[Federal Register Volume 77, Number 197 (Thursday, October 11, 2012)]
[Notices]
[Pages 61761-61767]
[FR Doc No: 2012-24973]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0018]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Healthcare
Professional Survey of 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
November 13, 2012.

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 Prescription Drug
Promotion.'' Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<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 Prescription Drug Promotion (0910-
New)

    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 903(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 pharmaceutical industry spends millions of dollars a year
promoting their products to American healthcare professionals and to
consumers. FDA regulates the promotion of prescription drugs to both
professionals and consumers. As such, FDA has an interest in
determining the attitudes, perceptions, and opinions of healthcare
professionals with prescribing authority regarding such promotion.
Direct to consumer (DTC) advertising captures the most public
attention, making it an important topic of interest to FDA, but the
bulk of industry resources are spent in professional promotion, making
this an equally important topic for investigation. The current research
is designed to explore prescriber opinions of professional and DTC
advertising and promotion as well as other aspects of prescriber
experience that relate to the promotion of prescription drugs.
    The rise of DTC drug advertising and prescription drug promotion
has affected healthcare professionals in a number of ways. First,
healthcare professionals regularly encounter patients who have been
exposed to DTC ads. Second, healthcare professionals also see and hear
such ads directly as mass media consumers themselves. Since
clarification of the adequate provision requirement for prescription
drug broadcast ads in 1997, FDA has faced numerous questions about the
influence of DTC pharmaceutical marketing because such advertising
directly engages consumers and potentially affects interactions between
patients and their physicians (Refs. 1 and 2). Those questions have
grown more urgent with the growth of DTC in recent years (Refs. 3 and
4). In 2002, FDA considered this form of promotion sufficiently
important as a force in the physician-patient interaction that they
surveyed both patients and physicians regarding their perceptions of
DTC (Ref. 5). Now, nearly a decade later, there are critical reasons to
return to the field to gather more evidence on the influence of DTC in
the examination room and on the relationships between healthcare
professionals and patients.
    One of the most noteworthy aspects of the current healthcare
environment in 2012 is the role now played by various physician
extenders. Naylor and Kurtzman (Ref. 6) recently noted that nurses are
the single largest group of healthcare professionals in the United
States and they argue that nurse practitioners will play an
increasingly vital role in primary care delivery. Similarly, physician
assistants also bolster the ability of our healthcare system to offer
some types of care at lower cost. The aforementioned 2002 FDA study did
not include nurse practitioners or physician assistants in the sample;
that study focused on general practitioners and specialists in several
key areas targeted by DTC. Murray and colleagues (Ref. 7) also
conducted a large-scale survey of U.S. physicians regarding their
perceptions of DTC, but they also did not include nurse practitioners
or physician assistants in their sample. Because DTC likely affects
daily interactions between patients and nurse practitioners and
physician assistants--similar to the 2002 FDA study that suggested the
influence of advertising on physicians' work lives--including these
groups in the new sample will further understanding of DTC in the
healthcare system.
    Another limitation of the 2002 FDA study was the extent to which
the results were nationally representative. As FDA has acknowledged,
the initial set of results as reported were applicable to survey
respondents but were not weighted to reflect national statistics as to
the age, sex, and racial composition of the healthcare professional
population. Similar to many types of surveys that have struggled in
recent decades with declines in cooperation rates (Ref. 8), surveys of
healthcare professionals in general often can benefit from weighting to
reduce nonresponse bias. The current survey will include weighted
responses from respondents that will reflect national demographic
patterns.
    Over the past decade, researchers have been able to better assess
how DTC has unfolded in the United States and determine the questions
that warrant further survey work. For example, researchers have worried
for a number of years that DTC might produce adverse outcomes, such as
clinically inappropriate patient requests for drugs or patient
overestimation of the efficacy of advertised medications (Refs. 5, 7,
9, and 10). At the same time, the 2002 FDA survey found that roughly as
many physicians thought DTC had a positive effect on their practice as
those who thought there had been a negative influence. Moreover, the
2002 FDA survey found that roughly a third of physicians surveyed
thought that DTC had essentially no influence on their practice. The
question of whether a similar pattern will emerge now, despite the
growth of DTC, is a vital one.
    In addition, with the proliferation of social media platforms, the
emergence of online pharmaceutical marketing, and the evolution of
office detailing practices (Refs. 11 and 12), FDA will benefit by
knowing more about healthcare professionals' awareness of new and
emerging drug promotion sites and practices. The proposed survey will
address these issues.

Design Overview

    We propose a nationally representative sample of healthcare
professionals that will yield 2,000 responses from 500 general
practitioners, 500 specialists, 500 nurse practitioners, and 500
physician assistants. Such a design will help to ensure our ability to
discuss not only healthcare professional perceptions generally but also
to assess potential

