[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Rules and Regulations]
[Pages 13312-13354]
[FR Doc No: 2020-04328]

Vol. 85

Friday,

No. 45

March 6, 2020

Part IV

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 882 and 895

Banned Devices; Electrical Stimulation Devices for Self-Injurious or
Aggressive Behavior; Final Rule

Federal Register / Vol. 85, No. 45 / Friday, March 6, 2020 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2016-N-1111]

Banned Devices; Electrical Stimulation Devices for Self-Injurious
or Aggressive Behavior

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
finalizing a ban on electrical stimulation devices (ESDs) for self-
injurious or aggressive behavior. FDA has determined that these devices
present an unreasonable and substantial risk of illness or injury that
cannot be corrected or eliminated by labeling. This ban includes both
new devices and devices already in distribution and use; however, this
ban provides transition time for those individuals currently subject to
ESDs for the identified intended use to transition off ESDs under the
supervision of a physician.

DATES: This rule is effective April 6, 2020. However, compliance for
devices currently in use and subject to a physician-directed transition
plan is required on September 2, 2020. Compliance for all other devices
is required on April 6, 2020.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov/ and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Acronyms
III. Background and Determination
    A. Public Participation, Clarifications, and Key Changes
    B. FDA's Determination That ESDs for SIB or AB Present an
Unreasonable and Substantial Risk of Illness or Injury
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
    A. Background Information About ESDs, SIB, and AB
    B. Evidence Interpretation
    C. Risks of ESDs for SIB or AB
    D. Effects of ESDs on SIB and AB
    E. State of the Art for the Treatment of SIB and AB
    F. Labeling and Correcting or Eliminating Risks
    G. Legal Issues
    H. Transition Time
VI. Effective Date and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is banning ESDs for self-injurious behavior (SIB) or aggressive
behavior (AB). ESDs are aversive conditioning devices that apply a
noxious electrical stimulus (a shock) to a person's skin to reduce or
cease such behaviors. SIB and AB frequently manifest in the same
individual, and people with intellectual or developmental disabilities
exhibit these behaviors at disproportionately high rates. Notably, many
such people have difficulty communicating and cannot make their own
treatment decisions because of such disabilities, meaning many people
who exhibit SIB or AB are part of a vulnerable population. SIB commonly
includes head-banging, hand-biting, excessive scratching, and picking
of the skin. However, SIB can be more extreme and result in: (1)
Bleeding; (2) broken, even protruding bones; (3) blindness from eye-
gouging or poking; (4) other permanent tissue damage; or (5) injuries
from swallowing dangerous objects or substances. AB involves repeated
physical assaults and can be a danger to the individual, others, or
property. In this rule, like much of the scientific literature, we
discuss SIB and AB in tandem and use the phrase ``SIB or AB'' to refer
to SIB or AB or both.
    Although the available data and information show that some
individuals subject to ESDs exhibit an immediate interruption of the
targeted behavior, the available evidence has not established a durable
long-term conditioning effect or an overall-favorable benefit-risk
profile for the devices. The medical literature shows that ESDs present
risks of a number of psychological harms including depression,
posttraumatic stress disorder (PTSD), anxiety, fear, panic,
substitution of other negative behaviors, worsening of underlying
symptoms, and learned helplessness (becoming unable or unwilling to
respond in any way to the ESD); and the devices present the physical
risks of pain, skin burns, and tissue damage.
    Because the medical literature likely underreports adverse events
(AEs), risks identified through other sources, such as from experts in
the field, State agencies that regulate ESD use, and records from the
only facility that has recently manufactured and is currently using
ESDs for SIB or AB, demand closer consideration. As discussed in the
proposed rule, these sources further support the risks reported in the
literature and indicate that ESDs pose additional risks such as
suicidality, chronic stress, acute stress disorder, neuropathy,
withdrawal, nightmares, flashbacks of panic and rage, hypervigilance,
insensitivity to fatigue or pain, changes in sleep patterns, loss of
interest, difficulty concentrating, and injuries from falling. State-
of-the-art treatments for SIB and AB further demonstrate that the risks
of ESDs for SIB or AB are unreasonable.
    The ESDs subject to this ban are aversive conditioning devices
intended to reduce or cease SIB or AB. Aversive conditioning pairs a
noxious stimulus, such as a noxious electric shock delivered to an
individual's skin by an ESD, with a target behavior such that the
individual begins to associate the noxious stimulus with the behavior.
The intended result is that the individual ceases engaging in the
behavior and, over time, becomes conditioned not to manifest the target
behavior. Some ESDs are intended for other purposes, such as smoking
cessation; however, the ban includes only those devices intended to
reduce or eliminate SIB or AB. ESDs are not used in electroconvulsive
therapy, sometimes called electroshock therapy or ECT, which is
unrelated to this rulemaking.
    The effects of the shock are both psychological (including
suffering) and physical (including pain), each having a complex
relationship with the electrical parameters of the shock. As a result,
the subjective experience of the person receiving the shock can be
difficult to predict. Physical reactions roughly correlate with the
peak current of the shock delivered by the ESD. However, various other
factors such as sweat, electrode placement, recent history of shocks,
and body chemistry can physically affect the sensation. As a result,
the intensity or pain of a particular set of shock parameters can vary
from person to person and from

shock to shock. Possible adverse psychological reactions are even more
loosely correlated with shock intensity. The shock need only be
subjectively stressful enough to cause trauma or suffering. Trauma
becomes more likely, for example, when the recipient does not have
control over the shock or has developed a fear of future shocks,
neither of which is an electrical parameter of the shock.
    In light of scientific advances, out of concern for ethical
treatment, and in an attempt to create generalizable interventions that
work in community settings, behavioral scientists have developed safer,
successful treatments for SIB and AB. The development of the functional
behavioral assessment, a formalized tool to analyze and determine
triggering conditions, has allowed providers to formulate and implement
plans based on positive behavioral techniques. As a result,
multielement positive interventions (e.g., paradigms such as positive
behavior support or dialectical behavioral therapy) have become state-
of-the-art treatments for SIB and AB. Such interventions achieve
success through environmental modification and an emphasis on teaching
appropriate skills. Behavioral intervention providers may also
recommend pharmacotherapy (the use of medications) as an adjunctive or
supplemental method of treatment. Positive-only approaches have low
risk and are generally successful even for challenging SIB and AB, in
both clinical and community settings. The scientific community has
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.
    Based on all available data and information, FDA has determined
that the risk of illness or injury posed by ESDs for SIB or AB is
substantial and unreasonable and that labeling or a change in labeling
cannot correct or eliminate the unreasonable and substantial risk of
illness or injury.

B. Summary of the Major Provisions of the Final Rule

    This ban only includes aversive conditioning devices that apply a
noxious electrical stimulus to a person's skin to reduce or cease
aggressive or self-injurious behavior. The ban applies to devices
already in commercial distribution and devices already sold to the
ultimate (end) user, as well as devices to be sold or commercially
distributed in the future. A banned device is an adulterated device,
subject to enforcement action. The ban does not, however, prevent
further study of such devices pursuant to an investigational device
exemption, if the requirements for such are met.

C. Legal Authority

    An ESD used for SIB or AB is a ``device'' as defined by the Federal
Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to
ban a device intended for human use by regulation if we find, 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, which cannot be corrected by labeling or a change
in labeling. A banned device is adulterated except to the extent it is
being studied pursuant to an investigational device exemption. This
final rule is also issued under the authority to issue regulations for
the efficient enforcement of the FD&C Act.

D. Costs and Benefits

    Under this final rule we are banning ESDs for SIB or AB. Because we
lack sufficient information to quantify the benefits, we include a
qualitative description of some potential benefits of the final rule.
We expect that the rule will affect only one entity. In addition to the
incremental costs this entity will incur to comply with the
requirements of the final rule, the ban may create potential transfer
payments of between $14 million and $15 million annually, either within
the affected entity or between entities. The present value of total
costs over 10 years ranges from $0 million to $44 million, with a
primary estimate of $22 million at a three percent discount rate, and
ranges from $0 million to $38 million, with a primary estimate of $18.8
million at a seven percent discount rate. Annualized costs range from
$0 million to $5.0 million, with a primary estimate of $2.5 million at
a three percent discount rate, and range from $0 million to $5.0
million, with a primary estimate of $2.5 million at a seven percent
discount rate.

II. Table of Abbreviations and Acronyms

------------------------------------------------------------------------
      Abbreviation or acronym                   What it means
------------------------------------------------------------------------
AB................................  Aggressive behavior.
ABA...............................  Applied behavior analysis.
ABC-I.............................  Aberrant Behavior Checklist--
                                     Irritability (scale).
ADHD..............................  Attention deficit hyperactivity
                                     disorder.
AE................................  Adverse event.
APA...............................  American Psychiatric Association.
ASD...............................  Autism spectrum disorder.
DBT...............................  Dialectical behavioral therapy.
DDS...............................  (Massachusetts) Department of
                                     Developmental Services.
DEEC..............................  (Massachusetts) Department of Early
                                     Education and Care.
DMDD..............................  Disruptive mood dysregulation
                                     disorder.
DPPC..............................  (Massachusetts) Disabled Persons
                                     Protection Committee.
DSM...............................  Diagnostic and Statistical Manual of
                                     Mental Disorders.
EA................................  Environmental assessment.
ESD...............................  Electrical stimulation device.
FAS...............................  Fetal alcohol syndrome.
FBA...............................  Functional behavioral assessment.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
FONSI.............................  Finding of no significant impact.
GED...............................  Graduated Electronic Decelerator.
ICD...............................  Implantable cardioverter
                                     defibrillator.
JRC...............................  Judge Rotenberg Educational Center,
                                     Inc.
MDD...............................  Major depressive disorder.
NASDDDS...........................  National Association of State
                                     Directors of Developmental
                                     Disability Services.
NDD...............................  Neurodevelopmental disorder.
NYSED.............................  New York State Education Department.

