[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8721-8727]
[FR Doc No: 2019-04307]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0215]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Healthcare
Professional Survey of Professional Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by April
10, 2019.

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_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title, ``Healthcare Professional Survey of Professional Prescription
Drug Promotion.'' Also include the FDA docket number found in brackets
in the heading of this document.

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

Healthcare Professional Survey of Professional Prescription Drug
Promotion

OMB Control Number 0910-New

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes

FDA to conduct research relating to drugs and other FDA regulated
products in carrying out the provisions of the FD&C Act.
    The FD&C Act prohibits the dissemination of false or misleading
information about medications in consumer-directed and professional
prescription drug promotion. As part of its Federal mandate, FDA
regulates whether advertising of prescription drug products is
truthful, balanced, and accurately communicated (see 21 U.S.C. 352(n)).
FDA's regulatory policies are aligned with the principles of free
speech and due process in the U.S. Constitution. To inform current and
future policies, and to seek to enhance audience comprehension, the
Office of Prescription Drug Promotion conducts research focusing on (1)
advertising features including content and format, (2) target
populations, and (3) research quality. This proposed research focuses
on healthcare professionals (HCPs). In 2002 (Ref. 1) and again in 2013
(Refs. 2 and 3), FDA surveyed HCPs about their attitudes toward direct-
to-consumer (DTC) advertising and its role in their relationships with
their patients. The 2013 survey included multiple types of HCPs:
Primary care physicians and specialists, as well as nurse practitioners
and physician assistants. Whereas the focus of both previous FDA
surveys was on DTC advertising and promotion, the current study is
designed to address issues related to professional prescription drug
promotion. The goal is to query a representative sample of HCPs about
their opinions of promotional materials and procedures targeted at
HCPs, clinical trial design and knowledge, and FDA approval status. We
will also take this opportunity to ask HCPs briefly about their
knowledge of abuse-deterrent formulations for opioid products.
    To educate themselves about prescription drugs, HCPs sometimes rely
on professionally directed promotional information (Refs. 4-8). In
2012, pharmaceutical companies spent more than $24 billion on marketing
to physicians (Ref. 9). The industry exposes healthcare professionals
to promotional materials through a variety of mechanisms, including
communication with pharmaceutical representatives, journal ads,
prescribing software, presentations at sponsored meetings, and direct
mail ads (Ref. 10). Several studies indicate that data presented in
promotional materials may not be fully comprehended and may even
potentially be misleading due to a variety of causes, such as
insufficient information, unsupported claims, or a failure to disclose
limitations of the information presented (Refs. 11-15).
    Although HCPs are learned intermediaries, like most people, they
may rely on heuristics, or rules of thumb, in making decisions and may
have cognitive biases in the type of information they attend to at any
given time. They may be persuaded by strong statements and may not have
the time to ascertain accuracy of such information (Ref. 16).
    The proposed survey is designed to provide further insights about
how professionally targeted prescription drug promotion might influence
healthcare professionals' decision-making processes and practices and
how information may be communicated more accurately. It is important to
note that FDA does not regulate the practice of medicine. However, as
previously mentioned, FDA does regulate prescription drug promotion.
This survey is designed to inform FDA of various responses to and
impacts of prescription drug promotion.
    The general research questions in the survey are as follows:
    1. What methods and/or channels are used to disseminate
prescription drug promotional information to healthcare professionals/
prescribers?
    2. How knowledgeable and interested are HCPs in clinical trial data
and design and its presence in prescription drug promotion?
    3. How familiar are HCPs with the FDA approval of prescription
drugs and how does this affect prescribing behavior?
    In addition, given the critical problem with opioid abuse and
addiction in the United States at this time, we plan to ask several
questions about prescription drug promotion of opioid products.
    HCPs who fall into one of four categories will be recruited online
through WebMD's Medscape subscriber network. We propose to complete 700
primary care physician, 600 specialist, 350 nurse practitioner, and 350
physician assistant surveys. HCPs will be included if they see patients
at least 50 percent of the time. Both Doctors of Medicine and Doctors
of Osteopathy will be included. Primary care physicians will include
those who indicate they work in general, family, or internal medicine.
Specialties were chosen based on prevalence in the United States and
prescription drug promotional activity. Specialists will include
cardiologists, dermatologists, endocrinologists, neurologists,
obstetrician/gynecologists, oncologists, ophthalmologists,
psychiatrists, rheumatologists, and urologists. The data will be
weighted to adjust for differential coverage of select characteristics
such as region and respondent age and gender. Pretesting with 25
respondents will take place before the main study to evaluate the
procedures and measures used in the main study.
    In the Federal Register of March 15, 2018 (83 FR 11539), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received. One comment was
outside the scope of the research and is not addressed further. The
remaining three comments are addressed below. For brevity, some public
comments are paraphrased and therefore may not reflect the exact
language used by the commenter. We assure commenters that the entirety
of their comments was considered even if not fully captured by our
paraphrasing in this document. The following acronyms are used here:
DTC = direct-to-consumer; HCP = healthcare professional; FDA and ``The
Agency'' = Food and Drug Administration; OPDP = FDA's Office of
Prescription Drug Promotion.
    The first public comment had 19 individual comments, to which we
have responded.
    (Comment 1a) The exact reach of the WebMD Medscape subscriber
network among medical professionals is unclear. With this in mind, the
study design could introduce bias by self-selecting physicians who do
not accurately reflect the broader physician population. For example,
they may be more reliant on internet-based information, have seen more
web-based pharmaceutical advertisements, and be demographically
different than physicians outside the Medscape network.
    (Response 1a) It is true that Medscape is not an exhaustive listing
of the entire universe of HCPs, but the evidence suggests that coverage
is high. Table 1 below documents the number of providers subscribed to
WebMD for the four major strata of HCPs included in the study and the
estimated population totals. The coverage is particularly good for
primary care physicians (over 80 percent), is reasonable for
specialists and physicians assistants (between 60 and 70 percent), and
not as good for nurse practitioners (about 45 percent).

                     Table 1--Estimated Counts and Coverage by Healthcare Professional Group
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                                                                                Estimated
                  Healthcare professional group                      WebMD \1\      population       Estimated
                                                                                total        coverage %
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Primary care physicians (PCPs)..................................         197,980     \2\ 242,800            81.5
Specialists (SPs)...............................................         465,020     \2\ 724,249            64.2
Physicians assistants...........................................          62,874      \3\ 92,000            68.3
Nurse practitioners.............................................         102,552     \4\ 220,000            46.6
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\1\ WebMD estimated counts of Medscape subscribers by HCP group as of July 2017.
\2\ American Medical Association (https://www.mmslists.com/data/countspdf/AMA-SpecialtyByTOPS.pdf).
\3\ Kaiser Family Foundation (https://www.kff.org/other/state-indicator/total-physician-assistants/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D).
\4\ American Association of Nurse Practitioners (https://www.aanp.org/all-about-nps/np-fact-sheet).