variation between different types of healthcare professionals. The data
will be weighted to the national population of physicians, nurse
practitioners, and physician assistants who have prescribing authority.
We will develop weights to adjust for known unequal selection
probabilities, for unequal response rates, and for any remaining
deviations between the sample and population distributions. In the
final step, we will use poststratification to calibrate the sample
distribution to known population distribution to reduce the bias due to
frame undercoverage. We believe that poststratification should reduce
undercoverage bias to some extent for the same reasons that weighting
adjustment reduces nonresponse bias. Population counts for use in
poststratification will be obtained from the American Medical
Association Master List and Medical Marketing Service lists for nurse
practitioners and physician assistants. Available variables on which to
weight include: State of practice and specialty for nurse practitioners
and physician assistants. For physicians, these variables include: Age,
gender, specialty, office based/hospital based; degree (MD or DO) and
year of medical school graduation.
    All parts of this study will be administered over the Internet.
Participants will answer questions about their attitudes about DTC and
professional prescription drug promotion, their perceptions of the Bad
Ad program, and their usage of new technologies, including social media
(for complete questionnaire contact Daniel Gittleson (see FOR FURTHER
INFORMATION CONTACT). Demographic information will also be collected.
The entire procedure is expected to last approximately 20 minutes. This
will be a one-time (rather than annual) information collection.
    In the Federal Register of January 17, 2012 (77 FR 2299), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received five public comment submissions
which included over 50 comments embedded. In the following section, we
outline the observations and suggestions raised in the comments and
provide our responses:
    (Comment 1) Two comments recommended surveying pharmacists in
addition to the health care professionals described in the notice
(i.e., general practitioners, specialists, nurse practitioners, and
physician assistants).
    (Response) We respectfully acknowledge the large role played by
pharmacists in the health care system. However, the purpose of our
survey is to query health care professionals with prescribing
privileges. One comment noted that pharmacists have some limited
prescribing privileges in certain States. This is true; pharmacists
have certain privileges in Florida, can prescribe controlled substances
under Collaborative Drug Therapy Management agreements in seven States,
and with specific advanced training can prescribe within the Veterans
Administration system. This contrasts with the nearly universal
prescribing privileges of nurse practitioners and physician assistants,
with varying levels of physician supervision. To maximize our
resources, we propose to maintain our current distribution of health
care professionals. Given the variety of prescribing privilege rights
among physician extenders in different states, however, we will add a
screening question to ensure that our respondents do have prescribing
privileges.
    (Comment 2) One comment mentioned adding a variety of different
types of prescribers to our sample, including dentists, doctors of
osteopathy, and podiatrists.
    (Response) The comment incorrectly notes that the 2002 survey did
not include a variety of prescribers. Contrary to the comment, the 2002
survey did include a range of specialties, reflecting those therapeutic
areas with the highest amount of DTC advertising at that time. The
current survey will include specialists who practice in therapeutic
areas for which DTC advertising is or has recently been active:
Dermatologists; endocrinologists; allergists/pulmonologists,
psychiatrists (all of whom were sampled in 2002); rheumatologists;
cardiologists; ear, nose, and throat doctors; urologists; neurologists;
and pain specialists.
    (Comment 3) One comment recommended that demographic questions be
added to the beginning of the survey to attain adequate representation,
instead of occurring at the end.
    (Response) The Internet panel from which this data will be
collected already contains much of the demographic information we need
to ensure that participants represent a balanced stratification of
demographic variables. When relevant information is not available from
the panel, screening questions will be asked prior to the questionnaire
to obtain the desired information. We prefer to keep other demographic
variables at the end of the survey to avoid distracting participants
with questions about personal information before they have answered
substantive survey questions. We also prefer to ask our most important
questions first to avoid any respondent fatigue that may occur
throughout the survey. We expect that respondents will have an easier
time answering questions about themselves; therefore, these questions
will be less subject to participant fatigue.
    (Comment 4) One comment recommended adding open-ended questions in
several locations in the survey.
    (Response) We appreciate this suggestion and agree that open-ended
questions could provide extra, unprompted information from respondents.
However, given the current length of the survey, it is likely that
adding many open-ended questions would increase respondent demand and,
therefore, result in more respondents quitting before completion.
Moreover, the addition of several open-ended questions would increase
coding burden without adding a commensurate value to our data. Thus, we
do not plan to incorporate additional open-ended questions. If we find
data that we would like to pursue further, we can incorporate this
approach into future studies.
    (Comment 5) One comment recommended that we provide ``don't know''
and ``it depends'' responses for many questions.
    (Response) We understand the value of providing such responses for
items of a factual nature and for items to which health care
professionals might not know the answer (our items fall into the second
category). The drawback to providing such response options, however, is
that we may lose information by allowing respondents to choose an easy
response instead of giving the item some thought. Research by Krosnick
et al. (Ref. 13) demonstrated that providing ``no opinion'' options
likely results in the loss of data without any corresponding increase
in the data quality. Thus, we prefer not to add these options to the
survey. We plan to cognitively test the questionnaire before fielding
the survey, so we will observe whether participants have particular
difficulty with any of the questions.
    (Comment 6) A comment recommended interpreting the results of this
survey cautiously and in tandem with other ongoing research areas.
    (Response) We agree that careful interpretation of the data is
crucial. We plan to apply the most rigorous standards of analysis and
to interpret the findings based on those analyses alone. When relevant,
we will assimilate the findings from this project with other research
projects we conduct.

    (Comment 7) One comment suggested that Q2 (now Q1) be asked as a
screening question.
    (Response) We intend to screen based on percentage of time
prescribers spend with patients. We do not believe additional screening
based on the number of patients seen per week is necessary. We will ask
only one of the three options provided in the draft questionnaire.
Other comments have recommended asking respondents to recall the last
week in time, so we will use that question to assess their patient
volume.
    (Comment 8) One comment recommended asking about ``health and
lifestyle changes'' as an additional question in Q3 (now Q2).
    (Response) We have added this item to the questionnaire.
    (Comment 9) This comment recommended eliminating the ``almost
always'' option from Q3 (now Q2) because it may confuse respondents in
terms of exactly what we are asking.
    (Response) We have removed this option and have changed the other
responses so now the only responses are ``never,'' ``rarely,''
``sometimes,'' and ``often.'' We believe this better represents the
range of options available to answer this question and will make the
question easier to answer.
    (Comment 10) One comment recommended that we add a response option
to Q4 for in-office programming that occurs in waiting rooms.
    (Response) We have deleted this question entirely because of survey
time constraints.
    (Comment 11) Two comments stated that 1 week is a reasonable amount
of time to ask prescribers to recall information in Q5 (now Q3).
    (Response) As we have done in the screener and as suggested by
these comments, we will use 1 week as the time period.
    (Comment 12) This comment recommended that we use a more specific
probe in Q6 (now Q4) to gather information on why prescribers feel
positively or negatively about patients mentioning advertised
prescription drugs.
    (Response) We have added a followup probe (Q4a) to address why
respondents chose their answer.
    (Comment 13) This comment recommended asking prescribers how their
patients reference advertisements, for example, whether they
specifically mention the drug's name, the condition the drug treats, or
some element in the ad such as a butterfly or bee (Q8; now Q5).
    (Response) While this is a very interesting question, it is more
relevant to marketers of these products and outside the scope of what
FDA hopes to accomplish with this survey. Given the number of questions
in the survey, we respectfully decline to add this question.
    (Comment 14) This comment recommended shortening the timeframe in
Q9 (now Q6) from 1 month to 1 week.
    (Response) Given the feedback from this and other comments, we
agree that 1 week is a reasonable amount of time to reference when
answering these questions, and we have adjusted the questionnaire to
reflect this change.
    (Comment 15) One comment recommended wording changes to Q7.
    (Response) Q7 has been deleted because of survey time constraints.
    (Comment 16) This comment asked that the nature of the request also
be added to Q10 (now Q7).
    (Response) Although we agree that asking about the nature of the
request would be interesting, additional questions would increase the
burden on respondents, and we think that other areas of inquiry are
more relevant at this time. Please note that we have altered the
response option in this one question, which will yield additional
information.
    (Comment 17) One comment recommended specifying in Q10 (now Q7)
that patients have requested a drug after seeing it advertised.
    (Response) The purpose of the question is to assess the prescribing
behavior of the prescriber, not the source of the patient's request, so
we prefer to keep the question as is.
    (Comment 18) This comment recommended a change in the response
options in Q10 (now Q7) to further delineate the prescriber's behavior.
    (Response) We agree that this is a useful change and have
implemented this response format. We have made further changes based on
peer review comments.
    (Comment 19) Two comments indicated that it may be difficult for
health care professionals to answer Q12 (now Q9) as written.
    (Response) We agree that it might be difficult for prescribers to
reliably assess the feelings and emotions of members of another group.
We have changed the emphasis in this question from the patient's
expectation to the health care professional's feeling of obligation,
thus eliminating the issue over response options in the original item.
We have altered the question to put the focus back on what prescribers
feel rather than what their patients feel. Please note that we have
also altered the response options for this question to make the
question easier to answer.
    (Comment 20) This comment recommended emphasizing the part of the
stem of Q13 and Q14 (now Q11) that states, ``As a result of discussion
about advertised prescription drugs.''
    (Response) Given the survey length, we have deleted original Q13,
but this comment applies to current Q11. We have attempted to emphasize
the appropriate part of the stem in this question and will be cognizant
of this issue when working with the programmers of the actual survey.
We will use bolding techniques and color as necessary to make sure that
this part of the question is highlighted.
    (Comment 21) One comment questioned the utility of asking
prescribers about a variety of behaviors they engage in as a result of
a conversation about advertised drugs (Q14; now Q11). Their argument is
that the prescriber may respond ``never'' because the subject did not
come up, not because they did not want to provide that action.
    (Response) We agree that this is a possible interpretation of that
response and will be careful to include that in interpretations of the
data. Nevertheless, we are interested in obtaining information on the
number of times these behaviors occur and believe this is a useful
measure.
    (Comment 22) One comment recommended changing Q14 (now Q11) from
``provided a brochure for the drug'' to ``provided a patient education
brochure for the drug.''
    (Response) We respectfully decline to add this phrase because not
all brochures may be considered patient education brochures, and the
addition does not improve or clarify the question.
    (Comment 23) One comment recommended making Q15 (now Q12) more
specific.
    (Response) The purpose of this question is to get a general
reaction to DTC advertising. Although we cannot statistically compare
the results of this survey to FDA's 2002 physician survey for a number
of reasons, we plan to descriptively compare results from the new
survey with data obtained in 2002; thus, we prefer to keep the question
as is. Although we did not make the question more specific, we have
altered the wording slightly to make it clearer.
    (Comment 24) This comment recommended the addition of several
questions about what happens in the prescriber-patient relationship
when patients are exposed to advertised prescription drugs (Q16; now
Q13).
    (Response) We agree that these are useful questions and have
revised the questionnaire accordingly.