PBS...............................  Positive behavioral support.
PKU...............................  Phenylketonuria.
PTSD..............................  Post traumatic stress disorder.
SIB...............................  Self-injurious behavior.
SIBIS.............................  Self-Injurious Behavior Inhibiting
                                     System.
SNRI..............................  Serotonin-norepinephrine reuptake
                                     inhibitor.
SSRI..............................  Selective serotonin reuptake
                                     inhibitor.
------------------------------------------------------------------------

III. Background and Determination

    On April 25, 2016, FDA published a proposed rule to ban ESDs used
to treat SIB or AB and requested comments on the proposal (81 FR
24386).\1\ As explained in the proposed rule, ESDs for SIB or AB are
aversive conditioning devices that apply a noxious electrical stimulus
(a shock) to a person's skin to reduce or cease such behaviors.
Although FDA cleared a few of these devices more than 20 years ago, due
to scientific advances and ethical concerns tied to the risks of ESDs,
state-of-the-art medical practice has evolved away from their use and
toward various positive behavioral treatments, sometimes combined with
pharmacological treatments. Only one facility in the United States has
manufactured these devices or used them on individuals in recent years.
As a result of this evolution in treatment over the past several
decades, the available data and information on the risks and benefits
of ESDs are limited.
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    \1\ Available at https://www.federalregister.gov/documents/2016/04/25/2016-09433/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or.
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A. Public Participation, Clarifications, and Key Changes

    FDA convened a meeting of the Neurological Devices Panel of the
Medical Devices Advisory Committee (``the Panel'') on April 24, 2014
(``the Panel Meeting''), in an open public forum, to discuss issues
related to FDA's consideration of a ban on ESDs for SIB or AB (see 79
FR 17155, March 27, 2014 \2\; Ref. 1). FDA is not required to hold a
panel meeting before banning a device, but FDA decided to do so in the
interest of gathering as much data and information as possible, from
experts in relevant medical fields as well as all interested
stakeholders, and in the interest of obtaining independent expert
advice on the scientific and clinical matters at issue. In considering
whether to ban ESDs, FDA also conducted an extensive, systematic
literature review to assess the benefits and risks associated with ESDs
as well as alternative treatments for patients exhibiting SIB and AB.
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    \2\ Available at https://www.federalregister.gov/documents/2014/03/27/2014-06766/neurological-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting-request-for.
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    FDA invited interested parties to comment on the proposed rule by
May 25, 2016. However, we received a request to extend the comment
period and, in the Federal Register of May 23, 2016, we announced a 60-
day extension, ending July 25, 2016 (81 FR 32258).\3\ In addition to
requesting comments on the proposal generally, we specifically sought
comments on the determinations that the risk of illness or injury posed
by ESDs for SIB or AB is unreasonable and substantial, and that
labeling or a change in labeling cannot correct or eliminate the
unreasonable and substantial risk of illness or injury. We also sought
comments on other issues related to the proposal to ban these devices.
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    \3\ Available at https://www.federalregister.gov/documents/2016/05/23/2016-12026/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or.
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    FDA received more than 1,500 comments from several types of
stakeholders. We received hundreds of comments from parents of
individuals with intellectual and developmental disabilities. We
received comments from several people who have themselves manifested
SIB and AB in their lifetimes. We received submissions from dozens of
State agencies and their sister public-private organizations. We
received comments from the affected manufacturer and residential
facility, some of its employees, and parents of individual residents.
State and Federal legislators also expressed interest, as did State and
national advocacy groups.
    For this rulemaking, we also associated the Panel Meeting docket
with this action (Docket No. FDA-2014-N-0238) and considered the
approximately 300 comments submitted to the Panel Meeting docket. The
types of stakeholders and the concerns they raised were similar to the
comments on the proposed rule, in which we discussed many of the Panel
Meeting comments in detail.
    The overwhelming majority of comments supported this ban. The
comments in opposition to this ban were primarily from the Judge
Rotenberg Center (JRC) and people affiliated with JRC; this includes
comments made during the Panel Meeting and through submission of
comments to the Panel Meeting docket. Specifically, these comments were
from three former JRC residents, family members of individuals on whom
ESDs have been used at JRC (one of the parents association comments
included 32 letters from family members), a former JRC clinician, a
Massachusetts State Representative, and one concerned citizen.
    In its comments on the proposed rule, JRC included the hearing
transcripts and exhibits from a recent Massachusetts court proceeding
that considered the use of ESDs, in particular the Judge Rotenberg
Center's (JRC's) graduated electronic decelerator (GED) devices. See
Judge Rotenberg Center, Inc., et al., v. Comm'r of the Dep't of
Developmental Servs., et al., Docket No. 86E-0018-GI (Bristol, Mass.
Probate and Family Court, June 20, 2018) (Mass. Docket No 86E-0018-GI).
Therefore, some expert testimony from these transcripts is discussed in
this final rule to the extent the testimony is relevant to the risks or
benefits of ESDs for SIB or AB, or to the state of the art of treatment
for this patient population.\4\ However, the issues in that State
proceeding are different from the ones in FDA's ban proceeding, and the
court's decision has no legal or scientific bearing on this ban.
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    \4\ Any references to hearing transcripts or hearing exhibits
herein refer to transcripts and exhibits from Mass. Docket No. 86E-
0018-GI.
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    The Bristol County (Massachusetts) Probate and Family Court
considered whether a consent decree should be vacated based on
significant changes in fact or law, in particular whether the
professional consensus is that JRC's GED does not now conform to the
accepted standard of care for treating individuals with intellectual
and developmental disabilities. The court ultimately determined that no
significant change in consensus warranted vacating the consent decree:
``the evidence at the hearing did not establish that there is a
professional consensus with respect to whether Level III aversive
treatment [use of ESDs]

conforms to the accepted standard of care.'' (Opinion at 48). The
professional consensus regarding the accepted standard of care and such
use of ESDs is not an issue in this ban. Rather, to ban a device under
section 516 of the FD&C Act (21 U.S.C. 360f), FDA must determine the
device presents an ``unreasonable and substantial risk of illness or
injury.'' As explained in the proposed rule, in making this
determination, FDA analyzes whether the risks the device poses to
individuals are important, material, or significant in relation to its
benefits to the public health, and FDA compares those risks and
benefits to the risks and benefits posed by alternative treatments
being used in current medical practice (81 FR 24386 at 24388).
    Compared to the proposed rule, we have made minor changes to the
codified text of the classification regulation to make clear that only
ESDs, not other aversive devices for SIB or AB, are banned. We have
also added text to the device type classification to make clear that
this ban is not a special control. We reconsidered a few of the
representations and attributions of data and information made in the
proposed rule. Our explanation of these changes, as well as our
explanation why the revisions did not affect our overall evaluation of
the benefit-risk profile and our ultimate conclusion with respect to
the substantial and unreasonable risk of illness or injury from ESDs
used for SIB or AB, are in section V.C. in the corresponding comment
responses.

B. FDA's Determination That ESDs for SIB or AB Present an Unreasonable
and Substantial Risk of Illness or Injury

    FDA considered all available data and information from a wide
variety of sources, including the data and information submitted to the
docket for the Panel Meeting and proposed rule: scientific literature,
information and opinions from experts, information from State agencies
that also regulate ESDs as well as their actions on ESDs, information
from the affected manufacturer/residential facility, information from
individuals subject to ESDs and their family members, and information
from disability rights groups, other government entities, and other
stakeholders. In weighing each piece of data and information, 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 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 detail in the comment responses in section V,
although we found that certain risks had weaker support than we
asserted in the proposed rule, other information submitted in comments
provided greater support for other risks. We continue to find that the
medical literature shows that ESDs present a number of psychological
risks including depression, PTSD, anxiety, fear, panic, substitution of
other negative behaviors, worsening of underlying symptoms, and learned
helplessness; and the devices present the physical risks of pain, skin
burns, and tissue damage. Because the medical literature suggests an
underreporting of AEs, FDA carefully evaluated risks identified through
other sources, such as from experts in the field, State agencies that
regulate ESD use, and records from the only facility that is currently
using ESDs for SIB or AB. As discussed in the proposed rule, these
sources further support the risks reported in the literature and
indicate that ESDs have been associated with additional risks such as
suicidality, chronic stress, acute stress disorder, neuropathy,
withdrawal, nightmares, flashbacks of panic and rage, hypervigilance,
insensitivity to fatigue or pain, changes in sleep patterns, loss of
interest, difficulty concentrating, and injuries from falling.
    Although the available data and information show that some
individuals subject to ESDs may exhibit an immediate interruption of
the targeted behavior, the available evidence has not established a
durable conditioning effect or an overall-favorable benefit-risk
profile for ESDs for SIB or AB. No randomized, controlled clinical
trials have been conducted, and the studies that have been conducted
are very small and suffer from various limitations, including the use
of concomitant treatments that make determining the cause of any
behavioral changes difficult. The additional references cited in the
comments on the proposed rule suffer from the same methodological and
other limitations as those FDA considered previously, and the records
and summaries JRC submitted regarding its residents constitute an even
weaker source of evidence regarding the effectiveness of ESDs for SIB
or AB.
    State-of-the-art treatments for SIB and AB are positive-based
behavioral approaches along with pharmacotherapy, as appropriate. The
medical community now broadly recognizes that conducting careful
functional assessments and addressing the underlying causes of SIB and
AB 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 on the use of positive behavioral methods continues to
grow; literature published since the proposed rule shows even greater
success than described previously, as detailed in section V. Further,
recent advancements in psychiatric research and clinical care have
improved the understanding of psychiatric diagnosis and treatment,
particularly in individuals with intellectual and developmental
disabilities. This has facilitated the use of pharmacological
treatments that reduce SIB and AB, whether the drug products target SIB
or AB symptoms directly, regardless of the underlying condition, or by
more indirectly reducing SIB and AB by improving the underlying
condition. ESDs are only used at one facility in the United States on
individuals from a small number of States, and there is evidence,
including from the Massachusetts hearing, that the overwhelming
majority of patients exhibiting SIB or AB throughout the country are
being treated without the use of ESDs. Although positive behavioral
interventions may not always be completely successful 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 or the setting, and can achieve durable long-term
results while avoiding the risks posed by ESDs.
    Based on the serious risks posed by ESDs for SIB or AB, the
inadequacy of data to support their effectiveness, and the positive
benefit-risk profiles of the state-of-the-art alternatives for the
treatment of SIB or AB, FDA has determined that the risks posed by ESDs
for SIB or AB are important, material, or significant in relation to
their benefits to the public health, and that ESDs present an
unreasonable and substantial risk of illness or injury that cannot be
corrected or eliminated by labeling. FDA has decided to ban these
devices under section 516 of the FD&C Act. This rule applies to devices
already in distribution and use, as well as to future distribution of
these devices. The vulnerable population subject to ESDs for SIB or AB,
like all individuals, are entitled to the public health protections
under the FD&C Act.