    The Medscape frame has a smaller frequency of out-of-scope records
(retirees, for example, who have not been dropped from the list), and
much better contact information (including email addresses), compared
to other possible frames. Potential frame competitors, such as the
American Medical Association list of providers, have higher coverage of
PCPs and SPs, but also many out-of-scope records. Sampling these
records would lead to ineligibles in data collection. Considering both
coverage and ineligibility rates, Medscape is of better quality than
the alternatives. We are planning to calibrate the weights for the
sample providers who answer the questionnaire, using the National
Ambulatory Medical Care Survey (NAMCS) estimates as benchmarks, based
on gender, age, year of graduation, and practice size. Use of these
calibrated weights will guarantee that the percentages across provider
type, gender, age, year of graduation, and practice size match the
NAMCS percentages, which are our best unbiased estimates of the true
population percentages. Thus, the under-coverage from the use of the
Medscape frame will not lead to significant imbalances in the
distribution of these characteristics which could lead to bias.
Calibration eliminates bias-producing imbalances for cells defined by
the calibration characteristics, but does not eliminate imbalances
within these cells. It may be the case that within the provider type-
gender-age-graduation year-practice size cells, the Medscape population
differs from the universe because of their self-selection into
Medscape. This will generate coverage biases of unknown magnitude, but
we anticipate that the size of these biases will be small as a
component of overall mean-squared-error in this study and will not
materially affect the analyses.
    (Comment 1b) If specialties are planned to be analyzed
individually, the sample size should be at least 50 respondents from
each specialty.
    (Response 1b) Our analysis plan does not include a separate full-
scale analysis for each specialty, though specialty will be included in
the analyses as a covariate along with other provider characteristics.
Thus, the 50-respondent minimum per specialty is not necessary given
the goals of this study.
    (Comment 1c) We did not have access to the full screening criteria
and have several suggestions for the criteria: a mix of age, practice
experience, practice setting, number of patients seen each month, and
gender.
    (Response 1c) Our screening instrument captures the suggested
items, including age, gender, race/ethnicity, practice setting, percent
of time seeing patients, and clinical specialty. The survey instrument
collects information on the number of patients seen weekly and number
of years in practice.
    (Comment 1d) Q[uestion]2 currently asks how often physicians visit
commercial prescription drug websites. This is a broad question, and we
suggest adding followup questions to understand why the physician went
to the website (i.e., interested in getting specific product
information, patient assistance program information, etc.), what
specific information was sought (i.e., promotional information,
educational resources, patient support services, prescribing
information) and how helpful was the information.
    (Response 1d) Prescription drug websites are one of several
information sources that are asked about in the survey. The primary
goal of our questions about sources of information is to capture the
amount of exposure or use of various information sources by HCPs. This
may be a good avenue for further research.
    (Comment 1e) Responses to Q3 could skew towards more frequent use
than the average prescriber since the sample is being recruited from a
network of physicians subscribing to a reference website (WebMD
Medscape).
    (Response 1e) We acknowledge there may be a coverage bias from the
use of the WebMD Medscape as a frame, but do not know exactly the
magnitudes of bias for particular items. We will document the nature of
our frame and the potential implications of that. See response to
comment 1a for more details on WebMD sample.
    (Comment 1f) Q7a asks respondents to gauge the influence of various
information sources on their colleagues' prescribing decisions. Q7b
asks about the influence of various information sources on the
respondent's prescribing decisions. Influence is subjective and
respondent answers to these questions are inherently unreliable. We
suggest asking about behavior to help understand influence. If these
questions are retained, we suggest reordering the questions.
    (Response 1f) We are interested in HCPs' perceptions of relative
influence of different information sources. An assessment of the actual
influence of these sources through prescribing data is beyond the scope
of this project. This is a valuable avenue for future research.
Moreover, this question is designed to build on research literature
which suggests that HCPs typically rate promotional materials as being
more influential on colleagues than on themselves (Refs. 17 and 18).
Thus, we ask about the influence of promotional information for both
colleagues and the respondent. We will randomize the presentation order
of these two questions in the survey.
    (Comment 1g) For Q9-Q10, questions and answer choices are overly
broad to provide actionable insight. For example, respondents might
define ``information about clinical trial designs or clinical trial
outcomes'' differently, along with what ``Some'' versus ``Lots'' of
information represent. We suggest revising Q9 to ``Do you need more
clinical trial design information in order to understand or interpret
the clinical

trial data and outcomes presented in promotional material?'' We suggest
revising Q10 to ``Do you need more clinical trial outcomes information
in order to make sound clinical decisions for your patients?''
    (Response 1g) We have made some changes to these questions as a
result of cognitive testing. For example, we replaced ``clinical trial
design'' with ``clinical trial methodology'' and included examples of
what is meant by methodology in parenthesis (e.g., sample, study
design). We also changed answer choices to make them more distinct. The
choices are now: All information, a moderate amount, a minimal amount,
and none.
    (Comment 1h) We suggest revising Q14 into two separate questions.
One question about the type of training (e.g. formal school, continuing
medical education, peers) and a separate question on how much training
in different aspects of clinical trial design the respondent completed.
    (Response 1h) We are using the question about clinical trials
training as a covariate to other questions in the survey about clinical
trials. Training may influence the amount of clinical trials
information HCPs want included in promotions or their level of comfort
with clinical trials data. We have added the word ``formal'' to the
question to indicate that we are referring to actual training rather
than informal discussions with colleagues.
    (Comment 1i) Q18 assumes the physician knows whether the drugs
prescribed are approved or not approved. We suggest including a
selection of ``Do not know.''
    (Response 1i) We will add ``Do not know'' as a response option to
this question.
    (Comment 1j) We have concerns that Q21 fails to define what the
Agency means by ``promotion.'' As a result, the question as phrased may
suggest that the Agency has broader authority than delegated by
Congress or as permitted under the First Amendment to regulate (i.e.,
``allow'') protected manufacturer speech that is truthful and non-
misleading. We suggest revising Q21 to ask respondents if they value
the ability of pharmaceutical companies to provide truthful and non-
misleading information about their drugs for indications not approved
by FDA.
    (Response 1j) Q21 has been deleted.
    (Comment 1k) We agree that having an option of ``not sure'' for Q22
is appropriate since many respondents might not be familiar with this
approval pathway. However, this could reduce the amount of information
this question could assess. We suggest modifying the question to
incorporate the definition of accelerated approval and then ask the
respondent about his/her comfort level with prescribing. This approach
would allow the survey to collect responses from the most respondents
possible. We also suggest adding a question prior to Q22 to ask about
familiarity or experience with an accelerated approval drug that could
be used to assess prior behavior as well as understand how experience
with accelerated approval impacts comfort to use.
    (Response 1k) We have purposefully not included a definition of
accelerated approval, as we are interested in assessing comfort with
accelerated approval based on their own understanding of the term. We
have added an open-ended question prior to Q22 that asks respondents to
describe what an accelerated approval drug is in their own words.
    (Comment 1l) We recommend modifying the open-ended question (Q23)
about scientific exchange and offering respondent components for
consideration (i.e., criteria for who is part of exchange of
information, description for type of scientific information,
description of context of scientific information, and the forum or
setting where exchange of information occurs). We also recommend adding
question(s) to understand how often respondents engage in settings
where scientific exchange typically occurs, such as oral presentations/
poster sessions at scientific congresses, review of articles in medical
journals, data and clinical trial summaries on clinical trial
registries.
    (Response 1l) The goal of this open-ended question is to assess
general awareness/understanding of the term ``scientific exchange.'' In
cognitive testing, we found that several HCPs had never heard this term
before. Therefore, we need to get a broader sense of general awareness,
which may be low, before following up with more specific questions. We
have added the option to check ``do not know'' for this question.
    (Comment 1m) The open-ended question (Q24) seeking a description of
biosimilars will likely result in an extremely wide range of answers
with no ability to categorize responses based on the HCP's true
knowledge of the term. We suggest framing the question along the lines
of how comfortable the HCP is with prescribing biosimilars, therefore,
the responses may help correlate knowledge of the term with a greater
comfort level in prescribing.
    (Response 1m) The goal of this open-ended question is to assess HCP
general awareness/knowledge of biosimilars. We have added the option to
check ``do not know'' for this question. We also plan to code open-
ended responses to determine their level of closeness to the
established definition: a biological product that is highly similar to
and has no clinically meaningful differences from an existing FDA-
approved reference product (42 U.S.C. 262(i)(2)). We have also added a
close-ended question prior to Q24 to ask HCPs how comfortable they are
prescribing biosimilars.
    (Comment 1n) For Q25-26, we recommend including ``don't know'' or
``it depends'' as answer options for these two questions.
    (Response 1n) While some cognitive effort is required, we believe
the scenarios included in these questions provide sufficient
information to allow respondents to make ratings. We also note that
during cognitive testing, respondents did not have difficulty answering
these questions.
    (Comment 1o) For Q28, we recommend incorporating a description or
definition of ``REMS'' materials.
    (Response 1o) We have revised the question to spell out the term,
Risk Evaluation or Mitigation Strategy (REMS) materials.
    (Comment 1p) For Q28a, we recommend a small modification to the
question in order to fully capture and connect to the list from the
previous question. For example, How often do these materials or events
mention abuse potential?
    (Response 1p) We will revise the question to include ``events.''
    (Comment 1q) We suggest adding a followup question to Q27 and Q28
to understand the impact of education/information about opioids on
prescribing behaviors. For example, ``Is the number of patients you
prescribed opioids for chronic pain in the last 3 months relative to 12
months ago: (1) the same, (2) less or (3) more?''
    (Response 1q) We have added this question to the survey.
    (Comment 1r) We suggest an additional followup question to Q27 and
Q28 to capture how the discussion and information on opioids and abuse
potential has changed over recent years, rather than focusing only on
the previous 12 months. Asking a retrospective question might capture
how the type of information physicians receive has changed as the
critical opioid situation has gained more widespread recognition.
    (Response 1r) The proposed followup question broadens the scope of
the survey in a way that may prevent us from collecting the most
relevant data. To capture the element of change in practice over time,
as suggested, we

