[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26552-26559]
[FR Doc No: 2023-09183]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0081]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tradeoff Analysis of
Prescription Drug Product Claims in Direct-to-Consumer and Healthcare
Provider 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: Submit written comments (including recommendations) on the
collection of information by May 31, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Tradeoff Analysis of Prescription Drug
Product Claims in Direct-to-Consumer and Healthcare Provider
Promotion.'' Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].
    For copies of the questionnaire, contact: Office of Prescription
Drug Promotion (OPDP) Research Team, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-
Consumer and Healthcare Provider 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 OPDP's mission is to protect the public health by helping to
ensure that prescription drug promotion is truthful, balanced, and
accurately communicated. OPDP's research program provides scientific
evidence to help ensure that our policies related to prescription drug
promotion will have the greatest benefit to public health. Toward that
end, we have consistently conducted research to evaluate the aspects of
prescription drug promotion that are most central to our mission. Our
research focuses in particular on three main topic areas: (1)
advertising features, including content and format; (2) target
populations; and (3) research quality. Through the evaluation of
advertising features, we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits. Focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience, and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
the first and second topic areas, advertising features and target
populations.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved by using the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our home page,
which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    The proposed research examines the relative importance of
prescription drug product information such as prescription drug
efficacy, risk, adherence, and patient preference claims in two medical
conditions (type 2 diabetes and psoriasis) in consumer and physician
samples. When confronted with an important decision, people tend to
make choices that reflect a series of tradeoffs between certain
desirable and undesirable attributes of a product, service, or
experience. Pharmaceutical manufacturers provide information about
prescription drug products, including side effects, contraindications,
and effectiveness, through product labeling and promotional materials
(21 CFR 202.1(e)). The treatment choices of diagnosed consumers and
treating physicians have been shown to be influenced by certain
characteristics, such as the drug's perceived impact on quality of
life, complexity of dosage regimens, mode of administration, cost to
family and self, and marketing claims unrelated to medicinal properties
(Refs. 1 to 5). Although diagnosed consumers may weigh the risks,
benefits, or other salient characteristics of prescription drug
products differently than physicians, little research directly compares
the treatment preferences of these two groups (Ref. 6). Understanding
the tradeoffs among drug product characteristics diagnosed consumers
make--and how the tradeoffs could potentially differ from the tradeoffs
made by physicians--will provide valuable insight into the relevance
and impact of various product attributes and promotional claims on
informed choices and treatment decisions.
    We intend to examine these tradeoffs using a choice-based conjoint
analysis, also known as a discrete choice experiment. Conjoint analysis
is a broad class of survey-based techniques used to estimate how
attractive or influential different features of choice options or
product attributes are in determining purchase behavior or treatment
choices (Ref. 7). Conjoint analysis can be used to examine the joint
effects and tradeoffs of multiple variables or product attributes on
decisions. A choice-based conjoint analysis is based on the principle
that products are composed of a set of attributes, and each attribute
can be described using a finite number of levels. In the proposed
research, participants will be shown a carefully designed sequence of
choice tasks containing up to five hypothetical product attributes--in
this case, profiles describing fictitious prescription drug products
for either type 2 diabetes or psoriasis. Using data from the choices
that participants make across these tasks, we can use statistical
techniques to draw inferences about the relative value they place on
different product attributes, estimate the relative importance of
different attributes, explore the tradeoffs that consumers and
physicians are willing to make to avoid or accept specific attribute
levels, and compare the preferences of these two groups (Ref. 8).
    We estimate that participation in the study will take approximately
20 minutes. Adult participants aged 18 years or older will be recruited
by email through an internet panel, and participant eligibility will be
determined with a screener at the beginning of the online survey. The
consumer sample will consist of adults who self-report as having been
diagnosed by a healthcare provider with either psoriasis or type 2
diabetes. For the consumer sample, we will exclude

individuals who work in healthcare settings because their knowledge and
experiences may not reflect those of the average consumer. The
physician sample will consist of primary care physicians and
specialists who report treating patients with psoriasis or type 2
diabetes. For the physician sample, we will exclude individuals who
spend less than 50 percent of their time on direct patient care.
Department of Health and Human Services employees and individuals who
work in the marketing, advertising, or pharmaceutical industries will
be excluded from both respondent groups. Respondents will receive a
survey invitation with a unique password-protected link. All panel
members are recruited following a double opt-in process. Sample sizes
were estimated by combining approaches for conjoint analysis suggested
by Orme (Ref. 9) and Johnson et al. (Ref. 10).
    The target sample size for the main study is 800 physicians and 800
consumers, with half of each cohort focusing on treatments for
psoriasis and the other half focusing on treatments for type 2
diabetes. Prior to conducting the main study, we will conduct at least
one pretest. If the first pretest reveals that changes to the
measurement instruments, stimuli, or procedures are required, a second
pretest will be conducted with revised materials. The target sample
size for each wave of pretests is 60 physicians and 60 consumers.
    In the Federal Register of April 25, 2022 (87 FR 24313), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two submissions (https://www.regulations.gov
tracking numbers l3s-66ri-uyh2 and l2z-6w2l-mpk1) were outside the
scope of the research and are not addressed further.
    FDA received eight comments that were PRA-related. Within those
submissions, FDA received multiple comments that the Agency has
addressed. For brevity, some public comments are paraphrased and
therefore may not state the exact language used by the commenter. We
assure the commenter that the entirety of their comments was considered
even if not fully captured by our paraphrasing in this document.
Comments and responses are numbered here for organizational purposes
only.
    (Comment 1) Five comments expressed support for the study.
    (Response 1) We acknowledge and appreciate the support of this
study.
    (Comment 2) One comment stated the collection of information is not
necessary for the proper performance of FDA functions and questioned
the practical utility of the study. Another comment asked for
clarification about how the results would be applied to OPDP decision
making. The first of these comments suggests that an alternate approach
would be to dedicate resources to enforcing heavier penalties for
misleading, incomplete, or false information.
    (Response 2) The OPDP's mission is to protect the public health by
helping to ensure that prescription drug promotion is truthful,
balanced, and accurately communicated. Understanding the tradeoffs
among drug product characteristics diagnosed consumers make--and how
the tradeoffs could potentially differ from the tradeoffs made by
physicians--will provide OPDP valuable insight into the relevance and
impact of various product attributes and promotional claims on informed
choices and treatment decisions. Gaining a better understanding of what
information has the most meaning and impact for audiences informs
OPDP's approach to ensuring that promotional communications are
truthful, balanced, and accurately communicated.
    (Comment 3) One comment expressed concern that results of the study
possibly could inform potential guidance on patient-focused drug
development.
    (Response 3) The purpose of this research is to examine the
tradeoffs that consumers and physicians make when considering product
claims that may appear in promotional communications. The fact that FDA
is conducting research does not create any requirements.
    (Comment 4) One comment asked how adherence and patient preference
claims would be included in drug product information, as the commenter
does not believe there is currently a patient preference claim or
adherence data in FDA-approved prescription drug information for any
product in either of the two conditions proposed in this study.
    (Response 4) Prescription drug promotion often includes information
beyond what is contained in the FDA-approved prescription information
for the product. The attributes that make up the ``additional
information about the drug'' are example marketing claims that have
been used in product promotion. We will test reasonable scenarios based
on realistic examples.
    (Comment 5) One comment suggested clarification of the sentence,
``The treatment preferences of diagnosed consumers and treating
physicians have been shown to be influenced by certain characteristics,
such as the drug's perceived impact on quality of life, complexity of
dosage regimens, mode of administration, cost to family and self, and
marketing claims unrelated to medicinal properties (Refs. 1 to 5)'' (87
FR 24313 at 24315). The comment asserts that it is inaccurate to state
that ``preferences'' are influenced by the characteristics of
alternatives, when it is actually ``choice'' that is a reflection of
the characteristics or attributes.
    (Response 5) We have revised the sentence in question, as
suggested, to make it clear that treatment choices are influenced by
these example characteristics. The revised sentence reads, ``The
treatment choices of diagnosed consumers and treating physicians have
been shown to be influenced by certain characteristics, such as the
drug's perceived impact on quality of life, complexity of dosage
regimens, mode of administration, cost to family and self, and
marketing claims unrelated to medicinal properties.''
    (Comment 6) Two comments asked for clarification on the guidelines
that will be used to determine the attributes and levels in the
experiment.
    (Response 6) We selected attributes and attribute levels based on
information gathered through: (1) a systematic literature review of
preference elicitation studies targeted toward prescription
pharmacological treatments for psoriasis or type 2 diabetes among
diagnosed consumers or healthcare providers (HCPs) reported in peer-
reviewed journal articles or book chapters published in English through
the end of September 2020 and (2) semistructured, one-on-one interviews
with physicians and diagnosed consumers conducted as part of the
formative work for this project.
    The systematic literature review focused on research examining
preferences for attributes and characteristics of prescription drug
products indicated for psoriasis and type 2 diabetes. The review
addressed two research questions with an emphasis on informing our
choice of elicitation method for the main study and identifying
characteristics of prescription drug products relating to risk, burden,
adherence, and benefits that physicians and consumers who have been
diagnosed with the target medical conditions consider when choosing
among treatment options. After screening candidate articles against our
eligibility criteria, we retained and extracted information from 30
articles related to psoriasis and 28 articles for type 2 diabetes that
informed our choice of attributes and levels. Our aim with the one-on-
one interviews was