IV. Legal Authority

    An ESD used for SIB or AB is a ``device'' as defined under section
201(h) of the FD&C Act (21 U.S.C. 321(h)). 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,
which cannot be corrected or eliminated by labeling or change in
labeling (21 U.S.C. 360f(a)(1) and (2)). A banned device is adulterated
under section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the
extent it is being studied pursuant to an investigational device
exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)).
This rule is also issued under section 701(a) of the FD&C Act (21
U.S.C. 371(a)), which provides authority to issue regulations for the
efficient enforcement of the FD&C Act.
    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 21 CFR 895.21(a)(1)). Although FDA's device banning
regulations do not define ``unreasonable risk,'' in the preamble to the
final rule issuing 21 CFR part 895, FDA explained that, with respect to
``unreasonable risk,'' we will conduct a careful analysis of risks
associated with the use of the device relative to the state of the art
and the potential hazard to patients and users (44 FR 29214 at 29215,
May 18, 1979).\5\ The state of the art with respect to this rule is the
state of current technical and scientific knowledge and medical
practice with regard to the treatment of patients exhibiting self-
injurious and aggressive behavior.
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    \5\ Available at https://www.govinfo.gov/content/pkg/FR-1979-05-18/pdf/FR-1979-05-18.pdf.
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    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 individuals, 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; FDA need only find that a device presents the
requisite degree of risk on the basis of all available data and
information (H. Rep. 94-853 at 19; 44 FR 29214 at 29215).
    Whenever FDA finds, on the basis of all available data and
information, that the device presents substantial deception or an
unreasonable and substantial risk of illness or injury, and that such
deception or risk cannot be, or has not been, corrected or eliminated
by labeling or by a change in labeling, FDA may initiate a proceeding
to ban the device (see 21 CFR 895.20). If FDA determines that the risk
can be corrected through labeling, FDA will notify the responsible
person of the required labeling or change in labeling necessary to
eliminate or correct such risk (see 21 CFR 895.25).
    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).

V. Comments on the Proposed Rule and FDA's Responses

    In the proposed rule, in addition to seeking comment on our
determination of substantial and unreasonable risk that cannot be
corrected or eliminated with a change in labeling, we sought comments
on other issues such as how long transitions away from ESDs for SIB or
AB may take as well as the proposed effective date. We also requested
comments on the proposed regulatory impact (economic) analysis. We have
divided the comments and responses by subject matter, organized like
the proposed rule: background information, evidence interpretation,
risks of ESDs for SIB or AB, effects of ESDs on SIB or AB, state-of-
the-art for the treatment of SIB or AB, labeling and correcting or
eliminating risks, legal issues, and finally, transition time. Of the
comments to the docket, the overwhelming majority supported a finding
of substantial and unreasonable risk that cannot be corrected or
eliminated with a change in labeling. The comments related to
transitioning away from ESDs for SIB or AB, as well as the proposed
effective date, supported no transition time and an immediate effective
date. We received no comments on the proposed regulatory impact
analysis.
    Any comments received relating to ECT are outside the scope of this
rulemaking, and consequently, we do not address those comments. We
issued a Final Order on ECTs in 2018. (see 83 FR 66103, December 26,
2018).\6\
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    \6\ Available at https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of.
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    We describe and respond to the comments in this section. We have
numbered each comment to help distinguish between different comments.
We have grouped similar comments together under the same number, and in
some cases, we have separated different issues discussed in the same
comment and designated them as distinct comments for purposes of our
responses. The number assigned to each comment or comment topic is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which comments were received. As
most of the comments support this ban without raising questions or
concerns, our responses primarily relate to the few comments that do
not support the ban.

A. Background Information About ESDs, SIB, and AB

    (Comment 1) A comment states that FDA's characterization of
behaviors associated with SIB and AB is broadly true but does not
adequately convey the extreme behaviors exhibited by some individuals
on whom ESDs are used. The comment states that such behaviors can put
both the patients and caregivers at immediate risk of irreparable,
serious, and even life-threatening injury.
    (Response) FDA agrees with the commenter that in some cases the
behaviors exhibited by individuals with SIB or AB are extreme and could
cause serious injury to the individual or their caregiver. As stated in
the proposed rule, SIB commonly includes: Head-banging, hand-biting,
excessive scratching, and picking of the skin. However, SIB can be more
extreme and result in bleeding; broken and even protruding bones;
blindness from eye-gouging or poking; other permanent tissue damage; or
injuries from swallowing dangerous objects or substances. AB involves
repeated physical assaults and can be a danger to the individual,
others, or property. We referred in the proposed rule to a JRC
submission that states a link between SIB and death. Thus, FDA has
taken into account the extremity of behaviors associated with SIB and
AB.
    (Comment 2) A comment states that FDA incorrectly defined the
intended use population for ESDs and, in doing so, overstated the
limited patient population that uses ESDs for SIB or AB. The commenter
asserts that FDA has performed an erroneous benefit-risk analysis by
``improperly inflating the intended use population by orders of
magnitude.''
    (Response) FDA disagrees with this assertion. The commenter has
incorrectly interpreted FDA's estimates,