have added a question to ask HCPs whether in the last year the content
of promotional materials for opioid products have contained more or
less information on abuse potential.
    The second public comment responder had 13 comments, to which we
have responded.
    (Comment 2a) The public comment responder expressed concern that
they had difficulty obtaining the proposed survey questionnaire via
email, but acknowledged that they were able to obtain it promptly once
they contacted the telephone number provided in the 60-day notice.
Among other suggestions, the commenter recommended that FDA specify a
contact that can directly provide the survey in future notices.
    (Response 2a) We appreciate the commenter bringing their experience
to our attention. While other commenters that requested the survey did
not report that they experienced difficulty promptly obtaining the
survey, we take this concern very seriously. Moving forward, in
addition to the contact information that has been provided, we will
also include the email address of the research team,
<EMAIL_ADDRESS>in all notices to facilitate obtaining
information collection instruments directly from the research team.
    (Comment 2b) The proposed HCP survey is duplicative of other
information already collected by FDA, such as the previous Healthcare
Professional Survey of Prescription Drug Promotion (HCP I survey) and a
project referenced on the OPDP website \1\ entitled, ``Clinical Trial
Data in Professional Prescription Drug Promotion.''
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    \1\ https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm
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    (Response 2b) The HCP I survey was conducted 5 years ago (summer
2013) and focused mainly on HCPs' attitudes toward DTC advertising and
its role in their relationship with patients (Refs. 2, 3). The current
HCP II survey focuses on promotions directed at healthcare
professionals. The existence of some overlapping questions does not
constitute in itself a duplicative effort, as there is often a need to
compare responses at multiple time points for comprehensive analysis of
the issues at hand. Many federally funded national surveys ask the same
or similar questions at multiple time points to detect changes and
identify trends over time.
    We also note the study referenced on the OPDP website is
qualitative research with a small non-representative sample, so the
design differs considerably from this proposed study. Having multiple
studies focusing on differing aspects of a phenomenon, using differing
designs and modes, is in accordance with OMB standards to avoid
unnecessary duplication of research efforts.
    (Comment 2c) The commenter recommends that FDA ask questions about
non-opioid analgesic options, medication-assisted treatment for opioid
deterrence, and opioid overdose-reversal agents. By asking about this
broader range of treatments, the survey would be consistent with the
Administration's emphasis on the whole range of medical advances that
can help address the opioid crisis.
    (Response 2c) We have added a question to address references to
these medical advances in prescription drug promotion.
    (Comment 2d) We recommend that FDA amend Q1b to ask how closely
HCPs read different types of advertisements (e.g., advertisement for
new products, or for products related to the HCPs practice).
    (Response 2d) We have replaced Q1b with two questions to capture
how closely HCPs read the suggested types of advertisements. One will
ask about advertisements for new products and one will ask about
advertisements for products related to the HCP's practice.
    (Comment 2e) We recommend that FDA reword Q2 to avoid the ambiguous
term ``commercial.'' Specifically, we recommend FDA revise the question
to read as follows: ``How often do you visit product-specific or
manufacturer-sponsored commercial prescription drug product websites,
such as lipitor.com?''
    (Response 2e) In cognitive testing conducted to develop this
survey, the word ``commercial'' was easily understood by respondents
and is needed in this question to differentiate it from ``reference''
websites in the subsequent question.
    (Comment 2f) We recommend that FDA include a new question under Q2
(i.e., 2a) that is similar to 3b (i.e., that asks how closely the HCP
usually reads the prescription drug websites it visits).
    (Response 2f) We have added this question.
    (Comment 2g) We recommend that FDA clarify whether Q5a applies only
to in-person visits from pharmaceutical sales representatives.
    (Response 2g) During cognitive interviews, respondents had no
difficulty understanding that question 5a was asking only about in-
person visits. However, we have revised the question to read, ``How
often do pharmaceutical representatives bring promotional materials to
your practice?'' to clarify that the question refers to in-person
visits.
    (Comment 2h) We recommend that FDA delete responses 2 (``Lunch for
staff'') and 7 (``Personal use item'') from Q5b. It is not clear how
these topics relate to FDA's jurisdiction. Other agencies of the
Department of Health and Human Services, not FDA, regulate such
practices. In addition, these responses do not seem to fall within the
stated scope of the survey.
    (Response 2h) We have made a minor change to this question by
replacing ``lunch for staff'' with ``food and beverages.'' The survey
includes questions about the various types of prescription drug
promotions and promotional practices that HCPs might be exposed to. To
fully understand promotional practices, we also need to know what
pharmaceutical representatives provide HCPs during an in-person visit.
    (Comment 2i) We recommend that FDA clarify what is meant by the
term ``conference'' in Q6.
    (Response 2i) We have revised the survey to ask separate questions
about ``pharmaceutical dinner meetings'' and ``professional
conferences.'' This distinction should make the meaning of professional
conference clear.
    (Comment 2j) We recommend deleting Q7, as it asks HCPs to speculate
about colleagues' perception of promotional materials.
    (Response 2j) This question is designed to build on research
literature which suggests that HCPs typically rate promotional
materials as being more influential on colleagues than on themselves
(Refs. 17, 18). Thus, we ask about the influence of promotional
information for both colleagues and the respondent. We will randomize
the presentation order of these two questions in the survey.
    (Comment 2k) We recommend that response 3 for Q8 be amended to
identify both the number and type of trials: ``Number and type of
trials conducted.''
    (Response 2k) Including number and type of trials conducted as one
response option will be confusing for respondents and we believe that
type of trial is captured by the second response option: ``Study design
(e.g., blinded or not, cohort study, length of trial, etc.).''
    (Comment 2l) We recommend adding the following language to Q18 to
ensure consistent use throughout the survey: ``How often do you
prescribe a drug for conditions for which it is not approved (referred
to as unapproved use below)?'' We also recommend amending Q20 to use
the term ``unapproved use'' instead of ``off-label use,'' to correspond
with

question 19 and ensure consistent terminology throughout the survey.
    (Response 2l) We determined through cognitive testing that HCPs are
familiar with and use the term off-label use. The questions have been
revised to use ``off-label use'' for all three questions.
    (Comment 2m) We recommend deleting Q21, as HCPs perspectives on
whether promotion of unapproved uses should be allowed presumes that
HCPs know the existing regulatory framework. Moreover, the relevancy of
this question is unclear given the stated research goals.
    (Response 2m) We have deleted this question.
    (Comment 2n) Q31 asks about the respondent's Secondary Specialty.
However, it is not clear from the survey if and where Primary Specialty
is recorded; we recommend amending the survey to clearly identify the
respondent's Primary Specialty.
    (Response 2n) Primary specialty is asked in the screener. We have
removed the question about ``secondary specialty'' from the survey.
    The third public comment responder had one comment, to which we
have responded.
    (Comment 3a) We suggest adding questions to the survey about how
promotional materials and procedures address abuse deterrent
formulations (ADF) for opioid products. Specifically, we suggest adding
questions related to the following topic areas to assess HCPs'
knowledge and understanding of these areas:
     That ADF products have not proven any less addictive than
standard non-ADF formulations.
     That the potential for patient harm from dose-dependent
misuse of ADF products (e.g., adverse effects resulting from patients
taking higher doses of the product than prescribed) or for patients
that switch to non-prescribed drugs (e.g., heroin) still remains.
     That potential methods for defeating the ``tamper-proof''
formulation still exist.
     That there are effective ways to protect against
accidental ingestion of the drug or theft by others.
    (Response 3a) We address the first bullet in question 28c. Various
aspects of the remaining bullets are addressed in question 28d.
Although the specific points mentioned in this comment are important
public health messages, we think these questions are more appropriate
for an indepth study of the topic, which is beyond the scope of this
project. Please also see our responses to Comments 1r and 2c.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Study:
    HCP screener............................              63               1              63  0.08 (5 minutes)..........................               5
    Informed Consent........................              25               1              25  0.08 (5 minutes)..........................               2
    HCP Survey..............................              25               1              25  0.33 (20 minutes).........................               8
Main Study:
    HCP screener............................           5,037               1           5,037  0.08 (5 minutes)..........................             403
    Informed Consent........................           2,000               1           2,000  0.08 (5 minutes)..........................             160
    HCP Survey..............................           2,000               1           2,000  0.33 (20 minutes).........................             660
                                             -----------------------------------------------------------------------------------------------------------
        Total...............................  ..............  ..............  ..............  ..........................................           1,238
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and maintenance costs associated with this collection of information.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff, OC/Office of Executive Secretariat,
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20857 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. References without
asterisks are not on public display at https://www.regulations.gov
because they have copyright restrictions. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

*1. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm. Last accessed
February 6, 2019.
2. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al. (2016).
``Healthcare Professional Social Media Membership and Participation:
Findings From a Nationally Representative Sample,'' Journal of the
American Association of Nurse Practitioners. Doi: 10.1002/2327-
6924.12383.
3. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al. (2015).
``Awareness of FDA's Bad Ad Program and Education Regarding
Pharmaceutical Advertising: A National Survey of Prescribers in
Ambulatory Care Settings,'' Journal of Health Communication, vol.
20(11), pp. 1330-1336.
4. Crigger, N.J. (2005). ``Pharmaceutical Promotions and Conflict of
Interest in Nurse Practitioner's Decision Making: The Undiscovered
Country,'' Journal of the American Academy of Nurse Practitioners,
vol. 17(6), pp. 207-212.
5. Fischer, M. ., M.E. Keough, J.L. Baril, et al. (2009).
``Prescribers and Pharmaceutical Representatives: Why Are We Still
Meeting?'' Journal of General Internal Medicine, vol. 24(7), pp.
795-801.
6. C. Robertson, S. Rose, and A.S. Kesselheim (2012). ``Effect of
Financial Relationships on the Behaviors of Health Care
Professionals: A Review of the Evidence,'' The Journal of Law,
Medicine & Ethics, vol. 40(3), pp. 452-466.
7. Srivastava, V., M. Handa, and A. Vohra (2014). ``Promotional
Tools: Do Physicians Really Bite the Hook?'' Drishtikon: A
Management Journal, vol. 5(2).
8. Austad, K.E., J. Avorn, J.M. Franklin, et al. (2014).
``Association of Marketing Interactions With Medical Trainees'
Knowledge About Evidence-Based Prescribing: Results From a National
Survey,'' JAMA Internal Medicine, vol. 174(8), pp. 1283-1290.
*9. Cegedim Strategic Data (2013). ``2012 U.S. Pharmaceutical
Company Promotion Spending.'' Available at: https://www.skainfo.com/health_care_market_reports/2012_promotional_spending.pdf.
10. Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al. (2010).
``Information From Pharmaceutical Companies and the Quality,
Quantity, and Cost of Physicians' Prescribing: A Systematic
Review,'' PLoS Medicine, vol. 7(10), e1000352. doi: 10.1371/
jounal.pmed.