to better understand how physicians and diagnosed consumers navigate
decision making related to prescription drug products and to verify
that attributes identified through the systematic literature review
corresponded with the characteristics that physicians and consumers
care about when making prescription drug choices. In all, we conducted
35 interviews with physicians who treat psoriasis or type 2 diabetes
and 70 interviews with consumers who self-reported that they have been
diagnosed with one of the two chronic conditions (n = 35 per
condition). We asked specific questions about attributes and attribute
levels found in the literature review. We also used the interviews to
elicit additional characteristics that may not have been represented in
the literature.
    (Comment 7) One comment suggests use of an opt-out (i.e., decline
therapy) or status quo (i.e., no change) option in the questionnaires.
    (Response 7) There can be benefits to including an ``opt-out'' or
``status quo'' option in choice experiments, depending on the goals of
the research. For example, if one is interested in estimating treatment
uptake, the inclusion of an ``opt-out'' option may be helpful. However,
estimating treatment uptake is not a goal of this study, and we believe
the limitations of including an ``opt-out'' or ``status quo'' option
outweigh the benefits in this instance. One limitation is the potential
for satisficing--participants choosing the ``opt-out'' or ``status
quo'' option because it requires less effort than reflecting on the
option that best aligns with their preferences (Ref. 11). Additionally,
in the context of this study, the status quo will differ among
participants, raising the issue of how to interpret findings from
diagnosed consumers who choose that option.
    (Comment 8) Two comments question the decision to employ a discrete
choice experiment (DCE) method and the number of attributes chosen,
with one comment noting that there are other methods that may allow for
a higher number of attributes to be tested. One of the comments noted
the existence of other DCE studies conducted in similar treatment
populations and requested clarification about how this study would
differ from prior research.
    (Response 8) One of the goals of the systematic literature review
we conducted as part of the formative work for this study was to
examine methods that have been used to elicit consumer or HCP
preferences regarding treatment options for psoriasis and type 2
diabetes. An overarching observation from the systematic literature
review is that there is a gap in the literature for studies that
directly compare treatment preferences of diagnosed consumers and HCPs.
There is also a lack of studies that examine the relative importance of
marketing claims versus other types of promotional claims. This study
will help fill these gaps. A DCE was the most common methodology used
in prior research, and it has clear advantages over other methods for
the purposes of the proposed study. Perhaps the most relevant benefits
of the method are the flexibility to efficiently estimate the overall
utility of different treatment profiles, the relative importance of
attributes, and the preference weights for specific attribute levels
all within the same design (see Ref. 12 for an analysis that covers all
three of these aspects). Moreover, tradeoffs that diagnosed consumers
and HCPs are willing to make between attributes can be estimated from
DCE data by calculating the marginal rate of substitution or the ratio
of relative importance scores for pairs of attributes (Refs. 12 to 15).
    In designing the DCE for this project, we aim to conduct subgroup
analyses comparing these research populations. Generally, this requires
using the same attributes and levels for both research populations,
though some degree of latitude is required to tailor the wording of
background information, questions, and stimuli to match the target
audience (e.g., plain language for consumers, medical terminology when
appropriate for HCPs).
    For planning purposes and in order to establish target sample
sizes, in the 60-day Federal Register notice for this study, we assumed
a design with 5 attributes, 2 to 4 levels per attribute, 10 choice
tasks per participant, and 2 options per task square. Our review
revealed that these assumptions are well within the median design
parameters used in prior studies.
    We will include methodological details concerning the experimental
design in the report of results. Finally, while the comment did not
identify any specific ongoing research as overlapping, we note that in
general, in any event, OPDP may conduct concurrent or overlapping
studies on similar topics.
    (Comment 9) One comment suggested use of an efficient design,
including blocking, as a way to minimize the burden of collection on
respondents.
    (Response 9) We intend to use an efficient design to reduce the
number of choice tasks and have noted it as a burden reduction strategy
in the information collection submission to OMB.
    (Comment 10) One comment asserted that internet panels are prone to
selection bias and suggested the study address this potential
limitation.
    (Response 10) Participants in the proposed studies will be
convenience samples rather than probability-based samples of diagnosed
consumers and physicians. The strength of the experimental design used
in this study lies in its internal validity, on which meaningful
estimates of differences across manipulated attributes can be produced
and generalized. This is a counterpoint to observational survey
methodologies, where estimating population parameters is the primary
focus of statistical analysis. The recruitment procedures in this study
are not intended to meet criteria used in survey sampling, where each
unit in the sampling frame has an equal probability of being selected
to participate. In a representative, observational survey study,
response rates are often used as a proxy measure for survey quality,
with lower response rates indicating poorer quality. Nonresponse bias
analysis is also commonly used to determine the potential for
nonresponse sampling error in survey estimates. However, concerns about
sampling error do not generally apply to experimental designs, where
the parameters of interest are under the control of the researcher--
rather than being pre-established characteristics of the participants.
Participants will be recruited through online panels, which include a
diverse range of participants in regard to age, race/ethnicity, income,
education, and employment. We also have proposed the use of soft quotas
to further ensure that we will recruit a diverse sample. See Response
12 for a more detailed description of the panels to be used in this
research.
    (Comment 11) Two comments questioned the Agency's methods for
ensuring it is selecting patients as study participants.
    (Response 11) Our eligibility criteria involve a self-reported
diagnosis of plaque psoriasis or type 2 diabetes, which appropriately
reflects the audience for DTC promotion where a verified diagnosis is
not a criterion. The screener includes a question (screening question 5
(S5)) that asks whether a doctor, nurse, or other health professional
has ever told the respondent they had at least one of seven health
conditions. Participants who do not select plaque psoriasis or type 2
diabetes will be flagged as ineligible for the study. The other
conditions are included as response

options to help disguise eligibility criteria from respondents as they
complete the screener.
    (Comment 12) One comment stated it is unclear how physicians will
be recruited, and one comment asserted that how consumers will be
identified is not mentioned.
    (Response 12) For the pretests and main study, participants will be
drawn from participant panels managed by Dynata. Dynata recruits panel
members through a combination of email and online marketing and by
invitation, with over 300 diverse online and offline affiliate partners
and targeted website advertising. By using multiple recruitment
methods, Dynata is able to recruit a diverse set of consumers and
decision makers to participate in their panels and will ensure
demographic diversity of participants' genders, ages, and education
levels. Panel inclusion is by invitation only, and Dynata invites only
pre-validated individuals with known characteristics to participate in
the consumer panels. The physician sample for the pretest and main
study will be drawn from Dynata's Healthcare Panel, which is a
physician panel used exclusively for healthcare research. Dynata's
Healthcare Panel uses a multimode approach that combines email, fax,
and direct mail to recruit HCPs to participate in online surveys.
Additionally, Dynata purchases professional association and
governmental databases to verify an HCP's practicing status. These
verification resources include the Drug Enforcement Agency number
(DEA#) and the American Medical Association Medical Education Number
(ME#).
    (Comment 13) One comment suggested that the samples should be
prepared for heterogeneity of preference.
    (Response 13) We agree that our modeling approach is to account for
potential preference heterogeneity. At the design phase, we are
intentionally setting up the study to allow us to compare preference
weights between diagnosed consumers and physicians within each health
condition. Additionally, we intend to analyze the data using several
modeling approaches with other sources of preference heterogeneity in
mind.
    (Comment 14) One comment suggested the study collect respondents'
demographic information, including race/ethnicity, income, geographical
region, educational attainment, and healthcare system experiences,
particularly negative experiences with an HCP due to their race; two
comments suggested the study collect additional data on participants'
baseline HbA1c status.
    (Response 14) We will measure several demographic variables about
respondents, including race/ethnicity, educational attainment, gender,
age, geographical location, health literacy, and numeracy. We will also
collect information about time since diagnosis, perceived severity of
their health condition, and experience/familiarity with prescription
drugs to treat the condition. Based on prior experience, we expect
these variables to have a direct or indirect effect on our measures.
See also Response 13 regarding preference heterogeneity (i.e., the
extent to which tastes and preferences vary across participants and/or
groups). We are avoiding requesting potentially sensitive personal
information from respondents. Although we agree that information about
consumers' A1C status could be useful for explaining preference
heterogeneity that we may observe, collecting data at that level of
personal detail is not warranted given the goals of the research.
Instead, we have included a less intrusive perceived severity measure.
    (Comment 15) One comment requested clarification of the rationale
for determining the study's sample size (800 consumers and 800
physicians). Another comment questioned whether the sample size per
demographic may be insufficient to understand how these conditions
affect different populations.
    (Response 15) The proposed sample size in the two main studies is n
= 400 participants for each subgroup of interest (diagnosed consumers
and physicians), for a total combined N = 1600. For our power
estimates, we assumed an experimental design with no less than 5
conjoint questions per participant (t = 5), 2 alternatives per question
(a = 2), and 4 levels per attribute (c = 4). This implies a sample of
400 participants per subgroup per study.
    (Comment 16) One comment asked that a Spanish-language version of
the survey be included to ensure that the experiences of this
population are included.
    (Response 16) We are limiting the survey to the English language,
as the majority of advertising for these products is disseminated in
English at this time.
    (Comment 17) One comment encouraged FDA to broadly and
systematically disseminate all final results of completed research
related to this topic.
    (Response 17) The Agency anticipates disseminating the results of
the study after the final analyses of the data are completed, reviewed,
and cleared. The exact timing and nature of any such dissemination has
not been determined but may include presentations at trade and academic
conferences, publications, articles, and posting on FDA's website.
    (Comment 18) One comment asserted that access to the choice tasks
and proposed questions, including content-specific language and terms,
would allow a more substantive review of the proposed research.
    (Response 18) Our questionnaires were made available during the
public comment process. Our full stimuli are under development during
the PRA process. We do not make draft stimuli public during this time
because of concerns that this may contaminate our participant pool and
compromise our research. In our research proposals, we describe the
purpose of the study, the design, the population of interest, and the
estimated burden.
    (Comment 19) One comment suggested considering adding a ``don't
know'' response option throughout the questionnaire, where appropriate.
    (Response 19) We understand the value of providing such responses
for items of a factual nature. The drawback to providing such response
options to these questions, however, is that we may lose information by
allowing respondents to choose an easy response instead of giving the
item some thought. Research has demonstrated that providing ``no
opinion'' options likely results in the loss of data without any
corresponding increase in the quality of the data. Thus, we prefer not
to add these options to the survey.
    (Comment 20) One comment suggested revising S5 to read ``are you
currently being treated for the following conditions . . .''
    (Response 20) The current wording of S5 is consistent with the
eligibility criterion that consumers self-identify as having been
diagnosed with plaque psoriasis or type 2 diabetes. We will maintain
this wording.
    (Comment 21) One comment noted that it is unclear what method will
be used to achieve the literacy goal of screening question 11.
    (Response 21) The programming note for question S11 indicates that
participants would count toward the low health literacy quota if the
numeral value assigned to their response is greater than or equal to 3,
where 3 = ``Sometimes,'' 4 = ``Often,'' and 5 = ``Always.''
    (Comment 22) Two comments expressed confusion about whether
question A2 is measuring severity from the patient's or physician's
perspective

