[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40295-40303]
[FR Doc No: 2018-17360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1315]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Risk Information Amount and Location in Direct-to-Consumer Print Ads

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by
September 13, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--New and
title ``Experimental Study of Risk Information Amount and Location in
Direct-to-Consumer Print Ads.'' Also include the FDA docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office
of Operations, Food and Drug Administration, Three White Flint North,
10A-12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Experimental Study of Risk Information Amount and Location in Direct-
to-Consumer Print Ads

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 (the 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.
    Section 502(n) of the FD&C Act (21 U.S.C.352(n)) specifies that
advertisements (ads) for prescription drugs and biological products
must provide a true statement of information ``in brief summary''
describing the advertised product's ``side effects, contraindications
and effectiveness.'' This is clarified further in the prescription drug
advertising regulations. The brief summary shall include a true
statement of information relating to side effects, contraindications,
warnings, precautions, and any such information under such headings as
cautions, special considerations, important notes, etc., as well as
effectiveness (Sec.  202.1(e)(1)). The prescription drug advertising
regulations also specify that the phrase side effect and
contraindication refers to all of the categories of risk information
contained in the required, approved, or permitted product labeling
written for health professionals, including the side effects, warnings,
precautions, and contraindications (Sec.  202.1(e)(3)(iii)). Ads must
also ``present a fair balance between information relating to side
effects and contraindications and effectiveness . . .'' An ad must
present true information relating to side effects and contraindications
in comparable depth and detail with the claims for effectiveness or
safety (Sec.  202.1(e)(5)(ii)).
    To fulfill the regulatory requirements for fair balance and the
brief summary, sponsors have typically included risk information about
the product in direct-to-consumer (DTC) print ads both in the main part
of the ad where the product claims appear, and in a separate brief
summary page. The section of the main ad where the risks appear is
often referred to as the ``Important Safety Information'' (ISI).
Including risks in both the ISI and the brief summary may have
advantages. Some research has found that repetition of information
improves recall, especially for older adults (Ref. 1). This might
result in improved recall for risks that appear both in the ISI and
brief summary. However, it is possible that risks appearing on the main
page in the ISI may be more likely to be read than risks appearing in
the brief summary. Based on FDA survey research, about 27 percent of
consumers surveyed in 2002 reported reading half or more of the brief
summary in DTC print ads (Ref. 2). In comparison, when asked how much
of the ``main'' ad they read, about 78 percent reported reading ``all''
or ``almost all'' of the main body portion of the ad.
    One potential downside to including the same warnings in both the
ISI and again in the brief summary is the potential to overwarn
consumers. Overwarning is the concept that individuals are exposed to
so many warnings in the course of daily life that they are less likely
to pay attention to any one particular warning (Ref. 3). In terms of
presenting risk information, detailing too many risks may lead
consumers to discount all risks, or miss the most important risk
information. Similarly, habituation follows when readers see the same
warning repeatedly. Upon seeing a particular warning repeatedly,
consumers may cease to pay attention to it (Refs. 4-6). Even if a
warning has features that make it noticeable, it still has the
potential for habituation with repeated exposure (Ref. 5). Although
researchers caution against habituation and overwarning, there appears
to be limited empirical research in the area of DTC advertising for
prescription drugs for the logical supposition that seeing repeated
warnings will lead to increased selectivity and reduced attention by
recipients over time. Of note, the Office of Prescription Drug
Promotion (OPDP) is studying the presentation of risk information in
the context of DTC TV ads (``Disclosure Regarding Additional Risks in
Direct-to-Consumer Prescription Drug Television Advertisements,'' OMB
control number 0910-0785).
    OPDP plans to investigate, through empirical research, various
combinations of the ISI and brief summary. We propose to test two
levels of the ISI (short versus long) and the presence of a consumer
brief summary (absent versus present) in two different medical
conditions (overactive bladder (OAB) and rheumatoid arthritis). The
consumer brief summary will follow the draft recommendations for
language, readability, content, and format described in ``Brief Summary
and Adequate Directions for Use: Disclosing Risk Information in
Consumer-Directed Print Advertisements and Promotional Labeling for
Prescription Drugs: Guidance for Industry, Revised Draft Guidance''
(Ref. 7). The ``long'' ISI is a selection of risks from the brief
summary and is typical of what would appear in current DTC ads for each
condition. The ``short'' ISI was created by applying the ideas from
recent FDA work on the major statement in broadcast ads (see Refs. 8
and 9).

Figures 1 and 2 describe the study design. This will be investigated in
DTC print ads for prescription drugs.
[GRAPHIC] [TIFF OMITTED] TN14AU18.002

    This project is designed to use eye-tracking technology. Eye-
tracking technology is an effective method to determine the extent to
which consumers attend to risk information presented in DTC print ads.
This technology allows researchers to unobtrusively detect and measure
where a participant looks while viewing a print ad and for how long,
and the pattern of their eye movements may indicate attention to and
processing of information in the ad.
    We plan to collect descriptive eye-tracking data on voluntary
participants' attention to the following: (1) The ISI, (2) the brief
summary, and (3) the indication and benefit claims. All participants
will be 18 years of age or older. We will exclude individuals who are
trained as healthcare professionals, employees of the U.S. Department
of Health and Human Services (HHS), or who work in pharmaceutical,
advertising, or marketing settings because their knowledge and
experiences may not reflect those of the typical consumer. We will also
exclude individuals who have photosensitive epilepsy; use a medical
device that is sensitive to infrared light; or wear various kinds of
eyeglasses, hard contact lenses, or colored contact lenses, or have
certain vision disorders.
    To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
With the sample size described in this document, we will have
sufficient power to detect small-to-medium sized effects in the main
study.
    We plan to conduct one 60-minute pilot study with 40 participants
and two 60-minute studies with 200 voluntary participants each (50
participants in each cell), for a total of 400 main study voluntary
participants. The studies will be conducted in person in at least five
different cities across the United States. These locations include
Chicago, IL, Tampa, FL, Phoenix, AZ, Houston, TX, and Marlton, NJ. The
pilot study and main studies will have the same design and will follow
the same procedure. Participants who self-identify as having one of the
medical conditions of interest will be randomly assigned to one of four
test conditions. In Study 1, the ad will be for a fictitious drug to
treat rheumatoid arthritis. In Study 2, the ad will be for a fictitious
drug to treat OAB. After obtaining consent, we will explain the study
procedure to participants and calibrate the eye-tracking device. To
collect eye-tracking data, we will use an unobtrusive glasses-based
real-world eye tracker with a minimum speed of 50 hertz. The test
images will be presented on paper and sized similarly to how they would
appear in print materials such as magazines. To simulate normal ad
viewing, participants will view two ads. One of the ads will be the
study ad. The non-study ad will be for a consumer product unrelated to
health. Only eye-tracking data from the study ad will be analyzed.
Next, participants will complete a questionnaire that assesses risk
perceptions, risk recall, efficacy perceptions, efficacy recall, and
covariates such as demographics and health literacy. In the pilot
study, participants will also answer questions as part of a debriefing
interview to assess the study design and questionnaire.
    In the Federal Register of June 19, 2017 (82 FR 27842), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Five public comments were received. Comments
received along with our responses to the comments are provided 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: FRN = Federal Register Notice; DTC = direct-to-consumer;
FDA and the Agency = Food and Drug Administration; OPDP = FDA's Office
of Prescription Drug Promotion.
    (Comment 1a, regulations.gov tracking number 1k1-8xet-419m
(verbatim)) The research methodology that is outlined here, does not
take into consideration prior exposure to ads and the fact that it is
known to take about seven exposures to anything before the information
sticks. Exposing the respondents to an hour-long eye-tracking research
study does not take this into consideration.
    (Response) We are not testing long-term retention of information.
We are recruiting participants who have the medical condition of
interest and may currently be under treatment. Also, Question 21 asks
about familiarity with treatments for the targeted condition, which can
be used as a covariate in analyses. We do not expect participants to
have prior exposure to advertising for the product in the study because
the ad is for a fictional product.
    (Comment 1b (verbatim)) A sample of 400 is what is considered
robust for comparative analysis. Although you will have enough to do
some comparison with 200 respondents in each group, it would be better
to increase to 400 per group.
    (Response) Analysis will be conducted within medical condition.
This yields a sample size within each study of 200, which will be used
to