    (Comment 25) One comment suggested adding a question to Q16 (now
Q13) about whether DTC advertising increases the likelihood of
conversations that the prescriber would not have otherwise had with his
or her patients.
    (Response) We have included this suggestion in the revised
questionnaire.
    (Comment 26) This comment recommended that we add ``the patient
requests to be taken off the prescribed medicine'' to Q17 (now Q10).
    (Response) We agree this is a useful addition and have added it to
the revised questionnaire.
    (Comment 27) The comment agreed that the item in Q17 (now Q10)
asking about patient recall of aspects of advertised drugs they discuss
with their prescribers is valuable, but questions whether the item as
worded will yield interpretable results.
    (Response) We have revised the question and response options and
will pay close attention to this when we conduct cognitive testing with
nine participants prior to pretesting the instrument.
    (Comment 28) The comment recommended removal of the series of
questions in Q17 (now Q10) because many factors may enter into the
responses to each question. Specifically, the comment refers to
personal characteristics of a patient that may influence these answers.
    (Response) We agree that patient characteristics may play a role,
but we are interested in the overall responses of prescribers to these
questions. Other surveys capture patient characteristics that may
influence this question (Ref. 14). We have made minor improvements in
the wording of these items based on peer review comments.
    (Comment 29) Two comments recommended adding questions to Q18, one
of which referred to the effect of DTC advertising on prescription
drugs patients are already taking.
    (Response) We have added questions on these topics to Q18 (now
Q14).
    (Comment 30) The comment recommended the addition of several items
related to cost to Q21 (now Q17).
    (Response) These questions are outside the scope of the current
project because FDA does not have authority over the cost of
prescription drugs. Given the current length of the survey, we have
chosen not to include these recommendations.
    (Comment 31) One comment recommended the addition of two questions
to the question series for Q22.
    (Response) We have included the recommendation in Q14 of the
revised questionnaire.
    (Comment 32) This comment encouraged FDA to cautiously interpret
the results of Q22 (now Q14), which asks whether prescribers believe
that DTC advertising caused their patients to think drugs work better
than they actually do.
    (Response) We agree that all responses should be interpreted
cautiously and will take care to avoid overinterpreting beyond the
data.
    (Comment 33) The comment suggested removing the concept of ``less
expensive treatments'' from Q22 (now Q15) about whether prescribers
thought DTC advertising caused patients to want advertised drugs over
others.
    (Response) Although we have heard this complaint frequently in
focus groups, we have modified this question so that instead of the
comparator in the question being ``less expensive treatments,'' the
comparator is ``other recommended treatments.''
    (Comment 34) This comment recommended deleting the question about
the cost of prescription drugs (Q22).
    (Response) We have deleted this question from the questionnaire.
    (Comment 35) One comment suggested a change in wording to Q23 (now
Q16).
    (Response) We have replaced the word ``diagnoses'' with the word
``treatment,'' as suggested by the comment.
    (Comment 36) This comment refers to Q23 (now Q18) and the questions
following it that inquire about patients bringing coupons to their
doctors for specific prescription drugs. Coupons and other incentives
are frequently used in DTC promotion. This comment recommended
rewording the question to assess whether patients are more likely to
ask prescribers for drugs with coupons rather than those without.
    (Response) We are unsure how prescribers would know this
information because they are likely not current with the range of
active advertising campaigns at any given time. We maintain that the
currently worded question is a useful measure for assessing
prescribers' general opinions about the use of incentives in DTC
promotion.
    (Comment 37) The comment expressed concern about Q23-25 (now Q18-
20) because they believe that without clarification we may miss
important nuances such as the possibility that a coupon may initiate a
quality conversation about an illness.
    (Response) As with all questions in this survey, we will carefully
interpret the data, making sure not to draw conclusions not supported
by the data. Nevertheless, we believe that if the presentation of a
coupon resulted in a good doctor-patient conversation, the respondent
would indeed select a positive answer to this question.
    (Comment 38) Two comments stated that Q25 (now Q20) repeats Q24
(now Q19) in the questionnaire.
    (Response) Q24 (now Q19), asked only of respondents who have
encountered a patient with a coupon, asks how they did feel about that.
Q25 (now Q20), asked only of respondents who have not encountered a
patient with a coupon, asks how they would feel about that. Respondents
will only see one of these two questions, depending on whether a
patient has ever asked them about a prescription drug that has been
advertised with a coupon. We like the suggested wording in one comment
for Q24 (Q19) and have applied it to both questions.
    (Comment 39) The comment suggested modifying Q26 to ask whether
prescribers have ever had patients become concerned about their
medication after seeing an ad for it.
    (Response) We believe this would have been a good introductory
question for the former Q26; however, because of survey time
constraints, we were forced to limit the number of questions in this
area. Based on peer review comments, we replaced these questions with a
question that more directly asks whether prescribers have ever had a
patient refuse to take or to stop taking their medication for these
reasons (now Q21).
    (Comment 40) One comment recommended adding a response of ``depends
on the condition'' to the question of whether there should be more or
less information about medical conditions in DTC advertising (Q27).
    (Response) Because of survey time constraints, this question has
been deleted.
    (Comment 41) One comment recommended changing the order of Q28 and
Q29.
    (Response) Because of survey time constraints, all questions in
this series have been deleted except Q29b (now Q22).
    (Comment 42) This comment has taken a subsection of the questions
about awareness of the Bad Ad program (Q31-37; now Q23-30) and claimed
that FDA is using this forum as a way to inform prescribers about the
Bad Ad program.
    (Response) Looking at the entire set of questions, it is clear that
the goal of this series is to assess whether prescribers have heard
about the program and to explore their opinions about it. A description
of the Bad Ad program is