and recommended clarifying the question or replacing it.
    (Response 22) We have revised question A2, as suggested, to clarify
that we are asking about the perceived severity of the condition from
the participant's perspective.
    (Comment 23) One comment recommended rephrasing question A6 to
specify ``forms'' rather than ``types'' and to clarify the difference
between a prefilled pen and a syringe (diabetes questionnaire).
    (Response 23) We have reworded question A6, replacing the term
``types'' with ``forms.'' In the one-on-one interviews, none of the
participants expressed confusion about the two terms.
    (Comment 24) One comment recommended revising the patient profile
in the physician survey to reflect that most patients are diagnosed
with type 2 diabetes in their 50s or 60s.
    (Response 24) We appreciate your recommendations concerning the
realism of the patient profile. In consultation with a medical advisor,
we have maintained the patient profile age of 57 years but have changed
the diabetes duration in the patient profile from 14 years to 4 years
to reflect more standard disease state information.
    (Comment 25) One comment suggested adding context to the diabetes
questionnaire instructions to reduce ambiguity and facilitate
comparisons between the physician and consumer surveys. Specifically,
the comment suggests adding more information to the consumer survey
about the baseline and changed A1C levels in the introduction (Section
B).
    (Response 25) Section B introduces each attribute that will be
varied in the DCE. The language in the Section B introduction in the
physician and consumer questionnaires is tailored to the audience but
has the same information about the A1C goal and point reductions that
will be examined in the study, which will facilitate comparisons
between the two samples. Section C provides the patient profile that
will be used as the basis for the DCE. For physicians, the profile is
for a hypothetical patient. For consumers, the instructions ask the
participant to imagine their doctor recommends they try a prescription
drug to help lower their A1C. The change in A1C levels used in the
choice tasks for both consumers and physicians includes examples that
are anchored to an A1C of 8.5.
    (Comment 26) One comment suggested adding itch (pruritis) as an
attribute.
    (Response 26) In choosing and defining product attributes to
include in the study, we selected characteristics based on evidence
that they will impact choice. Itch relief didn't feature prominently in
the results of our literature review or in the one-on-one interviews
with consumers or physicians. In comparison, effectiveness at achieving
skin clearance was an attribute in every DCE study included in our
literature review, had the greatest relative importance in many of
those studies, and was mentioned as an important consideration in open-
ended comments and ranked among the three most important
characteristics by most participants in our one-on-one interviews.
    (Comment 27) One comment recommended adding more description, using
both simple text and simple graphics, to the ``serious side effects''
to depict the chance of experiencing a serious side effect, and it
recommended adding definitions for the additional attributes.
    (Response 27) Rare but serious adverse reactions/side effects will
be presented to participants as a single attribute but may be treated
as a set of dichotomous attributes for study design and analysis
purposes (e.g., each side effect will be either present or absent in a
profile). Varying more than one factor at a time within an attribute
makes it difficult to distinguish the effect of each factor separately.
    The ``additional information'' attributes are essentially marketing
claims; however, we have labeled the attribute ``additional information
about the drug'' to avoid eliciting reactance from participants in
response to the term ``marketing.'' Marketing claims are not typically
presented with definitions, so we do not provide definitions for the
levels of this attribute.
    (Comment 28) One comment suggested replacing ``adherence'' with
``usage'' in the consumer questionnaires and standardizing preference
description across the patient and physician questionnaires.
    (Response 28) We will assess participant comprehension of the term
``adherence'' during cognitive interviews, and we can make changes, if
indicated.
    Descriptions of the preference attribute are the same in the
physician and consumer questionnaires within each health condition. The
attributes for each health condition are designed to be relevant to
that particular health condition. We do not intend to make formal
comparisons between health conditions.
    (Comment 29) One comment suggested revising questions B1 to B5 from
``how important is it'' to instead obtain information about prior
experience with each attribute.
    (Response 29) The purpose of questions B1 to B5 is to collect self-
report ratings of how important each attribute is to participants,
which we may use to validate the relative importance scores derived
from the DCE. We derived these questions from similar questions
included in Janssen et al. (Ref. 17), a study that was conducted to
illustrate how DCE could be conducted when following International
Society for Pharmacoeconomics and Outcomes Research (ISPOR)
recommendations for good research practices.
    (Comment 30) One comment asserted that most current diabetes drugs
are not associated with heart disease and suggested removing that
attribute and adding questions related to weight loss and potential
cardiovascular benefits.
    (Response 30) We agree that cardiovascular mortality is not an
adverse reaction associated with most diabetes drugs; however, there is
evidence of increased risk of cardiovascular mortality for some oral
antidiabetic agents (e.g., sulfonylureas, thiazolidinediones, and
dipeptidyl peptidase 4 inhibitors (Refs. 18 and 19); we are not
examining use of insulin in this study). Our approach with the serious
adverse reactions/side effects attribute is to present a range of
category-appropriate adverse reactions that differ greatly in terms of
severity. The reasoning is similar to that behind manipulating extremes
in an experimental study in order to increase variance, even if the
resulting attributes do not reflect what is typical for the category.
    (Comment 31) One comment asserted that the planned data analysis
and how data between consumers and physicians would be compared is
unclear.
    (Response 31) We will use a variety of statistical techniques to
analyze the data, adapting our modeling approach to the specific
research questions and observed characteristics of the data. A variety
of modeling approaches can be used to estimate preference weights in
choice-based conjoint studies (Ref. 14)--including conditional logit,
mixed logit, Bayesian latent utility, and latent class conditional
logistic regression models. The results of the statistical analysis
will be used to: (1) identify which attributes of prescription drug
products diagnosed consumers and physicians value most, (2) calculate
the relative importance of attributes, (3) identify differences in
preferences between the

two subgroups (e.g., by including interaction terms in the model), and
(4) determine how participants make tradeoffs among attributes to make
treatment choices. We intend to examine responses within medical
conditions. Where commonalities in survey questions exist, we may
compare the consumer and physician responses. Details of our research
questions are included as part of the information collection submission
to OMB.
    (Comment 32) One comment suggested that physicians review the
patient survey during pretesting to ensure that the physician and
patient surveys are aligned.
    (Response 32) Although some wording may differ between the
physician and consumer questionnaires to reflect the knowledge and
expertise of each sample, we have endeavored to ensure that the
concepts are equally represented in the questionnaires across samples.
Additionally, we have solicited peer review feedback on the
questionnaires from experts in the field. We will also conduct
cognitive interviews and pretests to help identify areas where the
materials are ambiguous or confusing for participants and make any
necessary refinements.
    (Comment 33) Three comments had questions about the purpose of the
pretesting and the accuracy of the burden estimation for the
pretesting, and one comment stated that the burden estimate seemed
reasonable.
    (Response 33) We will conduct both cognitive interviews and
pretests. The burden chart reflects both the cognitive interviews and
the pretesting. Qualitative, one-on-one cognitive testing will be used
to help identify areas where the materials would benefit from
refinements. Additionally, up to two rounds of quantitative pretesting
per study will be employed to evaluate the procedures and measures used
in the main study. We will balance various factors that affect study
completion time and limit the questionnaire to a mean of 20 minutes or
less.
    The way attribute levels are combined to form hypothetical choice
options in a choice-based conjoint analysis, or DCE, are determined by
the study's experimental design. Although the number of possible
combinations is often too large for each participant to evaluate them
all, we will generate a statistically efficient design that reduces the
number of choice tasks participants must complete while maintaining
sufficient balance and orthogonality for reliable parameter estimation.
    (Comment 34) One comment referred to an abstract describing a DCE
examining patients' preferences for newer second-line antihyperglycemic
agents.
    (Response 34) We appreciate bringing the abstract to our attention.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual        Average burden per response \1\         Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interview Screener, Consumers......             150               1             150  0.08 (5 min).............................              12
Cognitive Interviews, Consumers..............               9               1               9  1........................................               9
Pretest 1 Screener, Physicians \2\...........              95               1              95  0.08 (5 min).............................               8
Pretest 1 Screener, Consumers \3\............              95               1              95  0.08 (5 min).............................               8
Physician Pretest 1..........................              66               1              66  0.33 (20 min)............................              22
Consumer Pretest 1...........................              66               1              66  0.33 (20 min)............................              22
Pretest 2 Screener, Physicians \2\ \3\.......              95               1              95  0.08 (5 min).............................               8
Pretest 2 Screener, Consumers \2\ \3\........              95               1              95  0.08 (5 min).............................               8
Physician Pretest 2 \2\......................              66               1              66  0.33 (20 min)............................              22
Consumer Pretest 2 \2\.......................              66               1              66  0.33 (20 min)............................              22
Physician Main Study Screener \2\............           1,258               1           1,258  0.08 (5 min).............................             101
Physician Main Study.........................             880               1             880  0.33 (20 min)............................             290
Consumer Main Study Screener \2\.............           1,258               1           1,258  0.08 (5 min).............................             101
Consumer Main Study..........................             880               1             880  0.33 (20 min)............................             290
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............           5,079  .........................................             923
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\2\ Number of screener respondents assumes a 70 percent eligibility rate with targeted recruitment.
\3\ Pretest 2 will be conducted only if changes to study materials are made in response to the findings of Pretest 1.