examine the main effect of length of ISI, the main effect of the
presence of a brief summary, and the interaction effects of the two.
The sample size of 200 was determined through a power analysis using an
alpha level of 0.05, a power of 0.90 and a medium effect size (f =
0.25). The power to detect a medium effect size (f = 0.25) is 0.999
given an alpha of 0.05 if the sample size for each study was increased
to 400. The increase in sample size would not substantially improve our
ability to detect differences.
    (Comment 1c (verbatim, edited for length)) It seems like the
research is front loaded to give the answer that the FDA is looking
for--give less information to consumers so that they think less about
the side effects of the product and buy more product. Consumers should
be given all the information to make an informed choice by themselves
not determined by what the FDA or other governmental organization feels
is what they can handle.
    (Response) Please see our responses to Comments 2i and 5a. This
research is intended to develop scientific evidence to help inform
policy decisions and ensure that our policies related to prescription
drug promotion will have the greatest benefit to public health. OPDP
seeks to ensure that prescription drug promotional materials provide
truthful, balanced and accurately communicated information that helps
patients make informed decisions about their treatment options. In each
study, the ads will all include the same risk concepts and we will
measure comprehension of these risks. We will vary the amount of detail
about each risk concept in the ISI section of the ad and we will test
the effects of repeating information across the ISI and the consumer
brief summary.
    (Comment 2a, regulations.gov tracking number 1k1-8xz7-z732
(verbatim)) Do the exclusion criteria adequately account for all
potential subjects that have vision impairments that can affect how
their eyes move as they read? Additional exclusions may be needed to
address these (e.g. blindness in one eye, artificial eye, etc.).
    (Response) The study design currently calls for excluding potential
participants with vision impairments that interfere with the
capabilities of the eye-tracking glasses. This includes wearing regular
glasses, bifocals, trifocals, progressive lenses, hard contact lenses,
and colored contact lenses. We will also add exclusion criteria for
potential participants who have cataracts, amblyopia (lazy eye/blind in
one eye), strabismus (cross-eyed), mydriasis (permanent pupil
dilation), nystagmus (involuntary eye movements), an ocular prosthesis
(glass eye), and who are designated as legally blind.
    (Comment 2b (verbatim)) Consider adding an arm to the design that
shows an ad without any specific risk content or a brief summary, but
alternatively consists of a statement that informs a potential patient
that the drug in question has risks, including serious risks,
associated with its use, and that it is very important that a patient
talk with his/her doctor about these risks, prior to use, to determine
if the drug is appropriate for the patient. It would be interesting to
see what type of recall and what type of eye movement data would occur
for this type of statement.
    (Response) FDA regulations state that prescription drug
advertisements must contain ``a true statement of information in brief
summary relating to side effects, contraindications (. . .[to] include
side effects, warnings, precautions, and contraindications and include
any such information under such headings as cautions, special
considerations, important notes, etc.) and effectiveness'' (Sec.
202.1(e)(1)). Additionally, advertisements must also ``present a fair
balance between information relating to side effects and
contraindications and . . . effectiveness. . . .'' (Sec.
202.1(e)(5)(ii)). We decline the suggestion to test the proposed
statement at this time.
    (Comment 2c (verbatim)) Question 1: The relevance of asking a
subject to assess how many risks are presented in comparison to how
many benefits is not apparent. We recommend that FDA consider deleting
the question or alternatively rewording it to get data on how many
risks the subjects think are presented in the ad. Response options
should be quantitative, such as: No risks, 1-3 risks, 4-6 risks,
6 risks.
    (Response) The purpose of Question 1 is to assess participants'
initial impressions of balance of risks versus benefits in the ad.
Additionally, Question 4 has been revised based on the results of
cognitive testing to collect risks that participants can recall. This
provides both a quantitative measure and an accuracy evaluation. We
believe this approach will yield richer data as far as how many risks
the participant recalls from the ad.
    (Comment 2d (verbatim)) Question 4: If subjects are going to be
asked to recall, using free text, the risks presented in the ad, it
would similarly be interesting to add a similar question to recall,
using free text, which benefits were presented in the ad.
    (Response) The questionnaire contains several questions about
benefit/efficacy (Questions 3, 10, and 11). We also have questions that
measure the perceived risk/benefit tradeoff (Questions 1, 18, and 19).
Although it would be interesting from a conceptual standpoint to
include an open-ended recall question about product benefits, our focus
in this study is on the risk information. Further, we are concerned
about adding length to the questionnaire as we have worked to minimize
the burden of the collection of information on respondents.
    (Comment 2e (verbatim)) Questions 8, 10, and 11: Suggest rewording
the questions so that they describe the likelihood that a person taking
the drug experiences a side effect or a benefit.
    (Response) The items used in this section were developed through
scale validation research. Thus, we prefer to retain them in their
original form.
    (Comment 2f (verbatim)): Questions 12-15: It may be confusing for
the reader to discern differences between the terms ``main ad'', ``page
following the main ad'', and ``advertisement''. These terms might need
to be accompanied by further explanatory text.
    (Response) Cognitive testing revealed participants did have
difficulty discerning the differences in the ad components based on the
descriptive terms provided. To address this problem and help with data
quality, thumbnail images will be provided next to Questions 13-15, so
that participants will have a visual cue of what portion of the ad the
question is asking about without allowing them to re-read the ad
stimulus.
    (Comment 2g (verbatim)) Questions 16 and 17: Randomize the order in
which the personal involvement adjectives/tasks are presented to
minimize bias.
    (Response) Question 16 is The Personal Involvement Inventory, a
validated measure with high internal consistency (coefficient [alpha] =
.88) and has been used in prior studies to provide useful information
about personal relevance (Refs. 10 and 11). The author of the inventory
confirmed that it was developed and has been administered without
randomization of these items. For the current study, values across
items will be averaged in order to produce an overall personal
involvement score for comparison across participants. Since this
question is a validated measure and will be used only as a moderator
variable, the item order will not change. Question 17 is a measure of
self-efficacy, which will serve as an additional outcome of interest.
We will randomize Question 17.