provided in current Q24 because we want to ask the subsequent questions
of all respondents and can only do so if they know about the program.
This survey provides a logical vehicle for assessing opinions about the
Bad Ad program. Furthermore, because the Bad Ad program is directly
related to prescription drug promotion, we believe it is clearly within
the scope of the survey. We recognize, however, that we did not make
this clear in the introductory section of the Federal Register notice,
and we have included additional verbiage to remedy this omission. We
note that no other comments expressed concern about these questions.
    (Comment 43) One comment recommended wording changes to the
followup open-ended item about the Bad Ad program (Q34a; now Q27).
    (Response) We agree that the revised wording is preferable and have
incorporated it into the questionnaire.
    (Comment 44) One comment recommended wording changes to Q36/Q37
(now Q29/Q30).
    (Response) We agree that changing the wording of these two
questions may make them easier for respondents to understand and have
done so in the questionnaire.
    (Comment 45) This comment recommended deleting Q38-43 (now Q31-36)
regarding social media membership and participation, citing the
justification that the survey is about DTC advertising and these
questions are irrelevant.
    (Response) We reiterate that the purpose of the survey is to obtain
opinions and responses from a variety of prescribers regarding
prescription drug promotion. This topic encompasses both professional
and DTC advertising and labeling and a variety of different media
through which this promotion occurs. The Agency has an interest in
determining the extent of promotion in emerging technologies such as
social media, and various stakeholders have pressed the Agency to
produce guidance related to new technologies. This survey provides an
opportunity to explore prescribers' use of social media sites in order
to assess whether future research is warranted regarding these emerging
and potentially promotional venues. We have added language to the
introduction section to clarify the scope of the survey.
    (Comment 46) One comment recommended that we change the word
``post'' to ``comment'' in Q42/Q43 (now Q35/36).
    (Response) We have made this change in these two questions. Please
note that we have also added a time period to help respondents answer
the questions more easily.
    (Comment 47) One comment recommended the addition of Internet
search engines to Q44 (now Q37a and 37b).
    (Response) We have added search engines as an option for this
question. We have also separated the question into two parts based on
peer review comments to avoid a cognitively demanding ranking task.
    (Comment 48) This comment expressed support for FDA's data
collection from health care professionals regarding prescription drug
promotion. One general issue raised by this comment was the exclusion
and inclusion criteria for prescribers.
    (Response) Prescribers must see patients at least 50 percent of the
time in a non-hospital or non-inpatient setting. Primary care
physicians will include internists, general practitioners, family
practitioners, and obstetricians/gynecologists (all of whom were
sampled in 2002). We will exclude pediatricians because relatively
little DTC advertising is aimed at children or their parents.
Specialists will include those who practice in therapeutic areas for
which DTC advertising is or has recently been active: Dermatologists;
endocrinologists; allergists/pulmonologists; psychiatrists (all of whom
were sampled in 2002); rheumatologists; cardiologists; ear, nose, and
throat doctors; urologists; neurologists; and pain specialists. Nurse
practitioners and physician assistants must have prescribing
privileges.
    (Comment 49) One comment raised the issue of weighting.
    (Response) Although we did not provide details on weighting in the
60-day Federal Register notice, we agree and have implemented all
suggestions provided by this comment. For example, this comment noted
that FDA did not explain at what level results will be reported (i.e.,
aggregate versus each group as a separate sample). Results will be
reported both in aggregate and for each group separately, and weights
will be adjusted to produce national-level estimates.
    (Comment 50) This comment supported FDA's use of equal-sized
samples of four different types of health care professionals (general
practitioners, specialists, nurse practitioners, and physician
assistants) although it suggests that the artificial nature of equal-
sized samples may make it difficult to find population parameters and
targets to use for weighting purposes.
    (Response) We note that the target population is all health care
professionals with prescribing authority in the United States. This is
considered the inferential population, which is rarely achieved. The
proposed sample will be selected from the ``responding population.''
The final survey weights will be constructed to reduce the coverage
error and to compensate for nonresponse error and unequal probability
of selection to represent the target population.
    (Comment 51) This comment expressed skepticism that sample
weighting can adjust or correct for noncoverage that results from
inadequacies in sampling frames.
    (Response) We agree that frame undercoverage cannot completely
eliminate noncoverage bias in an estimator completely but will apply
poststratification as the primary method for dealing with this
undercoverage (Ref. 15). We believe that poststratification should
reduce this bias to some extent for the same reasons that weighting
adjustment reduces nonresponse bias. We will consider trimming extreme
weights and redistributing them to avoid losses in precision.
    (Comment 52) With regard to the questionnaire, this comment
recommended adding specific questions about the prescriber's practice,
including the size of the practice, whether it is part of a managed
care organization, whether it is part of an integrated health system
that involves hospitals, and whether the practice has a low- or no-
access policy with regard to pharmaceutical sales representatives.
    (Response) We agree that these may be relevant variables, and these
questions are represented in the demographic section.
    (Comment 53) One comment suggested adding a series of questions to
assess the market dynamics that may affect prescribing decisions.
    (Response) Although these are interesting questions, they are
outside the scope of the current project. Many of the suggested
questions deal with issues of cost and reimbursement, which FDA does
not regulate.
    (Comment 54) One comment recommended that we should ask particular
questions of nurse practitioners and physician assistants to assess
their characteristics.
    (Response) We agree with the comment and have several questions in
the questionnaire, asked of all respondents, that will address some of
these questions. We have added a question to the screener to ensure
that all respondents have at least some prescribing authority, and we
have added a question to the questionnaire to