    As with most online and mail surveys, it is always possible that
some participants will be in the process of completing the survey when
the target number is reached and that those surveys will be completed
and received before the survey is closed out. To account for this, we
have estimated approximately 10 percent overage for both samples in the
pretest and main study.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Aikin, K.J., K.R. Betts, K.S. Ziemer, et al. (2019). ``Consumer
Tradeoff of Advertising Claim Versus Efficacy Information in Direct-
to-Consumer Prescription Drug Ads.'' Research in Social and
Administrative Pharmacy, 15(12), 1484-1488. https://doi.org/10.1016/j.sapharm.2019.01.012.
* 2. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, et al. (2017).
``Conjoint Analysis to Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying Therapy Attributes in
Spain: A Cross-Sectional Observational Study.'' BMJ Open, 7(3),
e014433. https://doi.org/10.1136/bmjopen-2016-014433.
3. Fraenkel, L., L. Suter, C.E. Cunningham, et al. (2014).
``Understanding Preferences for Disease-Modifying Drugs in
Osteoarthritis.'' Arthritis Care & Research, 66(8), 1186-1192.
https://

pubmed.ncbi.nlm.nih.gov/24470354.
4. Katz, D.A., C. Hamlin, M.W. Vander Weg, et al. (2020).
``Veterans' Preferences for Tobacco Treatment in Primary Care: A
Discrete Choice Experiment.'' Patient Education and Counseling,
103(3), 652-660. https://doi.org/10.1016/j.pec.2019.10.002.
5. Wouters, H., G.A. Maatman, L. Van Dijk, et al. (2013). ``Trade-
Off Preferences Regarding Adjuvant Endocrine Therapy Among Women
With Estrogen Receptor-Positive Breast Cancer.'' Annals of Oncology,
24(9), 2324-2329. https://doi.org/10.1093/annonc/mdt195.
6. Gregorian, R.S., A. Gasik, W.J. Kwong, et al. (2010).
``Importance of Side Effects in Opioid Treatment: A Trade-Off
Analysis With Patients and Physicians.'' The Journal of Pain,
11(11), 1095-1108. https://doi.org/10.1016/j.jpain.2010.02.007.
7. Johnson, FR, E. Lancsar, D. Marshall, et al. (2013).
``Constructing Experimental Designs for Discrete-Choice Experiments:
Report of the ISPOR Conjoint Analysis Experimental Design Good
Research Practices Task Force.'' Value in Health, 16(1), 3-13.
https://doi.org/10.1016/j.jval.2012.08.2223.
8. Bridges, J.F.P., A.B. Hauber, D. Marshall, et al. (2011).
``Conjoint Analysis Applications in Health--A Checklist: A Report of
the ISPOR Good Research Practices for Conjoint Analysis Task
Force.'' Value in Health, 14(4), 403-413. https://doi.org/10.1016/j.jval.2010.11.013.
9. Orme, B. (2019). Getting Started With Conjoint Analysis:
Strategies for Product Design and Pricing Research (Fourth ed.).
Madison, WI: Research Publishers LLC.
10. Johnson, FR, B. Kanninen, M. Bingham, et al. (2006).
``Experimental Design for Stated-Choice Studies.'' In: Valuing
Environmental Amenities Using Stated Choice Studies (pp. 159-202).
B.J. Kanninen (Ed.). Dordrecht: Springer.
11. Campbell, D. and S. Erdem (2019). ``Including Opt-Out Options in
Discrete Choice Experiments: Issues to Consider,'' The Patient--
Patient-Centered Outcomes Research, 12, 1-14. https://doi.org/10.1007/s40271-018-0324-6.
12. Feldman, S.R., S.A. Regnier, A. Chirilov, et al. (2019).
``Patient-Reported Outcomes Are Important Elements of Psoriasis
Treatment Decision Making: A Discrete Choice Experiment Survey of
Dermatologists in the United States.'' Journal of the American
Academy of Dermatology, 80, 1650-1657. https://doi.org/10.1016/j.jaad.2019.01.039.
13. Hauber, A.B., J.M. Gonz[aacute]lez, B. Schenkel,et al. (2011).
``The Value to Patients of Reducing Lesion Severity in Plaque
Psoriasis.'' Journal of Dermatological Treatment, 22, 266-275.
https://doi.org/10.3109/09546634.2011.588193.
14. Hauber, A.B., J.M. Gonz[aacute]lez, C.G.M. Groothuis-Oudshoom,
et al. (2016). ``Statistical Methods for the Analysis of Discrete
Choice Experiments: A Report of the ISPOR Conjoint Analysis Good
Research Practices Task Force.'' Value in Health, 19, 300-315.
https://doi.org/10.1016/j.jval.2016.04.004.
15. Seston, E.M., D.M. Ashcroft, and C.E.M. Griffiths (2007).
``Balancing the Benefits and Risks of Drug Treatment.'' Archives of
Dermatology, 143, 1175-1179. https://doi.org/10.1001/archderm.143.9.1175.
16. Yang J., FR Johnson, V. Kilambi, et al. (2015). ``Sample Size
and Utility-Difference Precision in Discrete-Choice Experiments: A
Meta-Simulation Approach.'' Journal of Choice Modeling, 16, 50-57.
17. Janssen, E.M., A.B. Hauber, and J.F. Bridges (2018).
``Conducting a Discrete-Choice Experiment Study Following
Recommendations for Good Research Practices: An Application for
Eliciting Patient Preferences for Diabetes Treatments.'' Value in
Health, 21(1), 59-68.
18. Cavaiola, T.S. and J. Pettus (2017). ``Management of Type 2
Diabetes: Selecting Amongst Available Pharmacological Agents.'' In:
Endotext [internet]. K.R. Feingold, B. Anawalt, A. Boyce, et al.
(Eds.). South Dartmouth, MA: MDText.com, Inc. https://www.ncbi.nlm.nih.gov/books/NBK425702.
* 19. Sanofi (2018). Amaryl (sulfonylurea): Full prescribing
information, https://products.sanofi.us/amaryl/amaryl.pdf.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09183 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Proposed Rules]
[Pages 67313-67319]
[FR Doc No: 2012-27209]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1926

[Docket ID-OSHA-2012-0025]
RIN 1218-AC75

Revising the Exemption for Digger Derricks in the Cranes and
Derricks in Construction Standard

AGENCY: Occupational Safety and Health Administration (OSHA); Labor.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: OSHA is broadening the exemption for digger derricks in its
standard for cranes and derricks. OSHA issued a final standard updating
the requirements for cranes and derricks on August 9, 2010, and the
Edison Electric Institute (EEI) petitioned for review of the standard
in the United States Court of Appeals. After petitioning, EEI provided
OSHA with new information regarding digger derricks. OSHA reviewed the
additional information and the rulemaking record, and decided to
broaden the exemption for digger derricks used in the electric-utility
industry by means of this proposed rule.

DATES: Comment by December 10, 2012. All submissions, whether
transmitted, mailed, or delivered, must bear a postmark or provide
other evidence of the submission date.

