So when that happens, then you move--one of the things you can do is
move to higher levels of stimulation . . . [W]hat JRC found in the
'90s was that if you start off at a level of 15, then you're less
likely to encounter that adaptation. And then we've also found that,
in the rare cases where there is adaptation to the GED, we can move
to the GED-4 and we generally don't see adaptation at all after
that.

He later stated that JRC has ``even seen adaptation to [the GED-4] in a
few cases, and we've had to put in special protocols to help those
particular people,'' which include ``a very comprehensive alternative
behavior program'' that has been ``very effective'' for at least one
individual.
6. Information From Patients and Their Family Members
    At the Panel Meeting, a member of a JRC parent association
explained that her child's treatments were not successful until they
tried JRC's GED device. The speaker thought that the skin shock quickly
and effectively targeted specific behaviors while other treatments did
not stop dangerous or self-abusive actions. The three individuals
formerly at JRC who expressed their opposition to a ban at the Panel
Meeting described their severe behavior issues and the failures of
alternative treatments. They described successful outcomes after
application of GED devices at JRC, and they described how they are now
independent, well-

functioning members of society and, in one case, married with children.
The family members of individuals at JRC who opposed a ban described
the serious SIB and AB that the individuals exhibited and the various
treatments that they tried and that failed (pharmacological treatments,
physical restraints, and positive behavioral interventions) prior to
application of a GED device at JRC. They stated that as a result of GED
application, their family members have exhibited less SIB and AB, are
happier, and are improving their lives.
    One of the parents' associations submitted a comment that included
32 letters from family members of individuals at JRC reporting success
stories for the GED devices. One letter includes seven case reports of
individuals said to have been successfully treated at JRC with ESDs.
The letters contend ESDs were the only successful treatment for their
family members. They describe the individuals' severe behaviors prior
to GED use, some life-threatening, including eye-gouging, suicidality,
depression, swallowing sharp objects, cutting wrists, biting
themselves, head-banging, hitting themselves with hard objects, running
into walls, jumping out of windows, scrotal tearing, rumination, and
projectile vomiting. The family members describe how previous
treatments failed, leading many schools to reject or expel the
individuals; in contrast, they described successful treatment with ESDs
at JRC.
7. Information From Other Stakeholders
    One speaker at the Panel Meeting, who described himself as a doctor
who worked in the field for over 25 years, said that he had published
peer-reviewed articles on both positive behavior support and punishment
technologies. He opposes a ban ``in the spirit of the right to
effective treatment.'' He believes that for some individuals, ``primary
salient punishment is what's necessary in order to compete with their
repertoires.''
    Several of the written comments we received from disability rights
advocates assert that ESDs provide little if any benefit, and they
criticize the scientific integrity of some of the sources cited by JRC
in support of effectiveness. One comment from an advocate concludes
that ``the existing literature demonstrates only that electric shock
aversives have inconsistent short-term efficacy with absolutely no
long-term efficacy in reducing or eliminating destructive and self-
injurious behaviors.'' The comment criticizes the evidence relied upon
by JRC to support effectiveness as ``published internally with the sole
involvement of their own personnel or those closely connected to their
facility with no meaningful external review.'' For example, the comment
states that JRC's Web site represents a self-published followup study
on 65 individuals at JRC as data-based research, yet no related paper
was accepted for peer review and there is no explanation or context for
the methods of data collection.
8. Conclusion
    Our search of the scientific literature regarding the effect of
ESDs on SIB and AB revealed a number of studies showing that ESDs
result in the immediate interruption of the target behavior upon shock,
and some of the literature also suggested varying degrees of durable
conditioning. However, these studies suffer from serious limitations,
including weak study design, small size, and adherence to outdated
standards for study conduct and reporting. Also, the conclusions of
several of the studies are undermined by study-specific methodological
limitations, lack of peer review, and author conflicts of interest.
There is also evidence that the shocks are completely ineffectual for
certain individuals. FDA has determined that the evidence shows that
ESD shocks generally interrupt and cause immediate cessation of the
target behavior when applied at the onset of such behavior, but the
evidence is otherwise inconclusive and does not establish that ESDs
improve the underlying condition or successfully condition individuals
to achieve durable long-term reduction of SIB or AB.

C. State of the Art

    FDA considers the reasonableness of the risks of ESDs relative to
the state of the art, i.e., the current state of technical and
scientific knowledge and medical practice (see 44 FR 29214; May 18,
1979).
1. Scientific Literature
    In our systematic review of the scientific literature, FDA found
that the weight of the evidence indicates the state of the art for the
treatment of SIB or AB relies on multi-element positive methods,
especially positive behavioral support (PBS), sometimes in conjunction
with pharmacological treatments, and has evolved away from the use of
ESDs. The first published studies of contingent skin shock (the
stimulus delivered by an ESD) took place in the 1960s (see Ref. 3,
summarizing published research). Since then, advances in science and
medicine have led to a better understanding of the environmental
triggers and organic origins of SIB and AB, improved behavior analysis
methodology, and heightened ethical and human rights concerns regarding
the use of ESDs, particularly in vulnerable patient populations (e.g.,
Refs. 99 and 100). We found that the state of the art has progressed
along with these advancements, which have led to treatments that are
successful in treating SIB and AB, and hold greater promise for
achieving long-term results, while avoiding the risks posed by ESDs.
    a. Multi-element positive interventions. Elements, sometimes called
components, of multi-element positive methods such as PBS, span several
categories for a wide variety of purposes (e.g., Refs. 101 and 102).
The term ``positive'' can apply to many different treatment modalities,
such as educative programming, functional communication training, and
non-aversive behavior management, but it does not include aversive
interventions such as contingent skin shock (Refs. 103 and 104).
    Positive-intervention treatments incorporate the scientific and
medical developments of recent decades as their foundation. For
example, researchers have learned that behavioral treatment strategies
should account for emotions and self-invalidation (rejecting the
validity of one's own thoughts or emotions), which can be underlying
factors associated with challenging behaviors (e.g., Ref. 105).
Relative to approaches in previous decades, multi-element positive
interventions broaden the scope for treatment of SIB or AB to include
such factors. Pharmacotherapy (the use of medications) has similarly
evolved in terms of understanding the relationship between underlying
factors and SIB or AB (discussed in more detail in this section). In
essence, medical approaches now treat SIB and AB as results of
environmental cues and biological processes rather than subdue them
through punishment-based techniques (Refs. 99 and 106).
    The key to creating a plan to address these cues and processes was
the development of a formalized analysis, called a functional
behavioral assessment (Ref. 106). Such an assessment is an analytical
tool that facilitates various methods of applied behavioral analysis
(ABA), which tailors treatment to the specific patient, particularly
with respect to preventive measures. ABA is a fairly large family of
treatment models that has existed as a general category for several
decades. Although different authors define its scope differently, and
older ABA models included aversives, in reviewing

the state of the art, we have focused on behavioral treatment models
descended from ABA that are based on current scientific and medical
research. Overall, ABA and its progeny treatment models have led the
treatment of SIB and AB beyond ESDs toward multi-element positive
interventions, sometimes alongside pharmacotherapy, designed for the
individual patient (Refs. 97, 99, and 106).
    To design the intervention, clinicians first conduct a
comprehensive functional behavioral assessment to identify the target
behaviors and the environmental and social triggers that contribute to
them. This includes identifying the frequency of the unwanted behaviors
as well as the social context and other environmental conditions (e.g.,
loud noise, crowded room) in which the behaviors are more likely to
occur (e.g., Ref. 106 discussing ``environmental redesign''). Failure
to conduct a functional behavioral assessment may actually lead to harm
because the resulting plan may inadvertently reinforce and consequently
increase the problem behavior (Ref. 107). Following the functional
behavioral assessment, a behavioral treatment plan is developed
utilizing a positive behavioral therapy approach, such as those
discussed in the paragraphs that follow. Clinicians would ordinarily
try multiple treatment interventions if the initial treatment is not
successful.
    One particular type of positive behavioral therapy discussed in the
literature is PBS. PBS uses functional behavioral assessment to develop
a treatment strategy geared toward teaching new behaviors (Refs. 59,
99, and 108). These new behaviors proactively displace undesirable
behaviors such as SIB and AB by teaching patients to express themselves
with behavioral substitutions that will not cause harm to themselves or
others. Functional communication training is one such approach. This
process examines the communicative intent of the problem behaviors
(what the individual is trying to tell or obtain from others), and then
focuses on teaching the individual a functionally equivalent, but non-
problematic, behavior (Ref. 107; see also Ref. 104). Several studies
have demonstrated the value of functional communication training,
especially when included as part of a comprehensive, multi-element
intervention such as PBS (see Ref. 109 for a review of 29 studies).
    PBS also relies on reinforcing desired behaviors, altering the
environment to prevent or avoid triggers, and is explicitly
nonpunitive. Thus, PBS treatments exclude physical aversive
conditioning techniques, which react to self-injurious or aggressive
behavior rather than prevent such behavior from occurring in the first
place, and can often lead to the escalation of the same events they are
trying to prevent (Refs. 97, 99, and 101). Although proactive in
nature, PBS plans may include rapid-reaction strategies for potentially
serious problem behaviors that might pose a risk of harm to the subject
or others to reduce the severity of an episode of problem behavior
(Ref. 97). In contrast to a punishment technique, such plans are not
intended to condition the individual or provide behavioral
reinforcement.
    Another more recently developed positive-based behavioral therapy
for SIB and AB is dialectical behavioral therapy (DBT). Like PBS, DBT
grew out of ABA principles (Ref. 105). DBT is a cognitive behavioral
treatment that was originally developed to treat chronically suicidal
individuals diagnosed with borderline personality disorder, and it is
now recognized as a standard psychological treatment for this
population (Ref. 110). Research has shown that it is also successful in
treating a wide range of other disorders such as substance dependence,
depression, PTSD, and eating disorders.
    DBT consists of four components: A skills training group,
individual treatment, DBT phone coaching, and a DBT therapist
consultation team. Similar to PBS, DBT is a multi-element, empirical
approach to treatment that relies on a behavioral analysis and
emphasizes empathy, acceptance, and collaboration (Refs. 105 and 111).
In both therapies, the goal is to impart new skills such as
mindfulness, distress tolerance, interpersonal effectiveness, and
emotion regulation (Refs. 105 and 111). However, because DBT was
developed to treat certain conditions that may give rise to SIB and AB,
such as borderline personality disorder, it differs subtly from PBS and
centers on treating emotional dysregulation (Refs. 105 and 111). Thus,
even though two patients may manifest SIB, DBT may be suited to treat
one more than the other, depending on the underlying condition (Ref.
105).
    b. Evolution of the state of the art away from ESDs and toward
positive interventions. During the 1960s and 1970s, aversive
conditioning procedures were often used because they potentially
offered a relatively easy way to immediately, if only temporarily, stop
problem behaviors such as SIB or AB (Ref. 112). In one study of
contingent skin shock, the authors observed that patients in treatment
wards exhibiting such behaviors often went untreated because of
staffing inadequacies, including lack of training in reinforcement
techniques (Ref. 36). In an overwhelmed ward, contingent shock
potentially offered a quick fix (Ref. 36). The authors noted, however,
that to get such results, they chose ``a strong shock which guaranteed
quick suppression,'' one they felt was ``definitely painful'' (Ref.
36).
    Despite the apparent convenience, researchers have long raised
ethical concerns about purposefully subjecting patients to the harms
caused by physically aversive stimuli (Refs. 36 and 103). Patients
subject to ESDs ``gave every sign of fear and apprehension'' associated
with pain and anxiety (Ref. 36), yet decades ago, there was little
oversight by human rights or behavior committees (Ref. 112). Indeed,
experiments in punishment contributed to the development of behavior
committees, and eventually the modern institutional review boards that
are now mandatory for human research. As discussed in section II.A.1,
patients may adapt to a particular shock level, which may lead to
stronger shocks, thereby escalating ethical concerns (Ref. 59). Given
the ethical implications, experts were cautioning as early as 1990
against allowing a crisis intervention procedure to turn into a
continuous management technique (Ref. 103).
    Whereas ethical and human rights concerns related to the risks
posed by aversive techniques, especially ESDs, were drivers of the
movement in the medical community away from these techniques (Refs. 106
and 112), the rise of positive behavioral interventions appears to be
attributable to their success in treating problem behaviors while
posing little to no risk. The literature supports a finding that newer,
positive treatment approaches that are not combined with any aversive
techniques are equally successful as approaches that use both positive
and aversive techniques, regardless of the problem behavior targeted
(Ref. 113). Indeed, providers and researchers have found that PBS is
successful in the treatment of even the most challenging behaviors
(Refs. 97 and 101), including in community and home settings (Refs. 95,
114, and 115). A review of 12 outcome studies for multi-element
positive interventions, for a total of 423 patients, also concluded
that PBS appears to be successful for the most challenging behaviors
(Ref. 97). Similarly, randomized controlled trials have demonstrated
that DBT successfully reduces self-injury in patients with borderline
personality