delve further into how much authority respondents have. We will also
ask all respondents how many prescriptions they write in 1 week.
    (Comment 55) One comment suggested reexamining the questionnaire
from the Office of Prescription Drug Promotion's online DTC promotion
study (Docket No. FDA-2011-N-0230) in light of this survey to explore
the possibility of comparing responses on similar questions.
    (Response) We appreciate this suggestion and will examine the data
from both studies to see if any descriptive comparisons can be made.
    Please note that in response to all comments received, whether we
have adapted the suggestions or not, we will specifically examine the
items mentioned in cognitive testing. During this testing, nine
respondents will participate in the survey while explaining why and how
they have chosen their answers and which questions they find difficult
to respond to or to understand.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Screener........................           3,500               1           3,500            0.03             105
Pretest.........................              25               1              25            0.33               8
Main Study......................           2,000               1           2,000            0.33             660
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             773
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

V. References

    The following references have been placed on display in the
Division of Dockets Management (FDA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.

1. Fintor, L., ``Direct-to-Consumer Marketing: How Has it Fared?''
Journal of the National Cancer Institute, 94, 329-331, 2002.
2. Palumbo, F.B., and C.D. Mullins, ``The Development of Direct-to-
Consumer Prescription Drug Advertising Regulations.'' Food and Drug
Law Journal, 57, 423-443, 2002.
3. Curry, T.J., J. Jarosch, and S. Pacholok, ``Are Direct to
Consumer Advertisements of Prescription Drugs Educational? Comparing
1992 to 2002.'' Journal of Drug Education, 35, 2172-2232, 2005.
4. Government Accountability Office (GAO). ``Improvements Needed in
FDA's Oversight of Direct-to-Consumer Advertising.'' GAO-07-54.
Washington, DC: GAO, November 16, 2006.
5. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs,'' Washington, DC: Food and Drug Administration,
November 19, 2004.
6. Naylor, M.D., and E.T. Kurtman, ``The Role of Nurse Practitioners
in Reinventing Primary Care.'' Health Affairs, 29, 893-899, 2010.
7. Murray, E., B. Lo, L. Pollack, K. Donelan, and K. Lee, ``Direct-
to-Consumer Advertising: Physicians' Views of its Effects on Quality
of Care and the Doctor-Patient Relationship.'' Journal of the
American Board of Family Practice, 16, 513-524, 2003.
8. Dey, E.L., ``Working With Low Survey Response Rates: The Efficacy
of Weighting Adjustments.'' Research in Higher Education, 38, 215-
227, 1997.
9. Mintzes, B., M.L. Barer, R.L. Kravitz, A. Kazanjian, K. Bassett,
J. Lexchin, R.G. Evans, R. Pan, and S.A. Marion, ``Influence of
Direct to Consumer Pharmaceutical Advertising and Patients' Requests
on Prescribing Decisions: Two Site Cross Sectional Study.'' British
Medical Journal, 324, 278-279, 2002.
10. Mitra, A., J. Swasy, and K. Aikin, ``How Do Consumers Interpret
Market Leadership Claims in Direct-to-Consumer Advertising of
Prescription Drugs?'' Advances in Consumer Research, 33, 381-387,
2006.
11. Donohue, J.M., M. Cevasco, and M.B. Rosenthal, ``A Decade of
Direct-to-Consumer Advertising of Prescription Drugs.'' New England
Journal of Medicine, 357, 673-681, 2007.
12. Chew, L.D., T.S. O'Young, T.K. Hazlet, K.A. Bradley, C. Maynard,
and D.S. Lessler, ``A Physician Survey of the Effect of Drug Sample
Availability on Physician's Behavior.'' Journal of General Internal
Medicine, 15, 478-483, 2000.
13. Krosnick, J.A., A.L. Holbrook, M.K. Berent, R.T. Carson, W.M.
Hanemann, R.J. Kopp, M. Conaway, ``The Impact of `No Opinion'
Response Options on Data Quality: Non-attitude Reduction or an
Invitation to Satisfice?'' Public Opinion Quarterly, 66, 371-403,
2002.
14. Prevention Magazine. (2011). http://www.rodaleinc.com/newsroom/12th-annual-survey-iconsumer-reaction-dtc-advertising-prescription-drugsi-reveals. Last accessed March 29, 2012.
15. Korn, E.L., and B.I. Graubard, ``Analysis of Health Surveys''
(p. 42, lines 10-16). John Wiley & Sons: New York, NY, 1999.

    Dated: October 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24973 Filed 10-10-12; 8:45 am]
BILLING CODE 4160-01-P


outlet of the electrostatic      water flow rate at
 precipitator.                    the outlet of the
                                  electrostatic
                                  precipitator.
----------------------------------------------------------------------------------------------------------------
                                           Activated carbon injection
----------------------------------------------------------------------------------------------------------------
Mercury sorbent injection rate.  Minimum mercury      Hourly.............  Hourly............  12-hour block.
                                  sorbent injection
                                  rate.
Dioxin/furan sorbent injection   Minimum dioxin/
 rate.                            furan sorbent
                                  injection rate.
Carrier gas flow rate or         Minimum carrier gas  Continuous.........  Every 15 minutes..  12-hour block.
 carrier gas pressure drop.       flow rate or
                                  minimum carrier
                                  gas pressure drop.
----------------------------------------------------------------------------------------------------------------
                                                   Afterburner
----------------------------------------------------------------------------------------------------------------
Temperature of the afterburner   Minimum temperature  Continuous.........  Every 15 minutes..  12-hour block.
 combustion chamber.              of the afterburner
                                  combustion chamber.
----------------------------------------------------------------------------------------------------------------
a As specified in Sec.   62.15985, you may use a continuous emissions monitoring system or continuous automated
  sampling system in lieu of establishing certain operating limits.
b This recording time refers to the minimum frequency that the continuous monitor or other measuring device
  initially records data. For all data recorded every 15 minutes, you must calculate hourly arithmetic averages.
  For all parameters, you use hourly averages to calculate the 12-hour or 3-hour block average specified in this
  table for demonstrating compliance. You maintain records of 1-hour averages.