which we explained in the proposed rule. The commenter focuses on the
narrow ``patient population that uses ESD therapy for SIB and AB''
whereas FDA's estimate more broadly refers to the total number of
individuals in the United States who exhibit SIB and AB (330,000) and
the number of the most extreme cases (25,000), regardless of how they
are treated (81 FR 24386 at 24389).
    We based these numbers on the scientific literature, which shows
that the prevalence of SIB in individuals with intellectual or
developmental disabilities ranges from 2.6 percent to 40 percent, or 2
to 23 percent in community samples (Ref. 2). More recently, one
analysis found a prevalence of SIB in a clinical population of children
with developmental disabilities at 32 percent, suggesting that the
actual prevalence may be at the high end of earlier estimates (Ref. 3).
Further, estimates of the prevalence of AB in individuals with
intellectual or developmental disabilities range as high as 52 percent,
though 10 percent is more commonly reported (Ref. 2). Thus, by
conservative estimates, based on a population of 330 million in which 1
to 3 percent of individuals have intellectual or developmental
disabilities (and counting only them, not all people who manifest SIB
or AB), at least 330,000 people in the United States manifest SIB, AB,
or both; less conservative estimates are much higher (see Ref. 2).
    Elsewhere in its comments, the commenter, JRC, appears to agree
with FDA's estimates of 330,000 and 25,000 but explains that it enrolls
an even smaller subset of the most severe, refractory residents. This
represents, in its view, the totality of the intended use population
for ESDs for SIB or AB, which in 2016 numbered 51 individuals from 12
States.
    FDA does not contest that ESDs for SIB or AB were, in 2016, used on
about 51 individuals in the United States, or that these individuals
come from 12 States (in the proposed rule, FDA estimated the number of
States to be 6-11 (81 FR 24386 at 24408)). Indeed, as explained in the
comment responses about the state of the art, the professional field,
with the sole exception of JRC, has moved beyond the use of ESDs for
SIB or AB. However, FDA continues to believe that 25,000 is a reliable,
conservative estimate for the number of the more extreme cases of SIB
and AB in the United States. We have no evidence establishing that, of
those, JRC receives the most extreme or refractory cases. The comment
does not provide evidence of this other than contending that ESDs are
only used after all alternative treatments have failed and offering
some documentation purporting to show as much. This does not mean that
JRC is unique in encountering severe cases. Rather, this shows that JRC
is unique in which methods it chooses to employ. We have evidence that
extreme cases are treated elsewhere in the United States without the
use of ESDs, as discussed in more detail in the comment responses
regarding the state of the art. Thus, in considering the number of more
extreme cases in the United States compared to the limited number and
geographic origins of patients subject to ESDs at JRC, we continue to
believe that JRC's patients are not uniquely refractory or responsive
to ESDs.
    (Comment 3) A comment argues that applying the ban only to a
discrete use of ESDs in one type of patient population, instead of all
aversive conditioning devices, is arbitrary. The comment specifically
outlines several shock aversive products and uses that FDA is not
proposing to ban, including skin shock products for smoking cessation,
alcohol and drug addiction, and other ``bad habits,'' shock aversives
for inappropriate sexual behavior after traumatic brain injury, and
shock aversives for nonsuicidal self-injury cutting behaviors. The
commenter states that FDA has not provided a discussion or rationale
distinguishing why the risks of skin shock are acceptable for these
devices for these other conditions and not for the treatment of
patients with SIB and AB. The commenter further argues that FDA's
distinction based on patient control over the shocks is misplaced
because in all cases, parental or guardian consent is required and
obtained.
    (Response) The commenter is correct in that this rule only applies
to ESDs for SIB or AB and not to ESDs for other intended uses. FDA
explained in the proposed rule that, although these products have
parallels in technology and behavior modification strategy, products
for other uses address different conditions or behaviors in different
patient populations, and as a result, they present different benefit-
risk profiles. We explained, for example, that many people who exhibit
SIB or AB have disabilities that present vulnerabilities, such as
difficulty communicating pain and other harms caused by ESDs, not
likely to be present in people who use ESDs for other purposes. As a
result, individuals who exhibit SIB or AB would bear a higher risk of
injury or illness from the shock than, for example, smokers who choose
to use an ESD to help quit smoking. Smokers can immediately communicate
pain to the device's controller or remove the device themselves. They
can communicate symptoms of other harms that may be caused by ESDs to
their healthcare provider, which may lead to discontinuation of the
device's use, or decide to stop using the device. In addition, people
who exhibit SIB or AB may not be able to associate cause and effect or,
as with some people with an autism spectrum disorder (ASD), they may
express pain atypically or not at all.
    ESDs for other intended uses also differ from ESDs for SIB or AB
with respect to whether the individual subject to the shocks has
control over them as well as the level of control they have. FDA
recognizes that, at the facility that still uses ESDs for SIB or AB,
legal consent is obtained to use the devices. However, the person who
provides legal consent is typically not the person subject to the risks
of the use of the device. This distinction is significant because
consent does not mitigate the risk in that the person subject to the
risk has no control over use of the device. For example, a person who
fears future shocks could not opt out and thereby reduce the fear.
Similarly, a person who experiences extreme pain or suffering could not
opt out to avoid those harms in the future. FDA is not questioning the
validity or importance of legal consent, but rather pointing out that
legal consent does not eliminate concerns related to the shock
recipients' communication difficulties and lack of control over use of
the device on them.

B. Evidence Interpretation

    (Comment 4) Many comments state that FDA's analysis for the
proposed rule was thorough and well supported. Some of them
characterize the evidence for the ban as strong and contrast that with
the evidence for the effectiveness of ESDs for SIB or AB, which they
characterize as weak.
    (Response) FDA agrees. As we stated in the proposed rule, FDA first
conducted an extensive, systematic literature review to assess the
benefits and risks associated with ESDs as well as the state of the art
of treatment of patients exhibiting SIB or AB. As we explained in the
proposed rule, SIB and AB were considered in tandem, and these
conditions presented in individuals with intellectual and developmental
disabilities, such as ASD, Down syndrome, Tourette's syndrome, as well
as other cognitive or psychiatric disorders and severe intellectual
impairment (including a broad range of intellectual measures). The
studies encompassed both children and adults.

    As noted in section III.B, FDA convened the Panel Meeting on April
24, 2014, in an open public forum, to discuss issues related to FDA's
consideration of a ban of ESDs for SIB or AB (see 79 FR 17155).
Although FDA is not required to hold a panel meeting before banning a
device, FDA decided to do so in the interest of gathering as much data
and information as possible, from experts in relevant medical fields as
well as all interested stakeholders, and in the interest of obtaining
independent expert advice on the scientific and clinical matters at
issue. Eighteen panelists with expertise in both pediatric and adult
patients represented the following biomedical specialties: Psychology,
psychiatry, neurology, neurosurgery, bioethics, and statistics;
panelists included representatives for patients, industry, and
consumers (Ref. 4). FDA provided a presentation that described the
banning standard, the regulatory history of aversive conditioning
devices, alternative treatments, and a summary of the benefits and
risks of ESDs, including a comprehensive, systematic literature review
based on the information available at that time (see generally Refs. 5
and 6). After the Panel Meeting, FDA reviewed approximately 300
comments submitted to the public docket created for the Panel Meeting
(Docket No. FDA-2014-N-0238). FDA associated that docket with this
rulemaking and considered those comments in this rulemaking, as
appropriate.
    (Comment 5) A comment asserts that FDA ignored, misrepresented, and
distorted the available information and data, favoring evidence that
supports the ban while dismissing evidence that supports the use of
ESDs for SIB or AB.
    (Response) FDA disagrees and addresses the commenter's assertions
regarding specific information and data in separate comment responses
in this final rule. FDA has thoroughly and fairly reviewed the
available data and information, with multiple opportunities for input
from stakeholders on all sides of the issue. FDA considered all
additional information timely submitted to the docket in this
rulemaking, including comments by the public. The public comments
included data and information as well as court documents (including
transcripts and exhibits) from litigation related to the use of ESDs
for SIB or AB. In some cases, as explained in responses to various
comments, the comments led FDA to reconsider and change its evaluations
of particular sources. In other cases, the docket information repeated
previously received material, thus reinforcing our evaluation. Some
information was not relevant, for example, when it sought to refute a
premise that FDA did not rely upon in the proposed ban.
    However, FDA did not dismiss evidence that supports the use of ESDs
for SIB or AB. We weighed all available data and information, taking
into account its quality, such as the scientific rigor supporting it,
the objectivity of its source, its recency, and any limitations that
might weaken its value. Scientific rigor is greater when the study
includes randomization or other controls and covers a large number of
subjects. For less controlled studies, such as a case report, a greater
number of study subjects across many reports will generally bolster
confidence, for example, when many case reports are examined within a
meta-analysis. Thus, we generally gave more weight to observations
under controlled conditions than to reports of anecdotes. Similarly,
peer review bolsters confidence because the process allows other
experts to question or critique potential inaccuracies or errors. We
generally gave more weight to the results of a study in a peer-reviewed
journal than we did to non-peer-reviewed papers.
    We considered the opinions of Panel members and other experts, some
of whom support the use of ESDs for SIB or AB and some of whom do not.
We generally gave more weight to expert opinions about scientific
subjects than opinions from laypersons about scientific subjects.
Although expert opinions are generally weaker scientific evidence than
studies, the weight of such opinions is increased, for example, when
they report data or include confirmatory or supportive citations to
peer-reviewed scientific references, the subject matter is within the
offeror's expertise, the opinion is based on regular professional
practice or first-hand experiences, and/or the offeror is free from
conflicts of interest. We considered opinions from commenters and
others, including individuals at JRC, their parents, JRC staff, and JRC
itself although such opinions merit relatively less weight in drawing
scientific conclusions.
    We explained in the proposed rule, and throughout this final rule,
how this evidence relates to our conclusions and the strength of the
evidence as it pertains to those conclusions. While the commenter may
or may not agree with how we weighed any given piece of evidence, FDA
did not ignore, misrepresent, distort, dismiss or favor evidence merely
because it supported a particular result.
    (Comment 6) A comment argues that FDA dismisses evidence supporting
the benefits of ESDs for SIB or AB because of various weaknesses yet
accepts evidence of risks that may have the same weaknesses.
    (Response) FDA disagrees. FDA considered all available data and
information, derived from a variety of sources and methods. As
discussed in Responses 5 and 7, because the strength of different data
and information--for example, from the scientific literature, experts,
and various stakeholders--varied greatly, we weighed the evidence
accordingly. Although the commenter may disagree with how FDA weighed
the evidence, we did not dismiss evidence.
    With respect to accepting evidence of risks from sources that
exhibit weaknesses, we explain throughout this rulemaking that we
believe AEs have been underreported and the reasons why (see Responses
26 to 28). Information submitted to FDA after the proposal supports
that proposition and has helped us, upon further consideration, to
update our evaluation. For example, as explained in Response 13, we
believe the proposed rule understated the risk and harm of pain. We
believe that the risk of pain is greater and that the harm of pain is
more frequent than stated in the proposed rule.
    In other cases, we explain that we evaluated particular risks
consistent with our view of the weight of evidence. For example, we
explain in Response 24 that the risk of seizures is not well
established, in part because the information came from individuals who
attributed their seizures to ESDs, lay people, as well as advocacy
groups that stated shocks could trigger seizures (as opposed to, e.g.,
peer-reviewed scientific articles). Because we did not accord this
information significant weight, it did not greatly affect our
evaluation of the benefit-risk profile.
    As another example, the commenter argues that we have identified
the risk of suicidality based on anecdotes from individuals who were
subject to ESDs and that suicidality was not related specifically to
ESD application. The comment highlights an individual who experienced
suicidal ideation yet later credited use of the ESD for saving her life
by replacing what the commenter describes as ``ineffective and harmful
psychotropic medication.'' To support this risk of ESDs for SIB or AB,
we explained in the proposed rule that experts in the field of
behavioral science (including members of the Panel) and State agencies
that regulate ESDs indicate that the devices have been