ADDRESSES: Submit comments (including comments to the information-
collection (paperwork) determination described under the section titled
AGENCY DETERMINATIONS), hearing requests, and other information and
materials, identified by Docket No. OSHA-2012-0025, by any of the
following methods:
    Electronically: Submit comments and attachments electronically at
http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for submitting comments.
    Facsimile: OSHA allows facsimile transmission of comments that are
10 pages or fewer in length (including attachments). Fax these
documents to the OSHA Docket Office at<PHONE_NUMBER>; OSHA does not
require hard copies of these documents. Instead of transmitting
facsimile copies of attachments that supplement these documents (e.g.,
studies, journal articles), commenters must submit these attachments to
the OSHA Docket Office, Technical Data Center, Room N-2625, OSHA, U.S.
Department of Labor, 200 Constitution Ave., NW., Washington, DC 20210.
These attachments must clearly identify the sender's name, the date,
and the docket number (OSHA-2012-0025), so that the Docket Office can
attach them to the appropriate document.
    Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments and any additional information or material to
the OSHA Docket Office, Docket No. OSHA-2012-0025 or RIN No. 1218-AC75,
Technical Data Center, Room N-2625, OSHA, U.S. Department of Labor, 200
Constitution Ave., NW., Washington, DC 20210; telephone: (202) 693-
2350. (OSHA's TTY number is<PHONE_NUMBER>.) Contact the OSHA Docket
Office for information about security procedures concerning delivery of
materials by express mail, hand delivery, and messenger service. The
Docket Office will accept deliveries (express mail, hand delivery, and
messenger service) during the Docket Office's normal business hours,
8:15 a.m. to 4:45 p.m. ET.
    Docket: To read or download comments or other information or
material in the docket, go to http://www.regulations.gov or to the OSHA
Docket Office at the address above. Documents in the docket are listed
in the http://www.regulations.gov index; however, some information
(e.g., copyrighted material) is not available publicly to read or
download through this Web site. All submissions, including copyrighted
material, are available for inspection at the OSHA Docket Office.
Contact the OSHA Docket Office for assistance in locating docket
submissions.

FOR FURTHER INFORMATION CONTACT: General information and press
inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    Technical inquiries: Mr. Garvin Branch, Directorate of
Construction, Room N-3468, OSHA, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-
2020; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For copies of this Federal Register notice, news releases, and
other relevant document: Electronic copies of these documents are
available at OSHA's Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Request for Comment
II. Direct Final Rulemaking
III. Discussion of the Digger-Derrick Exemption in 29 CFR 1926,
Subpart CC
    A. Background
    B. Changes to the Text of the Exemption in 29 CFR
1926.1400(c)(4)
    C. Discussion of Conforming Revisions to 29 CFR 1926, Subpart V
(Power Transmission and Distribution)
IV. Agency Determinations
    A. Significant Risk
    B. Final Economic Analysis and Final Regulatory Flexibility
Analysis
    C. Technological Feasibility
    D. Paperwork Reduction Act of 1995
    E. Federalism
    F. State Plan States
    G. Unfunded Mandates Reform Act
    H. Consultation and Coordination With Indian Tribal Governments
List of Subjects in 29 CFR Part 1926
Authority and Signature
Amendments to Standards

I. Request for Comment

    OSHA requests comments on all issues related to this proposed rule,
including economic, paperwork, or other regulatory impacts of this rule
on the regulated community. If OSHA receives no significant adverse
comment to either this proposal or the direct final rule, OSHA will
publish a Federal Register document confirming the effective date of
the direct final rule and withdrawing this companion proposed rule
published in the ``Proposed Rules'' section of today's Federal
Register. Such confirmation may include minor stylistic or technical
changes to the document. For the purpose of judicial review, OSHA views
the date of confirmation of the effective date of this direct final
rule as the date of promulgation.

II. Direct Final Rulemaking

    In direct final rulemaking, an agency publishes a direct final rule
in the Federal Register with a statement that the rule will go into
effect unless the agency receives significant adverse comment within a
specified period. The agency may publish an identical proposed rule at
the same time. If the agency receives no significant adverse comment in
response to the direct final rule, the rule goes into effect. OSHA
typically confirms the effective date of a direct final rule through a
separate Federal Register notice. If the agency receives a significant
adverse comment, the agency withdraws the direct final rule and treats
such comment as a

response to the proposed rule. An agency typically uses direct final
rulemaking when an agency anticipates that a rule will not be
controversial.
    For purposes of this proposed rule and the companion direct final
rule, a significant adverse comment is one that explains why the
amendments to OSHA's digger-derrick exemption would be inappropriate.
In determining whether a comment necessitates withdrawal of the direct
final rule, OSHA will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-
comment process. OSHA will not consider a comment recommending an
additional amendment to be a significant adverse comment unless the
comment states why the direct final rule would be ineffective without
the addition. Furthermore, OSHA will not consider a comment requesting
any narrowing of the existing digger-derrick exemption to be a
significant adverse comment because narrowing the existing exemption is
beyond the scope of this rulemaking. Moreover, a comment requesting an
expansion of the exemption to encompass activities not related to
digger-derrick use by electric utilities also would be beyond the scope
of this rulemaking, and OSHA will not consider such a comment to be a
significant adverse comment unless the commenter explains why the
provisions of the direct final rule, as these provisions apply to
digger derricks, would be ineffective without the expansion.
    In addition to publishing this proposed rule, OSHA is publishing a
companion direct final rule in the ``Final Rules'' section of today's
Federal Register. The comment period for this proposed rule runs
concurrently with that of the direct final rule. OSHA also will treat
comments received on the companion direct final rule as comments
regarding the proposed rule. Likewise, OSHA will consider significant
adverse comment submitted to the proposed rule as comment to the direct
final rule. Therefore, if OSHA receives a significant adverse comment
on either the direct final rule or this proposed rule, it will publish
a timely withdrawal of the direct final rule and proceed with this
proposed rule. In the event that OSHA withdraws the direct final rule
because of significant adverse comment, OSHA will consider all timely
comments received in response to the direct final rule when it
continues with this proposed rule. After carefully considering all
comments to the direct final rule and the proposal, OSHA will decide
whether to publish a new final rule.
    OSHA determined that the subject of this rulemaking is suitable for
direct final rulemaking. OSHA originally included the digger-derrick
exemption in the proposed Cranes and Derricks in Construction standard
as a result of negotiated rulemaking involving stakeholders from many
affected sectors. The existing rule for Cranes and Derricks in
Construction, subpart CC of 29 CFR part 1926, exempts the majority of
digger derricks used in the telecommunications and electric-utility
industries from the requirements of that subpart. Because the revision
specified in this proposed rule extends the exemption to a small number
of digger derricks used in the electric-utility industry, and does not
impose any new costs or duties, OSHA does not expect objections from
the public to this rulemaking action.

III. Discussion of the Digger-Derrick Exemption in 29 CFR 1926, Subpart
CC

A. Background of the Digger-Derrick Exemption

    A ``digger derrick'' or ``radial boom derrick'' is a specialized
type of equipment designed to install utility poles. A digger derrick
typically is equipped with augers to drill holes for the poles and with
a hydraulic boom to lift the poles and set them in the holes. Employers
also use the booms to lift objects other than poles; accordingly,
electric utilities, telecommunication companies, and their contractors
use booms both to place objects on utility poles and for general
lifting purposes at worksites (Docket ID OSHA-2007-0066-0139.1). When
OSHA promulgated subpart V (Power Transmission and Distribution) in
1972, it excluded digger derricks from certain requirements of 29 CFR
1926, subpart N, the predecessor to the current 29 CFR 1926, subpart
CC, standard.
    OSHA developed the proposed standard for cranes and derricks in
construction through a negotiated rulemaking involving stakeholders
from many affected sectors. The proposed standard included a limited
exemption for digger derricks (73 FR 59714, 59916 (Oct. 9, 2008)).
After the publication of the proposed rule, OSHA received many comments
criticizing the scope of the exemption because the scope applied to
digger derricks designed for the electric-utility industry, and then
only when used to dig holes for utility work. Commenters noted that
customary use of the digger derrick also involved placing a pole in the
hole and attaching transformers and other items to the pole. Commenters
complained that the exemption would be largely meaningless unless it
also encompassed these functions. Several representatives of the
telecommunications industry noted that the industry used digger
derricks routinely for similar purposes, and requested that OSHA expand
the digger-derrick exemption to encompass telecommunications work in
addition to electric-utility work (Docket ID OSHA-2007-0066-0234 and
OSHA-2007-0066-0129.1).
    When OSHA issued the final Cranes and Derricks in Construction
rule, it noted concerns about the scope of the exemption, and broadened
the scope of the exemption (see 75 FR 47906, 47924-47926, and 48136
(Aug. 9, 2010)). Current subpart CC, therefore, exempts digger derricks
used by both the electric-utility and the telecommunications
industries, and encompasses all pole work in these industries,
including placing utility poles in the ground and attaching
transformers and other equipment to the poles (see 29 CFR 1400(c)(4)).
In that exemption, OSHA clarifies that digger derricks in construction
that are exempt from subpart CC must still comply with the applicable
worker protections in the OSHA standards governing electric-utility and
telecommunications work at Sec. Sec.  1910.268 and 1910.269. The
existing exemption in Sec.  1926.1400(c) states that the subpart does
not cover digger derricks when used for augering holes for poles
carrying electric and telecommunication lines, placing and removing the
poles, and for handling associated materials to be installed on or
removed from the poles. Digger derricks used in work subject to 29 CFR
part 1926, subpart V, must comply with 29 CFR 1910.269. Digger derricks
used in construction work for telecommunication service (as defined at
29 CFR 1910.268(s)(40)) must comply with 29 CFR 1910.268.
    When the activities are exempt from subpart CC of 29 CFR part 1926,
they must still comply with all other applicable construction
standards, such as 29 CFR part 1926, subpart O (Motor Vehicles,
Mechanized Equipment, and Marine Operations), and subpart V.\1\
---------------------------------------------------------------------------

    \1\ For telecommunications work, compliance with the provisions
of Sec.  1910.268 is a condition of the exemption in Sec.
1926.400(c)(4). The scope limitations in Sec.  1910.268(a) (such as
the language stating that it does not apply to construction) are
irrelevant to application of the exemption. If an employer uses a
digger derrick for telecommunications construction work and does not
comply with the provisions in Sec.  1910.268, then that employer
fails to qualify for the exemption in Sec.  1926.400(c)(4). As a
result, that employer must comply with all of the requirements in
subpart CC of part 1926, including the operator-certification
requirements in Sec.  1926.1427. If the employer fails to comply
with subpart CC, and cannot demonstrate that it complied with Sec.
1910.268 for telecommunications work, or Sec.  1910.269 for
electric-utility work, then OSHA will cite the employer under
subpart CC (not Sec.  1910.268 or Sec.  1910.269). If the employer
demonstrates that it complies with the exemption in subpart CC, but
does not comply with the separate requirements in subpart O
applicable to all motorized vehicles in construction, then OSHA will
cite the employer under subpart O. Note that this explanation does
not suggest that OSHA is restricting its enforcement discretion on
whether to issue citations at all.