      Table 5 to Subpart LLL of Part 62--Toxic Equivalency Factors
------------------------------------------------------------------------
                                                               Toxic
                   Dioxin/Furan isomer                      equivalency
                                                               factor
------------------------------------------------------------------------
2,3,7,8-tetrachlorinated dibenzo-p-dioxin................         1
1,2,3,7,8-pentachlorinated dibenzo-p-dioxin..............         1
1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin.............         0.1
1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin.............         0.1
1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin.............         0.1
1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin..........         0.01
octachlorinated dibenzo-p-dioxin.........................         0.0003
2,3,7,8-tetrachlorinated dibenzofuran....................         0.1
2,3,4,7,8-pentachlorinated dibenzofuran..................         0.3
1,2,3,7,8-pentachlorinated dibenzofuran..................         0.03
1,2,3,4,7,8-hexachlorinated dibenzofuran.................         0.1
1,2,3,6,7,8-hexachlorinated dibenzofuran.................         0.1
1,2,3,7,8,9-hexachlorinated dibenzofuran.................         0.1
2,3,4,6,7,8-hexachlorinated dibenzofuran.................         0.1
1,2,3,4,6,7,8-heptachlorinated dibenzofuran..............         0.01
1,2,3,4,7,8,9-heptachlorinated dibenzofuran..............         0.01
octachlorinated dibenzofuran.............................         0.0003
------------------------------------------------------------------------

                  Table 6 to Subpart LLL of Part 62--Summary of Reporting Requirements for Existing Sewage Sludge Incineration Units a
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Report                                 Due date                               Contents                             Reference
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increments of progress report.........  No later than 10 business days after   1. Final control plan including air    Sec.   62.16030(a).
                                         the compliance date for the            pollution control device
                                         increment.                             descriptions, process changes, type
                                                                                of waste to be burned, and the
                                                                                maximum design sewage sludge burning
                                                                                capacity.
                                                                               2. Notification of any failure to
                                                                                meet an increment of progress.
                                                                               3. Notification of any closure.......
Initial compliance report.............  No later than 60 days following the    1. Company name and address..........  Sec.   62.16030(b).
                                         initial performance test.             2. Statement by a responsible
                                                                                official, with that official's name,
                                                                                title, and signature, certifying the
                                                                                accuracy of the content of the
                                                                                report.
                                                                               3. Date of report....................
                                                                               4. Complete test report for the
                                                                                initial performance test.
                                                                               5. Results of CMS \b\ performance
                                                                                evaluation.
                                                                               6. The values for the site-specific
                                                                                operating limits and the
                                                                                calculations and methods used to
                                                                                establish each operating limit.
                                                                               7. Documentation of installation of
                                                                                bag leak detection system for fabric
                                                                                filter.
                                                                               8. Results of initial air pollution
                                                                                control device inspection, including
                                                                                a description of repairs.
                                                                               9. The site-specific monitoring plan
                                                                                required under Sec.   62.15995.
                                                                               10. The site-specific monitoring plan
                                                                                for your ash handling system
                                                                                required under Sec.   62.15995.
Annual compliance report..............  No later than 12 months following the  1. Company name and address.           Sec.   62.16030(c)
                                         submission of the initial compliance  2. Statement and signature by
                                         report; subsequent reports are to be   responsible official.
                                         submitted no more than 12 months      3. Date and beginning and ending
                                         following the previous report.         dates of report.
                                                                               4. If a performance test was
                                                                                conducted during the reporting
                                                                                period, the results of the test,
                                                                                including any new operating limits
                                                                                and associated calculations and the
                                                                                type of activated carbon used, if
                                                                                applicable.

                                                                               5. For each pollutant and operating
                                                                                parameter recorded using a CMS, the
                                                                                highest recorded 3-hour average and
                                                                                the lowest recorded 3-hour average,
                                                                                as applicable.
                                                                               6. If no deviations from emission
                                                                                limits, emission standards, or
                                                                                operating limits occurred, a
                                                                                statement that no deviations
                                                                                occurred.
                                                                               7. If a fabric filter is used, the
                                                                                date, time, and duration of alarms..
                                                                               8. If a performance evaluation of a
                                                                                CMS was conducted, the results,
                                                                                including any new operating limits
                                                                                and their associated calculations.
                                                                               9. If you met the requirements of
                                                                                Sec.   62.16000(a)(3) and did not
                                                                                conduct a performance test, include
                                                                                the dates of the last three
                                                                                performance tests, a comparison to
                                                                                the 50 percent emission limit
                                                                                threshold of the emission level
                                                                                achieved in the last three
                                                                                performance tests, and a statement
                                                                                as to whether there have been any
                                                                                process changes.
                                                                               10. Documentation of periods when all
                                                                                qualified SSI unit operators were
                                                                                unavailable for more than 8 hours
                                                                                but less than 2 weeks.
                                                                               11. Results of annual pollutions
                                                                                control device inspections,
                                                                                including description of repairs.
                                                                               12. If there were no periods during
                                                                                which your CMSs had malfunctions, a
                                                                                statement that there were no periods
                                                                                during which your CMSs had
                                                                                malfunctions.
                                                                               13. If there were no periods during
                                                                                which your CMSs were out of control,
                                                                                a statement that there were no
                                                                                periods during which your CMSs were
                                                                                out of control.
                                                                               14. If there were no operator
                                                                                training deviations, a statement
                                                                                that there were no such deviations.
                                                                               15. Information on monitoring plan
                                                                                revisions, including a copy of any
                                                                                revised monitoring plan.
Deviation report (deviations from       By August 1 of a calendar year for     If using a CMS:                        Sec.   62.16030(d).
 emission limits, emission standards,    data collected during the first half  1. Company name and address..........
 or operating limits, as specified in    of the calendar year; by February 1   2. Statement by a responsible
 Sec.   62.16030(e)(1)).                 of a calendar year for data            official..
                                         collected during the second half of   3. The calendar dates and times your
                                         the calendar year.                     unit deviated from the emission
                                                                                limits or operating limits.
                                                                               4. The averaged and recorded data for
                                                                                those dates.
                                                                               5. Duration and cause of each
                                                                                deviation.
                                                                               6. Dates, times, and causes for
                                                                                monitor downtime incidents.
                                                                               7. A copy of the operating parameter
                                                                                monitoring data during each
                                                                                deviation and any test report that
                                                                                documents the emission levels.
                                                                               8. For periods of CMS malfunction or
                                                                                when a CMS was out of control, you
                                                                                must include the information
                                                                                specified in Sec.
                                                                                62.16030(d)(3)(viii).
                                                                               If not using a CMS:..................
                                                                               1. Company name and address..........
                                                                               2. Statement by a responsible
                                                                                official.
                                                                               3. The total operating time of each
                                                                                affected SSI.