disorder and adolescents with SIB (Refs. 111, 116, and 117).
    PBS is also more adaptable than aversive conditioning techniques
because it can achieve durable results for patients for whom aversive
conditioning cannot. In particular, a consequential strategy such as
aversive conditioning cannot achieve behavioral conditioning for some
patients who have conditions that impair their ability to understand
consequences and react by changing their behaviors. For example, a
patient exhibiting SIB or AB may have severely impaired short-term
memory and impulse control such that that any consequential strategy
(like ESD shocks delivered in consequence of exhibiting a target
behavior) may be limited in what it can accomplish (Ref. 97). Since PBS
relies on preemptively identifying and reducing the problem behaviors'
triggers, proactively reducing the problem behavior and not reactively
relying on consequences, it has an inherent advantage over aversive
conditioning techniques for such patients (Ref. 97).
    The adaptability of PBS is also intentional, resulting from
providers' efforts to translate positive treatment outcomes that were
demonstrated in clinical settings (inpatient treatment facilities) to
community settings (Refs. 99 and 106). The relatively little basic
clinical research on contingent shocks (shocks given in response to
certain behaviors), such as those applied by an ESD, is difficult to
translate into treatment plans because aversive conditioning-based
techniques, including the application of ESDs, are context-sensitive
and may not remain effectual in different physical environments, from
different providers, or for different patients (Refs. 36, 44, 59, and
93). Further, as discussed in section II.B.2, the available evidence
does not demonstrate that aversive conditioning-based techniques
provide durable long-term effectiveness (Refs. 34, 36, 59, and 95). In
contrast to continual application of physical aversive conditioning
techniques to suppress problem behaviors, PBS can achieve durable,
successful treatment in community and home settings by targeting the
underlying causes of the behavior and imparting the skills needed to
address it (Refs. 99 and 106).
    Like PBS, DBT is adaptable and has been shown to be successful in
individuals with intellectual disabilities, in particular in reducing
the severe SIB or AB of such individuals (Ref. 105). DBT also appears
to achieve durable results after in-patient treatment (Ref. 117), and
recent research suggests that, for some people, DBT approaches can
effectively treat SIB on an outpatient basis (Ref. 116).
    The only risk FDA found to be associated with positive behavioral
treatments is one posed by ``extinction,'' a common, integral component
of behavioral plans (Refs. 118 and 119). An extinction process reduces
a target behavior by withholding the reinforcer, i.e., the response
sought with the target behavior (e.g., Ref. 120). Extinction exhibits
the potential risk of ``extinction bursts,'' an upsurge of the actual
undesirable behavior, particularly manifested in the early stages of
the intervention. If this upsurge in behavior poses a danger to the
individual or others, then an extinction paradigm may not be a feasible
option (Ref. 120). In general, however, positive behavioral therapies
pose little to no risk to patients.
    Not all treatment providers follow a positive-only behavioral
treatment model such as PBS (Refs. 113 and 115). As explained in
section II.B.1, FDA's review of the available data and information did
reveal that aversive conditioning techniques may provide some effect of
immediate cessation (e.g., Ref. 59), especially when paired with
positive approaches (e.g., Ref. 113). As such, providers may believe
that aversive conditioning techniques offer a viable option of last
resort (Refs. 36, 99, and 112). However, the literature contains
reports that when health care providers have resorted to punishers, the
method was usually no more intrusive than water mist, and the addition
of punishers proved no more successful than PBS-only techniques (Refs.
99 and 113). Reflecting this trend, a 2008 survey of members of the
Association for Behavior Analysis found that providers generally view
punishment procedures as having more negative side effects and being
less successful than reinforcement procedures (Ref. 115).
    The comments submitted by JRC question the effectiveness of
positive behavioral interventions, citing three case review studies of
``positive-only'' approaches covering successive time periods. In JRC's
characterization, a study covering 1969 to 1988 found a success rate of
37 percent for such an approach (Ref. 121), one covering 1985 to 1996
found a 52 percent success rate (Ref. 99), and the third, covering 1996
to 2000, found a 60 percent success rate (Ref. 122). JRC also cites a
literature review to support its claim that positive-only interventions
sometimes require supplementation with punishment techniques (Ref.
123).
    These studies do not alter FDA's conclusions regarding the
effectiveness of positive behavioral interventions or the state of the
art for the treatment of SIB and AB. We note that the first review
cited by JRC (Ref. 121) includes comparative assessments of positive-
only approaches showing that, for the category of behaviors referred to
by JRC (positive-only approaches targeting SIB), skills acquisition and
stimulus-based interventions had 50 and 52 percent success rates,
respectively, during the reviewed time period. FDA recognizes that
positive behavioral interventions may not always be successful on their
own for all problem behaviors in all patients. However, we note the
substantial progress in non-aversive approaches for the treatment of
SIB and AB as providers have gained experience with them over time,
which is evident in the increasing success rates cited in JRC's
comment.
    Further, one review cited by JRC (Ref. 123) studied the addition of
punishment procedures generally and did not address the use of ESDs in
particular. Punishment procedures can take a wide variety of forms in
addition to ESDs, such as daily point deductions, verbal reprimands, or
food deprivation. Although the authors concluded that aversives
appeared to improve some patients' outcomes, they did not conclude ESDs
were a necessary aversive, and the intervening years have yielded even
more favorable results for positive-only approaches (Ref. 97).
    Review of the current scientific literature confirms that, in
recent decades, medical practice has shifted away from restrictive
physical aversive conditioning techniques such as ESDs and toward
treating patients with SIB and AB with positive-based behavioral
interventions (Ref. 113). PBS emerged beginning in the 1980s (Refs. 97,
106, and 112), and continued to develop in the ensuing years,
emphasizing empirical analysis and applicability to non-clinical
settings (Ref. 106). One analysis showed that, beginning in the 1990s,
the use of positive techniques increased while the use of punishment
techniques, which include physical aversives, dropped (Ref. 124). A
survey of experts in the related fields of PBS and ABA found that the
largest dropoff in usage of punishment techniques occurred between the
1980s and 1990s (Ref. 112). Such surveys show the ABA field as a whole
moved away from intrusive physical aversive conditioning techniques
such as ESDs 2 decades ago (Refs. 103 (reprinted from 1990) and 112).
    Correspondingly, many authors have noted that research of
punishment-based techniques--which includes a broad range of
consequences, from the

application of ESDs, to food deprivation, down to deducting daily
points--has dwindled for decades (Refs. 59, 93, and 115). Most of the
papers written since 2000 on the use of ESDs are by JRC employees and
JRC consultants (Ref. 98), which raises questions regarding their
impartiality, as discussed earlier in section II.B.2. Although the
anecdotal reports in two of JRC's self-authored papers purport to
provide evidence of persons refractory (resistant) to all behavioral
controls except ESDs (Refs. 30 and 94), these findings were not
published in a peer-reviewed journal, and they suffer from a number of
methodological shortcomings that raise questions about their validity,
as discussed earlier in section II.B.2. In direct contrast, one study
that followed up on adults on whom ESDs were used in an unnamed
residential facility in the northeast United States (most likely JRC)
found that less restrictive interventions successfully treated SIB and
AB after ESDs were removed (Ref. 95).
    c. Use of pharmacotherapy to treat SIB and AB. In current medical
practice, the treatment of SIB and AB with positive behavioral
interventions (e.g., PBS or DBT) is sometimes supplemented with
pharmacotherapy. Drugs that act in the brain may provide clinical
benefit, although the biochemical pathways that may contribute to SIB
and AB are not well understood.
    SIB and AB are seen in patients with a variety of diagnoses,
including autistic disorder, Fragile X syndrome, Lesch-Nyhan syndrome,
and other developmental disorders. There are currently two drugs that
have been approved by FDA for the treatment of irritability associated
with autistic disorder in children, a population representing a small
subset of all patients with SIB and AB. RISPERDAL (risperidone) was
approved in 2006 for the treatment of irritability associated with
autistic disorder based on clinical trials in patients ages 5 to 17
years old, and ABILIFY (aripiprazole) was approved in 2009 for the same
indication based on clinical trials in patients ages 6 to 17 years old.
In the trials conducted for approval, SIB and AB were among the
emotional and behavioral symptoms of autism that were measured in the
overall evaluation of irritability.
    The most common adverse reactions observed in the trials conducted
for approval of these two drugs were sedation, increased appetite,
fatigue, constipation, vomiting, and drooling. Other serious adverse
reactions with the use of these drugs may include neuroleptic malignant
syndrome, tardive dyskinesia, and metabolic changes.
    Published literature describes the clinical use of pharmacotherapy
for the treatment of SIB and AB, which includes the use of atypical
antipsychotics such as risperidone and aripiprazole as well as drugs
from other pharmacological classes. (See Ref. 3 for a review of
relevant literature examining the use of pharmacotherapeutic
interventions in the treatment of SIB and AB.) Reports describing the
use of certain atypical antipsychotic drugs (e.g., risperidone and
aripiprazole) are the most common, which may be in part because safety
data on their use in pediatric patients are already available and
because two of them (risperidone and aripiprazole) have been approved
by FDA for use in the subset of patients with SIB and AB who have
irritability associated with autistic disorder.
2. Information and Opinions From Experts
    FDA asked the Panel whether treatment options other than ESDs,
including behavioral, pharmacological, alternative, and experimental
therapies, are adequate to address SIB or AB. Most of the Panel opined
that other treatments are not adequate for all individuals who exhibit
SIB or AB, citing a lack of sufficient data demonstrating efficacy,
especially when evaluating the durability of benefits, drug side
effects, and that ``it's unfortunately rare that any treatments in
psychiatric or behavioral issues are universally effective.'' FDA also
asked the Panel whether a specific subpopulation of patients exhibiting
SIB or AB exists for whom pharmacological and behavioral treatment
options other than ESDs are inadequate. The panel unanimously concluded
that such a subpopulation seems to exist but is very difficult to
define and recommended additional research into refractory
subpopulations.
    Based on the available data and information, FDA is not aware of
any recognized clinical criteria to identify refractory patients. We
could not find rigorous or systematically collected data that
distinguish a refractory subpopulation that does not respond to other
available treatments. Even assuming a subpopulation exists for which
treatments other than ESDs are not adequately effective, that does not
mean ESDs are effective for that subpopulation. As with other
psychological or neurological conditions, there may simply be a
subpopulation of patients for whom there is no adequate treatment
option. As discussed previously, although some evidence suggests ESDs
reduce SIB and AB in some patients, no randomized controlled clinical
trials have been conducted to demonstrate effectiveness generally or
that ESDs are effective for behavioral conditioning when other options
fail.
    Accordingly, the Agency agrees with the observation made by one of
the Panel experts: Although other treatments may not completely reduce
or eliminate SIB or AB in all patients, that does not mean ESDs should
be used. In determining whether to ban these devices, FDA balances
effectiveness against the risks they pose and assesses the
reasonableness of such risks in light of the state of the art. The
state of the art is to use positive behavioral interventions, sometimes
in conjunction with pharmacotherapy, even for the most challenging SIB
and AB; the unsubstantiated claim that ESDs are uniquely effective for
refractory individuals does not alter that conclusion. As the Panel
expert cited previously explained, ``the statements of professional
programs and the fact of wholesale abandonment of aversive electrical
shock therapy by the peers in this field show that it is unreasonable
to conclude that these devices are part of the standard of care for
this class of patients . . . ''.
    Epitomizing the decades-long shift away from ESDs, one of the
device's pioneers has publicly repudiated contingent shock for its lack
of effectiveness (see Ref. 125). Another expert summarized in an
interview that the modern clinical approach is the result of science
establishing better methods, compared to ESDs, for the treatment of
severe problem behaviors (see Ref. 126), and another expert repudiated
behavioral treatments that use punishment techniques more broadly as
early as 1989 (see Ref. 107 for a summary).\4\
---------------------------------------------------------------------------