    (Comment 2h (verbatim)) Question 18: It is not clear what the term
``leave'' means. It may mean ``take time off from work.'' Please
clarify.
    (Response) Question 18 was developed through scale validation
research. ``Leave'' does in fact mean ``take time off from work.'' We
did not encounter any confusion on the part of respondents during
cognitive testing of the questionnaire. We prefer to retain this
question in its original form.
    (Comment 2i (verbatim)) Question 19: A consumer should not be
expected to make a risk/benefit assessment of a drug simply by reading
an ad. Such an assessment can occur only after a patient has had a
discussion with his/her healthcare provider. Thus, we suggest deletion
of this question.
    (Response) An important purpose of communicating the drug's
specific risk and benefit information in DTC advertising is to position
consumers as active and well-informed participants in their health care
decisionmaking. FDA seeks to improve our understanding of what baseline
judgements about product risks and benefits individuals make on the
basis of advertising. Question 19 does not indicate that FDA expects
that the advertisement will be the sole basis for individuals to assess
benefit and risk or make ultimate healthcare decisions. Rather,
Question 19, which was developed through scale validation research,
measures one aspect of the consumer's perception of the drug's risk-
benefit tradeoff. Further, we did not encounter any confusion on the
part of respondents during cognitive testing of the questionnaire.
    (Comment 2j (verbatim)) Questions 28-33: We note these questions
assess the ability of the respondent to answer questions using an ice
cream nutrition facts label. We assume the inclusion of these questions
is to assess how well respondents are capable of comprehending complex
numeric information. However, we note that some respondents may not be
able to comprehend and apply numeric information or be motivated to do
so, regardless of how it appears. The format may not matter when this
is the case. Therefore, we suggest that FDA consider analyzing results
based on those who can vs. cannot answer the ice cream questions.
Alternatively, the ice cream questions could be used at the start of
the survey to screen out those who are unable to answer the questions,
thereby further focusing the sample on persons who are able to
comprehend numeric presentations likely to be found in drug promotion.
    (Response) Questions 28-33 make up the Newest Vital Sign (NVS),
developed by Pfizer. (See https://www.pfizer.com/health/literacy/public-policy-researchers/nvs-toolkit). The NVS is a valid and reliable
measure of health literacy and numeracy that was used and recommended
by two studies (Refs. 12 and 13). In this study, the NVS will be used
as a covariate that measures risk of low health literacy/numeracy. It
is important that potential participants of various health literacy
levels are included, because level of health literacy/numeracy of the
individual has been shown to play a particularly strong role in viewing
and processing health information (Ref. 14).
    For the stated reasons, no change to the analysis or use of the
questions to filter the sample of participants is planned.
    (Comment 3a, regulations.gov tracking number 1k1-8y5u-ecif
(verbatim)) One omitted variable in the study design is recall after
viewing the ad and ISI/brief summary. It would seem potential negative
effects of overwarning and habituation would be even more apparent
after a lapse of time. The commenter suggests incorporating a parameter
to capture this, for example, including a re-contact option to test
recall and interpretation after a period of 2-4 days. For this recall
option, we suggest that a quota of ~ 30 respondents per cell in order
to ensure a robust sample for statistical testing.
    (Response) Question 4 captures open-ended recall of risks and
negative effects. The comment proposes an interesting research idea.
However, testing long-term retention of information is beyond the scope
of this study.
    (Comment 3b (summarized)) The commenter suggests ensuring a
representative sample of respondents with the conditions of interest is
collected (~ 30 per cell). Analysis of these respondents compared to
those without the conditions would act as a control.
    (Response) The study design calls for only including individuals
who have the medical condition targeted for each study. This is based
on the rationale that, relative to the general population, individuals
who suffer from a specific medical condition pay more attention to DTC
ads related to that medical condition (Refs. 15-17). Thus, we do not
plan to add a general population sample.
    (Comment 3c (verbatim)) Neither the full stimuli nor specific
examples of the disclosure language were provided. The lack of access
to these makes full interpretation of the study objectives difficult as
well as leaves us unable to provide suggestions or comments on the
stimuli to be tested.
    (Response) We have described the purpose of the study, the design,
the population of interest, and have provided the questionnaire to
numerous individuals upon request. The brief summary for each ad
contains a summary of the product risks, side effects, and
contraindications. The ``long'' ISI is a selection of risks from the
brief summary and is typical of what would appear in current DTC ads
for each condition. The ``short'' ISI was created by applying the ideas
from recent FDA work on the major statement in broadcast ads (see Refs.
16 and 17). Our full stimuli are under development during the PRA
process. We do not make draft stimuli public during this time because
of concerns that this may contaminate our participant pool and
compromise the research.
    (Comment 3d (summarized)) The commenter suggests that the data and
information collected with eye-tracking be used as secondary evidence
of attention. This is due to both difficulty of interpretation inherent
in eye-tracking data along with subjectivity introduced by the ad copy
stimuli under examination, as stimuli can be manipulated to increase/
decrease attractiveness to a respondents' eye. The commenter believes
these limitations make use of this data to direct policy difficult.
Additionally, the briefing document does not expand upon exactly how
the eye-tracking data will be analyzed other than tracking attention.
There are various ways to analyze eye-tracking data, such as order of
attention, number of multiple viewings, and possibly pupil dilation as
a measure of attention. The commenter has traditionally added
qualitative elements to its use of eye-tracking technology in research,
by discussing what the respondent saw after viewing the stimuli and
even reviewing a respondents' eye-tracking map with them to get further
insights.
    (Response) To clarify, two types of data will be collected in each
study. Both data types are considered useful evidence. Self-report
measures will be collected via a web-based questionnaire, and physical
measures of attention will be collected via eye-tracking glasses.
Existing research has relied on self-report measures to determine how
much and what parts of the risk and benefit information consumers are
reading. Because of the known unreliability of self-report measures
(Ref. 18), research is needed to accurately determine what and how much
consumers are reading when they see risk and benefit statements in
prescription drug ads.

    During the debriefings for the pilot study, respondents will be
shown their eye-gaze data and asked to comment on the elements of the
stimuli they attended to, the elements they did not attend to, and why.
These data in aggregate form will be reviewed to determine whether to
modify the stimuli prior to the main studies. Eye-tracking data (both
heat maps and gaze plots) will be used in the analyses to identify
general patterns across participants and to investigate how those
relate to questionnaire measures.
    (Comment 3e (verbatim)) The FRN states the location of risk
information is also an objective of the study. The commenter assumes
this ``location'' testing will be via testing risk information
communicated in stimuli having the ISI plus the Brief Summary against
stimuli having the ISI only. If this is inaccurate, then we are not
sure the study design as described in the FRN adequately tests for a
variable of ``location.'' If varying location of risk information
beyond ISI versus ISI + Brief Summary is desired, the commenter
suggests this be tested in a subsequent study or that the proposed
study better specify variation of ``location.''
    (Response) The commenter has correctly interpreted the study
design. We are not manipulating where the information appears on the
page. Location, as used here, refers to the presence of information in
both the brief summary and the ISI, or just the ISI. Within each
medical condition, we have endeavored to maintain consistency of where
the information appears on the page, and the order of the information,
across experimental conditions.
    (Comment 3f (summarized)) Through the survey, the commenter
suggests maintaining a single scale for all rating questions. For
example, the commenter generally employs a 5-point scale, which
includes a midpoint, and is defined at each point. In the current
questionnaire, the scales switch from 5-point to 6-point scales which
could cause confusion among some respondents. If the 6-point scales are
included explicitly to omit a neutral mid-point, the commenter suggests
that each of the points are defined to ensure that respondents know
what the point on the scale they are choosing means (similarly to what
is provided in Question 20 onwards).
    (Response) Many of the items used in the survey were developed
through scale validation research (i.e., Questions 8-11, 18, and 19).
These items utilize a six-point scale, so we have attempted to use six-
point scales where possible. In other cases, however, we are using
items that have been used in prior FDA studies (i.e., Questions 1 and
24) or are established measurement inventories (Question 16 is the
Personal Involvement Inventory; Ref. 11). Changing the scale range or
altering the scale to add definitions to each scale point would
preclude comparison with prior study results. Thus, we prefer to
maintain the scale ranges currently in use.
    (Comment 3g (summarized)) For Questions 8-11, the commenter
suggests adding a ``Don't know'' option as respondents might not be
able to assess likelihood of side effects, seriousness of side effects,
efficacy, and potential improvement based on the information presented
in the ad. The current range of answer choices may force inaccurate or
speculative responses; a ``Don't Know'' answer would be a legitimate
choice and informative for the study. The commenter's standard practice
is to provide a ``Don't Know'' option whenever it could be a valid
answer.
    (Response) The items used in this section were developed through
scale validation research. Thus, we prefer to retain them in their
original form, for this study, though we will consider this for future
measurement studies.
    (Comment 3h (verbatim)) For Question 12, without ability to review
the stimuli, it is unclear what content will appear in Area A, B, C and
D. It is also unclear whether the content will be the same across all 4
stimuli ads or whether content will change location in the ad.
    (Response) We have endeavored to maintain consistency of
information location across conditions. Area A is the part of the ad
with a picture. Areas B, C, and D are all sections of the ISI.
    (Comment 3i (summarized)) The commenter wonders what the utility of
asking Question 16 is as the question appears to be out of scope with
the objectives of the study. Whether or not the ad is important,
boring, or relevant to the respondent seems irrelevant to the stated
goals. We suggest removing the question.
    (Response) Please see our response to Comment 2g.
    (Comment 3j (summarized) In Question 18, the inclusion of ``. . .
outweigh all the things I have to do to obtain it (appointments,
prescriptions, leave)'' seems out of scope when considering the
objectives of the study. The commenter suggests removing the question.
    (Response) This question measures one aspect of product benefits,
the benefit-inconvenience tradeoff, which is an important component of
drug product perceptions. Additionally, please see our response to
Comment 2h.
    (Comment 3k (summarized)) For Question 19, the commenter suggests a
minor adjustment to the wording. Instead of saying ``The benefits of
[DRUG NAME] outweigh any side effects it may have'', the commenter
suggests saying ``. . . any side effects it is described/indicated as
having''. ``May have'' could be interpreted subjectively by respondents
to include side effects not in the ISI and brief summary.
    (Response) Question 19 is a validated question so it will be
retained as is. Cognitive testing revealed no comprehension or
reporting issues for this question.
    (Comment 3l (verbatim)) For Questions 22-23 pertaining to
respondent perception of condition. There does not appear to be any
skip logic to ensure that only those with one of the specified
conditions can answer those questions. These questions should not be
asked of those who do not suffer from one of the specified conditions.
    (Response) We intend to recruit individuals who self-identify as
having either OAB or rheumatoid arthritis. Those individuals will be
assigned to view an ad that treats their medical condition. The
questionnaire will contain questions relevant to that medical condition
only.
    (Comment 4a, regulations.gov tracking number 1k1-8y4d-os71
(summarized)) The commenter recommends that greater emphasis be placed
on the recall/questionnaire metric rather than the eye-tracking metric.
The eye-tracking data will determine if there is indeed a direct
correlation between the length (amount) of the risk information and
length of time spent looking at that information; however, it will not
differentiate between what content and format is more effective for
communicating that risk information. The commenter suggests that FDA
include in the questionnaire (and/or debriefing interview) specific
inquiries regarding the repetitiveness of the risk information in order
to further explore the link between the amount and placement of risk
information and the ultimate recall of this information.
    (Response) Please see our response to Comment 3d. In addition, we
will add a question regarding repetitiveness to the questionnaire.
    (Comment 4b (summarized)) The commenter believes it is important
that the fictitious drugs in this study have safety profiles reflecting
the complex safety profiles of actual, currently-approved and promoted
products.