                                                                               4. The calendar dates and times your
                                                                                unit deviated from the emission
                                                                                limits, emission standard, or
                                                                                operating limits.
                                                                               5. The averaged and recorded data for
                                                                                those dates.
                                                                               6. Duration and cause of each
                                                                                deviation.
                                                                               7. A copy of any performance test
                                                                                report that showed a deviation from
                                                                                the emission limits or standards.
                                                                               8. A brief description of any
                                                                                malfunction, a description of
                                                                                actions taken during the malfunction
                                                                                to minimize emissions, and
                                                                                corrective action taken.
Notification of qualified operator      Within 10 days of deviation..........  1. Statement of cause of deviation...  Sec.   62.16030(e).
 deviation (if all qualified operators                                         2. Description of actions taken to
 are not accessible for 2 weeks or                                              ensure that a qualified operator
 more).                                                                         will be available.
                                                                               3. The date when a qualified operator
                                                                                will be accessible.
Notification of status of qualified     Every 4 weeks following notification   1. Description of actions taken to     Sec.   62.16030(e).
 operator deviation.                     of deviation.                          ensure that a qualified operator is
                                                                                accessible.
                                                                               2. The date when you anticipate that
                                                                                a qualified operator will be
                                                                                accessible.
                                                                               3. Request for approval to continue
                                                                                operation.
Notification of resumed operation       Within five days of obtaining a        1. Notification that you have          Sec.   62.16030(e).
 following shut down (due to qualified   qualified operator and resuming        obtained a qualified operator and
 operator deviation and as specified     operation.                             are resuming operation.
 in Sec.   62.15945(b)(2)(i).
Notification of a force majeure.......  As soon as practicable following the   1. Description of the force majeure    Sec.   62.16030(f).
                                         date you first knew, or through due    event.
                                         diligence should have known that the  2. Rationale for attributing the
                                         event may cause or caused a delay in   delay in conducting the performance
                                         conducting a performance test beyond   test beyond the regulatory deadline
                                         the regulatory deadline; the           to the force majeure.
                                         notification must occur before the    3. Description of the measures taken
                                         performance test deadline unless the   or to be taken to minimize the delay.
                                         initial force majeure or a            4. Identification of the date by
                                         subsequent force majeure event         which you propose to conduct the
                                         delays the notice, and in such         performance test.
                                         cases, the notification must occur
                                         as soon as practicable.
Notification of intent to start or      1 month before starting or stopping    1. Intent to start or stop use of a    Sec.   62.16030(g).
 stop use of a CMS.                      use of a CMS.                          CMS.
Notification of intent to conduct a     At least 30 days prior to the          1. Intent to conduct a performance
 performance test.                       performance test.                      test to comply with this subpart.
Notification of intent to conduct a     At least 7 days prior to the date of   1. Intent to conduct a rescheduled
 rescheduled performance test.           a rescheduled performance test.        performance test to comply with this
                                                                                subpart.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This table is only a summary, see the referenced sections of the rule for the complete requirements.
\b\ CMS means continuous monitoring system.

[FR Doc. 2015-08777 Filed 4-24-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45417-45418]
[FR Doc No: 2012-18571]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2012-0176]

Pipeline Safety: Inspection and Protection of Pipeline Facilities
After Railway Accidents

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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

SUMMARY: PHMSA is issuing an advisory bulletin to alert all pipeline
owners and operators of the circumstances of the Cherry Valley,
Illinois derailment and remind them of the importance of assuring that
pipeline facilities have not been damaged either during a railroad
accident or other event occurring in the right-of-way. Further, the
advisory bulletin reminds pipeline owners and operators of the
importance of providing pertinent information to rail operators and
emergency response officials during an incident. This information
should include the presence, depth and location of the pipelines so
that the movement of heavy equipment and debris on the right-of-way
does not damage or rupture the pipeline or otherwise pose a hazard to
people working in, and around, the accident location. The advisory also
encourages pipeline owners and operators to inform rail operators and
emergency response officials of the benefits of using the 811 ``Call
Before You Dig'' program to identify and notify underground utilities
that an incident has occurred in the vicinity of their buried
facilities.

FOR FURTHER INFORMATION CONTACT: David Appelbaum by phone at 202-366-
1419 or by email at<EMAIL_ADDRESS>Information about PHMSA
may be found at http://phmsa.dot.gov.

SUPPLEMENTARY INFORMATION:

Background

    On Friday, June 19, 2009, at approximately 8:36 p.m., CST, a
Canadian National Railway Company (CN) freight train U7069l-l8,
traveling eastbound at 36 mph, derailed at a highway/rail grade
crossing in Cherry Valley, Illinois. The train consisted of two
locomotives and 114 cars, 19 of which derailed. All of the derailed
cars were tank cars carrying denatured fuel ethanol, a flammable
liquid. Thirteen of the derailed tank cars were breached or lost
product and caught fire. At the time of the derailment, several motor
vehicles were stopped on either side of the grade crossing waiting for
the train to pass. As a result of the fire that erupted after the
derailment, a passenger in one of the stopped cars was fatally injured,
two passengers in the same car received serious injuries, and five
occupants of other cars waiting at the highway-rail crossing were
injured. Two responding firefighters also sustained minor injuries. The
release of ethanol and the resulting fire prompted a mandatory
evacuation of about 600 residences within a \l/2\-mile radius of the
accident site.
    The National Transportation Safety Board (NTSB) determined that the
probable cause of the accident was the washout of the track structure
that was discovered about one hour before the train's arrival, and CN's
failure to notify the train crew of the known washout in time to stop
the train because of the inadequacy of CN's emergency communication
procedures.
    At the site of the derailment was a 12-inch diameter underground
natural gas transmission pipeline operated by Nicor Gas. The pipeline
well exceeded Federal standards for protective ground cover. Yet, as
the wreckage was removed from above the pipeline, Nicor's crews
discovered that a railcar wheel and axle assembly had impinged on the
pipeline. Although the pipeline was buried about 11 feet deep and
protected within a 16-inch diameter casing, the rail car wheels
impacted and severely dented the pipeline. The impact caused a severe
flattening of the pipe casing with sharp angular bends at two locations
where it was contacted by the rail car wheel assembly. This degree of
deformation to the 16-inch casing pipe likely caused similar damage to
the 12-inch carrier pipe. The NTSB concluded that had the gas pipeline
been installed at the railroad crossing with the minimum level of
ground cover permitted by the current Federal and industry pipeline
construction standards, it likely would have failed as a result of
being struck by derailed equipment in this accident.