    \4\ Sidman, M., Coercion and Its Fallout. Authors Cooperative:
1989.
---------------------------------------------------------------------------

    FDA also considered information and opinions on state-of-the-art
treatment for SIB and AB in the expert reports it obtained. Dr. Smith's
opinion notes similar trends that FDA has identified regarding the
development of positive interventions for SIB and AB based on a
functional behavioral assessment, which allows the customization of a
treatment plan to meet the individual's needs. In his view, the data do
not support a precise estimate for success rates of positive
interventions in patients exhibiting SIB or AB, but he notes the rapid
increase in reported effectiveness, from a 1990 review that

found a success rate of 50 percent to a recent unpublished result of 84
percent. Dr. Smith concludes that non-aversive interventions can be
effective for most, but not all, people with intellectual or
developmental disabilities, which is true of any such treatment (Ref.
8).
    Dr. Brown's report provides additional detail on the development of
the PBS field. She believes 20 years of empirical evidence demonstrate
that plans designed around a functional behavioral assessment can
effectively address even the most serious problem behaviors. She
contrasts this evidence base with that for contingent skin shock, for
which she identifies a sharp decline beginning in the 1990s. In her
view, dated research on contingent skin shock is not particularly
relevant to current perspectives on people with disabilities,
especially given that such research does not meet modern standards for
study conduct or comport with the current medical understanding of
serious psychological disorders.
    One of the developments that Dr. Brown highlights is the
understanding that the ``[r]eduction of problem behavior is an
important, but not the sole, outcome of successful interventions''
(Ref. 107). Instead, an effective PBS intervention will enhance quality
of life, acquisition of valued skills, and access to valued activities
(Ref. 107; see also Refs. 127-129).
    Dr. Brown also contrasted the amount and availability of
publication and training between PBS and contingent skin shock. In
particular, several books and peer-reviewed journals focus specifically
on PBS, and graduate training programs and organizations foster the
competent development and implementation of PBS. In contrast, to her
knowledge, ``no journals, books, graduate programs, or organizations
focus [ ] on the skills necessary to use contingent electric shock or
other aversive interventions'' (Ref. 107).
    Dr. Brown further points out that while no professional
organization publishes standards of practices for the use of ESDs, the
Association for Positive Behavior Supports has adopted standards of
practice for the elements that comprise PBS (Ref. 107).\5\ To meet the
current standards of practice, a PBS plan must: (1) Address the
communicative intent of the problem behavior, e.g., with functional
communication training; (2) identify and implement curricular and
environmental modifications; and (3) focus on the patient's choice and
control. In Dr. Brown's opinion, ``professionals who are willing to use
[contingent electric shock] are likely those that do not have any
expertise in the use of PBS'' and so would not have previously
implemented plans that meet the standards of practice, reducing their
likelihood of success (see also Ref. 101).
---------------------------------------------------------------------------

    \5\ Association for Positive Behavior Supports, Positive
Behavior Support Standards of Practice: Individual Level, 2007,
available at http://apbs.org/standards-of-practice.html.
---------------------------------------------------------------------------

    Similar to Dr. Brown's conclusions, Dr. LaVigna's expert report
also emphasizes that a positive-only treatment plan developed according
to specific guidelines will adequately address even the most
challenging behaviors, regardless of the individual's diagnosis or
functioning level (Ref. 130). He separates possible elements of a PBS
plan into four categories: (1) Ecological strategies, which address a
mismatch between the individual's needs and the environment; (2)
positive programming strategies, which teach new skills with specific
instructional methods; (3) focused support strategies, which reduce or
eliminate the behavior primarily through antecedent control; and (4)
reactive strategies, which, unlike a punishment-based method, are
intended only to reduce the immediate behavior (Ref. 130).
    Dr. LaVigna elaborates on the relatively recent development of a
new outcome measure and principles to define challenging behaviors,
including episodic severity as well as the principles of resolution and
escalation (Ref. 130). Episodic severity allows a provider to account
for more than the frequency of the target behavior by adding data about
how severe the particular occurrence was (Ref. 130). In this way,
progress can be measured more completely by including a reduction in
severity, rather than merely looking at the number of occurrences. The
principles of resolution and escalation allow a provider to categorize
outcomes of interventions, which means they ``can explicitly take
responsibility'' for strategies to achieve reductions in episodic
severity (resolution) rather than increases in severity (escalation)
(Ref. 130).
    With the advent of PBS, along with refinements such as improved
outcome measures and definitions, Dr. LaVigna points to recent
literature that studied over 500 patients and found that PBS was
effective (Ref. 130). He also recounts an example of a patient for whom
ESDs had been recommended, observing that correctly implemented
positive-only methods were able to treat the patient instead (Ref.
130). He asserts that, not only is PBS highly effective even for the
most challenging behaviors, but that it can be implemented in community
and institutional settings cost effectively and accessibly (Ref. 130).
He concludes that ``[p]unishment is unnecessary, and is not the
accepted standard of care in the relevant treatment community'' (Ref.
130).
    The limited and generally outdated evidence base supporting the use
of ESDs contrasts markedly with the extensive, current, and growing
evidence base for PBS. While ESD use is founded upon research that
incorporates outmoded assumptions and in practice has often sought
compliance with staff-determined norms rather than focusing on
clinically relevant behaviors, PBS reflects modern medical advancements
and emphasizes patient choice, participation, and skills acquisition,
even for patients with the most challenging behaviors. PBS enjoys
thriving academic support and PBS practitioners can refer to practice
guidelines published by a professional organization, while academic
interest in aversive conditioning has languished and the use of ESDs is
not contemplated in a comparable publication.
3. Information From State Agencies and State Actions on ESDs
    FDA considered the actions of States with respect to ESDs and
aversive interventions generally, and we found that many already
prohibit the use of these devices. In 2011, the Massachusetts
Department of Developmental Services (DDS) proposed regulations to
prohibit the use of contingent skin shock on individuals other than
those who have an existing court-approved treatment plan that includes
the use of such devices as of September 1, 2011.\6\ According to the
Massachusetts DDS response to comments on its proposed regulation, 20
States as well as the District of Columbia specifically prohibit
aversive interventions (Ref. 131). Massachusetts' finalization of its
regulations brings the number up to 22 jurisdictions. According to a
comment from NASDDDS on the 2014 Panel Meeting, 40 States and the
District of Columbia ``have adopted regulations or policies that
expressly prohibit the use of interventions that cause pain, are
humiliating, and violate human rights.''
---------------------------------------------------------------------------

    \6\ Massachusetts DDS specifically addressed comments that
sought an extension of the prohibition to patients with court-
approved treatment plans that include the use of ESDs. However,
noting the many guardians and family members of individuals
receiving treatment with ESDs believe this is the only form of
effective treatment for their loved ones, DDS expressed a desire not
to repeat the history of extensive litigation over access to these
devices (Ref. 131).
---------------------------------------------------------------------------

    These State laws prohibiting or restricting the use of ESDs provide
further support that these devices are

not part of the state-of-the-art treatment for SIB or AB. The fact that
only one site in the United States uses ESDs on individuals with SIB or
AB (Ref. 73), and that the individuals subject to ESDs are
predominantly from two States, and from fewer than a dozen in total,\7\
strongly suggest the overwhelming majority of patients exhibiting SIB
and AB throughout the country are being treated with methods that do
not involve ESDs. Given that, as discussed in section I.B, at least
330,000 individuals in the United States exhibit SIB or AB, JRC (with
fewer than 300 residents) observes a very tiny fraction of all such
individuals.
---------------------------------------------------------------------------

    \7\ Although JRC stated at the Panel Meeting that it serves
patients from 11 States, according to one of JRC's comments, the 82
patients on whom GED devices had been used as of April 2014 are from
only 6 States, and 60 of them are from either New York or
Massachusetts (Ref. 21).
---------------------------------------------------------------------------

    In fact, the Massachusetts DDS has successfully transitioned
several patients who were subject to ESDs at JRC to providers who do
not use ESDs (Ref. 132; see also Ref. 95). FDA agrees with the
assessment of the current standard of care by the Massachusetts DDS:

    The Department concludes that there has been an evolution in the
treatment of severe behavioral disturbances in persons with
intellectual disability over the past thirty years, and particularly
in the last two decades, which has moved towards forms of treatment
that are non-aversive and involve positive behavioral supports.
    The Department bases this opinion both on the body of empirical
evidence showing the effectiveness of other less intrusive forms of
treatment that do not involve pain; on the overwhelming support of
this position by virtually every local, statewide or national
organization supporting individuals with intellectual disability,
and by providers and clinicians whose practice demonstrates that
non-aversive treatment can modify difficult or dangerous behaviors
effectively and for the long-term, while aversive interventions, in
addition to causing pain and anxiety in such individuals, have no
proven long-term efficacy.

(Ref. 131; see also Ref. 132.)

    Evidence from other States further corroborates our conclusions.
For example, as discussed earlier, according to NYSED, following
promulgation of regulations in 2006 by NYSED prohibiting future
introduction of ESDs in public and private schools and requiring review
of students then subject to ESDs, independent panels of behavior
experts determined that ESDs were not warranted in almost every
instance over a 6-year period. Similarly, at the Panel Meeting, the
Assistant Attorney General for the State of Utah, representing his
State's agencies that provide services and protection for individuals
with disabilities, observed that programs in Utah and across the nation
effectively treat SIB and AB without ESDs.
4. Comments From the Affected Manufacturer
    At the Panel Meeting, the presenters for the manufacturer stated
that the data demonstrate a clear clinical need for these devices. In
their view, therapy for these individuals has failed at all other
treatment centers, and other treatments have failed at JRC prior to the
utilization of their GED devices. They asserted that a wide range of
therapeutic interventions over long periods of time have been
ineffective for their residents on GED devices, and that typically 12
to 15 other facilities have expelled or rejected these residents before
they come to JRC. They stated that the individuals on whom ESDs are
used are those with extraordinary behavior disorders. JRC's position is
that few other treatment facilities, if any, will accept patients who
have not improved without aversives, and that the only other options
besides ESDs would be psychotropic drugs and various restraints (Ref.
21).
    FDA has found no basis to believe that the patients on whom ESDs
are used at JRC are patients with the most severe SIB and AB in the
United States. FDA also has reason to doubt whether all alternatives
were adequately attempted before resorting to ESDs. As noted in section
II.C.5, we are aware that some parents have reported that JRC did not
attempt positive approaches based on functional behavioral assessments,
and the parents felt pressured into accepting the necessity of ESDs
(Ref. 133). Similar to the NYSED review discussed in sections II.A.4
and II.B.4, another review revealed that the facility using ESDs for
SIB and AB either did not conduct a functional behavioral assessment or
did so in a non-standard way, which could reduce the effectiveness of
the resulting behavioral intervention (Ref. 107). Although there is
anecdotal evidence that treatments other than ESDs were tried on
individuals at JRC and failed prior to use of ESDs, there is evidence
in the literature that patients have been successfully treated with
alternatives after ESDs were used (Ref. 95).
    Further, evidence of failures of treatments other than ESDs is not
evidence that ESDs safely or successfully treat patients or are within
the state of the art. To cope with patients' apparent adaptation, the
manufacturer itself acknowledges that increasing the electric current
may be necessary, and if that does not work, the ESD may need to be
replaced with ``an alternative behavior program'' (Ref. 21). In fact,
consistent with our understanding of the state of the art, JRC touts
positive behavioral therapies, for example on the ``Unparalleled
Positive Programing'' page on its Web site, but its Web site does not
even mention its use of ESDs (Refs. 134 and 135).
    The comments submitted by JRC question the effectiveness of
positive behavioral interventions based on its belief that there does
not appear to be any clinical data supporting such, an absence of
research concluding that ``all problem behaviors can be effectively
treated using only PBS procedures,'' and ``literature stating that PBS
is not always effective for self-injurious behaviors.'' The comment
from a former JRC clinician also asserts that PBS and medications are
not effective for all individuals with serious behavior disorders.
    Contrary to JRCs assertion, there are clinical data supporting the
effectiveness of positive behavioral interventions such as PBS and DBT
in treating SIB and AB, as discussed earlier in this section. Further,
even though positive behavioral interventions may not always be
successful on their own for all problem behaviors in all patients, this
does not mean they are not generally effective, sometimes used in
conjunction with pharmacotherapy, or that they are not state-of-the-art
treatments for SIB and AB. Rather, the literature provides evidence
showing that multi-element positive interventions are at least as
successful as methods that include use of aversives regardless of the
behavior targeted, as discussed earlier in this section.
    JRC also submitted a paper by Dr. Blenkush, the Director of
Clinical Research at JRC, purporting to show that ESDs have a more
favorable side effect profile than antipsychotic medications (Ref. 21).
FDA notes that no peer-reviewed literature compares treatment regimens.
Further, the JRC paper makes comparisons that may not be relevant to
the selection of treatment for an individual. For example, the paper
compares frequency of specific side effects from pharmacotherapy to the
frequency of different categories of side effects from ESDs. However,
aggregate frequency data on dissimilar effects across different patient
populations provide scant basis for a comparison of treatment regimens.
Comparing a comprehensive list of the side effects of several
antipsychotic medications against the side effects of a single device,
which the paper admits ``have not been evaluated in the same depth or

