--Mississippi

0
2. In Sec.  52.1270(e), amend the table by adding an entry for
``110(a)(1) and (2) Infrastructure Requirements for the 2015 8-hour
ozone NAAQS'' at the end of the table to read as follows:

Sec.  52.1270   Identification of plan.

* * * * *
    (e) * * *

                               EPA Approved Mississippi Non-Regulatory Provisions
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                                     Applicable           State
   Name of non-regulatory SIP       geographic or    submittal date/  EPA approval date        Explanation
           provision             nonattainment area  effective date
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                                                  * * * * * * *
110(a)(1) and (2)                Mississippi.......       1/25/2021  9/22/2022, [Insert  With the exception of
 Infrastructure Requirements                                          citation of         the visibility
 for the 2015 8-hour ozone                                            publication].       provision of section
 NAAQS.                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 4), the PSD
                                                                                provisions related to
                                                                                major sources under
                                                                                sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3), and
                                                                                110(a)(2)(J), and the
                                                                                modeling provision of
                                                                                110(a)(2)(K).
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[FR Doc. 2022-20424 Filed 9-21-22; 8:45 am]
BILLING CODE 6560-50-P