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

    On October 6, 2010, Edison Electrical Institute petitioned for
review of the Cranes and Derricks in Construction standard in the U.S.
Court of Appeals for the District of Columbia. During subsequent
discussions with OSHA, EEI provided new information to OSHA regarding
the use of digger derricks in the electric-utility industry and the
resulting impact on the utilities' operations under the current digger-
derrick exemption in subpart CC. According to EEI, the exemption from
subpart CC covers roughly 95 percent of work conducted by digger
derricks in the electric-utility industry (see OSHA-2012-0025-0004 for
EEI Dec. 7, 2010, letter, page 2). The majority of the work under the
remaining five percent is work that is closely related to the exempted
work. Id. For example, when electric utilities use digger derricks to
perform construction work involving pole installations, the same
digger-derrick crew that performs the pole work typically installs pad-
mount transformers on the ground as part of the same power system as
the poles. While the pole work is exempt under 29 CFR 1926.1400(c)(4),
the placement of the pad-mount transformer on the ground is not.
    Furthermore, in comparison to currently exempted pole work, OSHA
believes most (if not all) of the remaining five percent of work is at
least as safe. Weight measurements provided by EEI demonstrate that
transformers placed on a pad on the ground are roughly the same weight
as, or in some cases lighter than, the weight of the transformers
lifted onto the poles, or the poles themselves (see OSHA-2012-0025-0003
for EEI handout, ``Typical Weights'' chart).\2\ In addition, electric
utilities typically place distribution transformers in a right of way
along front property lines, close to a roadway, or along rear property
lines, irrespective of whether the transformers are pole- or pad-
mounted. In those cases, the lifting radius of a digger derrick placing
a transformer on a pad is similar to the lifting radius of a digger
derrick placing a transformer on a pole. Consequently, the lifting
forces on a digger derrick should be approximately the same regardless
of whether the transformer is pole- or pad-mounted (see, e.g., OSHA-
2012-0025-0003). Finally, the approximate height of the transformer
relative to the employee installing the transformer is the same for the
two types of transformers. An employee installing a pad-mounted
transformer is on the ground, near the pad, whereas an employee
installing a pole-mounted transformer is either on the pole, or in an
aerial lift, near the mounting point for the transformer. In either
case, the transformer would be around the same height as the employee.
---------------------------------------------------------------------------

    \2\ EEI's chart does not show weights for concrete and plastic
transformer pads, and EEI did not indicate that utilities use digger
derricks to place those pads. If utilities do use digger derricks to
lift pads, EEI's presentation indicates that the digger derricks
lift the transformers separately. Because the surface area of these
pads is comparable to the transformers on them, and because these
pads are generally only a few hundred millimeters thick, OSHA does
not believe that the pads weigh any more than transformers or poles.
---------------------------------------------------------------------------

    Because the same workers generally perform both types of work,
utility employers must, when the standard becomes fully effective in
November 2014, incur the cost of meeting all other requirements in
subpart CC, including the operator-certification requirements, for
those workers to perform the five percent of the work not currently
exempted. The result could be a sizable cost (about $21.6 million
annually) for an activity that does not appear significantly more
dangerous than the type of activity that OSHA already exempted. (See
Section IV.B. (Final Economic Analysis and Final Regulatory Flexibility
Act Analysis) in this preamble for a summary of these costs.) OSHA did
not consider this result when it promulgated the standard.
    OSHA acknowledges the arguments that there are minimal safety
benefits attributable to imposing the standard's requirements on the
remaining five percent of non-exempted work; moreover, the exempted
digger-derrick operations are still subject to the protections afforded
to workers by OSHA's electric-utility and telecommunications standards
(Sec.  1910.269, subpart V of 29 CFR part 1926, and Sec.  1910.268,
respectively). OSHA also notes that the largest labor organization for
workers in the electric-utility industry, the International Brotherhood
of Electrical Workers, participated in settlement discussions,
corroborated the general validity of the information provided by EEI,
and actively supported EEI's request for an expanded digger-derrick
exemption. In light of these factors, OSHA is removing the burdens on
employers for the remaining five percent of non-exempted work, and
revising the digger-derrick exemption to include all digger derricks
used in construction work subject to 29 CFR part 1926, subpart V. Based
on its estimates in the Final Economic Analysis in the 2010 final rule,
the Agency determined that expanding the exemption for digger derricks
will enable employers in NAICS 221120 to avoid compliance costs of
about $15.9 million per year, while employers in NAICS 221110 will
avoid about $5.7 million per year, for a total cost savings of about
$21.6 million annually.
    When the Agency promulgated the final Cranes and Derricks in
Construction rule, OSHA's primary concern about extending the digger-
derrick exemption beyond pole work was that such an extension would
provide employers with an incentive to use digger derricks on
construction sites to perform construction tasks normally handled by
cranes--tasks that are beyond the original design capabilities of a
digger derrick. In discussing this concern, OSHA stated, ``[T]he
general lifting work done at those other worksites would be subject to
this standard if done by other types of lifting equipment, and the same
standards should apply as apply to that equipment . . . .'' (75 FR
47925). OSHA acknowledges that revising the exemption would extend the
digger-derrick exemption to include some work at substations. However,
EEI indicated that the employers in the electric-utility industry limit
such uses to assembly or arrangement of substation components, and that
these employers use other types of cranes instead of digger derricks to
perform lifting and installation work at substations (see OSHA-2012-
0025-0005 for Jan. 2011 EEI letter). If OSHA finds that, should the
direct final rule become a final rule, employers are using digger
derricks increasingly for other tasks, the Agency may revisit this
issue and adjust the exemption accordingly. The Agency also recognizes
that, because the exemption only applies to work subject to the
electrical-power and telecommunications standards, employers cannot use
digger derricks within this exemption to perform unrelated tasks such
as the construction of a building or the foundation or structural
components of a substation before the installation of electric power-
transmission or power-distribution equipment. A digger derrick used for
this type of construction will still be subject to the requirements in
29 CFR 1926, subpart CC, and operators will

have to be certified in accordance with Sec.  1926.1427.

B. Changes to the Text of the Exemption in 29 CFR 1926.1400(c)(4)

    OSHA is revising the exemption in 29 CFR 1926.1400(c)(4) to include
within the exemption ``any other work subject to subpart V of 29 CFR
part 1926.'' This revision expands the exemption to remove from
coverage under subpart CC of 29 CFR part 1926 the types of non-pole,
digger-derrick work described by EEI. OSHA is not expanding the
exemption for pole work performed by employers in the
telecommunications industry because no party raised or requested such
an exemption in the litigation; therefore, this issue is outside the
scope of this rulemaking.
    The Agency also is making several minor clarifications to the text
of the exemption. First, OSHA is making a minor grammatical
clarification by replacing ``and'' with ``or'' in the phrase ``poles
carrying electric or telecommunication lines'' (emphasis added). This
revision will ensure that the regulated community does not misconstrue
the exemption as limited to poles that carry both electric and
telecommunications lines. This clarification is consistent with OSHA's
explanation in the preamble of the Cranes and Derricks in Construction
final rule (see 75 FR 47925).
    Second, OSHA is adding the phrase ``to be eligible for this
exclusion'' at the beginning of the sentence requiring compliance with
Sec.  1910.268 and subpart V of 29 CFR part 1926, respectively. This
revision limits the exemption to the use of digger derricks that comply
with the requirements in subpart V or Sec.  1910.268; if an employer
uses a digger derrick for subpart V or telecommunications work without
complying with all of the requirements in subpart V or Sec.  1910.268,
then the work is not exempt, and the employer must comply with all of
the requirements of subpart CC of 29 CFR part 1926. This clarification
is consistent with OSHA's explanation of the exemption in the preamble
of the final rule (see 75 FR 47925-47926).
    Third, OSHA is replacing the reference to Sec.  1910.269 with a
reference to 29 CFR part 1926, subpart V. The current exemption in
Sec.  1926.1400(c)(4) requires employers using digger derricks for work
covered by subpart V to comply with the requirements in Sec.  1910.269.
However, in the 2010 final rule for Cranes and Derricks in
Construction, OSHA also revised 29 CFR 1926.952(c)(2) of subpart V to
require digger derricks used for the purposes exempted from subpart CC
to comply with Sec.  1910.269. Thus, although the revised exemption in
this proposed rule specifies compliance with subpart V instead of Sec.
1910.269, there is no substantive revision to digger derricks used for
augering holes and handling associated materials. The primary purpose
for this revision is to harmonize the Sec.  1926.1400(c)(4) exemption
with 29 CFR 1926.952(c)(2) to ensure that non-pole digger-derrick work
covered by subpart V receives the same protections as pole work covered
by subpart V.