with as many participants'' (Ref. 21), does not represent a valid
comparison.
    The comment from a former JRC clinician asserts the standard of
care for treatment resistant individuals such as those at JRC includes
consideration of aversive conditioning devices such as the GED, citing
a textbook that discusses punishment techniques including the use of
ESDs.\8\ FDA notes that the cited chapter reviews information on the
SIBIS, not the GED, and except for a SIBIS case report, the chapter
relies on pre-1990 studies. Furthermore, it concludes with the
observation that electric shock is usually not necessary and can be
replaced with ``more acceptable aversive outcomes'' such as a squirt of
lemon juice or a reprimand. This evidence does not demonstrate that
ESDs are currently considered by the scientific and medical community
to be an acceptable option for patients exhibiting SIB and AB.
---------------------------------------------------------------------------

    \8\ Malott, R.W. and J.T. Shane, ``Punishment (Positive
Punishment),'' in Principles of Behavior. 7th ed. 2013, Boston, MA:
Pearson.
---------------------------------------------------------------------------

5. Comments From Patients and Family Members of Patients
    The three former JRC residents who opposed a ban at the Panel
Meeting described their severe behavior issues and the failures of
alternative treatments (psychotropic medications, physical restraints,
and reward systems). One stated that the drugs made him feel like ``a
walking zombie.'' Comments from family members of JRC residents
similarly describe numerous failed alternative treatment attempts prior
to finding success with ESDs at JRC. Many family members report that
the side effects of drugs are much worse than ESDs and included:
Extreme sedation, not recognizing or interacting with others, bizarre
behavior, toxicity effects (such as damage to internal organs), loss of
personality, and lack of learning. One parent listed 26 drugs her child
had tried and other treatments that failed, including electroconvulsive
therapy (which is different from ESD application and not the subject of
this proposed rule). One mother noted that the behavior medications
interacted with her child's seizure medications and caused an increase
in seizures.
    FDA understands that family members of individuals exhibiting SIB
or AB face very difficult choices regarding treatment options, and FDA
does not doubt their best intentions, the sincerity of their belief
that an ESD is the best or perhaps only option for their loved one, or
that they have tried alternative treatments without success. However,
FDA does have reason to question the information provided to these
family members by JRC. One article reports that some parents who
consented to the use of GEDs on their children did so only under
pressure (Ref. 133). These parents reported feelings of coercion upon
admission to the facility and intimidation when attempting to change
their children's intervention plans (Ref. 133).\9\ The parents reported
facing a choice between restrictive aversive strategies justified as
measures of last resort, such as between the GED and use of a four-
point restraint board, and chose the GED as the lesser evil (Ref. 133).
---------------------------------------------------------------------------

    \9\ The authors do not identify the facility by name. However,
they are clear that the ESD in question was the GED, refer to JRC's
Web site, and rely on an article about JRC when characterizing the
facility.
---------------------------------------------------------------------------

    Although the facility touts itself as accepting refractory
patients, all of the parents interviewed provided information
suggesting that interventions in public schools prior to JRC admission
did not attempt all treatment options, such as using a functional
behavioral assessment to develop prevention or antecedent strategies
(Ref. 133). Once at JRC, none of the parents reported the development
of prevention or antecedent strategies for their children (Ref. 133).
Given that functional behavioral assessments, as well as prevention and
antecedent strategies such as those in a positive multi-element
intervention, are generally successful even for challenging SIB and AB,
such patients may well have been responsive to PBS techniques had they
been attempted.
    FDA acknowledges that these reports are only from certain parents
who volunteered to share negative experiences, and we cannot conclude
that these reported experiences were shared by others or are generally
representative of families' experiences at JRC. Nevertheless, the
reports do indicate that at least some parents felt pressured by JRC to
continue to agree to the use of GEDs on their children, and for at
least some children, alternative treatments were not exhausted. For
them, GEDs were not in fact applied as a last resort.
6. Comments and Information From Others
    Information from other Federal agencies, behavioral psychologists,
disability rights groups, and the United Nations corroborates FDA's
conclusions regarding the risks of ESDs relative to the state of the
art. For example, in its comment, the U.S. Department of Justice (DOJ)
explained that it has concluded that ESDs are outside the generally
accepted standard of care (Ref. 136). DOJ enforces the Civil Rights of
Institutionalized Persons Act (42 U.S.C. 1997 et seq.), which entitles
eligible patients to receive services that meet generally accepted
standards of care. In order to protect that right, DOJ must determine
relevant standards of care, giving DOJ experience in comparing
treatment to that which providers generally accept as the standard. In
DOJ's view, far from the standard of care, ESDs are physically and
psychologically harmful punishments that have uncertain efficacy.
According to DOJ, the current, generally accepted professional
standards of care for individuals with intensive behavioral needs
require PBS, implemented according to individualized plans, and not
restrictive methods such as ESDs. DOJ asserts that thousands of people
throughout the country with similar behavioral needs receive effective
treatment without being subjected to the risks posed by ESDs.
    Behavioral psychologists who have practiced for decades treating
patients with SIB and AB indicated in comments on the Massachusetts ban
that they have not had to resort to aversives such as ESDs, describing
painful aversives as ``unnecessary, unacceptable, and not supported by
the professional literature'' (Refs. 137 and 138). Another commenter on
the Massachusetts ban stated that in 30 years working in programs
serving individuals with severe behavior challenges and dangerous
behavior in more than 20 States, no program allowed use of pain to
control behavior (Ref. 131). At the Panel Meeting, disability rights
groups' presentations concurred that positive behavioral interventions
have been shown to result in long-term reduction or elimination of
challenging self-injurious or aggressive behaviors.
    Finally, the United Nations Special Rapporteur on torture and other
cruel, inhuman, or degrading treatment or punishment, has determined
that the application of ESDs violates the rights of individuals at JRC
under the United Nations Convention Against Torture, as well as other
international standards, and supports a complete ban on ``electroshock
procedures.'' Although the United Nations is composed of many countries
in addition to the United States, the fact that this multi-nation body
does not merely consider ESDs to be inappropriate or unacceptable
treatment, but considers them to constitute torture, suggests that
there is great distance between these devices and state of the art for
treatment of SIB and AB. Although JRC claims ESDs are used for SIB and
AB in other

nations, it has not provided any examples, and FDA is unaware of one.
7. Conclusion
    FDA has determined, on the basis of all available data and
information, that state-of-the-art treatments for SIB and AB are
positive-based behavioral approaches, sometimes alongside
pharmacotherapy, as appropriate, and do not include ESDs. We focused on
data in the scientific literature, current clinical practices, and
information about the evolution of treatments for SIB and AB.
    Significant scientific advances have yielded new insights into the
organic causes and external triggers of SIB and AB. Although
researchers have much yet to learn, the advent of functional behavioral
assessment, and, subsequently, approaches like PBS and DBT, have
allowed providers to move beyond aversive conditioning techniques such
as the contingent shocks delivered by ESDs. The state of the art
represents the achievements of an empirical response to the
inadequacies of such techniques from both a safety and effectiveness
standpoint. The scientific community has long recognized that
addressing the underlying causes of SIB or AB, rather than suppressing
it with painful shocks, not only avoids the risks posed by ESDs, but
can achieve durable, long-term benefits.
    As a result, the use of aversive conditioning techniques overall,
and ESDs in particular, has diminished considerably over the past
several decades, while the use of positive behavioral methods has
risen. The overwhelming majority of remaining providers who employ some
type of aversive conditioning use methods that are much less intrusive
than contingent shock. ESDs are only used at one facility in the United
States on individuals from a small number of States; almost half of the
States have specifically prohibited their use. Practitioners in the
field with decades of experience have asserted that they have never had
to resort to ESDs, and surveys of experts show that such views are
common. Meanwhile, modern positive behavioral treatments have been
demonstrated to work in complex environments like community settings
and achieve durable results while posing very little risk (Refs. 99,
101, and 106). Although positive behavioral interventions such as PBS
may not always be completely successful on their own for all behaviors
in all patients, the literature indicates that they are generally
successful, sometimes alongside pharmacotherapy, regardless of the
severity of the behavior targeted, and the success rates continue to
improve.

III. Determination That ESDs for SIB and AB Present an Unreasonable and
Substantial Risk of Illness or Injury

    As discussed in section I.F, section 516 of the FD&C Act authorizes
FDA to ban a device intended for human use by regulation if it finds,
on the basis of all available data and information, that such a device
presents substantial deception or an unreasonable and substantial risk
of illness or injury.
    In determining whether a deception or risk of illness or injury is
``substantial,'' FDA will consider whether the risk posed by the
continued marketing of the device, or continued marketing of the device
as presently labeled, is important, material, or significant in
relation to the benefit to the public health from its continued
marketing (see Sec.  895.21(a)(1)). With respect to ``unreasonable
risk,'' FDA analyzes the risks associated with the use of the device
relative to the state of the art (44 FR 29214 at 29215). Thus, in
determining whether a device presents an ``unreasonable and substantial
risk of illness or injury,'' FDA analyzes the risks and the benefits
the device poses to patients, comparing those risks and benefits to the
risks and benefits posed by alternative treatments being used in
current medical practice. Actual proof of illness or injury is not
required; as Congress explained when it amended the medical device
banning provisions in the FD&C Act, FDA need only find that a device
presents an ``unreasonable and substantial risk of illness or injury''
on the basis of all available data and information (H. Rep. 94-853 at
19; 44 FR 29214 at 29215).
    FDA has considered evidence from a wide variety of sources,
including the scientific literature, experts in the field, State
agencies that also regulate ESD use, the affected manufacturer/
residential facility, individuals on whom ESDs have been used and the
views of their family members, disability rights groups, and other
government entities. In weighing each piece of evidence, FDA took into
account its quality, such as the level of scientific rigor supporting
it, the objectivity of its source, its recency, and any limitations
that might weaken its value. Thus, for example, we generally gave much
more weight to the results of a study reported in a peer-reviewed
journal by an objective author than we did to anecdotal evidence.
    As discussed in section II.A, the scientific literature
demonstrates that ESDs for SIB and AB pose a number of psychological
harms including depression, PTSD, anxiety, fear, substitution of other
negative behaviors, worsening of underlying symptoms, and learned
helplessness, as well as the physical risks of pain, and skin burns.
These risks are not exclusive, and their harmful impact is magnified
when an individual experiences two or more of them together.
Misapplications of shocks present the same risks without any
possibility of benefit. FDA determined that AEs have very likely been
underreported due to various methodological limitations in the
scientific literature as well as the impaired ability of many subjects
to recognize and communicate AEs, which also increases the risk of harm
to these individuals. Because of the likely underreporting of AEs in
the literature and the fact that actual proof of harm is not required,
FDA carefully considered the risks identified through other sources,
which provide further support for the risks reported in the literature
and indicate that ESDs are associated with additional risks such as
suicidality, chronic stress, neuropathy, and injuries from falling.
Although JRC has only publicly acknowledged the risks of pain and
erythema, JRC's own records provide compelling evidence that aversive
interventions such as ESDs are associated with several other risks,
including nightmares, flashbacks of panic and rage, hypervigilance,
insensitivity to fatigue or pain, changes in sleep patterns, loss of
interest, difficulty concentrating, and withdrawal from usual activity.
    As discussed in section II.B, the studies reported in the
scientific literature show that ESDs can immediately interrupt SIB or
AB upon shock, and some studies suggest varying degrees of durable
conditioning. However, the studies in the literature suffer from
various limitations, such as weak study design, including failure to
control for concomitant treatments, small size, other methodological
limitations, lack of peer review, and author conflicts of interest. As
a result, the evidence is inadequate to establish that ESDs improve
individuals' underlying conditions or successfully condition
individuals to reduce or cease the target behavior to achieve durable
long-term reduction of the target behavior. Further, to the extent ESDs
do cause immediate interruption for some, the evidence also suggests
that the shocks are completely ineffective for others, regardless of
shock strength. Regardless of whether adaptation is the correct
characterization, even JRC has acknowledged that its strongest ESD
sometimes becomes ineffective,