    (Response) The DTC ads to be used in this research were developed
using actual ads for these medical conditions. Additionally, we
consulted with expert reviewers in OPDP on content and format to ensure
the stimuli are realistic.
    (Comment 4c (summarized)) The ``short'' versus ``long'' ISI should
be defined explicitly. The commenter believes it is critical to know
the specific ISI content (``short'' and ``long'') in order to fully
understand the study results. Additionally, OPDP examples of adequate
``short'' and ``long'' ISIs used in the context of print ads would be
valuable templates for industry, especially given the lack of consensus
in acceptable utilization of ``short'' iterations of ISI as observed in
past OPDP advisory comments and Warning Letters.
    (Response) Please see our responses to comments 1c and 3c. This
study is not intended to provide specific guidelines on what content
should be included in the ISI.
    (Comment 4d (summarized)) The commenter proposes the content of the
brief summary be stated as well so as to understand what risk
information is repeated from the ISI and what impact this may have on
the study results.
    (Response) We have described how the consumer brief summary will be
constructed in the Background section. Please see our responses to
Comment 1c and 3c.
    (Comment 4e (summarized)) The commenter questions the utility of
including the control, consumer product ad if the eye-tracking data is
not utilized. FDA should clarify if the questionnaire will assess the
recall of the control ad. The commenter recommends FDA fully evaluate
the data from the control ad in order to provide appropriate context
for the results obtained from the study, health-related ads.
    (Response) The purpose of participants viewing the consumer product
ad, otherwise known as the warm-up ad, is to orient them to the ad-
viewing task. In addition, the warm-up ad permits the research team to
do an initial review and adjustment of the eye-tracking equipment as
needed before the study task begins. Therefore, there is no plan to
analyze the warm-up ad data as it is not relevant to the focus of the
study, and is mainly a procedure to orient the participant to the eye-
tracking task.
    (Comment 5a, regulations.gov tracking number 1k1-8y60-6g3m
(summarized)) The commenter is concerned with the Agency's recent
approaches to studies in this area. FDA has proposed to undertake
projects in a variety of disparate topics without articulating a clear,
overarching research agenda or adequate rationales on how the proposed
research related to the goal of further protecting public health.
Within the last year, the Agency has increased such efforts at an
exponential pace. At times, FDA proposes new studies seemingly without
fully appreciating its own previous research published on the OPDP
website. Proposed studies are often unnecessary in light of existing
data. The commenter suggests that the Agency publish a comprehensive
list of its prescription drug advertising and promotion studies from
the past 5 years and articulate a clear vision for its research
priorities for the near future. Going forward, FDA should use such
priorities to explain the necessity and utility of its proposed
research and should provide a reasonable rationale for the proposed
research.
    (Response) OPDP's mission is to protect the public health by
helping to ensure that prescription drug information is truthful,
balanced, and accurately communicated, so that patients and health care
providers can make informed decisions about treatment options. OPDP's
research program supports this mission by providing 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 we believe are most central to our
mission, focusing 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 research data through
analytical methodology development and investigation of sampling and
response issues.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through 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 FRNs and peer-reviewed publications
produced by our office. The website maintains information on studies we
have conducted, dating back to a survey of DTC attitudes and behaviors
conducted in 1999.
    (Comment 5b (The commenter provided a summary of their comments
followed by a more detailed description of the same comments. For
brevity, the summary of comments has been omitted and only the specific
comments [5b through 5t] are provided below. The commenter's full
comments may be accessed at regulations.gov via tracking number 1k1-
8y13-m7td) (summarized)) The PRA Notice states there has been little
empirical research for the logical supposition that seeing repeated
warnings will lead to increased selectivity and reduced attention. This
is not correct. As some authors have commented, ``[h]abituation has
been found in a variety [of] contexts and domains.'' The commenter is
aware of at least three empirical research studies, none cited in the
PRA Notice, that demonstrate the ``habituation effect is a robust
phenomenon.'' This effect has been documented in ``studies involving
different contexts and response measures.''
    (Response) We thank the commenter for pointing out this
mischaracterization. We have revised our introduction to clarify that
whereas there is an overall body of research relating to habituation,
there is limited, if any, research on habituation in the specific
context of DTC print advertising for prescription drugs.
    (Comment 5c (summarized)) FDA should clarify whether the proposed
study will adopt the brief summary format outlined in ``Guidance for
Industry--Brief Summary and Adequate Directions for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs'' (Draft Guidance).
    (Response) We plan to utilize the Question and Answer consumer-
friendly format described in the referenced draft guidance.
    (Comment 5d (summarized)) The commenter requests that the Agency
make available for public comment the study stimuli, including the non-
study ad for a consumer product unrelated to

health. In particular, the commenter wishes to provide comments on: (1)
What constitutes ``short'' and ``long'' length for the ISI and (2) the
content, format, and design of the Brief Summary.
    (Response) Please see our responses to Comments 1c, 3c, 4c, and 4e.
    (Comment 5e (summarized)) The Agency proposes to use eye tracking
technology ``to determine how risk presentations in DTC print ads are
perceived.'' The commenter encourages the Agency to use this technology
in conjunction with other inputs (for example, qualitative research) to
understand why subjects are looking at a portion of the proposed
materials, rather than to draw conclusions that such portions were
viewed. Additionally, an explanation of the use of eye tracking
technology should also be included during the subject enrollment
process.
    (Response) FDA plans to collect and analyze eye-tracking (physical
measures of attention) data in conjunction with other measures,
including self-report measures of attention, recall, and comprehension.
The recall measures will be collected via qualitative (open-ended)
questions. To avoid the potential for priming effects, the goals of the
eye-tracking component of the study will not be explained to recruited
individuals before they report for their in-person sessions. However,
participants will be made aware of the eye-tracking component during
the informed consent process. Please also see our response to Comment
3d.
    (Comment 5f (summarized)) Recall Questions. FDA should capture
whether subjects comprehend that there are side effects and negative
outcomes, even if the subject does not recall information on the
specifics. The commenter suggests adding a question concerning whether
subjects were aided in the recall of information by the ``short'' or
``long'' ISI format.
    (Response) Questions 4a-c capture recall of risk in an open-ended
format. Our approach involves random assignment to experimental
conditions; each participant will see only one version of the stimuli.
Because participants will not be aware there is another, different
format, asking them their impressions of the long versus the short
format is not feasible.
    (Comment 5g (verbatim)) Recall questions (e.g., Question 4) ask
test subjects to identify specific side effects and negative outcomes
of the featured drug products. It is not clear why such questions are
necessary for the research purpose of the study.
    (Response) An important purpose of communicating the drug's
specific risk and benefit information in DTC advertising is to position
consumers as active and well-informed participants in their health care
decision-making. In this study, we are investigating how different
presentations of risk information impact perception and comprehension
of drug risks and benefits. These questions are designed to provide
information to help us identify effective ways to communicate risk and
benefit information in DTC advertising. See our response to Comment 2b
for additional context.
    (Comment 5h (verbatim)) The questionnaires do not define certain
key terms (e.g., risk, side effect). Subjects may interpret these terms
based on different standards. FDA might consider providing user-
friendly definitions.
    (Response) We appreciate the importance of ensuring uniform
interpretation of terms. In cognitive interviews preceding this work,
we assessed whether individuals interpret key terms similarly and made
revisions where necessary. We have also considered the additional time
(burden) that would be required to complete the survey if every term
were defined in the pilot and main study. With these factors in mind,
we have chosen not to provide additional definitions.
    (Comment 5i (summarized)) The commenter recommends that: (1) FDA
replace the phrase ``negative outcomes'' with ``risks and warnings''
and (2) insert ``possible'' before the phrase ``side effects.''
    (Response) We have deleted ``negative outcomes'' from the question
wording in Question 2 and Question 4b. Also, please see our response to
Comment 3g concerning the proposal to reword the previously validated
question.
    (Comment 5j (verbatim)) The Agency should consider changing the
sliding scale to an odd number system to permit a ``neutral'' response.
Most questions (e.g., Questions 2-3, Questions 8-11) provide six
choices, not permitting a neutral response.
    (Response) Please see our response to Comment 3f.
    (Comment 5k (verbatim)) FDA should reconsider the inclusion of the
perceived efficacy likelihood (Question 10) and perceived efficacy
magnitude (Question 11) questions. It is not apparent what utility
these specific questions have in the context of the study.
    (Response) We note that this comment is the opposite of Comment 2d,
which suggests adding recall questions about product benefits. Although
the main focus of this research is on the risk information, an
important purpose of communicating the drug's specific risk and benefit
information in DTC advertising is to position consumers as active and
well-informed participants in health care decision-making. These
questions will allow us to assess the impact of our study variables on
perception and comprehension of drug benefits.
    (Comment 5l (summarized)) The commenter supports a study design
that includes an analysis of whether the inclusion of the brief
summary, along with a short or long ISI, presents duplicative
information to the user, and therefore, introduces overwarning.
    (Response) We thank the commenter for their support of research. We
reiterate that the purpose of the study is to examine how various means
of presenting risk information impact consumer comprehension and
perceptions of product information.
    (Comment 5m (verbatim)) FDA states that it will conduct the studies
in person in at least five different cities across the United States.
The Agency should address what efforts it will take to avoid enrichment
of the sample population when selecting cities.
    (Response) We interpret the commenter's request for FDA to address
how it will ``avoid enrichment of the sample population when selecting
cities'' to mean that FDA should address how it will avoid collecting
data in cities where the medical conditions are more prevalent than in
other cities. This is not the aim of collecting data in five different
cities. Rather, the cities have been selected to represent metropolitan
areas in various geographic areas of the United States, including the
West, Southwest, Midwest, Southeast, and the mid-Atlantic. These
locations include Chicago, IL, Tampa, FL, Phoenix, AZ, Houston, TX, and
Marlton, NJ. Due to the low population prevalence rate of the two
medical conditions and the need to conduct sessions with 40 individuals
with the condition in each of 5 areas, testing in rural areas is not
feasible.
    (Comment 5n (summarized)) Study participants diagnosed with one of
the medical conditions of interest may be more prone to pay attention
and read information concerning prescription drugs for these
conditions. Additionally, the study setting may prompt participants to
pay closer attention to stimuli. FDA should clarify how it plans to
limit such response biases.
    (Response) The study method randomly assigns each participant to an
experimental condition, ensuring that potential pre-existing biases
will be evenly distributed across the conditions.