C. Discussion of Conforming Revisions to 29 CFR Part 1926, Subpart V

    As part of this harmonizing process, OSHA also is revising the
corresponding provision in subpart V that requires compliance with
Sec.  1910.269 for all digger-derrick work exempted from subpart CC,
including Sec. Sec.  1910.269(p) (Mechanical equipment), 1910.269(a)(2)
(Training), and 1910.269(l) (Working on or near exposed energized
parts) (see new 29 CFR 1926.952(c)(2)). When OSHA promulgated subpart
CC of 29 CFR part 1926 in 2010, the Agency also revised Sec.
1926.952(c)(2) in subpart V of its construction standards (75 FR
48135). The revision mirrored the terminology in the digger-derrick
exemption in Sec.  1926.1400(c)(4), and required employers using digger
derricks so exempted to comply with Sec.  1910.269 (Electric power
generation, transmission, and distribution). In making this revision,
the Agency noted that it added specific minimum clearance-distance
requirements, which are applicable to subpart V work, to the cranes and
derricks in construction rules at subpart CC, and explained that it
revised Sec.  1926.952(c) to require digger derricks to comply with
Sec.  1910.269 to provide ``comparable safety requirements'' (75 FR
47921).
    As revised, paragraph Sec.  1926.952(c)(2) requires employers using
digger derricks for subpart V work and, thus, not subject to the
requirements of subpart CC of 29 CFR part 1926, to comply with the
requirements in Sec.  1910.269. OHSA also is clarifying that paragraph
(c)(2) applies in addition to, not in place of, the general requirement
in Sec.  1926.952(c) that all equipment (including digger derricks)
must comply with subpart O of 29 CFR part 1926. As noted in the
preamble to the subpart CC final rule, OSHA currently is developing a
rule that will amend subpart V to avoid inconsistencies between subpart
V of the construction standards and Sec.  1910.269 (see 70 FR 34822
(June 15, 2005)). Pending completion of that rulemaking, digger
derricks excluded from subpart CC of 29 CFR 1926 will be subject to the
same requirements regardless of whether employers use them for work
covered by subpart V or work covered by Sec.  1910.269, and regardless
of whether employers use them for pole work or other subpart V work.

IV. Agency Determinations

A. Significant Risk

    The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act; 29 U.S.C. 651 et al.) is ``to assure so far as possible every
working man and woman in the Nation safe and healthful working
conditions and to preserve our human resources'' (29 U.S.C. 651(b)). To
achieve this goal, Congress authorized the Secretary of Labor to
promulgate and enforce occupational safety and health standards (29
U.S.C. 654(b), 655(b)). An occupational safety or health standard is a
standard that ``requires conditions, or the adoption or use of one or
more practices, means, methods, operations, or processes, reasonably
necessary or appropriate to provide safe or healthful employment and
places of employment'' (29 U.S.C. 652(8)). A standard is reasonably
necessary or appropriate within the meaning of Section 652(8) if it
substantially reduces or eliminates significant risk (see Industrial
Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607
(1980)).
    This proposed rule does not impose any additional requirements on
employers. Because OSHA previously determined that the Cranes and
Derricks in Construction standard substantially reduces a significant
risk (see 75 FR 47913), it is unnecessary for the Agency to make
additional findings on risk for the purposes of this minor amendment to
the digger-derrick exemption (see, e.g., Public Citizen Health Research
Group v. Tyson, 796 F.2d 1479, 1502 n.16 (D.C. Cir. 1986) (rejecting
the argument that OSHA must ``find that each and every aspect of its
standard eliminates a significant risk'').

B. Final Economic Analysis and Final Regulatory Flexibility Act
Analysis

    When it issued the final rule for Cranes and Derricks in
Construction, OSHA prepared a Final Economic Analysis (FEA) as required
by the Occupational Safety and Health Act of 1970 (``OSH Act''; 29
U.S.C. 651 et seq.) and Executive Orders 12866 and 13563. OSHA also
published a final regulatory flexibility analysis as required by the
Regulatory Flexibility Act (5 U.S.C. 601-612).
    In the FEA for the final rule (OSHA-2007-0066-0422), the Agency
estimated

that there were about 10,000 crane operators in NAICS 221110 Electric
Power Generation, and about 20,000 crane operators in NAICS 221120
Electric Power Transmission, Control, and Distribution. OSHA based
these figures on estimates of the number of construction work crews in
these industries from its subpart V FEA, with an allowance (to assure
maximum flexibility) that there be three trained crane operators for
every work crew. Based on submissions to the record, OSHA estimated
that 85 percent of these 30,000 operators (25,500) worked on digger
derricks, while 15 percent of the operators operated truck-mounted
cranes, or boom trucks; therefore, a total of 25,500 digger-derrick
operators would require operator certification.
    In its FEA for the final rule, OSHA estimated that the total costs
for NAICS 221110 would be $6.7 million ($4 million for operator
certification), and the total costs for NAICS 221120 would be $18.7
million annually ($8.7 million for operator certification) (see FEA
Table B-9 in the Aug. 9, 2010, FR notice). Fully exempting digger
derricks from the scope of the standard also eliminates costs for other
activities besides operator certification, such as inspections and
power-line safety. In the original FEA, the two main cost components
for an industry were the number of crane operators and the number of
jobs involving cranes. The original FEA estimated that digger derricks
represented 85 percent of operators, and 85 percent of jobs involving
cranes. OSHA, therefore, estimates that digger derricks account for 85
percent of the costs attributed to NAICS 221110 and NAICS 221120.
Applying this 85 percent factor to the total costs for the industries
yields costs for digger derricks of $5.7 million per year in NAICS
221110 and $15.9 million per year in NAICS 221120, for a total of $21.6
million per year.\3\
---------------------------------------------------------------------------

    \3\ Based on the size of digger derricks and EEI's descriptions
of digger-derrick activities, OSHA understands that the vast
majority of digger-derrick use for construction activity in the
electric-utility industry will involve transmission and distribution
work subject to subpart V of 29 CFR part 1926. Employers categorized
under NAICS 221120 generally conduct electric-transmission and -
distribution work. However, OSHA is including digger derricks under
NAICS 221110, which is the SIC code for power generation, because
some employers may be under that SIC code because their primary work
is in that area, but those employers also may engage in transmission
work covered by subpart V. Because the record does not indicate that
employers use digger derricks for power-generation construction
activities, OSHA assumes that the use of digger derricks under NAICS
221110 is for subpart V work.
---------------------------------------------------------------------------

    This proposed rule will eliminate nearly all of the estimated $21.6
million per year in costs associated with digger derricks. These
estimated cost savings may be slightly overstated because OSHA noted in
its FEA that the cost assumptions might not represent the most
efficient way to meet the requirements of the rule. However, OSHA
wanted to assure the regulated community that, even with somewhat
overstated cost estimates, the proposed rule would still be
economically feasible.
    In its original FEA (OSHA-2007-0066-0422), OSHA reported an average
of 0.5 crane-related fatalities per year in SIC codes NAICS 221110 and
NAICS 221120. However, the original FEA did not indicate that any of
these fatalities involved digger derricks or other equipment covered by
the standard. Moreover, in light of the information provided by EEI,
there is no indication that the additional five percent of digger-
derrick activity exempted through this rulemaking poses any hazard
greater than the hazard posed by the digger-derrick activities OSHA
already exempted in the 2010 final rule.
    Because this proposed rule estimates cost savings of $21.6 million
per year, this proposed rule is not economically significant within the
meaning of Executive Order 12866 (58 FR 51735). The proposed rule does
not impose additional costs on any private-sector or public-sector
entity, and does not meet any of the criteria for an economically
significant or major rule specified by Executive Order 12866 and the
relevant statutes. This rule is not a ``major rule'' under Section 804
of the Small Business Regulatory Enforcement Fairness Act of 1996 (5
U.S.C. 801 et seq.).
    OSHA developed this proposed rule consistent with the provisions of
Executive Orders 12866 and 13563. Accordingly, this proposed rule
follows closely the principle of EO 13563 that agencies should use new
data developed after completion of a rulemaking (retrospective
analysis) to determine if a regulation ``should be modified,
streamlined, expanded, or repealed.'' In this case, review of data
submitted after completion of the initial rulemaking provided OSHA with
the opportunity to streamline a rule by dropping its application to
digger derricks, thereby saving the industry an estimated $21.6 million
per year. As described previously, this action removes duties and costs
for the electric-utility industry, and does not impose any new duties
on any employer. Because small entities will have reduced costs as a
result of this proposed rule, the Agency certifies that the final
standard would not impose significant economic costs on a substantial
number of small entities.