1000352.
11. Villanueva, P., S. Peir[oacute], J. Librero, et al. (2003).
``Accuracy of Pharmaceutical Advertisements in Medical Journals,''
Lancet, vol. 361(9351), pp. 27-32.
12. Cooper, R.J. and D.L. Schriger (2005). ``The Availability of
References and the Sponsorship of Original Research Cited in
Pharmaceutical Advertisements,'' Canadian Medical Association
Journal, vol. 172(4), pp. 487-491.
13. Jureidini, J.N., L.B. McHenry, and P.R. Mansfield (2008).
``Clinical Trials and Drug Promotion: Selective Reporting of Study
329,'' International Journal of Risk & Safety in Medicine, vol.
20(1-2), pp. 73-81.
14. Garcia-Retamero, R. and M. Galesic (2010). ``Who Profits From
Visual Aids: Overcoming Challenges in People's Understanding of
Risks,'' Social Science & Medicine, vol. 70(7), pp. 1019-1025.
15. Cooper, R.J., D.L. Schriger, R.C. Wallace, et al. (2003). ``The
Quantity and Quality of Scientific Graphs in Pharmaceutical
Advertisements,'' Journal of General Internal Medicine, vol. 18(4),
pp. 294-297.
16. Sah, S. and A. Fugh-Berman (2013). ``Physicians Under the
Influence: Social Psychology and Industry Marketing Strategies,''
The Journal of Law, Medicine & Ethics, vol. 41(3), pp. 665-672. doi:
10.1111/jlme.12076.
17. Carroll, A.E., R.C. Vreeman, J. Buddenbaum, et al. (2007). ``To
What Extent Do Educational Interventions Impact Medical Trainees'
Attitudes and Behaviors Regarding Industry Trainee and Industry-
Physician Relationships?'' Pediatrics, 120, e1528-e1535.
doi:10.1542/peds.2007-0363.
18. Crigger, N., K. Barnes, A. Junko, et al. (2009). ``Nurse
Practitioners' Perceptions and Participation in Pharmaceutical
Marketing,'' Journal of Advanced Nursing, 65, 525-533. doi: 10.1111/
j.1365-2648.2008.04911.x.

    Dated: March 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04307 Filed 3-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Proposed Rules]
[Pages 58709-58716]
[FR Doc No: 2014-23196]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM14-13-000]

Communications Reliability Standards

AGENCY:  Federal Energy Regulatory Commission.

ACTION:  Notice of proposed rulemaking.

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SUMMARY:  The Commission proposes to approve Communications Reliability
Standard COM-001-2 and Operating Personnel Communications Protocols
Reliability Standard COM-002-4, developed by the North American
Electric Reliability Corporation (NERC), which the Commission has
certified as the Electric Reliability Organization responsible for
developing and enforcing mandatory Reliability Standards. The
Commission believes that the proposed Reliability Standards will
enhance reliability over the currently-effective COM standards in
several respects by, among other things, requiring adoption of
predefined communication protocols, annual assessment of those
protocols and operating personnel's adherence thereto, training on the
protocols, and use of three-part communications. However, the
Commission proposes to direct NERC to modify proposed Reliability
Standard COM-001-2 to include internal communications capabilities.

DATES:  Comments are due December 1, 2014.

ADDRESSES:  Comments, identified by docket number, may be filed in the
following ways:
     Electronic Filing through http://www.ferc.gov. Documents
created electronically using word processing software should be filed
in native applications or print-to-PDF format and not in a scanned
format.
     Mail/Hand Delivery: Those unable to file electronically
may mail or hand-deliver comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Comment
Procedures Section of this document.

FOR FURTHER INFORMATION CONTACT:
Vincent Le (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Michael Gandolfo (Technical Information), Office of Electric
Reliability, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Julie Greenisen (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Robert T. Stroh (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, Telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    1. Pursuant to section 215 of the Federal Power Act (FPA),\1\ the
Commission proposes to approve two Reliability Standards, COM-001-2
(Communications) and COM-002-4 (Operating Personnel Communications
Protocols), developed by the North American Electric Reliability
Corporation (NERC), which the Commission has certified as the Electric
Reliability Organization responsible for developing and enforcing
mandatory Reliability Standards. In addition, the Commission proposes
to approve three new terms to be added to the NERC Glossary of Terms,
and the violation risk factors, violation severity levels, and proposed
implementation plan for both revised standards.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824o (2012).
---------------------------------------------------------------------------

    2. Proposed Reliability Standard COM-001-2 is intended to establish
a clear set of requirements for the communications capabilities that
applicable functional entities must have in place and maintain.
Proposed Reliability Standard COM-002-4 requires applicable entities to
develop communication protocols with certain minimum requirements,
including use of three-part communication when issuing Operating
Instructions.\2\ Proposed Reliability Standard COM-002-4 also sets out
certain communications training requirements for all issuers and
recipients of Operating Instructions, and establishes a flexible
enforcement approach for failure to use three-part communication during
non-emergencies and a ``zero-tolerance'' enforcement approach for
failure to use three-part communications during an emergency.
---------------------------------------------------------------------------

    \2\ NERC proposes to define Operating Instruction as ``[a]
command by operating personnel responsible for the Real-time
operation of the interconnected Bulk Electric System to change or
preserve the state, status, output, or input of an Element of the
Bulk Electric System or Facility of the Bulk Electric System. (A
discussion of general information and of potential options or
alternatives . . . is not considered an Operating Instruction.)''
---------------------------------------------------------------------------

    3. The Commission believes that the proposed Reliability Standards
will enhance reliability over the currently-effective COM standards in
several respects. For example, the proposed Reliability Standards
expand applicability to include generator operators and distribution
providers and eliminate certain ambiguities in the currently-effective
standard. Thus, the Commission proposes to approve the modified COM
standards. However, the Commission seeks additional information and
explanation on responsibility for use of three-part communication by
transmission owners and generation owners that receive Operating
Instructions. In addition, the Commission proposes to direct NERC to
modify proposed Reliability Standard COM-001-2 to include internal
communication capabilities, and seeks additional information on the
lack of a testing requirement for distribution providers and generator
operators in COM-001-2 and on the intended meaning and use of the
proposed terms Interpersonal Communication and Alternative
Interpersonal Communication.

I. Background

A. Regulatory Background

    4. Section 215 of the FPA requires a Commission-certified Electric
Reliability Organization (ERO) to develop mandatory and enforceable
Reliability Standards, subject to Commission review and approval.\3\
Once approved, the Reliability Standards may be enforced by the ERO
subject to Commission oversight, or by the Commission independently.\4\
In 2006, the Commission certified NERC as the ERO pursuant to FPA
section 215.\5\
---------------------------------------------------------------------------

    \3\ 16 U.S.C. 824o(c) and (d).
    \4\ See id. 824o(e).
    \5\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g & compliance, 117 FERC ] 61,126 (2006), aff'd
sub nom. Alcoa, Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009).
---------------------------------------------------------------------------

    5. The Commission approved Reliability Standard COM-001-1 in

Order No. 693.\6\ In addition, the Commission directed NERC to develop
modifications to (1) expand the applicability of the standard to
include generator operators and distribution providers, (2) identify
specific requirements for telecommunications facilities for use in
normal and emergency conditions that reflect the roles of the
applicable entities, and (3) include adequate flexibility for
compliance to allow for the adoption of new technologies and cost-
effective solutions.\7\
---------------------------------------------------------------------------

    \6\ See Mandatory Reliability Standards for the Bulk-Power
System, Order No. 693, FERC Stats. & Regs. ] 31,242, at P 508, order
on reh'g, Order No. 693-A, 120 FERC ] 61,053 (2007); see also North
American Electric Reliability Corp., Docket No. RD09-2-000 (2009)
(delegated letter order accepting Reliability Standard COM-001-1.1).
    \7\ Order No. 693, FERC Stats. & Regs. ] 31,242 at P 508.
---------------------------------------------------------------------------

    6. In Order No. 693, the Commission also approved Reliability
Standard COM-002-2. In addition, the Commission directed NERC to
develop modifications to (1) include distribution providers as
applicable entities and (2) establish tightened communications
protocols, especially for communications during alerts and
emergencies.\8\
---------------------------------------------------------------------------

    \8\ Id. PP 531-535, 540.
---------------------------------------------------------------------------

    7. NERC initiated Project 2006-06 to address the Order No. 693
directives related to Reliability Standards COM-001 and COM-002,
resulting in two proposed Reliability Standards, COM-001-2 and COM-002-
3. NERC also initiated Project 2007-02 to develop a new Reliability
Standard (COM-003) that would require real-time system operators to use
standardized communication protocols during normal and emergency
operations, in order to improve situational awareness and shorten
response time. The two projects ultimately merged when drafts of
Reliability Standard COM-002-3 and COM-003-1 were combined into a
single proposed Reliability Standard, COM-002-4.