necessitating the use of an alternative behavior program instead of an
ESD.
    As discussed in section II.C, FDA has determined that state-of-the-
art treatments for SIB and AB are positive-based behavioral approaches
along with pharmacotherapy, as appropriate, and do not include ESDs.
The medical community now broadly recognizes that addressing the
underlying causes of SIB and AB, including environmental ones, rather
than suppressing behaviors with shocks not only avoids the risks posed
by ESDs, but can achieve durable, long-term benefits. As a result,
research about and use of aversive conditioning techniques overall, and
ESDs in particular, has diminished considerably over the past several
decades, while research about and use of positive behavioral methods
has increased and continues to increase. ESDs are only used at one
facility in the United States with individuals from a small number of
States. Almost half of the States prohibit ESD use, and there is
evidence that the overwhelming majority of patients exhibiting SIB and
AB throughout the country are being treated without the use of ESDs.
Although positive behavioral interventions such as PBS may not always
be completely successful on their own for all behaviors in all
patients, the literature shows that they are typically successful (on
their own or in conjunction with pharmacotherapy), regardless of the
severity of the behavior targeted, even in community settings, and can
achieve durable long-term results while avoiding the risks posed by
ESDs.
    FDA has determined that the risks posed by ESDs for SIB and AB are
important, material, or significant in relation to the benefit to the
public health from their continued marketing. FDA recognizes that ESDs
can cause the immediate cessation of self-injurious or aggressive
behavior; however, the immediate effects the ESDs provide are
outweighed by the numerous short- and long-term risks discussed earlier
in this section. For many individuals who exhibit SIB or AB, these
risks are magnified by their inability to adequately communicate the
harms they experience to their health care providers. Even when
immediate cessation is achieved, without durable conditioning the
target behavior will recur over time and necessitate ongoing shocks to
cause immediate cessation, magnifying the risks. If adaptation occurs,
it would render the shocks wholly ineffective and could lead to
stronger shocks with no effect. Thus, the degree to which the risks
outweigh the benefits increases over time.
    FDA has also considered the risks posed by ESDs for SIB and AB
relative to the state of the art. Decades ago, health care providers
had a poor understanding of the causes of SIB and AB and very limited
options to treat SIB or AB. Contingent skin shock was used even though
the result was fleeting and continual shock administration was needed.
Since then, state-of-the-art treatment for SIB and AB has evolved
considerably. Today we know that careful functional assessment, which
identifies specific unwanted or undesired behaviors, the frequency and
severity of these behaviors, and their specific triggers, allows for
the development of positive-based behavioral therapy that provides
greater benefit and poses less risk than using ESDs. Although they may
demand more health care provider training and effort than ESDs, various
multi-element positive interventions such as PBS and DBT are now very
much viable options for treatment of SIB and AB. These interventions
pose little risk and, on their own or alongside pharmacological
treatments, have been shown to be successful in treating even the most
severe behaviors in both clinical and community settings, and to
achieve durable long-term results.
    Several individuals have been successfully transitioned from ESDs
at JRC to positive-based therapies elsewhere. Thus individuals
exhibiting SIB or AB have alternative options to ESDs that pose less
risk and provide greater benefit through durable long-term
effectiveness in both clinical and community settings.
    Based on a careful evaluation of the risks and benefits of ESDs for
SIB and AB and the risks and benefits of state-of-the-art treatments
for SIB and AB, FDA has determined the risk of illness or injury posed
by ESDs for SIB and AB to be substantial and unreasonable. A majority
of the expert Panel also found that ESDs for SIB and AB present a
substantial and unreasonable risk of illness or injury. The Panel
members who opined that this standard is not met generally had concerns
about foreclosing the possibility that new ESDs may be developed in the
future and used in a way that can safely and effectively treat SIB and
AB. In this regard, FDA notes that a banned device is not barred from
clinical study under an investigational device exemption pursuant to
section 520(g) of the FD&C Act. However, any such study must meet all
applicable requirements, including but not limited to, those for:
Protection of human subjects (21 CFR part 50), financial disclosure by
clinical investigators (21 CFR part 54), approval by institutional
review boards (21 CFR part 56), and investigational device exemptions
(21 CFR part 812). Other panelists were reluctant to agree that the
banning standard had been met because it could be possible to develop
ESDs to treat SIB or AB without being noxious. In response to these
concerns, FDA notes that devices that are not noxious are not within
the scope of this ban.
    Other than JRC and the former JRC clinician, the only comments in
opposition to a ban either at the Panel Meeting or through submission
of comments to the Panel Meeting docket were from three former JRC
residents, family members of individuals on whom ESDs were used at JRC
(one of the parents association comments included 32 letters from
family members), a Massachusetts State Representative, and one
concerned citizen. As discussed earlier, FDA recognizes that family
members of individuals now and previously on ESDs at JRC have had to
make some very difficult decisions regarding the care of a loved one,
and FDA does not doubt their intentions or question the sincerity of
their belief that ESDs are the best or only option available. However,
as discussed in section II.C.5, FDA has reason to believe at least some
of these family members were pressured into choosing ESDs, and FDA
questions whether these family members were provided with full and
accurate information regarding the risks and benefits of ESDs and
alternative treatment options, and whether all other options were
adequately attempted prior to ESD use.

IV. Labeling

    FDA has determined that labeling, or a change in labeling, cannot
correct or eliminate the unreasonable and substantial risk of illness
or injury. At the Panel Meeting, only members who opined that ESDs
present an unreasonable and substantial risk of illness or injury (a
majority of the entire Panel) were asked whether labeling could correct
or eliminate this risk, and all concluded that labeling could not
correct or eliminate the risks or dangers.
    As explained in section II.A, the risks posed by ESDs fall under
two broad categories, psychological and physical, and these risks are
heightened when the devices are used to treat patients who exhibit SIB
or AB because of these patients' vulnerabilities. As explained in
sections I.C and II.A.1, individuals demonstrate great variability in
their experience of ESD shocks, including with respect to pain and the
psychological harms discussed. A person's physical state naturally

changes continuously, so the body's reaction to ESD shocks will change
continuously, and a person's mental state further shapes the
experience. The same electric shock, as characterized by electrical
current and stimulation site, may affect any given person in a variable
manner from one shock to another. This variability is seen across
different individuals, which prevents providers from using one person's
experience as a guide for another person, and within the same
individual over time, which prevents providers from using a single
person's past experience as a predictor of future experiences.
    Labeling cannot correct or eliminate the risks or dangers because
conditions under which providers could overcome the underlying inter-
or intrapersonal variability cannot be defined. Predicting an
individual's resulting experience would require knowing the initial
psychological and physical states of the person, which is subjective
information that providers cannot reliably know, especially when making
a split-second decision whether to apply a shock. Further, individuals,
especially ones with intellectual or developmental disabilities, may
not be able to accurately and reliably communicate information
regarding their physical or psychological state. Thus it would be
impossible to create broadly applicable labeling that could account for
these variables; labeling could only warn the provider that it is
impossible to account adequately for all relevant factors. Because
labeling cannot correct or eliminate the fact that providers lack
knowledge required to mitigate the risk of harm, it cannot correct or
eliminate the risks or dangers posed by ESDs for SIB or AB.
    Labeling also cannot correct or eliminate ESD risks or dangers by
specifying output parameters, for example, maximum current or optimal
electrode placement. As explained in section II.A.1, the subjective
experience, especially in terms of psychological harms, does not
necessarily vary in proportion to shock strength. Even a relatively
mild stimulus can trigger or contribute over time to a more serious
psychological reaction (e.g., Refs. 31-33). Thus it would not be
possible to provide warnings regarding output parameters to correct or
eliminate the risks and dangers.
    Labeling also cannot limit the risks to only the most refractory
patients. As explained, although evidence indicates that a
subpopulation of refractory individuals may exist, that subpopulation
is difficult if not impossible to define. The labeling of the GED
devices, the only ESDs currently in use in the United States of which
FDA is aware, already includes the statement that ``[t]he device should
be used only on patients where alternate forms of therapy have been
attempted and failed.'' Yet the available evidence, discussed in
section II.C.5, casts doubt on whether JRC in fact applies the devices
as a last resort after attempting all other approaches, and shows that
patients JRC considered to be refractory were transitioned successfully
to other treatments. Thus labeling has failed to limit use of the
device to patients who do not have other adequate treatment options.
Further, even if a refractory subpopulation could be defined, as
discussed in section II.C.4, the possibility that some patients are
refractory to treatment does not necessarily mean that ESDs would be an
effective treatment or that the benefits of ESD use outweigh the risks.
Thus labeling cannot correct or eliminate the substantial and
unreasonable risk posed by ESDs.
    In his report, Dr. Smith recommends against banning and that FDA
should instead impose the following restrictions: ``(1) A prescription
and ongoing, periodic review by a board-certified physician, licensed
psychologist, or licensed behavior analyst and (2) prior approval and
ongoing, periodic review by an independent patient-rights committee
convened by a healthcare organization that is accredited by an
organization such as the Joint Commission.'' Although FDA does not have
to consider whether restrictions would obviate the need for a ban, we
have considered Dr. Smith's proposal and do not believe restrictions
would correct or eliminate the substantial and unreasonable risk posed
by ESDs. The only ESDs currently in use are prescription devices and,
as explained by JRC, ``require multiple levels of review, approval,
consent and oversight.'' FDA has determined that JRC's measures do not
adequately mitigate the unreasonable and substantial risk posed by
these devices. While the measures Dr. Smith recommends are perhaps
stronger, there is not enough information to determine that such
measures would adequately mitigate the risks.