associated with short- and long-term trauma, including suicidal
ideation (81 FR 24386 at 24399). Given that ESDs can also contribute to
stress, anxiety, learned helplessness, and posttraumatic reactions,
among other outcomes, we do not believe that it is reasonable to
conclude that the risks presented by ESDs are unrelated to suicidal
ideation.
    The individual's belief that an ESD helped her does not speak to
whether suicidal ideation is a risk posed by the device. FDA has no
reason to doubt that she experienced suicidal ideation or that it
stopped and she felt better. However, her statement is not strong
evidence for the effects of ESDs on the processes underlying the
ideation; the statement is not offered by an expert in the field and is
not a result from a clinical study under controlled conditions. Such a
statement, for example, does not rule out the possibility that
concurrent therapies were responsible for the improvement, nor does it
necessarily represent any other individual's point of view. It also
does not provide any basis for concluding that state-of-the-art
therapies, properly attempted and continuously administered, would not
have succeeded.
    In another instance, the comment criticizes FDA for using a double
standard when presenting and evaluating data by quoting an expert in a
media report who explained that an individual went into a catatonic
condition after an ESD was used on him. However, this was one of
multiple sources FDA relied on for this risk. We explained that
catatonia may be an additional risk based on scientific literature that
describes catatonic sit-down associated with the use of ESDs, and
statements and comments from individuals on whom ESDs have been used,
their family members, disability rights groups, and others. Because the
statement appeared in a media report, we did we not accord it the same
weight as the information in the scientific literature.
    It is also important to understand that the premise of the
critique--that the same type of evidence should support establishing
benefits if it supports identifying risks--is flawed. For example, FDA
has long recognized that isolated case reports, random experience,
reports lacking sufficient details to permit scientific evaluation, and
unsubstantiated opinions are not regarded as valid scientific evidence
to show safety or effectiveness, but that such information may be
considered, however, in identifying a device the safety and
effectiveness of which is questionable (see 21 CFR 860.7(c)(2)). The
same general principle applies here. While the evidence purporting to
show the benefits of ESDs for SIB or AB is insufficient to establish
the effectiveness of the device, the same type of evidence may provide
useful risk information. For example, an isolated case report that
describes an initial increase in self-mutilative behavior following ESD
application indicates to FDA that an initial increase in self-
mutilative behavior is a risk even though the same report would not
meet the threshold of evidence to establish effectiveness. This does
not mean that any type or amount of evidence is sufficient to support a
risk of harm; it means only that certain evidence that may be
inadequate to establish effectiveness may nonetheless be adequate to
support certain risks.
    (Comment 7) A comment states that, in FDA's Executive Summary for
the Panel Meeting, we noted that the majority of behavioral studies
identified prior to the Panel Meeting were confined to small sample
sizes or case reports. The comment asserts that those limitations have
not stopped FDA from relying on literature about positive behavioral
support (PBS), while FDA dismisses evidence supportive of ESDs because
of those same limitations.
    (Response) FDA disagrees. The comment incorrectly attributes a
description from the Executive Summary to materials that FDA identified
after the Panel Meeting. Since the Panel Meeting, FDA identified
additional information and data, including behavioral studies with
larger numbers of subjects. Additionally, as explained elsewhere,
although the commenter may disagree with how FDA weighed the evidence,
FDA did not dismiss evidence due to small sample sizes or the fact that
they were case reports. However, these factors did result in FDA
assigning relatively less weight than we would to a more robust design
such as a randomized controlled trial with a large number of subjects.
    With respect to the evidence supportive of ESDs, the only article
specifically about JRC's GED device was published in a peer-reviewed
journal over a decade ago, and it studied only nine subjects at JRC
(Ref. 7). Studies of ESDs more generally have been published in peer-
reviewed journals, but many of them are decades old. In the intervening
decades, the understanding of pathophysiology has evolved as has the
ability to identify and systematically record AEs. These developments
are alongside heightened peer-review standards for study and reporting.
Accordingly, it is reasonable to assign these studies less weight than
more modern studies.
    Since the Panel Meeting, FDA identified several studies of PBS in
peer-reviewed journals that include more subjects, systematically
record AEs, and benefit from recent (not decades-old) knowledge. For
example, a recent single meta-analysis of PBS that FDA identified after
the Panel Meeting synthesized information from 423 case reports (Ref.
8), whereas JRC has stated in a comment that it only applied its GED to
269 individuals since 1990. The peer-reviewed data and information
about PBS were published more recently and better reflect modern
scientific advances and contemporary ethical standards of the
profession. The evidence also adheres to modern, more exacting peer-
review standards for study conduct and reporting. Recent studies also
benefit from the improvements in functional analysis and teaching
adaptive or replacement behaviors that began in the mid-1980s (see Ref.
9). Refinement and application of such knowledge increases the success
of the behavioral interventions (see Ref. 10). Further, more-modern
study designs that include more coded baseline and treatment data
points correlate with clearer demonstrations of treatment effects (see
Ref. 10). Another benefit is that relatively recent studies of
behavioral treatment of SIB more often report results that are
generalizable across settings (see Ref. 11). Modern study designs are
also more reflective of contemporary ethics and practice, making their
results more relevant to treatment (see Ref. 12, discussing outmoded
nomenclature and setting to study the effects of contingent shock on
body rocking). It is noteworthy that even recent meta-analyses that
included punishment techniques did not include the use of ESDs (see,
e.g., Ref. 10); one Panel member described the modern attitude toward
ESDs for SIB or AB as ``wholesale abandonment.'' To summarize the
advantages of more-recent data, the quality and quantity of the
available data tend to be higher, they tend to show clearer effects,
and the corresponding refinement in techniques leads to greater
treatment success.
    Therefore, although some PBS studies rely on small sample sizes or
are case reports, the overall number of subjects who have been studied
is significantly larger than for ESDs for SIB or AB. More robust
analysis has been conducted on these subjects, and the data and
information are more recent, more reflective of scientific advances and
modern ethical standards, and held to a higher peer-review standard.
Thus, we believe we have appropriately weighed the evidence and
disagree that we

should have considered the various studies to be of equivalent weight.
    (Comment 8) A comment criticizes the 2006 New York State Education
Department (NYSED) report on JRC as misleading and biased and questions
FDA's reliance on the report. The comment points to an earlier NYSED
report from 9 months prior that was more favorable to JRC.
    (Response) FDA disagrees that the report is misleading and biased.
As the 2006 report states, the NYSED undertook a review based on
documentation it received subsequent to its 2005 inspections (Ref. 22).
That documentation, according to NYSED, ``raised concern about JRC's
use of aversive interventions, as well as recent questions from
legislators.'' The 2005 Special Education Quality Assurance Nondistrict
Program Review, the earlier NYSED report, was more general, focusing on
``areas of greatest significance to the health and safety and provision
of special education programs and services.'' In contrast, the 2006
Observations and Findings of Out-of-State Program Visitation was
specifically conceived ``to gain an understanding of the scope of the
behavior intervention plans,'' paying particular attention to: (1)
Health and safety issues related to the use of aversive interventions;
(2) the general standard for implementing and monitoring behavior
plans; (3) whether the interventions were commensurate with the
individuals' behavioral difficulties; and (4) to determine if
individuals were receiving interventions consistent with individualized
education programs.
    Although the 2005 Program Review and the 2006 Observations and
Findings both examine practices at JRC, their scope and purpose are
separate and distinct. Further, the 2005 document contemplated all
students from New York, whereas the 2006 document considered those
whose behavioral intervention plans included the use of ESDs. Thus, to
the extent these documents shed light on the use of ESDs for SIB or AB,
the 2006 document is more relevant than the 2005 document.
    To provide context, the NYSED has itself submitted a docket comment
consistent with their 2006 report (Ref. 23). Specifically, regarding
the necessity of ESDs, the NYSED 2006 report relied in part on three
behavioral psychologists serving as independent consultants. The NYSED
in 2006 also conducted interviews with individuals at JRC. FDA believes
it reasonable to give more weight to the 2006 report because, unlike
the 2005 report, its objective was to examine the use of ESDs for SIB
or AB, and it included evaluations from independent behavioral
psychologists as well as the results of patient interviews.
    (Comment 9) A comment asserts that, because FDA did not visit JRC
and meet with its staff or obtain firsthand observations of residents,
we did not educate ourselves on the complete facts regarding JRC's use
of the device. The comment contrasts this with what it characterizes as
ex parte discussions with other parties, including three former
residents who approached FDA.
    (Response) While FDA did not directly observe residents in JRC's
facility, it did not need to do so to obtain relevant information for
this rulemaking. Such observations are not necessary for FDA to
understand JRC's use of ESDs or, more importantly, the risks and
benefits of ESDs for SIB or AB. Such observations would not be part of
a trial or study, nor would they proceed according to experimental
controls that could allow observers or analysts to draw generalizable
conclusions. Any observation may or may not be typical, whether by
chance or, for example, because a tour at JRC's invitation would be
controlled or the areas and individuals available for observation would
not be representative. Elsewhere, this commenter criticizes the
incorporation of anecdotal data and information; information obtained
by FDA on such a tour would likely be subject to the same criticism.
    Further, we have information about the residents at JRC and their
views, including firsthand accounts. JRC has provided FDA with pictures
and short biographies of many JRC residents. It has also provided
copies of emails expressing individuals' sentiments that are favorable
to JRC. During the Panel Meeting, individuals at JRC, including
representatives of JRC, presented their views. FDA also conducted
inspections of JRC.
    While FDA had discussions with three former residents prior to
issuing the proposed rule, to the extent we relied on these
communications, we summarized the relevant content and provided our
rationale in the proposed rule. The public had an opportunity to review
this information and comment on it.
    (Comment 10) A comment asserts that phone interviews conducted by
FDA with individuals formerly at JRC were anecdotal and unscientific,
yet the comment also claims that FDA dismissed clinical data from JRC
and did not interview patients and parents who support the use of ESDs
for SIB or AB. The commenter also states that FDA did not consider data
from 269 individuals at JRC since 1990 and argues that such data
plainly demonstrate the effects of ESDs on SIB and AB.
    (Response) FDA disagrees that we dismissed any data, either
clinical data from JRC or the views of individuals at JRC and parents
who support the use of ESDs for SIB or AB. We explained in the proposed
rule and elsewhere in this final rule how this evidence relates to our
conclusions and the strength of the evidence as it pertains to those
conclusions. We considered all commenters' stated opinions and weighed
them appropriately when drawing scientific conclusions. FDA considered
all data and information, including anecdotal evidence relating to the
individuals and families with current or former experience with JRC's
use of ESDs for SIB or AB. However, we agree with the commenter that
anecdotal evidence should not be accorded the same weight as scientific
evidence, and we weighed such evidence accordingly. Obtaining views
from all perspectives, including highly personal information, proved
helpful in understanding perspectives on the use of ESDs.
    Although FDA did not conduct interviews with individuals currently
at JRC or their parents, they have had the opportunity to submit
comments in the context of the Panel Meeting and proposed rule. Two
associations of family members of individuals at JRC submitted comments
to the Panel Meeting docket opposing a ban (one of the comments
included 32 letters from family members). At the Panel Meeting, one
parent and three individuals at JRC spoke in opposition to the ban. In
the docket for the proposed rule, we received a brief from JRC parents'
counsel, letters through counsel from parents of individuals at JRC, as
well as other individual comments opposing the ban, primarily from
those associated with JRC. Additionally, a comment alluded to an
editorial in a national newspaper and included copies of emails
apparently meant to convey that individuals formerly at JRC are
grateful for their time at JRC.
    Furthermore, although the commenter may disagree with how FDA
weighed the evidence, FDA did not dismiss clinical data from the
manufacturer (see Response 26; see also Responses 18, 38, and 39,
discussing other records). As explained elsewhere, we believe the
available data and information, including that from the manufacturer,
JRC, underreport AEs (see Responses 26 to 28). Noting such omissions or
weaknesses in the data and information