The only aspect of the participants' experiences that will be varied in
the study will be the manipulations that we have described. Thus, given
the experimental design of the study, if we find differences between
and among conditions, we can be reasonably sure that the manipulations
caused the differences. Similarly, any individual differences in
attention or ability should be spread across experimental conditions.
We have not found in the past that our participants spend an inordinate
amount of time viewing stimuli, but we will be careful to place the
research in context when we interpret the data.
    (Comment 5o (verbatim)) An ``FDA employee'' category, similar to S6
and S7, should be added to the Screener Survey. These individuals
should also be terminated from the study.
    (Response) We have added a category to exclude employees of HHS,
which includes employees of FDA.
    (Comment 5p (verbatim)) S2 and S3 of the Screener Survey should be
rewritten as follows: ``Has a doctor or other health care professional
ever diagnosed you with overactive bladder (OAB)?''
    ``Has a doctor or other health care professional ever diagnosed you
with rheumatoid arthritis (RA)?''
    (Response) We will leave the wording of the screener questions S2
and S3 as-is. Cognitive testing results in various contexts have
indicated comprehension and reporting errors associated with using the
more formal phrase ``. . . diagnosed you with . . . [condition].''
Common practice is to use the wording ``. . . ever told you . . . .''
    (Comment 5q (verbatim)) Question 16 of the Questionnaire and P1 of
the Pilot Study should be deleted. Whether a subject considers the
study stimuli to be ``Exciting/Unexciting'' or ``Boring/Interesting''
or whether the subject ``likes'' the study stimuli has no apparent
relevance to FDA's study goals.
    (Response) Please see our response to Comment 2g.
    (Comment 5r (verbatim)) Questions 12-17 should be the first
questions of the Questionnaire. A subject will likely answer these
questions most accurately immediately after reviewing the study stimuli
and before answering other questions that could influence these
answers.
    (Response) FDA agrees that it is important to position certain
questions where they will be answered in close proximity to the ad-
viewing time, which may improve reporting accuracy. However, the
decision was to place the questions that assess recall and recognition
of risks (Questions 4-7) earliest in the question sequence, so as to
minimize memory decay and contamination of responses by exposure to
questions covering other constructs (risk likelihood, risk magnitude).
The attention (Question 12) and ad reading (Questions 13-15) measures
will be retained in their current order (in the first half of the
questionnaire).
    (Comment 5s (verbatim)) Question 18 should include considerations
for prescription drug access.
    (Response) Please see our response to Comment 2h.
    (Comment 5t (summarized)) It is unclear how FDA plans to utilize
the non-study ad (related to ice cream). Questions 27-32 appear very
different in nature, substance, purpose, format, and length than the
questions concerning the drug ad. FDA should clearly articulate the
purpose of this stimulus and how it will be used in analyzing study
results (if at all). If the sole purpose is to ``stimulate normal ad
viewing,'' the commenter encourages adding another one to two non-study
ads.
    (Response) The comment suggests that the nutrition facts label was
interpreted as the ``non-study ad.'' That is not the case. The ice
cream nutrition facts label and accompanying questions (Questions 27-
33) are included in the questionnaire as skills-based measures of
health literacy and numeracy and have been adapted for self-
administration in these studies. Please see our response to Comment 2j.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Screener..............................             120               1             120  .03 (2 minutes)...........................               4
Study 1 Screener............................             600               1             600  .03 (2 minutes)...........................              18
Study 2 Screener............................             600               1             600  .03 (2 minutes)...........................              18
Completes, Pilot............................              40               1              40  1.........................................              40
Completes, Study 1..........................             200               1             200  1.........................................             200
Completes, Study 2..........................             200               1             200  1.........................................             200
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. 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. McGuire, L.C., ``Remembering What the Doctor Said: Organization
and Older Adults' Memory for Medical Information.'' Experimental
Aging Research, vol. 22, pp. 403-428, 1996.
2. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated with DTC Promotion of
Prescription Drugs: Summary of FDA Survey Research Results'' (2004).
Available at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm151498.htm.
3. Warnings and Risk Communication (2005). Wogalter, M.S., D.M.
DeJoy, and K.R. Laughery (Eds.). Philadelphia: Taylor & Francis,
Inc.
4. Conzola, V.C. and M.S. Wogalter, ``A Communication-Human
Information Processing (C-HIP) Approach to Warning Effectiveness in
the Workplace.'' Journal of Risk Research, vol. 4(4), pp. 309-322,
2001.
5. Wogalter, M.S. and K.R. Laughery, ``Warning! Sign and Label
Effectiveness.'' Current Directions in Psychological Science, vol.
5(2), pp. 33-37, 1996.
6. Wogalter, M.S., T.L. Smith-Jackson, B.J. Mills, and C.S. Paine,
``The Effects of