Advisory Bulletin (ADB-2012-08)

    To: Owners and Operators of Hazardous Liquid and Gas Pipeline
Systems.
    Subject: Inspection and Protection of Pipeline Facilities after
Railway Accidents.
    Advisory: To further enhance the Department's safety efforts, PHMSA
is issuing this advisory bulletin as a reminder for pipeline owners and
operators to appropriately inspect and protect pipeline facilities
following railroad accidents that occur in pipeline right-of-ways.
    As illustrated in the June 19, 2009, Cherry Valley, Illinois train
derailment, buried pipelines are susceptible to damage even when depth-
of-cover protection exceeds minimum Federal requirements. Pipeline
owners and operators should inspect their facilities following a
railroad accident or other significant event occurring in right-of-ways
to ensure pipeline integrity. Also, during response operations,
pipeline owners and operators need to inform rail operators and
emergency response officials of the presence, depth and location of the
pipelines so that the movement of heavy equipment on the right-of-way
does not damage or rupture the pipeline or otherwise pose a hazard to
people working in, and around, the accident location.
    Additionally, PHMSA encourages pipeline owners and operators, as a
part of their public awareness program, to inform rail operators and
emergency response officials of the benefits of using the 811 ``Call
Before You Dig'' program to identify and notify underground utilities
that an incident has occurred in the vicinity of their buried
facilities.

Linda Daugherty,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2012-18571 Filed 7-30-12; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Proposed Rules]
[Pages 33658-33660]
[FR Doc No: 2022-11896]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0514; Project Identifier AD-2022-00357-E]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain General Electric Company (GE) GEnx-1B model turbofan
engines. This proposed AD was prompted by several reports of fuel leaks
caused by high cycle fatigue (HCF) cracks found at the braze joints on
fuel manifolds, and the subsequent manufacturer redesign of the high-
pressure turbine (HPT) fuel hose variable stator vane (VSV) manifold,
VSV fuel hose manifold, low-pressure turbine (LPT) fuel hose variable
bleed valve (VBV) manifold, and VBV fuel hose manifold. This proposed
AD would require removal and replacement of the fuel hydraulic lines.
The FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by July 18,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact General
Electric Company, 1 Neumann Way, Cincinnati, OH 45215; phone: (513)
552-3272; email: [email protected]; website: www.ge.com. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 1200 District Avenue, Burlington,
MA 01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0514; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Alexei Marqueen, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0514; Project Identifier
AD-2022-00357-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Alexei Marqueen, Aviation Safety Engineer, ECO Branch, FAA, 1200
District Avenue, Burlington, MA 01803. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    The FAA received reports of fuel manifold leaks resulting in
multiple flight delays and cancellations on four separate occasions
between 2018 and 2021 on airplanes with GEnx-1B model turbofan engines
installed. The manufacturer's investigation revealed that variations in
braze coverage and braze fillet radii caused high stress concentration
factors at the braze block

joints, leading to HCF failure in the tube bundles with brazed joints.
As a result of its investigation, the manufacturer determined that the
HPT fuel hose VSV manifold, VSV fuel hose manifold, LPT fuel hose VBV
manifold, and VBV fuel hose manifold required redesign by replacing all
braze features and cushioned clamps with block clamps. The manufacturer
published GE GEnx-1B Service Bulletin 73-0099 R00, dated February 28,
2022, which specifies procedures for the replacement of fuel hydraulic
lines with redesigned fuel hydraulic lines. This condition, if not
addressed, could result in engine fire and damage to the airplane.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE GEnx-1B Service Bulletin 73-0099 R00, dated
February 28, 2022. This service information specifies procedures for
the removal and replacement of the fuel hydraulic lines. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require the removal and replacement of the
fuel hydraulic lines.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 298 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove fuel hydraulic lines...........  2 work-hours x $85 per                $0            $170         $50,660
                                         hour = $170.
Install redesigned fuel hydraulic       2.5 work-hours x $85 per         232,000      232,212.50      69,199,325
 lines.                                  hour = $212.50.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

General Electric Company: Docket No. FAA-2022-0514; Project
Identifier AD-2022-00357-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 18, 2022.

(b) Affected ADs

    None.

(c) Applicability

    General Electric Company (GE) GEnx-1B64, GEnx-1B64/P1, GEnx-
1B64/P2, GEnx-1B67, GEnx-1B67/P1, GEnx-1B67/P2, GEnx-1B70, GEnx-
1B70/75/P1, GEnx-1B70/75/P2, GEnx-1B70/P1, GEnx-1B70/P2, GEnx-1B70C/
P1, GEnx-1B70C/P2, GEnx-1B74/75/P1, GEnx-1B74/75/P2, GEnx-1B76/P2,
and GEnx-1B76A/P2 model turbofan engines with engine serial numbers
956-102 through 958-775, inclusive, 958-795, and 958-802.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7310, Engine Fuel
Distribution.

(e) Unsafe Condition

    This AD was prompted by several reports of fuel leaks caused by
high cycle fatigue cracks found at the braze joints on certain GEnx-
1B fuel manifolds. The FAA is issuing this AD to prevent fuel leaks
on the variable bypass valve and variable stator vane fuel hose
manifolds. The unsafe condition, if not addressed, could result in
engine fire and damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    At the next engine shop visit after the effective date of this
AD, remove and replace the fuel hydraulic lines using the
Accomplishment Instructions, paragraphs 3.A and 3.B, of GE GEnx-1B
Service Bulletin (SB) 73-0099 R00, dated February 28, 2022.

(h) Definition

    For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine case flanges, except for
the following situations, which do not constitute an engine shop
visit:
    (1) Separation of engine flanges solely for the purposes of
transportation of the engine without subsequent maintenance.

    (2) Separation of engine flanges solely for the purposes of
replacing the fan or propulsor without subsequent maintenance.

(i) Alternative Methods of Compliance (AMOCs)

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

(j) Related Information

    (1) For more information about this AD, contact Alexei Marqueen,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD, contact
General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email: [email protected]; website:
www.ge.com. You may view this referenced service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on May 5, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-11896 Filed 6-2-22; 8:45 am]
BILLING CODE 4910-13-P