is not to dismiss it but rather to explain why it does not necessarily
show what the commenter argues, much less show as much conclusively.
Likewise, as explained in Responses 33, 34, 38, and 39, we found that
because of the multitude of flaws and weaknesses, the data and
information provided by JRC do not establish durable effectiveness. For
instance, the data do not represent study data but rather only resident
records; the data and information fail to adequately detail behaviors
prior to ESD use, formal functional assessments, important aspects of
device application and data collection; and the data fail to account
for effects from concurrent treatments. We disagree that we did not
consider this data, and upon consideration, find the data do not
demonstrate the effectiveness of ESDs for SIB or AB.
    (Comment 11) A comment asserts that parent- and patient-centric
perspectives deserve more weight than unnamed parents' perspectives
reported to researchers who used pseudonyms for publication. The
commenter prefers ``parents who communicated on the record, direct and
unfiltered.''
    (Response) FDA disagrees. The fact that a researcher does not
identify parents by name does not make those parents' perspectives less
relevant or useful. FDA notes that the same comment elsewhere states
that FDA should discount certain parent- and patient-centric
perspectives that disagree with the commenter, even when those parents
and patients used their names and submitted their perspectives for the
record. Further, the comment does not explain why the fact that a
researcher does not identify an individual impacts reliability.
Nevertheless, when we discussed the opinions of unnamed parents in the
proposed rule, we noted that we could not conclude that the experiences
reported by those who volunteered to share negative experiences were
shared by others or are generally representative of families'
experiences with JRC. We have weighed the perspectives with these
considerations in mind.
    (Comment 12) A comment criticizes FDA for relying on unsourced
letters and papers and unscientific news articles with quotes from lay
people.
    (Response) As explained elsewhere, FDA considered opinions from
experts and lay people, and we took into account whether opinions were
offered by experts or supported by research, among other factors.
Opinions offered by behavioral experts about the treatment of SIB and
AB are afforded more weight than laypeople's opinions about the
treatment of SIB and AB; those expert opinions carry yet more weight
when, for example, they cite peer-reviewed research. Regarding
sourcing, since all of the references that the comment critiques as
unsourced were attributed to specific authors and institutions, FDA
fails to understand this criticism. Additionally, the sourcing provided
FDA with the information needed to determine the weight to give each
reference. Each reference was available for review during the comment
period, so the commenter had an opportunity to comment on their
substance.
    In terms of weighing the evidence from the references the commenter
cites, we recognize, for example, that Dr. Donnellan wrote a letter
that was not peer-reviewed. However, because Dr. Donnellan has
expertise in the field, the content of the letter merits more weight
than laypeople's opinions. So too does the chapter authored by Drs.
LaVigna, Willis, and Donnellan because of the authors' expertise in the
subject matter. Moreover, a named editor reviewed the information,
which merits additional weight compared to unedited documents, even
those from experts. Regarding the report from NYSED, FDA believes that
agency's responsibility and expertise to assess such information, as
well as draw conclusions from that information, is relevant in
determining how much weight to give the report.
    With respect to the news article referred to by the commenter, FDA
cited it solely with respect to our assessment of the state of the art,
to support the fact that one of the pioneers of ESDs publicly
repudiated contingent shock for a lack of effectiveness, and not as
part of our determination that the evidence fails to establish ESD
effectiveness. We believe it is appropriate to cite this type of source
for this limited point. Further, FDA notes that the commenter elsewhere
implores FDA to heed views presented in a newspaper, including
speculation by Dr. Israel, in an attempt to make a point regarding ESD
effectiveness and the lack of effectiveness of alternatives (Ref. 13).
In that case, the commenter relies on the newspaper article to make
conclusory claims about the negative effects of removing ESDs. Even
putting aside the relative weakness of this source, the newspaper
article makes clear that the individual's treatment plan consisted of
many elements in addition to ESDs, and that the individual subject to
shocks increasingly ``could not accept the price of this improvement,''
the improvement being an average of fewer than 200 shocks per month in
connection with decreased self-mutilation. We do not agree with the
commenter's criticisms and elsewhere explain how we weighed various
types of information differently.

C. Risks of ESDs for SIB or AB

    (Comment 13) A comment argues that FDA's evaluation of the benefit-
risk profile of ESD use is fundamentally flawed because the risks did
not materialize into harms. The comment also argues that FDA failed to
account for the risks posed by banning the device, which the comment
characterizes as a ``life-saving therapy.''
    (Response) FDA disagrees that we have overstated risks and have not
accurately evaluated the benefit-risk profile in consideration of those
risks. Risks do not need to have materialized into harms to be relevant
because proof of harm is not required under the banning standard.
Further, some of the risks posed by ESDs have materialized into harm,
including intense pain. The commenter itself recognizes that there are
potential risks associated with use of ESDs. It refers to a consent
form listing some of the risks, which are consistent with FDA's
analysis in the proposed rule:

    The potential physical risks associated with the GED may include
temporary skin redness, which clears up within a few minutes or a
few days at most, and there is a possibility that a small blister
may appear. JRC rotates the placement of the electrodes to avoid
superficial red marks or scaling of the skin. The psychological/
behavioral risks that might be associated with the GED include
anxiety (nervousness, tensing muscles) during the period between the
occurrence of the behavior and the occurrence of the programmed
consequence, escape responses and short-term or long-term collateral
effects including: nightmares; intrusive thoughts; avoidance
behaviors; marked startle responses; mistrust; depression;
flashbacks of panic and rage; anger; hyper-vigilance; and
insensitivity to fatigue or pain.

    The form adds to the evidence in the proposed rule, among other
information, that the shock ``is intended to function as a painful
stimulus.'' In the proposed rule, although we provided, for example,
descriptions of individuals who experienced ESDs describing the shock
as ``a thousand bees stinging you in the same place for a few
seconds,'' we also noted information from JRC suggesting that the
electric current may not be great enough to cause pain and its
statements that the shock ``may be'' painful to some patients (81 FR
24386 at 24397). Since then, behavioral experts testified in the
Massachusetts hearing regarding the level of pain caused by ESDs based
on their personal experience with ESD shocks. For example, they
testified the shocks felt ``excruciatingly painful,'' ``extremely
painful,'' ``quite