Print Format in Direct-to-Consumer Prescription Drug Advertisements
on Risk Knowledge and Preference.'' Drug Information Journal, vol.
36(3), pp. 693-705, 2002.
7. Brief Summary and Adequate Directions for Use: Disclosing Risk
Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs. Revised Draft Guidance.
Available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM069984.pdf.
8. ``Content of Risk Information in the Major Statement in
Prescription Drug Direct-to-Consumer Broadcast Advertisements;
Establishment of a Public Docket; Request for Information and
Comments.'' August 21, 2017, 82 FR 39598.
9. Betts, Kevin R., et al., ``Serious and Actionable Risks, Plus
Disclosure: Investigating an Alternative Approach for Presenting
Risk Information in Prescription Drug Television Advertisements.''
Research in Social and Administrative Pharmacy, 2017.
10. Bhutada, N.S., B.L. Rollins, and M. Perri III, ``Impact of
Animated Spokes-Characters in Print Direct-to-Consumer Prescription
Drug Advertising: An Elaboration Likelihood Model Approach.'' Health
Communication, vol. 32, pp. 391-400, 2017.
11. Zaichkowsky, J.L., ``The Personal Involvement inventory:
Reduction, Revision, and Application to Advertising.'' Journal of
Advertising, vol. 23, pp. 59-70, 1994.
12. Mackert, M., S.E. Champlin, K.E. Pasch, and B.D. Weiss,
``Understanding Health Literacy Measurement Through Eye Tracking.''
Journal of Health Communication, vol. 18, pp. 185-196, 2013.
13. Chiang, K.P. and A. Jackson, ``The Impact of Health Literacy on
Involvement and Attitude Toward Pharmaceutical Print Ads.''
International Journal of Healthcare Management, vol. 9(1), pp. 47-
57, 2016.
14. An, S. and N. Muturi, ``Subjective Health Literacy and Older
Adults' Assessment of Direct-to Consumer Prescription Drug Ads.''
Journal of Health Communication, vol. 16(3), pp. 242-255, 2011.
15. Ball, J.G., D. Manika, and P. Stout, ``Consumers Young and Old:
Segmenting the Target Markets for Direct-to-Consumer Prescription
Drug Advertising.'' Health Marketing Quarterly, vol. 28(4), pp. 337-
353, 2011.
16. Christensen, T.P., F.J. Ascione, and R.P. Bagozzi,
``Understanding How Elderly Patients Process Drug Information: A
Test of a Theory of Information Processing.'' Pharmaceutical
Research, vol. 14, pp. 1589-1596, 1997.
17. Mehta, A. and S.C. Purvis, ``Consumer Response to Print
Prescription Drug Advertising.'' Journal of Advertising Research,
vol. 43(2), pp. 194-206, 2003.
18. Paulhus, D.L. and S. Vazire, ``The Self-Report Method.''
Handbook of Research Methods in Personality Psychology, vol. 1, pp.
224-239, 2007.

    Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17360 Filed 8-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72242-72243]
[FR Doc No: 2014-28518]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2009-0074]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal
Regulations, this document provides the public notice that by a
document dated October 14, 2014, the Canadian National Railway Company
(CN), Brotherhood of Locomotive Engineers and Trainmen (BLET), and
International Association of Sheet Metal, Air, Rail and Transportation
Workers (SMART), have jointly petitioned the Federal Railroad
Administration (FRA) for an extension of their waiver of compliance
from certain provisions of the Federal hours of service laws contained
at 49 U.S.C. 21103(a)(4). FRA assigned the petition Docket Number FRA-
2009-0074.
    In their petition, CN, BLET, and SMART seek relief from 49 U.S.C.
21103(a)(4), which, in part, requires a train employee to receive 48
hours off duty after initiating an on-duty period for 6 consecutive
days. Specifically, CN, BLET, and SMART seek a waiver to allow a train
employee to initiate an on-duty period, each day, for 6 consecutive
days followed by 24 hours off duty. In support of the request, CN,
BLET, and SMART explained that CN has operated these schedules of 6
consecutive on-duty periods followed by 24 hours off duty successfully
since 2002. CN, BLET, and SMART indicate that these schedules have not
had an adverse impact on safety.
    CN provided work schedules for the employees covered by the waiver,
which shows them reporting for work within pre-set 4-hour calling
spreads with a regular rest day. CN also provided an analysis of the
most current 12-month period of train-employee on-duty human factor-
related accidents and injuries. CN indicates that its analyses revealed
that of the 22 human factor-related accidents involving CN employees in
the preceding 12 months, none involved employees covered under the
waiver working 6 consecutive days followed by 24 hours off duty.
Finally, CN said that all employees covered by the waiver were provided
information about the waiver extension petition, and that there were no
objections to the waiver extension by these employees.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.

     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 20, 2015 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be viewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov.

    Issued in Washington, DC, on December 1, 2014.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2014-28518 Filed 12-4-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Notices]
[Page 52962]
[DOCID:fr30au10-78]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1930-DR; Docket ID FEMA-2010-0002]

Iowa; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1930-DR), dated July 29, 2010, and related
determinations.

DATES: Effective Date: August 23, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
July 29, 2010.

    Calhoun, Clarke, Dallas, Keokuk, and Washington Counties for
Public Assistance.
    Hamilton and Ida Counties for Public Assistance (already
designated for Individual Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-21603 Filed 8-27-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Notices]
[Page 71608]
[FR Doc No: 2012-29146]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2012-0748]

Notification of the Removal of Conditions of Entry on Vessels
Arriving From the Republic of Indonesia

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that it is removing the conditions
of entry on vessels arriving from the country of the Republic of
Indonesia.

DATES: The policy announced in this notice is effective on December 3,
2012.

ADDRESSES: This notice is part of docket USCG-2012-0748 and is
available online by going to http://www.regulations.gov, inserting
USCG-2012-0748 in the ``Search'' box, and then clicking ``Search.''
This material is also available for inspection and copying at the
Docket Management Facility (M-30), U.S. Department of Transportation,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. This policy is also available at
www.homeport.uscg.mil under the Maritime Security tab; International
Port Security Program (ISPS Code); Port Security Advisory link.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call Mr. Michael Brown, International Port Security Evaluation
Division, United States Coast Guard, telephone<PHONE_NUMBER>. If you
have questions on viewing or submitting material to the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826 or (toll free) 1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Title 46, Section 70110, United States Code, enacted as part of
section 102(a) of the Maritime Transportation Security Act of 2002
(Pub. L. 107-295, Nov. 25, 2002) authorizes the Secretary of Homeland
Security to impose conditions of entry on vessels requesting entry into
the United States arriving from ports that are not maintaining
effective anti-terrorism measures. It also requires public notice of
the ineffective anti-terrorism measures. The Secretary has delegated to
the Coast Guard authority to carry out the provisions of this section.
Previous notices have imposed or removed conditions of entry on vessels
arriving from certain countries. All such notices are available for
review online by going to http://homeport.uscg.mil, clicking on the
``Maritime Security'' and then ``International Port Security Program''
tabs, and then following the link.
    On February 25, 2008, the Coast Guard published a Notice of Policy
in the Federal Register, (73 FR 10042), announcing that it had
determined that ports in the Republic of Indonesia, with certain
exceptions, were not maintaining effective anti-terrorism measures, and
imposed conditions of entry.
    Based on recent information, the Coast Guard has determined that
the Republic of Indonesia is now maintaining effective anti-terrorism
measures. Accordingly, the Coast Guard is removing the conditions of
entry announced in the previously published Notice of Policy. With this
notice, the current list of countries not maintaining effective anti-
terrorism measures is as follows: Cambodia, Cameroon, Comoros, Cote
d'Ivoire, Cuba, Equatorial Guinea, Guinea-Bissau, Iran, Liberia,
Madagascar, Sao Tome and Principe, Syria, Timor-Leste, Venezuela, and
Yemen. This current list is also available in the policy notice
available on the Homeport system as described in the ADDRESSES section
above.
    This notice is issued under authority of 46 U.S.C. 70110(d).

    Dated: November 3, 2012.
Joseph Servidio,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention
Policy.
[FR Doc. 2012-29146 Filed 11-30-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Rules and Regulations]
[Pages 45350-45354]
[FR Doc No: 2014-18205]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2014-0022; FRL-9914-53-Region-3]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Redesignation Requests, Associated Maintenance Plans, and
Motor Vehicle Emissions Budgets for the Delaware Portion of the
Philadelphia-Wilmington, PA-NJ-DE Nonattainment Area for the 1997
Annual and 2006 24-Hour Fine Particulate Matter Standards, and the 2007
Comprehensive Emissions Inventory for the 2006 24-Hour Fine Particulate
Matter Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
State of Delaware's requests to redesignate to attainment the Delaware
portion of the Philadelphia-Wilmington, PA-NJ-DE nonattainment area
(hereafter ``the Philadelphia Area'' or ``the Area'') for both the 1997
annual and the 2006 24-hour fine particulate matter (PM2.5)
National Ambient Air Quality Standards (NAAQS or standards). EPA is
also approving as revisions to the Delaware State Implementation Plan
(SIP), the associated maintenance plans to show maintenance of the 1997
annual and the 2006 24-hour PM2.5 NAAQS through 2025 for the
Delaware portion of the Area. EPA is also proposing to approve the
motor vehicle emissions budgets (MVEBs) included in Delaware's
maintenance plans for the Delaware portion of the Area for both the
1997 annual and 2006 24-hour PM2.5 standards. EPA is also
determining that the Delaware portion of the Philadelphia Area
continues to attain both the 1997 annual and the 2006 24-hour
PM2.5 NAAQS. In addition, EPA is approving the 2007
emissions inventory for the Delaware portion of the Area for

the 2006 24-hour PM2.5 NAAQS. These actions are being taken
under the Clean Air Act (CAA).