B. NERC Petition

    8. On May 14, 2014, NERC filed a petition seeking approval of two
revised communication standards, COM-001-2 (Communications) and COM-
002-4 (Operating Personnel Communications Protocols).\9\ Proposed
Reliability Standard COM-001-2 establishes a set of requirements for
the communications capabilities various functional entities must
maintain to enable communications with identified functional entities.
Proposed Reliability Standard COM-002-4 requires applicable entities to
develop documented communications protocols. NERC states that the
proposed standards are intended to address all relevant Commission
directives from Order No. 693.\10\ In addition, NERC states that the
revisions reflected in proposed COM-002-4 are intended to address
Recommendation No. 26 from the final report on the August 2003 blackout
issued by the U.S.-Canada Power System Outage Task Force (Blackout
Report) concerning the need to ``[t]ighten communications protocols,
especially for communications during alerts and emergencies.'' \11\
---------------------------------------------------------------------------

    \9\ The proposed COM Reliability Standards are not attached to
the NOPR. The complete text of the proposed Reliability Standards is
available on the Commission's eLibrary document retrieval system in
Docket No. RM14-13 and is posted on the ERO's Web site, available at
http://www.nerc.com.
    \10\ NERC Petition at 3.
    \11\ Id. (quoting U.S.-Canada Power System Outage Task Force,
Final Report on the August 14, 2003 Blackout in the United States
and Canada: Causes and Recommendations at 3 (April 2004), available
at http://energy.gov/sites/prod/files/oeprod/DocumentsandMedia/BlackoutFinal-Web.pdf).
---------------------------------------------------------------------------

Proposed Reliability Standard COM-001-2
    9. NERC states in its petition that proposed Reliability Standard
COM-001-2 is intended to establish requirements for Interpersonal
Communication capabilities necessary to maintain reliability.\12\ NERC
explains that proposed Reliability Standard COM-001-2 applies to
reliability coordinators, balancing authorities, transmission
operators, generator operators, and distribution providers. The
proposed Reliability Standard includes eleven requirements and two new
defined terms, ``Interpersonal Communication'' and ``Alternative
Interpersonal Communication,'' that, according to NERC, collectively
provide a comprehensive approach to establishing communications
capabilities necessary to maintain reliability.\13\ NERC states that
the definitions provide clarity that an entity's communication
capability must be redundant and that each of the capabilities must not
utilize the same medium.\14\ According to NERC, the definitions improve
the language used in the current Reliability Standard by eliminating
the use of the more ambiguous phrases ``adequate and reliable'' and
``redundant and diversely routed'' that relate to ``telecommunications
facilities for the exchange of Interconnection and operating
information.'' \15\
---------------------------------------------------------------------------

    \12\ Id. at 15.
    \13\ Id. NERC defines Interpersonal Communication as ``[a]ny
medium that allows two or more individuals to interact, consult, or
exchange information'' and Alternative Interpersonal Communication
as ``[a]ny Interpersonal Communication that is able to serve as a
substitute for, and does not utilize the same infrastructure
(medium) as, Interpersonal Communication used for day-to-day
operation.'' Id.
    \14\ Id.
    \15\ Id. at 15-16.
---------------------------------------------------------------------------

    10. The first six requirements address the Interpersonal
Communication capability and Alternative Interpersonal Communication
capability of the reliability coordinator, transmission operator, and
balancing authority. Requirement R1 requires each reliability
coordinator to have Interpersonal Communication capability with all
transmission operators and balancing authorities within its reliability
coordinator area, and with each adjacent reliability coordinator within
the same interconnection. Requirement R2 requires each reliability
coordinator to designate Alternative Interpersonal Communication
capability with those same identified entities. Requirements R3 and R4
set out the communications capability requirements for a transmission
operator. Under Requirement R3, Interpersonal Communication capability
is required between the transmission operator's reliability
coordinator, each balancing authority within its transmission operator
area, each distribution provider and generator operator within its
transmission operator area, and each adjacent transmission operator
whether synchronously or asynchronously connected. Under Requirement
R4, Alternative Interpersonal Communication capability must be
designated between the transmission operator's reliability coordinator,
each balancing authority within its transmission operator area, and
each adjacent transmission operator. Requirements R5 and R6 set out
similar requirements for each balancing authority, again identifying
the specific functional entities for which the balancing authority must
maintain Interpersonal Communication capability and for which it must
designate Alternative Interpersonal Communication capability.
    11. Requirements R7 and R8 address the communications capability
that distribution providers and generator operators must maintain, with
each required to have Interpersonal Communications capability with its
balancing authority and its transmission operator.
    12. Requirement R9 requires each reliability coordinator,
transmission operator, and balancing authority to test its Alternative
Interpersonal Communication capability at least once each calendar
month, and to initiate action to repair or designate a

replacement if the test is unsuccessful. Requirement R10 requires the
same entities to notify applicable entities (as identified in R1, R3
and R5) of the detection of an Interpersonal Communication capability
failure that lasts 30 minutes or longer. Finally, Requirement R11
requires distribution providers and generator operators to consult with
affected balancing authorities and transmission operators when a
failure is detected in their Interpersonal Communication capability,
and to determine a mutually agreeable action for the restoration of
that capability.
    13. NERC states in its petition that proposed Reliability Standard
COM-001-2 improves the currently-effective Reliability Standard by: (1)
Eliminating terms that do not adequately specify the desired actions
that applicable entities are expected to take in relation to their
telecommunication facilities; (2) clearly identifying the need for
applicable entities to be capable of Interpersonal Communication and
Alternative Interpersonal Communication; (3) not requiring specific
technology or systems to be utilized; and (4) including the
distribution provider and generator operator as applicable
entities.\16\ NERC adds that the proposed Reliability Standard also
addresses the Commission's directives from Order No. 693 related to
COM-001 by (1) adding generator operators and distribution providers as
applicable entities; (2) identifying specific requirements for
telecommunications capabilities for use in all operating conditions
that reflect the roles of the applicable entities and their impact on
reliability; and (3) including adequate flexibility to permit the
adoption of new technologies.\17\
---------------------------------------------------------------------------

    \16\ NERC Petition at 18.
    \17\ NERC Petition at 4; see also supra n.6 and accompanying
text.
---------------------------------------------------------------------------

    14. NERC proposes to retire the currently effective COM-001
Reliability Standard when proposed Reliability Standard COM-001-2
becomes effective, with the exception of Requirement R4, which
addresses communications protocols. NERC requests that Requirement R4
be retired when proposed Reliability Standard COM-002-4 becomes
effective.\18\
---------------------------------------------------------------------------

    \18\ Id. at 22. NERC notes that the substance of Requirement R5
in the currently effective standard, COM-001-1.1, is addressed by
Requirement R1 of EOP-008-1. Accordingly, NERC explains that the
requirement has not been carried forward in proposed COM-001-2. In
addition, NERC notes that Requirement R6 in the currently effective
standard, which requires adherence to certain policies when using
NERCnet, is not being carried forward, as NERC is in the process of
transitioning NERCnet to industry, and in order to preserve NERC's
ability to respond to new technologies without requiring
modification of a Reliability Standard. Id. at 22-23.
---------------------------------------------------------------------------

Proposed Reliability Standard COM-002-4
    15. NERC states that proposed Reliability Standard COM-002-4
improves communications surrounding the issuance of Operating
Instructions by requiring use of predefined communications protocols to
reduce the possibility of miscommunication that could lead to action or
inaction harmful to reliability.\19\ NERC notes that the proposed
standard requires use of the same protocols regardless of operating
condition (i.e., Emergency or non-emergency), but requires operating
personnel to use the documented communication protocols for three-part
communications ``without exception'' during an Emergency.\20\ As NERC
explains:
---------------------------------------------------------------------------

    \19\ Id. at 23. NERC states that COM-002-3 (which was adopted by
the NERC Board but not submitted to the Commission for approval) is
proposed for retirement in the Implementation Plan because the
proposed Reliability Standard has been combined with proposed COM-
003-1 to create proposed Reliability Standard COM-002-4. NERC states
that Reliability Standard COM-002-3 has not been submitted to the
Commission for approval, therefore, the currently effective version
of COM-002 is COM-002-2. Id. at 23 n.43. The proposed Reliability
Standard combines proposed Reliability Standard COM-002-3 and the
former draft COM-003-1 into a single standard that addresses
communications protocols for operating personnel in Emergency and
non-emergency conditions. Id. at 23-24.
    \20\ Id. at 3.