painful,'' like a ``bulging and a ruptured disc,'' and ``the most
painful thing I've ever experienced.'' (Ref. 14, respectively: day 7 at
161; day 9 at 82; day 21 at 81-82; day 13 at 218.) In light of this new
information from JRC and the experts in the Massachusetts hearing, we
believe that the proposed rule understated pain as a harm caused by
ESDs.
    The pain ESDs cause is relevant because, although ESDs are intended
to apply an aversive stimulus, the pain they cause to develop the
aversion is nevertheless harmful. We also noted that JRC does not
include pain in its discussion of AEs caused by the device, yet when
JRC's Dr. Nathan Blenkush was asked directly whether the stimulus
causes pain, he answered ``yes'' (81 FR 24386 at 24397; see also Ref.
15 at 123). People affiliated with JRC, including Drs. Edward Sassaman
and Anthony Joseph, have stated that they observed no harms in many
years of observing individuals subject to ESDs, so they appear not to
consider certain adverse effects, including pain, to be harms. As
stated in the proposed rule, such a view is in line with decades-old
research that considered pain or discomfort to be an indicator of
effectiveness (81 FR 24386 at 24397). However, this is not consistent
with contemporary standards, and we conclude that pain caused by the
devices is a harm. Far from overstating risks because they have not
materialized into harms, FDA believes that JRC has understated realized
harms, and the proposed rule understated at least the degree of harm of
pain.
    With regard to the risks of the ban itself, FDA has considered the
risks of the use of ESDs for SIB or AB in light of the state of the art
for SIB and AB and determined that they are substantial and
unreasonable. In contrast, as discussed in section V.E, state-of-the-
art therapies such as PBS pose little to no risk and are generally
successful regardless of the severity of the target behavior. FDA
acknowledges that a small subpopulation of people who manifest SIB or
AB may simply have no adequate treatment option. However, this does not
mean that ESDs are effective for that subpopulation or that such
individuals would be harmed if ESDs were not available. Claims that the
use of ESDs is necessary for some people are not supported by the
available data and information.
    (Comment 14) A comment asserts, while recognizing that pain has a
subjective element, that the shock delivered by an ESD is not capable
of physical harm to the patient, such as skin burns or other damage to
the body or impairment of any bodily functions. The comment asserts
that FDA's clearance of the GED-1 included review of data on pain
perception levels submitted by JRC.
    (Response) FDA agrees that pain has a subjective element, but
disagrees with the suggestions that pain is not a physical harm, or a
harm at all. As we explained in the proposed rule, although physical
reactions roughly correlate with the peak current, shock intensity and
its effects can also vary from person to person based on the amount of
sweat on the skin, electrode placement, recent history of shocks, and
body chemistry, among other factors (81 FR 24386 at 24387). Further,
adverse psychological reactions are even more loosely correlated with
shock intensity (see 81 FR 24386 at 24387). As such, the intensity and
subjective experience will vary, including the degree to which the
shock poses a risk of harm to the individual. For this reason, as
discussed here and in Response 18, the subjectivity of the pain and
variability of the shock intensity elevate FDA's concern regarding the
risk of pain and other harms in that they make it difficult to predict
the impact that a particular shock will have on a particular individual
at a particular time.
    Several Panel members expressed concerns regarding the difficulties
and lack of understanding regarding dosing (shock intensity) and
variability in individual pain thresholds from both safety and
effectiveness standpoints (see, e.g., Ref. 15 at 50, 89, 137, 296, 302,
326, 349). Further, although all ESDs covered by this ban present the
risk of pain, some ESDs, such as JRC's GED-4, which delivers more than
triple the maximum electrical current of the GED-1, present an even
higher risk of pain than others. The increased current means the device
is likely to cause more pain than lower current ESDs notwithstanding
the element of subjectivity in the experience of pain. In addition,
this physical pain may lead to psychological trauma, discussed further
in Response 18.
    FDA acknowledges that, in 1994, FDA found an earlier model of one
of JRC's GED devices substantially equivalent to predicate aversive
conditioning devices. Regardless of what data JRC may have submitted at
that time or how FDA evaluated it for substantial equivalence to
predicate devices in the context of a 510(k)--i.e., a premarket
notification submission under section 510(k) of the FD&C Act (21 U.S.C.
360(k))--we are not bound by such in a banning proceeding under section
516 of the FD&C Act. To ban a device, we consider all available data
and information. The past 25 years since the clearance of that GED have
yielded valuable data, analyses, and experience with ESDs for SIB or
AB, as well as advancements in science and medicine. These data and
information have improved our understanding of the risks posed by this
type of device, including the risk of pain, as well as the diagnosis
of, and treatment options for, patients that exhibit SIB or AB.
    As for other physical harms, FDA disagrees that the shock strength
of ESDs is not capable of producing other physical harms. In our
analysis of physical risks in the proposed rule, we explained that the
literature contains reports of tissue damage that ranged from burns to
bruises. As discussed further in the next comment response, the
literature is supported by evidence contained in numerous comments to
the docket, including those from NYSED, the U.S. Department of Justice,
and a former employee of JRC. Other risks that FDA identified in the
scientific literature include increased frequency or bursts of self-
injury and errant shocks from device misapplication or failure. In
addition, FDA considered risks identified through other sources, which
provide further support for the physical risks reported in the
literature and indicate that ESDs are associated with additional
physical risks of neuropathy and (potentially less seriously) injuries
from falling (see Ref. 15 at 312, summarizing additions to list of
risks).
    In sum, although pain has an element of subjectivity, pain
correlates roughly with the maximum electrical current output by the
device. The device is intended to cause pain and is capable of causing
other physical injuries under certain conditions. However, the
variability of those conditions as well as the subjective element in
the experience of pain make it difficult to minimize the risks of any
given shock or series of shocks. Experts on the Panel echoed these
concerns.
    (Comment 15) One comment specifically objects to FDA's
characterization of six references reporting on tissue damage or burns.
    (Response) FDA has reviewed the references and agrees that two do
not support the original analysis of tissue damage and burns, and we
have determined that the literature cited does not by itself establish
the risk of tissue damage or skin burns attributable to the use of
ESDs. However, the other references together with other sources do
support these risks, as we explain in the following paragraphs.
Further, based on the new analysis, FDA's ultimate conclusion that the
risk presented by

the device is unreasonable and substantial did not change.
    We stated in the proposed rule that the literature contains many
reports of tissue damage or burns from ESDs and cited several
references to that effect. However, one reference that we cited did not
report tissue damage or burns, and it stated that ``there was little to
suggest the development of adverse side-effects'' (Ref. 16).
Considering the study was conducted in 1975 and did not systematically
observe or record AEs, and given that it studied only two subjects, the
change to our evaluation of the benefit-risk profile is minimal. It
does not affect our overall conclusion with respect to the substantial
and unreasonable risks.
    Another reference that we cited for the risk of tissue damage, Ref.
17, did not report tissue damage as a direct result of individual
shocks applied to the skin. Instead, the reference discusses the
possibility that individuals may, after extended device application,
manifest SIB that eventually results in tissue damage. Although we no
longer consider this reference to support the risks of skin burns or
tissue damage as a direct result of ESD use, given the multiple other
references that support these risks, FDA continues to find that a risk
of using ESDs is skin burns or tissue damage. In our re-evaluation, we
note that this source did not systematically observe and record AEs,
that its conclusion about effectiveness was tentative (``might be''),
and that it had a small sample size (eight individuals) with high
variability. As such, the re-evaluation does not change our overall
conclusion with respect to the substantial and unreasonable risks of
ESDs.
    The comment also criticizes FDA's characterization of Ref. 18 as
providing a report of burns to the single individual it studied. The
comment notes that the device was not intended for human use and that
its replacement, a device intended for human use, did not cause burns
because the electrodes were placed directly on the skin. Although
placing electrodes directly on the skin would reduce the likelihood of
electrical arcing and the risk of skin burns from arcing, this does not
eliminate the risk of burns more generally; in the proposed rule, we
did not attribute the risk of burns solely to electrical arcing. As we
stated in the proposed rule, Dr. James Eason, a biomedical engineer,
opined that ESDs intended for human use, such as the SIBIS, GED-1, and
GED-4, are capable of causing superficial skin burns under certain
circumstances (81 FR 24386 at 24396). Similarly, a member of the Panel
noted that a 20-milliamps shock can cause a first-degree burn (Ref. 15
at 140). Further, the type of device that is banned could include
technology in which the electrodes are not placed on the skin and
arcing occurs. Thus, whether the electrodes are attached directly to
the skin or not, we continue to believe burns or other tissue damage
are risks posed by ESDs for SIB or AB.
    The comment also takes issue with FDA's interpretation of Ref. 19,
stating that reddened areas occurred from wearing the device and not
from the shocks themselves. FDA considers reddened areas from device
use to be evidence of tissue damage, although FDA considers Ref. 19 to
be evidence of a minor harm. During an exchange at the Panel Meeting,
some question arose over whether such damage is erythema or a first-
degree burn (see Ref. 15 at 140). A representative of JRC explained
that he did not know but had been told by dermatologists that it was
erythema (see Ref. 15 at 141). However, he later added ``[w]ell, that
depends on your definition. Is this a burn or not?'' and again referred
to dermatologists' statements (Ref. 15 at 141). FDA interprets these
statements to mean that some injury to the skin, although it may be
minor, has occurred from use of the device, and we believe that
referring to such an injury as ``tissue damage,'' as we did in the
proposed rule, is accurate.
    Similarly, the comment emphasizes that the tissue damage from a
SIBIS reported in Ref. 20 resembled a bruise rather than a burn.
According to the reference, this mark lasted about a week before it
disappeared. The comment also presents a quotation from Ref. 7 that the
use of GEDs resulted only in ``an occasional temporary discoloration of
the surface of the skin that cleared up within a few minutes or a few
days.'' As before, regardless of whether the bruise-like mark and
discolorations which could last for days were burns or bruises, we
consider both to be tissue damage and described them accurately in the
proposed rule as temporary. As such, FDA continues to identify tissue
damage or skin burns as risks.
    The risk of tissue damage or skin burns is supported by additional
sources. As discussed in the proposed rule, FDA reviewed complaints
made to the Massachusetts Disabled Persons Protection Committee related
to the use of ESDs for SIB or AB (Ref. 21, incident #49037). In 2007,
the Massachusetts Department of Early Education and Care (DEEC)
conducted an investigation of JRC's Stoughton Residence, where ESDs
were used (Ref. 21). According to the Investigation Report, an
individual reported waking up because his roommate was screaming; his
roommate had been asleep but was shocked by a GED, waking him and
causing him to scream. JRC staff reported that ``the skin was off of
the area'' of the leg where GED shocks had been applied, that the GED
was removed from the leg ``because the area . . . was too bad to keep
the device,'' and either the individual who received the shocks or the
staff believed a stage 2 ulcer had developed (Ref. 21).
    In addition, the NYSED conducted an onsite review of JRC's behavior
intervention program and ``witnessed staff rotating GED electrodes on
individuals' bodies at regular intervals to `prevent burns that may
result from repeated application of the shock to the same contact
point.' '' (See Ref. 22, summarized in the proposed rule, 81 FR 24386
at 24397.) Further, NYSED, in a comment submitted to the Panel Meeting,
stated that they ``received numerous reports of students who have
incurred physical injuries (burns, reddened marks on their skin) as a
result of being shocked,'' (Ref. 23). NYSED reviewers also noted that
school nurses monitor the individuals' skin for burns (Ref. 22).
    We also have reports of burns from individuals formerly at JRC as
well as their parents. At the Panel Meeting, one such parent described
burns their child acquired from ESD applications (Ref. 15 at 203). The
individuals who were interviewed by FDA staff shared their negative
experiences at JRC and similarly reported burns that they attributed to
the use of ESDs (see Ref. 15 at 62-63, summarizing experiences). In
sum, the literature, Panel Meeting proceedings, NYSED report, and
individual anecdotal reports support the conclusion that ESDs present
the risk of tissue damage, including skin burns.
    (Comment 16) Commenters point out instances in the proposed rule in
which FDA misattributed or misstated information from certain sources
regarding certain risks.
    (Response) FDA has reviewed the references, and we acknowledge some
misattributions and misstatements.
    We have revised our analysis as follows:
    (a) We stated that one risk is the intensification of an
undesirable behavior known as self-restraint. We attributed this
information, in part, to Ref. 24; however, this reference does not
provide support for the stated observation. Nonetheless, we cited
another reference for this observation, and FDA continues to regard the
intensification of self-restraint as a risk from the use of ESDs for
SIB or AB (Ref. 17).