DATES: This final rule is effective on September 4, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2014-0022. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) 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 for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Delaware Department of Natural Resources
and Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover,
Delaware 19903.

FOR FURTHER INFORMATION CONTACT: Maria A. Pino,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 12, 2012, the Delaware Department of Natural Resources
and Environmental Control (DNREC) formally submitted two separate
requests to redesignate the Delaware portion of the Philadelphia Area
from nonattainment to attainment for the 1997 annual and the 2006 24-
hour PM2.5 NAAQS, respectively. With the redesignation
requests, DNREC submitted maintenance plans as SIP revisions to ensure
continued attainment of the standards throughout the Delaware portion
of the Area over the next 10 years. Each maintenance plan contains
MVEBs for the Delaware portion of the Area for transportation
conformity purposes. The December 12, 2012 submittal for the 2006 24-
hour PM2.5 NAAQS also includes a 2007 comprehensive
emissions inventory to meet the requirement of section 172(c)(3) of the
CAA for the 2006 24-hour PM2.5 NAAQS.
    On April 11, 2014 (79 FR 20139), EPA published a notice of proposed
rulemaking (NPR) for the State of Delaware. In the NPR, EPA proposed
approval of Delaware's redesignation requests for the Delaware portion
of the Philadelphia Area for the 1997 annual and 2006 24-hour
PM2.5 NAAQS. EPA also proposed approval of the associated
maintenance plans as SIP revisions for the 1997 annual and 2006 24-hour
PM2.5 standards, and the MVEBs included in Delaware's
maintenance plans for the Delaware portion of the Area for both the
1997 annual and 2006 24-hour PM2.5 standards. In addition,
EPA proposed approval of the 2007 emissions inventory for the Delaware
portion of the Area for the 2006 24-hour PM2.5 NAAQS.
Finally, EPA proposed that the Philadelphia Area continues to attain
both the 1997 annual and the 2006 24-hour PM2.5 NAAQS.
    In the April 11, 2014 NPR, EPA addressed the effects of two
decisions of the United States Court of Appeals for the District of
Columbia Circuit (D.C. Circuit Court): The D.C. Circuit Court's January
4, 2013 decision to remand to EPA two final rules implementing the 1997
annual PM2.5 standard and the D.C. Circuit Court's August
21, 2012 decision to vacate and remand to EPA the Cross-State Air
Pollution Control Rule (CSAPR). However, subsequent to publication of
the NPR, United States Supreme Court reversed the D.C. Circuit decision
vacating and remanding CSAPR in EPA v. EME Homer City Generation, L.P.,
134 S.Ct. 1584 (2014).
    EPA has considered the recent decision from the U.S. Supreme Court
regarding CSAPR, and has concluded that the decision does not alter the
Agency's decision to redesignate the Delaware portion of the
Philadelphia Area to attainment for the 1997 annual and 2006 24-hour
PM2.5 NAAQS. EPA promulgated CSAPR (76 FR 48208, August 8,
2011) to replace the Clean Air Interstate Rule (CAIR), which has been
in place since 2005. See 76 FR 59517. The rules require significant
reductions in emissions of sulfur dioxide (SO2) and oxides
of nitrogen (NOX) from electric generating units (EGUs) to
limit the interstate transport of these pollutants and the ozone and
fine particulate matter they form in the atmosphere. The D.C. Circuit
Court initially vacated CAIR, North Carolina v. EPA, 531 F.3d 896 (D.C.
Cir. 2008), but ultimately remanded the rule to EPA without vacatur to
preserve the environmental benefits provided by CAIR, North Carolina v.
EPA, 550 F.3d 1176, 1178 (D.C. Cir. 2008). After staying implementation
of CSAPR on December 20, 2011 and instructing EPA to continue to
implement CAIR in the interim, on August 21, 2012, the D.C. Circuit
Court issued a decision to vacate CSAPR, with further instruction to
continue administering CAIR ``pending the promulgation of a valid
replacement.''
    As stated in the April 11, 2014 NPR, Delaware does not rely on
either CAIR or CSAPR for emission reductions that contributed to the
Delaware portion of the Philadelphia Area's attainment of the 1997 and
2006 PM2.5 NAAQS, nor does the State rely on either of the
rules in its maintenance plans. However, because CAIR was promulgated
in 2005 and incentivized sources and states to begin achieving early
emission reductions, the air quality data examined by EPA in issuing
the final determinations of attainment for the Philadelphia Area for
the 1997 and 2006 PM2.5 NAAQS (77 FR 28782, May 16, 2012 and
78 FR 882, January 7, 2013)) and the air quality data from the area
since 2005 necessarily reflect reductions in emissions from upwind
sources as a result of CAIR.
    Nonetheless, in this case, EPA believes that it is appropriate to
redesignate the Delaware portion of the Philadelphia Area. As stated in
the April 11, 2014 NPR, modeling conducted by EPA during the CSAPR
rulemaking process, which used a baseline emissions scenario that
``backed out'' the effects of CAIR, see 76 FR at 48223, projected that
the counties in the Philadelphia Area would have PM2.5
levels below the 1997 annual and 2006 24-hour PM2.5 NAAQS in
both 2012 and 2014 without taking into account emissions reductions
from CAIR or CSAPR. See ``Air Quality Modeling Final Rule Technical
Support Document,'' Appendix B, pages B-37, B-51, B-57, B-58, B-66, B-
80, B-86. This modeling is available in the docket for this rulemaking
action. In addition, the 2010-2012 quality-assured, quality-controlled,
and certified monitoring data for the Philadelphia Area confirms that
2012 PM2.5 annual design values for each monitoring site in
the Area remained well below the 1997 annual and 2006 24-hour
PM2.5 NAAQS, and thus the entire Area continued to attain
the standard in 2012. As stated in the NPR, 2010-2012 annual and 24-
hour design values for the Philadelphia Area are 13.1 micrograms per
cubic meter ([mu]g/m\3\) and 31 [mu]g/m\3\, respectively and
preliminary 2011-2013 annual and 24-hour design values of 12.3 [mu]g/
m\3\ and 28 [mu]g/m\3\, respectively. In addition, as stated in the
April 11, 2014 NPR, emissions of SO2 and NOX, the
two pollutants targeted by CAIR and CSAPR, have decreased greatly since
the Philadelphia Area was designated as nonattainment for the 1997 and
2006 PM2.5 NAAQS, and those reductions are projected to
continue throughout the maintenance period. Between 2002 and

2007, NOX and SO2 emissions were reduced by 25
percent and 70 percent, respectively, in the Delaware portion of the
Philadelphia Area. For maintenance of the 1997 annual NAAQS, between
2007 and 2025, NOX and SO2 emissions are
projected to decrease by 40 percent and 54 percent, respectively, in
the Delaware portion of the Philadelphia Area. For maintenance of the
2006 24-hour NAAQS, between 2008 and 2025, NOX and
SO2 emissions are projected to decrease by 38 percent and 61
percent, respectively, in the Delaware portion of the Philadelphia
Area. These reductions are due to a combination of strong state and
federal control measures that were listed in the NPR, and do not
include any emission reductions from CAIR or CSAPR.
    The status of CSAPR is not relevant to these redesignations. CSAPR
was promulgated in June 2011, and the rule was stayed by the D.C.
Circuit Court just six months later, before the trading programs it
created were scheduled to go into effect. Therefore, the Philadelphia
Area's attainment of the 1997 annual and 2006 24-hour PM2.5
NAAQS cannot have been a result of any emission reductions associated
with CSAPR. In sum, neither the current status of CAIR nor the current
status of CSAPR affects any of the criteria for proposed approval of
these redesignation requests for the Delaware portion of the
Philadelphia Area.
    Specific details of Delaware's submittals and the rationale for
EPA's proposed actions are explained in the NPR and will not be
restated here. No adverse public comments were received on the NPR. EPA
did receive one public comment in support of this rulemaking action,
which can be found in the publicly available docket for this rulemaking
action.