V. Application of Ban to Devices in Distribution and Use

    FDA is proposing that the ban apply to devices already in
commercial distribution and devices already sold to the ultimate user,
as well as devices sold or commercially distributed in the future (see
Sec.  895.21(d)(7)). This means ESDs currently in use on individuals
would be subject to the ban and thus adulterated under section 501(g)
of the FD&C Act and subject to FDA enforcement action.
    FDA is proposing this because the risk of illness or injury to
individuals on whom these devices are already used is just as
unreasonable and substantial as it is for future individuals on whom
these devices could be used. Indeed, as safer and more effective
alternative treatments continue to be developed, it is the individuals
on whom ESDs are currently used for whom the ban may have the most
impact. The majority of the Panel agreed that, if FDA were to ban ESDs,
the ban should apply to devices already in use.
    JRC believes that any action ``that would precipitously remove or
require the eventual removal of the GED from the patients who currently
rely on this court-ordered therapy would have dire consequences from a
patient safety and health perspective'' (Ref. 21). According to JRC,
the GED ``is the only treatment available to these patients''; all
others were tried and failed. As an example of what could result from a
mandated, sudden removal of the GED from a patient, JRC explains that
one patient whose GED was removed against the medical advice of JRC
health professionals soon resumed self-injurious scratching and picking
behaviors that led to serious blood and bone infections, paralysis of
his legs, and eventual death 3 years after leaving JRC (Ref. 139).
    As discussed in section II.C, FDA does not agree that ESDs are the
only treatment available for individuals exhibiting SIB or AB, no
matter how severe the behavior may be, and FDA has reason to doubt
whether all other treatment options were attempted for individuals
prescribed these devices. FDA has not been able to verify the accuracy
of JRC's account regarding an individual removed from the GED. However,
even if accurate, that does not mean that the GED was not harmful to
the individual, nor does it speak to the extent to which other
treatments were tried after he left JRC. The only support JRC offers
for this anecdote is a post on its Web site by Dr. Israel that does not
include information regarding possible harms from GED use or details
regarding treatment after the patient left JRC, and JRC states it
offered the post as an editorial to the New York Times but was
rejected. In contrast to JRC's assertions, we again note that one study
described in the literature found that less restrictive interventions
successfully treated SIB and AB in individuals after ESDs were removed
(Ref. 95), and that

Massachusetts DDS has successfully transitioned several patients who
were subject to ESDs at JRC to providers who do not use ESDs (Ref.
132).
    However, FDA recognizes that, for certain individuals currently
subject to ESDs, immediate cessation could possibly result in a
significant increase of SIB or AB before appropriate alternative
therapies are in effect, and a more gradual reduction toward complete
removal may be necessary for some patients, especially those who have
been subject to ESDs for a considerable amount of time. Thus, to
account for this possibility, in appropriate circumstances, FDA does
not intend to enforce the ban for a limited period of time with respect
to ESDs that continue to be used on patients after the effective date.
We intend to consider, for example, whether the patient has a
documented medical need for gradual transition to an alternative
therapy, as determined by an independent psychiatrist, psychologist, or
similar State-licensed behavioral expert. We welcome comment on how
long transitions may take. FDA does not intend to enforce against
individual patients.

VI. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register. FDA requests comment on the proposed effective date
for this proposed rule.

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of
this proposed rule and of possible alternative actions. In doing so,
the Agency focused on the environmental impacts of its action as a
result of disposal of unused ESDs that will need to be handled after
the effective date of the proposed rule.
    The environmental assessment (EA) considered each of the
alternatives in terms of the need to provide maximum reasonable
protection of human health without resulting in a significant impact on
the environment. The EA considered environmental impacts related to
landfill and incineration of solid waste. The proposed action would
result in an initial batch disposal of used and unused ESDs primarily
at a single geographic location followed by a gradual, intermittent
disposal of a small number of remaining devices in this and other
affected communities where these devices are used. The total number of
devices to be disposed is small, i.e., approximately less than 300
units. Overall, given the limited number of ESDs in commerce, the
proposed action is expected to have no significant impact on landfill
and solid waste facilities and the environment in affected communities.
    The Agency has concluded that the proposed rule would not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact (FONSI) and the evidence supporting that finding, contained in
an EA prepared under 21 CFR 25.40, may be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday. FDA invites comments and submission of data concerning
the EA and FONSI.

VIII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. We believe that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule would only affect one entity that
is not classified as small, we propose to certify that the proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary of Costs and Benefits

    FDA is proposing to ban ESDs for the purpose of treating self-
injurious or aggressive behavior. Non-quantified benefits of the
proposed rule include a reduction in adverse events, such as the risk
of burns, PTSD, and other physical or psychological harms related to
use of the device in this patient population.
    We expect that the proposed rule would only affect one entity that
currently uses these devices to treat residents of their facility. The
proposed rule would impose costs on this entity to read and understand
the rule, as well as to provide affected individuals with alternative
treatments. Although uncertain, other treatments or care at other
facilities may cost more. To account for this uncertainty, we use a
range of potential alternative treatment costs. At the lower bound, we
assume that alternative treatments would cost the same as the current
treatment. We use reimbursement data from the State of Massachusetts to
estimate a potential upper bound for alternative treatments. The costs
for the one affected entity to read and understand the rule range from
$438 to $753. The present value of the incremental treatment costs over
10 years ranges from $0 to $60.1 million at a 3 percent discount rate,
and from $0 to $51.4 million at a 7 percent discount rate. Annualized
costs range from $0 million to $6.8 million at a 3 percent discount
rate and from $0 million to $6.8 million at a 7 percent discount rate.
The lower-bound cost estimates only include administrative costs to
read and understand the rule with no incremental costs for alternative
treatments. Additionally, there would be transfer payments between
$11.5 million and $15 million annually either within the affected
entity to treat the same individuals using alternative treatments, or
between entities if affected individuals transfer to alternate
facilities for treatment. The proposed rule's costs and benefits are
summarized in table 2, ``Economic Data: Costs and Benefits Statement.''
    We also examined the economic implications of the rule as required
by the Regulatory Flexibility Act. The Regulatory Flexibility Act
requires us to analyze regulatory options that would minimize any
significant impact of a rule on small entities. Because the proposed
rule would only affect one entity that is not classified as small, we
propose to certify that the proposed rule would not have a significant
economic

impact on a substantial number of small entities.
    The full discussion of economic impacts is available in Docket No.
FDA-2016-N-1111 at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

                                                  Table 2--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                        Primary                    ------------------------------------------------
             Category                Low estimate      estimate      High estimate                                      Period              Notes
                                       (million)       (million)       (million)     Year dollars    Discount rate      covered
                                                                                (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized....................
    Monetized $millions/year......
    Annualized Quantified.........
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Reduction in
                                                                                physical and
                                                                                psychological
                                                                                adverse events
                                                                                related to use of
                                                                                the device.
Costs:
    Annualized....................              $0            $3.4            $6.8            2015               7              10
    Monetized $millions/year......               0             3.4             6.8            2015               3              10
    Annualized....................
    Quantified....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Transition costs to
                                                                                the affected entity
                                                                                and individuals for
                                                                                transitioning to
                                                                                alternative
                                                                                treatments.
Transfers:
    Federal.......................
    Annualized....................
                                   ------------------------------------------------------------------------------------------------
    Monetized $millions/year......  From:
                                    To:
                                   ------------------------------------------------------------------------------------------------
    Other Annualized..............            11.5            13.3              $5            2015               7              10
    Monetized $millions/year......            11.5            13.3              15            2015               3              10
                                   ------------------------------------------------------------------------------------------------
                                    From: Affected entity for current treatment
                                    To: Affected entity for other treatments or to
                                    other facilities that treat aggressive or self-
                                    injurious behavior
                                   ---------------------------------------------------------------------------------------------------------------------
Effects...........................  State, Local or Tribal Government: State expenditures may rise or fall if individuals move across state boundaries.
                                    Small Business: No effect.
                                    Wages: No effect.
                                    Growth: No effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

IX. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

X. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain state requirements ``different from or
in addition to'' certain Federal requirements applicable to devices.
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr,
518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)).
If this proposed rule is made final, it would create a Federal
requirement under 21 U.S.C. 360k that bans ESDs for AB and SIB.

XI. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Cooper, S.A., E. Smiley, L.M. Allan, et al., ``Adults With
Intellectual Disabilities: Prevalence, Incidence and Remission of
Self-Injurious Behaviour, and Related Factors.'' Journal of
Intellectual Disability Research, 53(3):200-216, 2009.
2. Ross-Collins, M.S. and K. Cornish, ``A Survey of the Prevalence
of Stereotypy, Self-Injury and Aggression in Children and Young
Adults with Cri du Chat Syndrome.'' Journal of Intellectual
Disability Research, 46(2):133-140, 2002.
3. FDA, Executive Summary. Meeting Materials of the Neurological
Devices Panel 2014. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM394256.pdf.
4. Mayes, S.D., S.L. Calhoun, R. Aggarwal, et al., ``Explosive,
Oppositional, and Aggressive Behavior in Children With Autism
Compared to Other Clinical Disorders and Typical Children.''
Research in Autism Spectrum Disorders, 6(1):1-10, 2012.
5. Hastings, R.P., ``Do Challenging Behaviors Affect Staff
Psychological Well-Being? Issues of Causality and Mechanism.''
American Journal on Mental Retardation, 107(6):455-467, 2002.
6. Emerson, E., Challenging Behavior, Analysis and Intervention in
People With Severe Intellectual Disabilities. 2d ed. New York, NY:
Cambridge University Press, 2001.
7. Griffin, J.C., R.W. Ricketts, D.E. Williams, et al., ``A
Community Survey of Self-Injurious Behavior Among Developmentally
Disabled Children and