    [T]he proposed Reliability Standard employs the phrase
``Operating Instruction during an Emergency'' in certain
requirements (R5, R6, R7) to provide a demarcation for what is
subject to a zero-tolerance compliance approach and what is not.\21\
---------------------------------------------------------------------------

    \21\ Id. at 25.

    NERC explains that, for Operating Instructions issued during non-
emergency operations, ``an entity will be assessed under a compliance
approach that focuses on whether an entity meets the initial training
Requirement (either R2 or R3) and whether an entity performed the
assessment and took corrective actions according to Requirement R4.''
\22\
---------------------------------------------------------------------------

    \22\ Id. at 26.
---------------------------------------------------------------------------

    16. Finally, NERC states that the proposed Reliability Standard
includes distribution providers and generator operators as applicable
entities, in accordance with the Commission's directive in Order No.
693, and in recognition of the fact that these types of entities can be
recipients of Operating Instructions.\23\
---------------------------------------------------------------------------

    \23\ Id. at 27-28.
---------------------------------------------------------------------------

    17. Proposed Reliability Standard COM-002-4 includes seven
requirements. Requirement R1 requires entities that can both issue and
receive Operating Instructions (balancing authorities, reliability
coordinators and transmission operators) to have documented
communications protocols that include a minimum set of elements,
including use of the English language unless otherwise specified, and
required use of three-part communications for issuance and receipt of
Operating Instructions.\24\ Requirement R2 requires these same entities
to conduct initial training on the communications protocols for each of
their operating personnel responsible for the real-time operation of
the bulk electric system. Requirement R3 requires distribution
providers and generator operators (who generally only receive but do
not issue Operating Instructions) to conduct initial training on three-
part communication for each of their operating personnel who can
receive an oral two-party, person-to-person Operating Instruction,
prior to that individual operator receiving an oral two-party, person-
to-person Operating Instruction.
---------------------------------------------------------------------------

    \24\ See id. at 29.
---------------------------------------------------------------------------

    18. Requirement R4 requires each balancing authority, reliability
coordinator and transmission operator to assess, at least once every
twelve months, its operating personnel's adherence to the documented
communication protocols required in Requirement R1, and to provide
feedback to its operating personnel on their performance.
    19. Requirement R5 requires balancing authorities, reliability
coordinators and transmission operators that issue an oral two-party,
person-to-person ``Operating Instruction during an Emergency'' to use
three-part communication, and to take an alternative action if a
confirmation is not received. Requirement R6 requires all applicable
entities (balancing authorities, distribution providers, generator
operators, and transmission operators) that receive an oral two-party,
person-to-person ``Operating Instruction during an Emergency'' to use
three-part communication, i.e., to repeat the Operating Instruction and
receive confirmation from the issuer that the response was correct, or
request that the issuer reissue the Operating Instruction. Both
Requirement R5 and R6 include the clarification that the requirement
does not apply to single-party to multiple-party ``burst'' Operating
Instructions. As noted above, NERC explains that Requirements R5 and R6
require use of three-part communication during an Emergency without
exception, because ``use of three-part communication is critically
important if

an Emergency condition already exists, as further action or inaction
could increase the harmful effects to the Bulk Electric System.'' \25\
NERC further explains, however, that applicable entities are expected
to use three-part communications at all times when issuing and
receiving Operating Instructions.\26\
---------------------------------------------------------------------------

    \25\ Id. at 39.
    \26\ Id. at 25-26.
---------------------------------------------------------------------------

    20. Finally, Requirement R7 requires that when a balancing
authority, reliability coordinator, or transmission operator issues a
written or oral single-party to multiple-party ``burst'' Operating
Instruction during an Emergency, they must confirm or verify that at
least one receiver received the Operating Instruction.
    21. NERC requests that proposed Reliability Standard COM-002-4
become effective on the first day of the first calendar quarter that is
twelve months after the date that the standard is approved.

II. Discussion

    22. Pursuant to section 215(d)(2) of the FPA, the Commission
proposes to approve proposed Reliability Standards COM-001-2 and COM-
002-4, the three new definitions referenced in the proposed standards
(Operating Instruction, Interpersonal Communication, and Alternative
Interpersonal Communication), and the assigned violation risk factors
and violation severity levels and proposed implementation plan for each
standard. We believe that proposed COM-001-2 will enhance reliability
by expanding the applicability of currently effective COM-001-1.1 to
include generator operators and distribution providers. Further, this
modification to the applicability provision satisfies the Commission's
directive in Order No. 693.
    23. Likewise, we believe that proposed Reliability Standard COM-
002-4 enhances reliability by expanding the applicability of the
standard to include distribution providers that receive Operating
Instructions, in accordance with the directive in Order No. 693.
Moreover, proposed COM-002-4 requires the development of communication
protocols for operating personnel that issue or receive Operating
Instructions that require the use of three-part communication, and
adopts a zero-tolerance approach in enforcing the use of three-part
communications during an Emergency. While the zero-tolerance approach
applies only during an Emergency, Requirement R4 imposes an important
requirement for an entity to assess, at least once every twelve months,
its operating personnel's adherence to the documented communication
protocols required in Requirement R1, and to provide feedback to its
operating personnel on their performance. This requirement should help
ensure a high level of compliance with three-part communication at all
times, not just during an Emergency. Without this mechanism, poor
performance at routine times could eventually lead to poor performance
at critical times. The Commission believes that the establishment of
clear communication protocols based on three-part communication
provides a fundamental element of maintaining Bulk-Power System
reliability. Thus, the revisions reflected in proposed Reliability
Standard COM-002-4 appear to address Recommendation No. 26 from the
final report on the August 2003 blackout issued by the U.S.-Canada
Power System Outage Task Force (Blackout Report) concerning the need to
``[t]ighten communications protocols, especially for communications
during alerts and emergencies.'' \27\ Finally, COM-002-4 eliminates the
ambiguity surrounding the meaning of ``directive'' in the currently-
effective version of COM-002-2.
---------------------------------------------------------------------------

    \27\ U.S.-Canada Power System Outage Task Force, Final Report on
the August 14, 2003 Blackout in the United States and Canada: Causes
and Recommendations at 3 (April 2004) (Blackout Report), available
at http://www.ferc.gov/industries/electric/indus-act/blackout.asp.
---------------------------------------------------------------------------

    24. While we propose to approve COM-001-2 and COM-002-4 for the
reasons stated above, we also have questions regarding specific
provisions of the proposed Reliability Standards, and we seek further
explanation or comment from NERC and others. Accordingly, we discuss
below the following issues: (1) Responsibility for use of three-part
communication by transmission owners and generation owners that receive
Operating Instructions; (2) whether proposed COM-001-2 should be
modified to address internal communication capability requirements, or
to address testing requirements for distribution providers and
generator operators; and (3) clarifications regarding the proposed
terms Interpersonal Communication and Alternative Interpersonal
Communication.

A. Applicability of Communications Standard Requirements to
Transmission Owners and Generator Owners

    25. Consistent with the Commission directives in Order No. 693,
proposed Reliability Standard COM-001-2 will apply to generator
operators and distribution providers (in addition to transmission
operators, balancing authorities, and reliability coordinators).
Likewise, proposed Reliability Standard COM-002-4 will apply to
distribution providers (in addition to balancing authorities,
reliability coordinators, transmission operators, and generator
operators).
    26. Proposed Reliability Standards COM-001-2 and COM-002-4 do not
identify transmission owners or generator owners as applicable
entities. Are there instances, however, in which transmission owners or
generation owners may receive and act on ``Operating Instructions,''
such as in areas operated by Regional Transmission Organizations or
Independent System Operators?
    27. We seek an explanation from NERC and other commenters regarding
the obligations of an applicable entity identified in COM-001-2 and
COM-002-4 when communicating with a transmission owner or generator
owner. For example, if a transmission operator, presumably required to
use three-part communication under the proposed standards, communicates
an Operating Instruction to a transmission owner or generation owner,
which entity (if any) is responsible if the transmission owner or
generation owner fails to perform three-part communication properly?
\28\ Among other things, NERC should explain its auditing practices in
reviewing operating agreements between transmission operators and
transmission owners and generation owners (or other agreements for
assigning operational and compliance responsibility), and its approach
in reviewing the protocols of any transmission owner or generator owner
that acts on Operating Instructions to ascertain that they use three-
part communication when and as required under proposed COM-002-4.
---------------------------------------------------------------------------

    \28\ We understand that NERC has issued a Compliance Bulletin
that discusses, in a general manner, the compliance obligations of
registered entities and various contractual mechanisms for sharing
or assigning compliance responsibility. See NERC Compliance Bulletin
2010-004 (Guidance for Entities that Delegate Reliability
Tasks to a Third Party Entity). Here, however, we seek a better
understanding of such obligations in the specific context of the
proposed COM standards.
---------------------------------------------------------------------------

B. Scope of COM-001-2--Internal Communications Capability and Testing
Requirements for Distribution Providers and Generator Operators

    28. Requirement R1.1 of currently-effective Reliability Standard
COM-001-1.1 states that each reliability coordinator, transmission
operator, and balancing authority ``shall provide

adequate and reliable telecommunication facilities for the exchange of
Interconnection and operating information . . . internally.'' Thus,
COM-001-1.1 explicitly requires applicable entities to have adequate
infrastructure for internal communications. We believe such a
requirement is appropriate, since internal communications can have an
impact on reliability, including certain communications between a
control center and a generating unit operator and other field personnel
or between two control centers (where operated by a single entity).
    29. Proposed Reliability Standard COM-001-2 does not carry forward
the explicit requirement with respect to internal communications.
Instead, it requires applicable entities to have ``Interpersonal
Communication'' \29\ capability with other identified functional
entities, as specified in the individual requirements. For example,
Requirement R1 provides:
---------------------------------------------------------------------------

    \29\ As noted above, NERC proposes to define Interpersonal
Communication as ``[a]ny medium that allows two or more individuals
to interact, consult, or exchange information.'' NERC Petition at
15.