II. Final Action

    EPA is approving Delaware's requests to redesignate the Delaware
portion of the Philadelphia Area from nonattainment to attainment for
the 1997 annual and the 2006 24-hour PM2.5 NAAQS. EPA has
evaluated Delaware's redesignation requests and determined that upon
approval of the 2007 comprehensive emissions inventory for the 2006 24-
hour PM2.5 NAAQS proposed as part of this rulemaking action,
it would meet the redesignation criteria set forth in section
107(d)(3)(E) of the CAA for both standards. As stated in greater detail
in the April 11, 2014 NPR, EPA believes that the monitoring data
demonstrate that the entire Philadelphia Area is attaining and will
continue to attain the 1997 annual and 2006 24-hour PM2.5
NAAQS. EPA is also proposing to approve the associated maintenance
plans for the Delaware portion of the Area as a revision to the
Delaware SIP for the 1997 annual and 2006 24-hour PM2.5
standards because they meet the requirements of CAA section 175A for
both standards. For transportation conformity purposes, EPA is also
proposing to approve MVEBs for both the 1997 annual and 2006 24-hour
PM2.5 standards. Final approval of the redesignation
requests would change the official designations of the Delaware portion
of the Philadelphia Area for the 1997 annual and the 2006 24-hour
PM2.5 NAAQS, respectively, found at 40 CFR part 81, from
nonattainment to attainment, and would incorporate into the Delaware
SIP the associated maintenance plans ensuring continued attainment of
the 1997 annual and 2006 24-hour PM2.5 NAAQS in the Delaware
portion of the Area for the next 10 years, until 2025.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of geographical area
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable Federal regulations. 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.
Accordingly, 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 action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 October 6, 2014. 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, in which EPA is approving of the redesignation requests and
maintenance plans for the Delaware portion of the Philadelphia Area for
the 1997 annual and 2006 24-hour PM2.5 NAAQS, MVEBs included
in Delaware's maintenance plans for the Delaware portion of the Area
for both the 1997 annual and 2006 24-hour PM2.5 NAAQS, and
the 2007 comprehensive emissions inventory for the 2006 24-hour
PM2.5 NAAQS, may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen oxides, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 81

    Air pollution control, National parks, Wilderness areas.

    Dated: July 11, 2014.
W.C. Early,
Acting Regional Administrator, Region III.
    40 CFR parts 52 and 81 are amended 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 I-- Delaware

0
2. In Sec.  52.420, the table in paragraph (e) is amended by adding
entries for the 1997 Annual and the 2006 24-Hour PM2.5
Maintenance Plans for the Delaware Portion of the Philadelphia-
Wilmington, PA-NJ-DE Area (New Castle County) at the end of the table
to read as follows:

Sec.  52.420  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP          Applicable           State                                Additional
             revision                geographic area    submittal date   EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Maintenance plan contained in      New Castle County..      12/12/2012  8/5/2014 [Insert     See Sec.
 ``Delaware Redesignation Request                                        page number where    52.427(d).
 and Maintenance Plan Under the                                          the document
 1997 Annual PM2.5 National                                              begins].
 Ambient Air Quality Standard For
 the New Castle County Portion of
 the Philadelphia-Wilmington, PA-
 NJ-DE Nonattainment Area for
 Fine Particles,'' dated November
 27, 2012.
Maintenance plan contained in      New Castle County..      12/12/2012  8/5/2014 [Insert     See Sec.
 ``Delaware Redesignation Request                                        page number where    52.427(e).
 and Maintenance Plan Under the                                          the document
 2006 Daily PM2.5 National                                               begins].
 Ambient Air Quality Standard For
 the New Castle County Portion of
 the Philadelphia-Wilmington, PA-
 NJ-DE Nonattainment Area for
 Fine Particles,'' dated November
 27, 2012.
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.423 is amended by revising the section heading and by
adding paragraph (d) to read as follows:

Sec.  52.423  Base year emissions inventory.

* * * * *
    (d) EPA approves as a revision to the Delaware State Implementation
Plan the comprehensive emissions inventory for the Delaware portion of
the Philadelphia-Wilmington, PA-NJ-DE 2006 24-hour fine particulate
matter (PM2.5) nonattainment area submitted by the Delaware
Department of Natural Resources and Environmental Control on December
12, 2012. The 2007 year emissions inventory includes emissions
estimates that cover the general source categories of point sources,
non-road mobile sources, area sources, on-road mobile sources, and
biogenic sources for New Castle County, Delaware. The pollutants that
comprise the inventory are nitrogen oxides (NOX), volatile
organic compounds (VOCs), PM2.5, ammonia (NH3),
and sulfur dioxide (SO2).

0
4. Section 52.427 is amended by adding paragraphs (d) and (e) to read
as follows:

Sec.  52.427  Control strategy: Particular matter.

* * * * *
    (d) EPA approves the maintenance plan for the Delaware portion of
the Philadelphia-Wilmington, PA-NJ-DE PM2.5 Nonattainment
Area (New Castle County) for the 1997 annual fine particulate matter
(PM2.5) national ambient air quality standard (NAAQS)
submitted by the Secretary of the Delaware Department of Natural
Resources and Environmental Control on December 12, 2012. The
maintenance plans include motor vehicle emission budgets in tons per
year (tpy) used for transportation conformity purposes for New Castle
County, Delaware.

                New Castle County Motor Vehicle Emissions Budgets for the 1997 Annual PM2.5 NAAQS
                                                      [tpy]
----------------------------------------------------------------------------------------------------------------
                                                                                Effective date
     Type of control strategy SIP                 Year                  NOX            PM2.5          of SIP
                                                                                approval
----------------------------------------------------------------------------------------------------------------
Maintenance Plan......................  2017 Interim Budget.....           6,273             199        9/4/2014
                                        2025 Final Budget.......           6,273             199
----------------------------------------------------------------------------------------------------------------

    (e) EPA approves the maintenance plan for the Delaware portion of
the Philadelphia-Wilmington, PA-NJ-DE PM2.5 Nonattainment
Area (New Castle County) for the 2006 24-hour fine particulate matter
(PM2.5) national ambient air quality standard (NAAQS)
submitted by the Secretary of the Delaware Department of Natural
Resources and Environmental Control on December 12, 2012. The
maintenance plans include motor vehicle emission budgets in tons per
year (tpy) used for transportation conformity purposes for New Castle
County, Delaware.

               New Castle County Motor Vehicle Emissions Budgets for the 2006 24-Hour PM2.5 NAAQS
                                                      [tpy]
----------------------------------------------------------------------------------------------------------------
                                                                                Effective date
     Type of control strategy SIP                 Year                  NOX            PM2.5           of SIP
                                                                                approval
----------------------------------------------------------------------------------------------------------------
Maintenance Plan......................  2017 Interim Budget.....           6,273             199        9/4/2014
                                        2025 Final Budget.......           6,273             199
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
5. The authority citation for Part 81 continues to read as follows:

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

0
6. In Sec.  81.308, the tables for Delaware--1997 Annual
PM2.5 NAAQS [Primary and secondary] and Delaware--2006 24-
Hour PM2.5 NAAQS [Primary and secondary] are amended by
removing footnote number 2 in each table and revising the entries for
the Philadelphia-Wilmington, PA-NJ-DE Area to read as follows:

Sec.  81.308  Delaware.

* * * * *

                                        Delaware--1997 Annual PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                    Designation \a\                       Classification
           Designated area            --------------------------------------------------------------------------
                                          Date \1\                Type                 Date            Type
----------------------------------------------------------------------------------------------------------------
Philadelphia-Wilmington, PA-NJ-DE:           8/5/2014  Attainment...............  ..............  ..............
 New Castle County.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after January 5, 2005, unless otherwise noted.

* * * * *

                                       Delaware--2006 24-Hour PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                    Designation \a\                       Classification
           Designated area            --------------------------------------------------------------------------
                                          Date \1\                Type                 Date            Type
----------------------------------------------------------------------------------------------------------------
Philadelphia-Wilmington, PA-NJ-DE:           8/5/2014  Attainment...............  ..............  ..............
 New Castle County.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 30 days after November 13, 2009, unless otherwise noted.

* * * * *
[FR Doc. 2014-18205 Filed 8-4-14; 8:45 am]
BILLING CODE 6560-50-P


February 12, 2004 The Honorable John Elias Baldacci Governor of Maine 1 State House Station Augusta, ME 04333 0001 Dear Governor Baldacci:

Thank you for your letter forwarding Maine= s recommendations on air quality designations for the national health based standards for fine particles. We received your letter on February 2, 2004.

Your letter is an important step toward providing citizens in your state with critical information about air pollution levels in their community. We intend to carefully review the recommendations and work with the Maine Department of Environmental Protection in determining final designations. The EPA must make its final official designation decisions for fine particles by December 31, 2004.

We look forward to working with Maine in the coming months on designations for the fine particle standards. If you have any questions, please do not hesitate to call me or Tim Williamson, Acting Manager of the Air Quality Planning Unit, at 617 918 1099.

Sincerely,

Robert W. Varney Regional Administrator cc: Dawn Gallagher, ME DEP James Brooks, ME DEP