Adolescents.'' Hospital and Community Psychiatry, 38(9):959-963,
1987.
8. Smith, T., solicited opinion, to FDA. Received June 30, 2015.
9. MacLean, W.E., Jr., R.C. Tervo, J. Hoch, et al., ``Self-Injury
Among a Community Cohort of Young Children at Risk for Intellectual
and Developmental Disabilities.'' The Journal of Pediatrics,
157(6):979-983, 2010.
10. Fish, R.M. and L.A. Geddes, ``Conduction of Electrical Current
to and Through the Human Body: A Review.'' Open Access Journal of
Plastic Surgery, 9:407-421, 2009.
11. Butterfield, W.H., ``Electric Shock--Hazards in Aversive Shock
Conditioning of Humans.'' Behavioral Engineering, 3(1):1-28, 1975.
12. Ekman, G., M. Frankenhaeuser, S. Levander, et al., ``The
Influence of Intensity and Duration of Electrical Stimulation on
Subjective Variables.'' Scandinavian Journal of Psychology, 7:58-64,
1966.
13. Mason, J.L. and N.A.M. MacKay, Pain Sensations Associated With
Electrocutaneous Stimulation. 1976.
14. Newman, A.L., ``Self-Injurious Behavior Inhibiting System.''
Johns Hopkins APL Technical Digest, 5(3):290-295, 1984.
15. Tursky, B., ``Factors That Can Affect the Use of Electric Shock
in Behavior Therapy.'' Behavioral Engineering, 2(3):61-67, 1975.
16. Verhoeven, K. and J.G. van Dijk, ``Decreasing Pain in Electrical
Nerve Stimulation.'' Clinical Neurophysiology, 117(5):972-978, 2006.
17. Blumenthal, T.D., T.T. Burnett, and C.D. Swerdlow, ``Prepulses
Reduce the Pain of Cutaneous Electrical Shocks.'' Psychosomatic
Medicine, 63:275-281, 2001.
18. Duker, P.C., J. van den Bercken, and M.-A. Foekens, ``Focusing
Versus Distraction and the Response to Clinical Electric Shocks.''
Journal of Behavior Therapy and Experimental Psychiatry, 30:199-204,
1999.
19. Tursky, B., ``Physical, Physiological, and Psychological Factors
That Affect Pain Reaction to Electric Shock.'' Psychophysiology,
11(2):95-112, 1973.
20. Nave, B.C. and C.R. Nave, ``Electrical Safety in the Hospital,''
in Physics for the Health Sciences, 3d ed. Philadelphia, PA: W.B.
Saunders Publishing Co., 1985.
21. JRC, Inc., public docket comment, FDA-2014-N-0238 (P0065).
Received Apr. 14, 2014.
22. Arntz, A. and P. De Jong, ``Anxiety, Attention and Pain.''
Journal of Psychosomatic Research, 37(4):423-432, 1993.
23. Delitto, A., M.J. Strube, A.D. Shulman, et al., ``A Study of
Discomfort With Electrical Stimulation.'' Physical Therapy,
72(6):410-421, 1992.
24. Jones, B., M. Planas, and T. Anuza, ``Painfulness Decreases the
Discriminability of Electric Shock.'' Perception & Psychophysics,
32(2):187-191, 1982.
25. Rollman, G.B. and G. Harris, ``The Detectability,
Discriminability, and Perceived Magnitude of Painful Electrical
Shock.'' Perception & Psychophysics, 42(3):257-268, 1987.
25a. FDA, ``Medical Devices; Establishment of Procedures to Make a
Device a Banned Device.'' Federal Register, 44(98): 29214-29224, May
18, 1979.
26. FDA, Meeting Materials of the Neurological Devices Panel 2014.
Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm394252.htm.
27. FDA, Roster. Meeting Materials of the Neurological Devices Panel
2014. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM394254.pdf.
28. FDA, FDA Presentation: Aversive Conditioning. Meeting Materials
of the Neurological Devices Panel 2014. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM395135.pdf.
29. Duker, P.C. and D.M. Seys, ``A Quasi-Experimental Study on the
Effect of Electrical Aversion Treatment on Imposed Mechanical
Restraint for Severe Self-Injurious Behavior.'' Research in
Developmental Disabilities, 21:235-242, 2000.
30. Israel, M.L., N.A. Blenkush, R.E. von Heyn, et al., ``Treatment
of Aggression With Behavioral Programming That Includes
Supplementary Contingent Skin-Shock.'' JOBA-OVTP, 1(4), 2008.
31. Rosen, G.M. and S.O. Lilienfeld, ``Posttraumatic Stress
Disorder: An Empirical Evaluation of Core Assumptions.'' Clinical
Psychology Review, 28(5):837-868, 2008.
32. Scott, M.J. and S.G. Stradling, ``Post-Traumatic Stress Disorder
Without the Trauma.'' British Journal of Clinical Psychology, 33:71-
74, 1994.
33. Levy-Gigi, E. and G. Richter-Levin, ``The Hidden Price of
Repeated Traumatic Exposure.'' Stress, 17(4):343-351, 2014.
34. Duker, P.C. and D.M. Seys, ``Long-Term Use of Electrical
Aversion Treatment With Self-Injurious Behavior.'' Research in
Developmental Disabilities, 17(4):293-301, 1996.
35. Bucher, B. and O.I. Lovaas, ``Use of Aversive Stimulation in
Behavior Modification,'' in Symposium on the Prediction of Behavior,
1967, M.R. Jones, Editor. 1968, University of Miami Press: Miami.
36. Lovaas, O.I. and J.Q. Simmons, ``Manipulation of Self-
Destruction in Three Retarded Children.'' Journal of Applied
Behavior Analysis, 2(3):143-157, 1969.
37. Merbaum, M., ``The Modification of Self-Destructive Behavior by
a Mother-Therapist Using Aversive Stimulation.'' Behavior Therapy,
4(3):442-447, 1973.
38. Baroff, G.S. and B.G. Tate, ``The Use of Aversive Stimulation in
the Treatment of Chronic Self-Injurious Behavior.'' Journal of the
American Academy of Child Psychiatry, 7(3):454-470, 1968.
39. Williams, D.E., S. Kirkpatrick-Sanchez, and W.T. Crocker, ``A
Long-Term Follow-Up of Treatment for Severe Self-Injury.'' Research
in Developmental Disabilities, 15(6):487-501, 1994.
40. Bucher, B. and L.W. King, ``Generalization of Punishment Effects
in the Deviant Behavior of a Psychotic Child.'' Behavior Therapy,
2:68-77, 1971.
41. Mudford, O.C., K. Boundy, and A.D. Murray, ``Therapeutic Shock
Device (TSD): Clinical Evaluation With Self-Injurious Behaviors.''
Research in Developmental Disabilities, 16(4):253-267, 1995.
42. Lovaas, O.I., B. Schaeffer, and J.Q. Simmons, ``Building Social
Behavior in Autistic Children by Use of Electric Shock.'' Journal of
Experimental Research in Personality, 1:99-109, 1965.
43. Birnbrauer, J.S., ``Generalization of Punishment Effects--A Case
Study.'' Journal of Applied Behavior Analysis, 1:201-211, 1968.
44. Miron, N.B., ``Behavior Modification Techniques in the Treatment
of Self-Injurious Behavior in Institutionalized Retardates.''
Bulletin of Suicidology. 1971. p. 64-69.
45. Ludwig, A.M., A.J. Marx, P.A. Hill, et al., ``The Control of
Violent Behavior Through Faradic Shock: A Case Study.'' The Journal
of Nervous and Mental Disease, 148(6):624-637, 1969.
46. Brandsma, J.M. and L.I. Stein, ``The Use of Punishment as a
Treatment Modality: A Case Report.'' The Journal of Nervous and
Mental Disease, 156(1):30-37, 1973.
47. Pace, G.M., B.A. Iwata, G.L. Edwards, et al., ``Stimulus Fading
and Transfer in the Treatment of Self-Restraint and Self-Injurious
Behavior.'' Journal of Applied Behavior Analysis, 19(4):381-389,
1986.
48. Young, J.A. and J.P. Wincze, ``The Effects of the Reinforcement
of Compatible and Incompatible Alternative Behaviors on the Self-
Injurious and Related Behaviors of a Profoundly Retarded Female
Adult.'' Behavior Therapy, 5:614-623, 1974.
49. Hall, H., D.E. Thorne, M. Shinedling, et al., ``Overcoming
Situation--Specific Problems Associated With Typical Institutional
Attempts to Suppress Self-Mutilative Behavior.'' The Training School
Bulletin. 1973. p. 111-114.
50. Ricketts, R.W., A.B. Goza, and M. Matese, ``A 4-Year Follow-Up
of Treatment of Self-Injury.'' Journal of Behavior Therapy and
Experimental Psychiatry, 24(1):57-62, 1993.
51. Kenny, F.T., L. Solyom, and C. Solyom, ``Faradic Disruption of
Obsessive Ideation in the Treatment of Obsessive Neurosis.''
Behavior Therapy, 4:448-457, 1973.
52. Michaelsson, G., ``Short-Term Effects of Behaviour Therapy and
Hospital Treatment of Chronic Alcoholics.''

Behaviour Research and Therapy, 14(1):69-72, 1976.
53. Russell, M.A.H., ``Effect of Electric Aversion on Cigarette
Smoking.'' British Medical Journal, 1:82-86, 1970.
54. Balsam, P.D. and A.S. Bondy, ``The Negative Side Effects of
Reward.'' Journal of Applied Behavior Analysis, 16(3):283-296, 1983.
55. Logan, D.L. and J.R. Turnage, ``Ethical Considerations in the
Use of Faradic Aversion Therapy.'' Behavioral Engineering, 3(1):29-
34, 1975.
56. Corbett, J., ``Aversion for the Treatment of Self-Injurious
Behaviour.'' Journal of Mental Deficiency Research, 19:79-95, 1975.
57. Lichstein, K.L. and L. Schreibman, ``Employing Electric Shock
With Autistic Children.'' Journal of Autism and Childhood
Schizophrenia, 6(2):163-288, 1976.
58. Meyer, L.H. and I.M. Evans, Nonaversive Intervention for
Behavior Problems: A Manual for Home and Community. Baltimore, MD:
Paul Brookes Publishing Co., 1989.
59. Lerman, D.C. and C.M. Vorndran, ``On the Status of Knowledge for
Using Punishment: Implications for Treating Behavior Disorders.''
Journal of Applied Behavior Analysis, 35(4):431-464, 2002.
60. Berkowitz, L., ``Aversively Stimulated Aggression: Some
Parallels and Differences in Research With Animals and Humans.''
American Psychologist, 38(11):1135-1144, 1983.
61. Sears, S.F., J.D. Hauf, K. Kirian, et al., ``Posttraumatic
Stress and the Implantable Cardioverter-Defibrillator Patient: What
the Electrophysiologist Needs to Know.'' Circulation: Arrhythmia and
Electrophysiology, 4(2):242-250, 2011.
62. Jacob, S., S.S. Panaich, S.K. Zalawadiya, et al., ``Phantom
Shocks Unmasked: Clinical Data and Proposed Mechanism of Memory
Reactivation of Past Traumatic Shocks in Patients With Implantable
Cardioverter Defibrillators.'' Journal of Interventional Cardiac
Electrophysiology, 34(2):205-213, 2011.
63. Sears, S.F. and J.B. Conti, ``Understanding Implantable
Cardioverter Defibrillator Shocks and Storms: Medical and
Psychosocial Considerations for Research and Clinical Care.''
Clinical Cardiology, 26:107-111, 2003.
64. Ladwig, K.H., J. Baumert, B. Marten-Mittag, et al.,
``Posttraumatic Stress Symptoms and Predicted Mortality in Patients
With Implantable Cardioverter-Defibrillators.'' Archives of General
Psychiatry, 65(11):1324-1330, 2008.
65. Ball, T.S., L. Sibbach, R. Jones, et al., ``An Accelerometer-
Activated Device to Control Assaultive and Self-Destructive
Behaviors in Retardates.'' Journal of Behavior Therapy and
Experimental Psychiatry, 6:223-228, 1975.
66. Allely, C.S., ``Pain Sensitivity and Observer Perception of Pain
in Individuals With Autistic Spectrum Disorder.'' The Scientific
World Journal, 2013. DOI: 10.1155/2013/916178. Available at: http://www.ncbi.nlm.nih.gov/pubmed/23843740.
67. Carr, E.G. and O.I. Lovaas, ``Contingent Electric Shock as a
Treatment for Severe Behavior Problems.'' The Effects of Punishment
on Human Behavior, S. Axelrod and J. Apsche, Eds. New York, NY:
Academic Press, Inc., 1983.
68. FDA, Transcript. Meeting Materials of the Neurological Devices
Panel 2014. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM398417.pdf.
69. Disability Law Center, public docket comment, FDA-2014-N-0238
(P0038). Received April 14, 2014.
70. Massachusetts DEEC, Investigation Report, Incident #49037,
November 1, 2007.
71. NYSED, Observations and Findings of Out-of-State Program
Visitation: Judge Rotenberg Educational Center, June 9, 2006.
72. NYSED, public docket comment, FDA-2014-N-0238 (P0028). Received
April 14, 2014.
73. JRC, Inc., public docket comment, FDA-2014-N-0238 (D0295).
Received June 23, 2014.
74. Cameron, M.J., public docket comment, FDA-2014-N-0238 (N0042).
Received April 14, 2014.
75. BRI Parents & Friends Association, Inc., public docket comment,
FDA-2014-N-0238 (P0037). Received April 14, 2014.
76. Anderson, K., Mother Sues Judge Rotenberg Center Over `Torture'
of Disabled Son. CBS Boston, April 11, 2012. Available at: http://boston.cbslocal.com/2012/04/11/mother-sues-judge-rotenberg-center-over-torture-of-disabled-son/.
77. McClennen, S., public docket comment, FDA-2014-N-0238 (P0049).
Received April 14, 2014.
78. Duker, P.C. and M. Van den Munckhof, ``Heart Rate and the Role
of the Active Receiver During Contingent Electric Shock for Severe
Self-Injurious Behavior.'' Research in Developmental Disabilities,
28(1):43-49, 2007.
79. Murphy, G.H. and B. Wilson, ``Long-Term Outcome of Contingent
Shock Treatment for Self-Injurious Behaviour.'' Frontiers of
Knowledge in Mental Retardation, Vol. II--Biomedical Aspects, P.
Mittler and J.M. deJong, Eds. Baltimore, MD: University Park Press,
1980, pp. 303-311.
80. Frankel, F. and J.Q. Simmons, ``Self-Injurious Behavior in
Schizophrenic and Retarded Children.'' American Journal of Mental
Deficiency, 80(5):512-522, 1976.
81. Browning, R.M., ``Treatment Effects of a Total Behavior
Modification Program With Five Autistic Children.'' Behaviour
Research and Therapy, 9:319-327, 1971.
82. Callias, M., J. Carr, J. Corbett, et al., ``Use of Behaviour
Modification Techniques in a Community Service for Mentally
Handicapped Children.'' Proceedings of the Royal Society for
Medicine, 66:1140-1142, 1974.
83. Corte, H.E., M.M. Wolf, and B.J. Locke, ``A Comparison of
Procedures for Eliminating Self-Injurious Behavior of Retarded
Adolescents.'' Journal of Applied Behavior Analysis, 4(3):201-213,
1971.
84. Foxx, R.M., ``The Treatment of Dangerous Behavior.'' Behavioral
Interventions, 18(1):1-21, 2003.
85. Foxx, R.M., R.G. Bittle, and G.D. Faw, ``A Maintenance Strategy
for Discontinuing Aversive Procedures: A 52-Month Follow-Up of the
Treatment of Aggression.'' American Journal of Mental Retardation,
94(1):27-36, 1989.
86. Griffin, J.C., B.J. Locke, and W.F. Landers, ``Manipulation of
Potential Punishment Parameters in the Treatment of Self-Injury.''
Journal of Applied Behavior Analysis, 8(4):458, 1975.
87. Linscheid, T.R. and H. Reichenbach, ``Multiple Factors in the
Long-Term Effectiveness of Contingent Electric Shock Treatment for
Self-Injurious Behavior: A Case Example.'' Research in Developmental
Disabilities, 23:161-177, 2002.
88. Linscheid, T.R., B.A. Iwata, R.W. Ricketts, et al., ``Clinical
Evaluation of the Self-Injurious Behavior Inhibiting System
(SIBIS).'' Journal of Applied Behavior Analysis, 23(1):53-78, 1990.
89. Muttar, A.K., D. Peck, D. Whitlow, et al., ``Reversal of a
Severe Case of Self-Mutilation.'' Journal of Mental Deficiency
Research, 19:3-9, 1975.
90. Salvy, S.J., J.A. Mulick, E. Butter, et al., ``Contingent
Electric Shock (SIBIS) and a Conditioned Punisher Eliminate Severe
Head Banging in a Preschool Child.'' Behavioral Interventions,
19:59-72, 2004.
91. Whaley, D.L. and J. Tough, ``Treatment of a Self-Injuring
Mongoloid With Shock-Induced Suppression and Avoidance.'' Michigan
Mental Health Research Bulletin, 2:33-35, 1968.
92. Williams, D.E., S. Kirkpatrick-Sanchez, and B.A. Iwata, ``A
Comparison of Shock Intensity in the Treatment of Longstanding and
Severe Self-Injurious Behavior.'' Research in Developmental
Disabilities, 14:207-219, 1993.
93. Lydon, S., O. Healy, L. Moran, et al., ``A Quantitative
Examination of Punishment Research.'' Research in Developmental
Disabilities, 36:470-484, 2014.
94. Israel, M.L., N.A. Blenkush, R. E. Von Heyn, et al., ``Seven
Case Studies of Individuals Expelled From Positive-Only Programs.''
JOBA-OVTP, 2(1):223-239, 2010.
95. Bird, F.L. and J.K. Luiselli, ``Positive Behavioral Support of
Adults With Developmental Disabilities: Assessment of Long-Term
Adjustment and Habilitation Following Restrictive Treatment
Histories.'' Journal of Behavior Therapy and Experimental
Psychiatry, 31:5-19, 2000.
96. van Oorsouw, W.M., M.L. Israel, R.E. von Heyn, et al., ``Side
Effects of Contingent Shock Treatment.'' Research in Developmental
Disabilities, 29(6):513-523, 2008.
97. LaVigna, G.W. and T.J. Willis, ``The Efficacy of Positive
Behavioural Support