    Each Reliability Coordinator shall have Interpersonal
Communication capability with the following entities * * *.
    1.1. All Transmission Operators and Balancing Authorities within
its Reliability Coordinator Area.
    1.2. Each adjacent Reliability Coordinator within the same
Interconnection.

    NERC's petition does not address the elimination of the explicit
requirement related to internal communications capability.
    30. The Commission believes that maintaining adequate internal
communications capability can be critical to reliability. For example,
the 2003 Blackout Report recommended improvements in internal
communication effectiveness along with improvements to external
communications.\30\ Moreover, the Blackout Report listed as one of the
causes of the blackout that First Energy's ``control center computer
support staff and operations staff did not have effective internal
communications procedures'' and ``lacked procedures to ensure that its
operators were continually aware of the functional state of their
critical monitoring tools.'' \31\ The Blackout Report found that these
factors contributed to First Energy's ``inadequate situational
awareness'' and its failure ``to recognize or understand the
deteriorating condition of its system'' during that event.\32\ However,
the proposed Reliability Standard does not retain an explicit
requirement with respect to internal communications capability. We
accordingly propose to direct NERC to develop modifications to COM-001
(or to develop a separate standard) that ensures that entities maintain
adequate internal communications capability, at least to the extent
that such communications could involve the issuance or receipt of
Operating Instructions or other communications that could have an
impact on reliability. Alternatively, a requirement for internal
communications capability may be implicit in the proposed requirements
for communications capability between functional entities such as
Reliability Coordinators and Transmission Operators, since the proposed
requirements are not explicitly limited to functional entities that are
different utilities and could be understood as including communications
capability within a utility performing and registered for multiple
functions. We seek comment on whether the proposed requirements can and
should be understood this way.
---------------------------------------------------------------------------

    \30\ Blackout Report at 161 (``NERC should work with reliability
coordinators and [balancing authorities] to improve the
effectiveness of internal and external communications . . . .'').
    \31\ Id. at 18.
    \32\ Id. at 18; see also id. at 51-53, 56 and 65-67.
---------------------------------------------------------------------------

    31. In addition, the Requirement 9 monthly testing requirement in
COM-001-2 applies to reliability coordinators, balancing authorities,
and transmission operators, but not generator operators and
distribution providers. We seek comment on why generator operators and
distribution providers should not have some form of requirement to test
or actively monitor vital primary and emergency telecommunication
facilities, particularly given the assumptions the Commission made in
Order No. 749 when approving Reliability Standard EOP-005-2 (System
Restoration from Blackstart Resources).\33\ In that order, the
Commission relied on NERC's assurances not only that COM-001-2 would be
revised to include distribution providers and generator operators, but
that such revisions would address the Commission's concerns about the
lack of certain testing requirements in EOP-005-2:
---------------------------------------------------------------------------

    \33\ See System Restoration Reliability Standards, Order No.
749, 134 FERC ] 61,215 at PP 26-28 (2011).

    The Commission believes the objectives of [the project to revise
COM-001-1.1] in managing, alarming, testing and/or actively
monitoring vital primary and emergency telecommunication facilities
will close this gap in the Reliability Standard after it is
completed and approved.\34\
---------------------------------------------------------------------------

    \34\ Id. P 28.

    Is the same objective intended to be addressed by Requirement 11?
(``Each Distribution Provider and Generator Operator that detects a
failure of its Interpersonal Communication capability shall consult
each entity affected by the failure, as identified in Requirement R7
for a Distribution Provider or Requirement R8 for a Generator Operator,
to determine a mutually agreeable action for the restoration of its
Interpersonal Communication capability.'') If so, we ask NERC to
provide support for this approach.

C. Reliability Standard COM-001-2--Definition of Interpersonal
Communications and Alternative Interpersonal Communication

    32. Finally, we seek clarification regarding the scope and meaning
of the proposed definitions of Interpersonal Communication and
Alternative Interpersonal Communication. As noted above, NERC proposes
to define those terms, respectively, as follows:

    Interpersonal Communication--Any medium that allows two or more
individuals to interact, consult, or exchange information.
    Alternative Interpersonal Communication--Any Interpersonal
Communication that is able to serve as a substitute for, and does
not utilize the same infrastructure (medium) as, Interpersonal
Communication used for day-to-day operation.

    NERC indicates that it developed these definitions to eliminate the
ambiguity of the terms ``adequate and reliable'' in requirement R1 of
COM-001-1.1, and the terms ``redundant and diversely routed'' in
Requirement R1.4.\35\
---------------------------------------------------------------------------

    \35\ NERC Petition at 15-16.
---------------------------------------------------------------------------

    33. While the Commission understands the need to allow flexibility
as to the type of communication medium or infrastructure to be used,
the definitions do not state explicitly a minimum expectation of
communication performance such as speed and quality to ensure that the
communication is sufficient to maintain the reliable operation of the
bulk power system. Further, while currently-effective Reliability
Standard COM-001-1.1, Requirement R1, addresses ``telecommunications
facilities for the exchange of Interconnection and operating
information,'' a term that appears to include facilities that directly
exchange or transfer data, the proposed definition of Interpersonal
Communication refers to exchanges between individual persons. It is

unclear whether the definition of Interpersonal Communications includes
mediums used directly to exchange or transfer data. Thus, we seek
further explanation from NERC and other interested commenters regarding
acceptable (and unacceptable) performance of communication for both
Interpersonal and Alternative Interpersonal Communications.

III. Information Collection Statement

    34. The collection of information contained in this Notice of
Proposed Rulemaking is subject to review by the Office of Management
and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act
of 1995.\36\ OMB's regulations require approval of certain information
collection requirements imposed by agency rules.\37\ Upon approval of a
collection(s) of information, OMB will assign an OMB control number and
an expiration date. Respondents subject to the filing requirements of a
rule will not be penalized for failing to respond to these collections
of information unless the collections of information display a valid
OMB control number.
---------------------------------------------------------------------------

    \36\ 44 U.S.C. 3507(d) (2012).
    \37\ 5 CFR 1320.11 (2013).
---------------------------------------------------------------------------

    35. We solicit comments on the need for this information, whether
the information will have practical utility, the accuracy of the burden
estimates, ways to enhance the quality, utility, and clarity of the
information to be collected or retained, and any suggested methods for
minimizing respondents' burden, including the use of automated
information techniques. Specifically, the Commission asks that any
revised burden or cost estimates submitted by commenters be supported
by sufficient detail to understand how the estimates are generated.
    36. This notice proposes to approve Reliability Standards COM-001-2
and COM-002-4, and to retire Reliability Standards COM-001-1.1 and COM-
002-2. Proposed Reliability Standard COM-001-2 will establish
Interpersonal Communication capability necessary to maintain
reliability, while proposed Reliability Standard COM-002-4 will improve
communications related to Operating Instructions, requiring issuers of
Operating Instructions to adopt predefined communications protocols and
requiring both issuers and recipients of Operating Instructions to use
three-part communications.
    Public Reporting Burden: Proposed Reliability Standards COM-001-2
and COM-002-4 do not require responsible entities to file information
with the Commission. However, the proposed Reliability Standards
require applicable entities to develop and maintain certain
information, subject to audit. In particular, COM-001-2 requires that
transmission operators, balancing authorities, reliability
coordinators, distribution providers, and generator operators must
maintain documentation of Interpersonal Communication capability and
designation of Alternate Interpersonal Communication, as well as
evidence of testing of the Alternate Interpersonal Communication
facilities. COM-002-4 requires balancing authorities, distribution
providers, reliability coordinators, transmission operators, and
generator operators to develop and maintain documented communication
protocols, and to be able to provide evidence of training on the
protocols and of their annual assessment of the protocols.
Additionally, all applicable entities (balancing authorities,
reliability coordinators, transmission operators, generator operators,
and distribution providers) must be able to provide evidence of three-
part communication when issuing or receiving an Operating Instruction
during an Emergency.
    Many of the record retention or information collection requirements
in proposed COM-001-2 and COM-002-4 are translated in some form from
the currently-effective Reliability Standards (COM-001-1 and COM-002-
2). For these requirements, the Commission estimates a zero net change
in burden. Accordingly, our estimate below shows the increase in
record-retention or information collection burden, based on the new
requirements to:

    (1) Develop communications protocols (a one-time burden under
COM-002-4, R1);
    (2) maintain evidence of required training, assessments, and use
of three-part communications, as applicable (an on-going burden
under COM-002-4 R2, R3, R4, R5 and R6); and
    (3) maintain evidence to demonstrate Interpersonal Communication
capability (a new, on-going burden for distribution providers and
generator operators under COM-001-2 R7 and R8).