C. Technological Feasibility

    A standard is technologically feasible when the protective measures
it requires already exist, when available technology can bring the
protective measures into existence, or when that technology is
reasonably likely to develop (see American Textile Mfrs. Institute v.
OSHA, 452 U.S. 490, 513 (1981) (ATMI); American Iron and Steel
Institute v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (AISI)). This
proposed rule does not require any additional protective measures. In
the original FEA, OSHA found the standard to be technologically
feasible (75 FR 48079). OSHA concludes that this revision is feasible
as well because it reduces or removes current requirements on
employers.

D. Paperwork Reduction Act of 1995

    When OSHA issued the final rule on August 9, 2010, the Agency
submitted an Information Collection Request (ICR) to OMB titled Cranes
and Derricks in Construction (29 CFR Part 1926 Subpart CC). On November
1, 2010, OMB approved the ICR under OMB Control Number 1218-0261, with
an expiration date of November 30, 2013. Subsequently, in December
2010, OSHA discontinued the Cranes and Derricks Standard for
Construction (29 CFR 1926.550) ICR (OMB Control Number 1218-0113)
because the new ICR superseded this ICR. In addition, OSHA retitled the
new ICR to Cranes and Derricks in Construction (29 CFR Part 1926,
Subpart CC and Subpart DD).
    This proposed rule, which expands the digger-derrick exemption,
does not require any additional collection of information or alter the
substantive requirements detailed in the 2010 ICR. The only impact on
the collection of information will be a reduction in the number of
entities collecting information. Accordingly, OSHA does not believe it
is necessary to submit a new ICR to OMB. OSHA will identify any
reduction in burden hours when it renews the ICR.
    Interested parties may comment on OSHA's determination that this
proposal contains no additional paperwork requirements by sending their
written comments to the Office of Information and Regulatory Affairs,
Attn: OMB Desk Officer for OSHA, Office of Management and Budget, Room
10235, 726 Jackson Place, NW., Washington, DC 20503. The Agency also
encourages commenters to submit their comments on this paperwork
determination to OSHA, along with their other comments on this proposed

rule, within the specified comment period.
    OSHA notes that a federal agency cannot conduct or sponsor a
collection of information unless it is approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995,
44 U.S.C. 3501 et seq. and the agency also displays a currently valid
OMB control number for the collection of information, and that the
public need not respond to a collection of information requirement
unless the agency displays a currently valid OMB control number. Also,
notwithstanding any other provisions of law, no person shall be subject
to a penalty for failing to comply with a collection of information
requirement if the requirement does not display a currently valid OMB
control number.

E. Federalism

    OSHA reviewed this proposed rule in accordance with the Executive
Order on Federalism (Executive Order 13132 (64 FR 43255 (Aug. 10,
1999))), which requires that Federal agencies, to the extent possible,
refrain from limiting state policy options, consult with states prior
to taking any actions that would restrict state policy options, and
take such actions only when clear constitutional authority exists and
the problem is national in scope. Executive Order 13132 provides for
preemption of state law only with the expressed consent of Congress.
Federal agencies must limit any such preemption to the extent possible.
    Under Section 18 of the OSH Act, Congress expressly provides that
states may adopt, with federal approval, a plan for the development and
enforcement of occupational safety and health standards. The OSH Act
refers to states that obtain federal approval for such a plan as
``State Plan States'' (29 U.S.C. 667). Occupational safety and health
standards developed by State Plan States must be at least as effective
in providing safe and healthful employment and places of employment as
the federal standards. Subject to these requirements, State Plan States
are free to develop and enforce under state law their own requirements
for safety and health standards.
    OSHA previously concluded that its promulgation of subpart CC
complies with Executive Order 13132 (75 FR 48128 and 48129). Because
the current rulemaking does not impose any additional burdens, that
analysis applies to the revision of the digger-derrick exemption.
Therefore, this proposed rule complies with Executive Order 13132. In
states without OSHA-approved state plans, any standard developed from
this proposed rule would impact state policy options in the same manner
as every standard promulgated by OSHA. In states with OSHA-approved
state plans, this proposed rulemaking does not limit state policy
options.

F. State Plan States

    When federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, the 27 states and U.S. territories
with their own OSHA-approved occupational safety and health plans must
amend their standards to reflect the new standard or amendment, or show
OSHA why such action is unnecessary, e.g., because an existing state
standard covering this area is at least as effective in protecting
employees as the new federal standard or amendment (29 CFR 1953.5(a)).
The state standard must be at least as effective in protecting
employees as the final federal rule. State Plan States must issue the
standard within six months of the promulgation date of the final
federal rule. When OSHA promulgates a new standard or amendment that
does not impose additional or more stringent requirements than an
existing standard, State Plan States are not required to amend their
standards, although OSHA may encourage them to do so. The 27 states and
U.S. territories with OSHA-approved occupational safety and health
plans are: Alaska, Arizona, California, Hawaii, Indiana, Iowa,
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North
Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Washington, and Wyoming. Connecticut, Illinois, New
Jersey, New York, and the Virgin Islands have OSHA-approved State Plans
that apply to state and local government employees only.
    The amendments made in this proposed rule do not impose any new
requirements on employers. Accordingly, State Plan States are not
required to amend their standards to incorporate the expanded exemption
specified in this proposal, but they may do so if they so choose.

G. Unfunded Mandates Reform Act

    When OSHA issued the final rule for Cranes and Derricks in
Construction (75 FR 48130), it reviewed the rule according to the
Unfunded Mandates Reform Act of 1995 (UMRA; 2 U.S.C. 1501 et seq.) and
Executive Order 13132 (64 FR 43255 (Aug. 10, 1999)), and concluded that
the final rule did not meet the definition of a ``Federal
intergovernmental mandate'' under the UMRA. OSHA's standards do not
apply to state or local governments except in states that have
voluntarily adopted state plans. OSHA further noted that the rule
imposed costs of over $100 million per year on the private sector and,
therefore, required review under the UMRA for those costs; the Agency
determined that its Final Economic Analysis met that requirement. Id.
    As discussed above in Section IV.B. (Final Economic Analysis and
Final Regulatory Flexibility Act Analysis) of this preamble, this
proposed rule reduces expenditures by private-sector employers. For the
purposes of the UMRA, OSHA certifies that this proposed rule does not
mandate that state, local, or tribal governments adopt new, unfunded
regulatory obligations, or increase expenditures by the private sector
of more than $100 million in any year.

H. Consultation and Coordination with Indian Tribal Governments

    OSHA reviewed this proposed rule in accordance with Executive Order
13175 (65 FR 67249 (Nov. 9, 2000)), and determined that it does not
have ``tribal implications'' as defined in that order. This proposed
rule does not have substantial direct effects on one or more Indian
tribes, on the relationship between the federal government and Indian
tribes, or on the distribution of power and responsibilities between
the federal government and Indian tribes.

List of Subjects in 29 CFR Part 1926

    Cranes and derricks, Construction industry, Occupational safety and
health.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC 20210, authorized the preparation
of this notice. OSHA is issuing this direct final rule under the
following authorities: 29 U.S.C. 653, 655, 657; 40 U.S.C. 3701 et seq.;
5 U.S.C. 553; Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan.
25, 2012); and 29 CFR part 1911.

    Signed at Washington, DC, on October 9, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

Proposed Amendments to Standards

    For the reasons stated in the preamble of this proposed rule, OSHA
is proposing to amend 29 CFR part 1926 as follows:

PART 1926--[AMENDED]

Subpart V--Power Transmission and Distribution

    1. Revise the authority citation for subpart V to read as follows:

    Authority:  40 U.S.C. 3701; 29 U.S.C. 653, 655, 657; Secretary
of Labor's Order Nos. 12-71 (36 FR 8754); 8-76 (41 FR 25059); 9-83
(48 FR 35736), 1-90 (55 FR 9033), 5-2007 (72 FR 31159), or 1-2012
(77 FR 3912), as applicable. Section 1926.951 also is issued under
29 CFR part 1911.
    2. Amend Sec.  1926.952 by revising paragraph (c)(2) to read as
follows:

Sec.  1926.952  Mechanical equipment.

* * * * *
    (c) * * *
    (2) Use of digger derricks must comply with Sec.  1910.269 (in
addition to 29 CFR part 1926, subpart O) whenever such use is excluded
from 29 CFR part 1926, subpart CC, in accordance with Sec.
1926.1400(c)(4).
* * * * *

Subpart CC--Cranes and Derricks in Construction

    3. Revise the authority citation for subpart CC to read as follows:

    Authority:  40 U.S.C. 3701; 29 U.S.C. 653, 655, 657; and
Secretary of Labor's Order No. 5-2007 (72 FR 31159) or 1-2012 (77 FR
3912), as applicable; and 29 CFR part 1911.

    4. Amend Sec.  1926.1400 by revising paragraph (c)(4) to read as
follows:

Sec.  1926.1400  Scope.

* * * * *
    (c) * * *
    (4) Digger derricks when used for augering holes for poles carrying
electric or telecommunication lines, placing and removing the poles,
and for handling associated materials for installation on, or removal
from, the poles, or when used for any other work subject to subpart V
of this part. To be eligible for this exclusion, digger-derrick use in
work subject to subpart V of this part must comply with all of the
provisions of that subpart, and digger-derrick use in construction work
for telecommunication service (as defined at Sec.  1910.268(s)(40))
must comply with all of the provisions of Sec.  1910.268.
* * * * *
[FR Doc. 2012-27209 Filed 11-8-12; 8:45 am]
BILLING CODE 4510-26-P