With the Most Challenging Behaviour: The Evidence and Its
Implications.'' Journal of Intellectual & Developmental Disability,
37(3):185-195, 2012.
98. JRC, Inc., JRC Publications (accessed August 7, 2015). JRC, Inc.
Available at: http://judgerc.org/school/jrc-publications.
99. Carr, E.G., R.H. Horner, A.P. Turnbull, et al., Positive
Behavior Support for People With Developmental Disabilities: A
Research Synthesis. 1999.
100. Gedye, A., ``Anatomy of Self-Injurious, Stereotypic, and
Aggressive Movements: Evidence for Involuntary Explanation.''
Journal of Clinical Psychology, 48(6):766-778, 1992.
101. McClean, B. and I. Grey, ``A Component Analysis of Positive
Behaviour Support Plans.'' Journal of Intellectual & Developmental
Disability, 37(3):221-231, 2012.
102. Snell, M.E., ``Fifteen Years Later: Has Positive Programming
Become the Expected Technology for Addressing Problem Behavior? A
Commentary on Horner et al. (1990).'' Research & Practice for
Persons With Severe Disabilities, 30(1):11-14, 2005.
103. Horner, R.H., G. Dunlap, R.L. Koegel, et al., ``Toward a
Technology of `Nonaversive' Behavioral Support.'' Research &
Practice for Persons With Severe Disabilities, 30(1):3-10, 2005.
Originally published in The Journal of the Association for the
Severely Handicapped. Reprinted from 15(3), 1990.
104. LaVigna, G.W., T.J. Willis, and A.M. Donnellan, ``The Role of
Positive Programming in Behavioral Treatment.'' Monographs of the
American Association of Mental Retardation, 12:59-83, 1989.
105. Brown, J.F., M.Z. Brown, and P. Dibiasio, ``Treating
Individuals With Intellectual Disabilities and Challenging Behaviors
With Adapted Dialectical Behavior Therapy.'' Journal of Mental
Health Research in Intellectual Disabilities, 6(4):280-303, 2013.
106. Dunlap, G., E.G. Carr, R.H. Horner, et al., ``Positive Behavior
Support and Applied Behavior Analysis: A Familial Alliance.''
Behavior Modification, 32(5):682-698, 2008.
107. Brown, F., solicited opinion, to FDA. Received October 9, 2015.
108. Palmes, T. and P. Millington, ``Positive Behaviour Support for
a Child With Severe Learning Disability.'' Learning Disability
Practice, 15(10):24-27, 2012.
109. Kurtz, P.F., E.W. Boelter, D.P. Jarmolowicz, et al., ``An
Analysis of Functional Communication Training as an Empirically
Supported Treatment for Problem Behavior Displayed by Individuals
With Intellectual Disabilities.'' Research in Developmental
Disabilities, 32(6):2935-2942, 2011.
110. American Psychiatric Association, Practice Guideline for the
Treatment of Patients With Borderline Personality Disorder, ed. J.M.
Oldham, et al., 2001.
111. Swenson, C.R., C. Sanderson, R.A. Dulit, et al., ``The
Application of Dialectical Behavior Therapy for Patients With
Borderline Personality Disorder on Inpatient Units.'' Psychiatric
Quarterly, 72(4):307-324, 2001.
112. Brown, F., C.A. Michaels, C.M. Oliva, et al., ``Personal
Paradigm Shifts Among ABA and PBS Experts: Comparisons in Treatment
Acceptability.'' Journal of Positive Behavior Interventions,
10(4):212-227, 2008.
113. Heyvaert, M., L. Saenen, J.M. Campbell, et al., ``Efficacy of
Behavioral Interventions for Reducing Problem Behavior in Persons
With Autism: An Updated Quantitative Synthesis of Single-Subject
Research.'' Research in Developmental Disabilities, 35(10):2463-
2476, 2014.
114. McClean, B. and I. Grey, ``An Evaluation of an Intervention
Sequence Outline in Positive Behaviour Support for People With
Autism and Severe Escape-Motivated Challenging Behaviour.'' Journal
of Intellectual & Developmental Disability, 37(3):209-220, 2012.
115. DiGennaro-Reed, F.D. and B.J. Lovett, ``View on the Efficacy
and Ethics of Punishment: Results From a National Survey.''
International Journal of Behavioral Consultation and Therapy,
4(1):61-67, 2008.
116. Courtney, D.B. and M.F. Flament, ``Adapted Dialectical Behavior
Therapy for Adolescents With Self-Injurious Thoughts and
Behaviors.'' The Journal of Nervous and Mental Disease, 203(7):537-
544, 2015.
117. Kleindienst, N., M.F. Limberger, C. Schmahl, et al., ``Do
Improvements After Inpatient Dialectial Behavioral Therapy Persist
in the Long Term? A Naturalistic Follow-Up in Patients With
Borderline Personality Disorder.'' The Journal of Nervous and Mental
Disease, 196(11):847-851, 2008.
118. Thompson, R.H., B.A. Iwata, G.P. Hanley, et al., ``The Effects
of Extinction, Noncontingent Reinforcement, and Differential
Reinforcement of Other Behavior as Control Procedures.'' Journal of
Applied Behavior Analysis, 36(2):221-238, 2003.
119. Kelley, M.E., D.C. Lerman, and C.M. Van Camp, ``The Effects of
Competing Reinforcement Schedules on the Acquisition of Functional
Communication.'' Journal of Applied Behavior Analysis, 35(1):59-63,
2002.
120. Lerman, D.C., B.A. Iwata, and M.D. Wallace, ``Side Effects of
Extinction: Prevalence of Bursting and Aggression During the
Treatment of Self-Injurious Behavior.'' Journal of Applied Behavior
Analysis, 32(1):1-8, 1999.
121. Carr, E.G., S. Robinson, J.C. Taylor, et al., Positive
Approaches to the Treatment of Severe Behavior Problems in Persons
With Developmental Disabilities: A Review and Analysis of
Reinforceent and Stimulus-Based Procedures, monograph. The
Association for Persons with Severe Handicaps, 1990.
122. Horner, R.H., E.G. Carr, P.S. Strain, et al., ``Problem
Behavior Interventions for Young Children With Autism: A Research
Synthesis.'' Journal of Autism and Developmental Disorders,
32(5):423-445, 2002.
123. Matson, J.L. and S.V. LoVullo, ``A Review of Behavioral
Treatments for Self-Injurious Behaviors of Persons With Autism
Spectrum Disorders.'' Behavior Modification, 32(1):61-76, 2008.
124. Kahng, S. and B.A. Iwata, ``Behavioral Treatment of Self-
Injury, 1964 to 2000.'' American Journal on Mental Retardation,
107(3):212-221, 2002.
125. Gonnerman, J., The School of Shock. Mother Jones, August 20,
2007. Available at: http://www.motherjones.com/politics/2007/08/school-shock.
126. Gonnerman, J., Experts on Self-Injurious Kids Challenge Dr.
Israel's Methods. Mother Jones, August 20, 2007. Available at:
http://www.motherjones.com/politics/2007/08/experts-self-injurious-kids-challenge-dr-israels-methods.
127. Brown, L., public docket comment, FDA-2014-N-0238 (P0059).
Received April 14, 2014.
128. McClean, B., I. Grey, and M. McCracken, ``An Evaluation of
Positive Behavioural Support for People With Very Severe Challenging
Behaviours in Community-Based Settings.'' Journal of Intellectual
Disabilities, 11(3):281-301, 2007.
129. Cole, C.L. and T.R. Levinson, ``Effects of Within-Activity
Choices on the Challenging Behavior of Children With Severe
Developmental Disabilities.'' Journal of Positive Behavior
Interventions, 4(1):29-37, 2002.
130. LaVigna, G.W., solicited opinion, to FDA. Received October 9,
2015.
131. Massachusetts DDS, Response to Testimony and Written Comments
to Proposed Amendments to Behavior Modification Regulations, October
14, 2011.
132. Howe, E.M., affidavit before Probate and Family Court,
Massachusetts, dated February 7, 2013.
133. Brown, F. and D.A. Traniello, ``The Path to Aversive
Interventions: Four Mothers' Perceptions.'' Research & Practice for
Persons With Severe Disabilities, 35(3-4):128-136, 2010.
134. JRC, Inc., JRC Homepage (accessed November 18, 2015). JRC, Inc.
Available at: http://judgerc.org.
135. JRC, Inc., Unparalleled Positive Programming (accessed November
18, 2015). JRC, Inc. Available at: http://judgerc.org/school/unparalleled-positive-programming.
136. Samuels, J., DOJ, letter, to A. Russell, FDA. Received June 24,
2014.
137. Donnellan, A.M., University of San Diego, letter, to E.M. Howe,
Massachusetts Department of Developmental Services, dated July 31,
2011.
138. Gant, S.A., Gant, Yackel & Associates, Inc., letter, to E.M.
Howe, Massachusetts Department of Developmental Services, dated
August 1, 2011.
139. JRC, Inc., public docket comment, FDA-2014-N-0238 (D0291).
Received May 14, 2014.

List of Subjects

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR parts 882 and 895 be amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Amend Sec.  882.5235 by revising paragraph (b) to read as follows:

Sec.  882.5235  Aversive conditioning device.

* * * * *
    (b) Classification. Banned when used to reduce or cease aggressive
or self-injurious behavior. See Sec.  895.105. Otherwise, Class II
(performance standards).

PART 895--BANNED DEVICES

0
3. The authority citation for 21 CFR part 895 continues to read as
follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

0
4. Add Sec.  895.105 in Subpart B to read as follows:

Sec.  895.105  Electrical stimulation devices to treat aggressive or
self-injurious behavior.

    Electrical stimulation devices to treat aggressive or self-
injurious behavior are devices that apply a noxious electrical stimulus
to a person's skin to reduce or cease aggressive or self-injurious
behavior.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09433 Filed 4-22-16; 8:45 am]
BILLING CODE 4164-01-P