    The Commission's estimate of the number of respondents is based on
the NERC compliance registry as of August 15, 2014. According to the
NERC compliance registry, NERC has registered 179 transmission
operators, 107 balancing authorities, 15 reliability coordinators, 475
distribution providers, and 853 generator operators within the United
States. However, under NERC's compliance registration program, entities
may be registered for multiple functions, so these numbers incorporate
some double counting, which has been accounted for in the table below.
The Commission estimates the annual reporting burden and cost as
follows:

----------------------------------------------------------------------------------------------------------------
                                                                                Total annual
    Information collection     Number and type   Annual number   Total number    Average burden   burden hours &
         requirement            of respondents   of responses    of responses      & cost per      total annual
                                                per respondent                   response \38\         cost
                               (1)............             (2)   (1)*(2) = (3)  (4)............  (3)*(4) = (5)
----------------------------------------------------------------------------------------------------------------
(One-time) Development of      212 (BA, RC &                 1             212  8 hrs. &         1,696 hours &
 Communication Protocols [COM-  TOP).                                            $485.60.         $102,947.20.
 002-4 R1].
(On-going) Maintain evidence   1,217 (DP &                   1           1,217  4 hrs. &         4,868 hours &
 of Interpersonal               GOP).                                            $115.72.         $140,831.24.
 Communication capability
 [COM-001-2 R7 and R8] \39\.
(On-going) Maintain evidence   212 (BA, RC &                 1             212  8 hrs. &         1,696 hours &
 of training and assessments    TOP).                                            $231.44.         $102,947.20.
 [COM-002-4 R2, R4, R5 and
 R6].
(On-going) Maintain evidence   1,217 (DP &                   1           1,217  8 hrs. &         9,736 hours &
 of assessments [COM-002-4      GOP).                                            $231.44.         $281,662.48.
 R3, and R6].
                                               -----------------------------------------------------------------

    Total....................  ...............  ..............           2,858  ...............  17,996 hours &
                                                                                $574,506.20.
----------------------------------------------------------------------------------------------------------------

    Title: Mandatory Reliability Standards for the Bulk-Power System:
COM Reliability Standards.
---------------------------------------------------------------------------

    \38\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor Statistics (BLS) information (available at http:/
/bls.gov/oes/current/naics3221000.htm#17-0000) for an
electrical engineer ($60.70/hour for review and documentation), and
for a file clerk ($28.93/hour for record retention). The first row
of the table (one-time burden) is done by an engineer, and the
latter three rows (ongoing burden) are done by a file clerk.
    \39\ No change is expected in the record-keeping burden under
COM-001-2 for reliability coordinators, balancing authorities, and
transmission operators as compared to the currently-effective COM-
001 standard.
---------------------------------------------------------------------------

    Action: Proposed FERC-725V.
    OMB Control No: To be determined.
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: One-time and ongoing.
    Necessity of the Information: Reliability Standard COM-001-2 and
COM-002-4, if adopted, would implement the Congressional mandate of the
Energy Policy Act of 2005 to develop mandatory and enforceable
Reliability Standards to better ensure the reliability of the nation's
Bulk-Power System. Specifically, the purpose of the proposed
Reliability Standards is to establish Interpersonal Communication
capability necessary to maintain reliability, and to improve
communications for the issuance of Operating Instructions with
predefined communications protocols. The proposed Reliability Standards
require entities to maintain records subject to review by the
Commission and NERC to ensure compliance with the Reliability
Standards.
    Internal Review: The Commission has reviewed the requirements
pertaining to the proposed Reliability Standards for the Bulk-Power
System and determined that the proposed requirements are necessary to
meet the statutory provisions of the Energy Policy Act of 2005. These
requirements conform to the Commission's plan for efficient information
collection, communication and management within the energy industry.
The Commission has assured itself, by means of internal review, that
there is specific, objective support for the burden estimates
associated with the information requirements.
    37. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426 [Attention:
Ellen Brown, Office of the Executive Director, email:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].
    38. Comments concerning the information collections proposed in
this NOPR and the associated burden estimates should be sent to the
Commission in these dockets and may also be sent to the Office of
Management and Budget, Office of Information and Regulatory Affairs
[Attention: Desk Officer for the Federal Energy Regulatory Commission].
For security reasons, comments should be sent by email to OMB at the
following email address<EMAIL_ADDRESS>Please
reference FERC-725V and the docket numbers of this Notice of Proposed
Rulemaking (Docket No. RM14-13-000) in your submission.

IV. Regulatory Flexibility Act Certification

    39. The Regulatory Flexibility Act of 1980 (RFA) \40\ generally
requires a description and analysis of proposed rules that will have
significant economic impact on a substantial number of small entities.
Proposed Reliability Standard COM-001-2 is expected to impose burdens
for the first time on 1,217 entities (i.e., distribution providers and
generator operators). Proposed Reliability Standard COM-002-4 may apply
to as many as 1,279 entities.\41\ Comparison of the applicable entities
with FERC's small business data indicates that approximately 934 of the
1,279 entities are small entities.\42\
---------------------------------------------------------------------------

    \40\ 5 U.S.C. 601-612.
    \41\ The applicable entities are balancing authorities,
reliability coordinators, transmission operators, generator
operators, and distribution providers. After accounting for entities
registered for more than one function, the total count is 1,279
entities.
    \42\ The Small Business Administration sets the threshold for
what constitutes a small business. Public utilities may fall under
one of several different categories, each with a size threshold
based on the company's number of employees, including affiliates,
the parent company, and subsidiaries. The possible categories for
the applicable entities have a size threshold ranging from 250
employees to 1,000 employees. We are using the 1000 employee
threshold for this analysis.
---------------------------------------------------------------------------

    40. Proposed Reliability Standard COM-002-4 will serve to enhance
reliability by, among other things, requiring adoption of predefined
communication protocols, annual assessment of those protocols and
operating personnel's adherence thereto, training on the protocols, and
use of three-part communications. The Commission estimates that each
small balancing authority, reliability coordinator, and transmission
operator subject to proposed Reliability Standard COM-002-4 will incur
one-time compliance costs of about $486 (i.e. development of
communication protocols), plus on-going annual costs of about $717
(i.e. performing training and maintaining evidence of training and
assessments).\43\ The Commission estimates that each of the small
distribution provider and generator operator entities potentially
subject to proposed Reliability Standards COM-001-2 and COM-002-4 will
incur on-going annual costs of about $833 (i.e. performing training and
maintaining evidence of interpersonal communication capability and of
training).\44\ The Commission does not consider the estimated costs per
small entity to have a significant economic impact on a substantial
number of small entities. Accordingly, the Commission certifies that
this NOPR will not have a significant economic impact on a substantial
number of small entities.
---------------------------------------------------------------------------

    \43\ The one-time paperwork-related implementation cost estimate
is based on a burden of eight hours at $60.70/hour, and the annual
ongoing cost estimate is based on a burden of eight hours at $28.93/
hour for maintaining evidence, and eight hours at $60.70/hour for
performing training.
    \44\ The ongoing cost is based on burden of 12 hours at $28.93/
hour for maintaining evidence, and eight hours at $60.70/hour for
performing training.
---------------------------------------------------------------------------

V. Environmental Analysis

    41. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human

environment.\45\ The Commission has categorically excluded certain
actions from this requirement as not having a significant effect on the
human environment. Included in the exclusion are rules that are
clarifying, corrective, or procedural or that do not substantially
change the effect of the regulations being amended.\46\ The actions
proposed herein fall within this categorical exclusion in the
Commission's regulations.
---------------------------------------------------------------------------

    \45\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, FERC Stats. & Regs. ] 30,783 (1987).
    \46\ 18 CFR 380.4(a)(2)(ii).
---------------------------------------------------------------------------

VI. Comment Procedures

    42. The Commission invites interested persons to submit comments on
the matters and issues proposed in this notice to be adopted, including
any related matters or alternative proposals that commenters may wish
to discuss. Comments are due December 1, 2014. Comments must refer to
Docket No. RM14-13-000, and must include the commenter's name, the
organization they represent, if applicable, and address.
    43. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.
    44. Commenters that are not able to file comments electronically
must send an original of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    45. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VII. Document Availability

    46. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through the Commission's Home Page (http://www.ferc.gov) and
in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A,
Washington, DC 20426.
    47. From the Commission's Home Page on the Internet, this
information is available on eLibrary. The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field.
    48. User assistance is available for eLibrary and the Commission's
Web site during normal business hours from the Commission's Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
    By direction of the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-23196 Filed 9-29-14; 8:45 am]
BILLING CODE 6717-01-P