    (b) We stated that an adverse outcome from ESD use for SIB or AB is
the manifestation of napkin-tearing, an undesirable behavior. However,
upon review, we do not regard napkin-tearing as an adverse outcome.
Because the risk to self and others from napkin-tearing is minimal, the
removal of this adverse outcome from our evaluation of the benefit-risk
profile is of little consequence and does not affect the overall
conclusion with respect to the substantial and unreasonable risks of
illness or injury from the use of ESDs for SIB or AB.
    (c) We stated that an adverse outcome from ESD use for SIB or AB is
an increase in affection seeking. However, the study indicates that
affection seeking replaced ``pathological behaviors,'' meaning
affection seeking was a relatively desirable effect (Ref. 25). This
affects our evaluation of the benefit-risk profile in that it updates
an incorrectly identified risk to be a potential benefit, meaning the
profile is slightly more favorable than previously appreciated.
However, considering the small magnitude of this change, and that this
study was conducted in 1965 and did not systematically observe or
record AEs, this change does not affect our overall conclusion with
respect to the substantial and unreasonable risks.
    (d) We stated that, except for the harms described elsewhere in the
proposed rule, JRC maintains that it ``has not found any side effects
associated with aversive conditioning'' and ``there are no confirmed
reports or confirmed medical evidence that patients have any negative
psychological side effects related to any discomfort experienced due to
therapy with the proper use of the GED devices.'' JRC has clarified
that the full sentence reads: ``JRC has not found any side effects
associated with aversive conditioning except the occasional
discoloration of the skin that disappears within an hour to a few days
and some brief, temporary anxiety just prior to the delivery of the
application.'' Because we included all of the information in this
sentence elsewhere in the proposed rule, this does not affect our
evaluation of the benefit-risk profile or our overall conclusion with
respect to the substantial and unreasonable risks.
    (Comment 17) Some comments question the validity of FDA's
attribution of certain risks of implantable cardioverter defibrillators
(ICDs) to ESDs. One such comment argues that risks must be considered
based on the intended patient population and the purposes of the
device, and there is no basis for attributing the risks of ICDs to ESDs
for SIB or AB. The comment also notes that the scientific literature
does not compare ESDs for SIB or AB to ICDs.
    (Response) FDA agrees that the differences between ESDs and ICDs,
including intended uses, prevent FDA from drawing meaningful
conclusions from ICDs about the risks of ESDs. In the proposed rule, we
expressly observed that the devices have drastically different intended
uses, patient populations, benefit-risk profiles, and states of the art
of treatments for the intended patient populations. Upon further
consideration, with stakeholder input, we have determined that
comparison of these devices is not enlightening for the purposes of
this final rule and have updated our assessment of the risk profile of
ESDs accordingly.
    Despite this update, FDA has determined that risks of illness or
injury posed by the use of ESDs for SIB or AB are substantial and
unreasonable. In the proposed rule, FDA used the comparison with ICDs
to support the risks of posttraumatic reactions, up to and including
PTSD, based on the pain and corresponding distress of potential future
shocks. FDA made a comparison on the basis that each device delivers an
electric shock to an individual that is out of the individual's
control, occurs multiple times, and is generally perceived as
surprising and painful or unpleasant. As such, our comparison was
narrow, limited to the particulars of such a stimulus, and yielded
additional support for observations already made based on consideration
of ESDs themselves. The removal of the narrow comparison from our
assessment therefore does not remove the basis for identifying such
risks even though it removes some support based on a device type
comparison.
    With regard to ESDs (considered on their own), FDA identified
distress of potential future shocks in particular as a trauma that
people subject to ESDs may experience, meaning that the ongoing
application of ESDs compounds the risk. Although we are no longer
drawing support from the narrow comparison to ICDs for this premise, we
have elsewhere explained our further consideration of the evidence
supporting posttraumatic reactions, up to and including PTSD. Comments
to the docket supported that people subject to ESDs experience this
trauma. To summarize very briefly, further consideration of that data
and information has bolstered our conclusion that the repeated
application of a painful stimulus such as that from an ESD, in
particular when it is not within the recipient's control, contributes
to and escalates the risk of developing acute and/or chronic
posttraumatic reactions. (See Response 18 for more detail.) Thus, we
believe the evidence for the risks of such reactions is as strong as
that discussed in the proposed rule.
    Further, as explained in Response 13 and elsewhere, we believe that
the proposed rule understated the harm of pain. As JRC acknowledges,
the shock from an ESD is intended to be painful, and the scientific
literature and statements from individuals who were subject to ESDs (as
well as others who have tested ESDs on themselves) indicate that the
pain from such shocks is severe, and it causes distress and fear. We
believe that this evidence bolsters our previous findings and suggests
the pain from the device is a reasonable basis to find support for
distress of future shocks from ESDs, potentially leading to
posttraumatic reactions (see Response 18).
    In sum, upon further consideration, we have removed the narrow
comparison to ICDs from our assessment of risks, but information and
data from other sources confirms and bolsters the risks of
posttraumatic reactions, up to and including PTSD, based on the pain
and corresponding distress of potential future shocks. As such, our
overall conclusion has not changed with regard to the substantial and
unreasonable risks of ESDs used for SIB or AB.
    (Comment 18) A comment questions whether references support FDA's
statements about psychological trauma, namely that: (1) When the
recipient does not have control over the shocks and has previously
received multiple such shocks, psychological trauma such as an anxiety
or panic reaction can result even when the strength is relatively
modest (see Ref. 26) and (2) a series of less traumatic events can
cause the development of stress disorders such as PTSD (see Ref. 27;
see also Ref. 26). The comment takes issue with FDA's interpretation of
the references, particularly regarding current diagnostic criteria for
PTSD, the nature of a Criterion A event (one of the diagnostic criteria
in DSM-5), and the evidence regarding a dose-response relationship
between traumatic events and manifestations of PTSD.
    (Response) FDA disagrees. As discussed in Response 13, based on
information submitted in comments, FDA believes it understated the harm
of pain in the proposed rule. For example, one clinician, Dr. Edwin
Mikkelsen, testified in the Massachusetts hearing that the shock was
excruciatingly painful and should not be used on humans, that it was
unconscionable,

and that it prompted the doctor to resign from the Level III
certification team (Ref. 14, day 7 at 161-63, 193-94). Another
clinician, Dr. James McCracken, stated that ``[t]his shock is intense.
It is not a simple tickle or a buzz. It is frightening.'' (Ref. 14, day
9 at 158.) The doctor went on to describe it as extremely painful,
causing involuntary movement, and that it raised very strong ethical
concerns (Ref. 14, day 9 at 82, 86). Yet another clinician, Dr. Jeffrey
Geller, described the shocks as quite painful, ``worse than a bee
sting,'' ``much worse than a hard pinch,'' and like a ``bulging and a
ruptured disc,'' causing ``writhing gyrations'' (Ref. 14, day 21 at 81-
83). Dr. Jennifer Zarcone, another clinician, described the shocks as
``very painful, and I got very upset. It's probably the most painful
thing I've ever experienced.'' (Ref. 14, day 13 at 217-18). In short,
FDA does not believe that the pain from the shocks from ESDs currently
in use is actually modest for the individuals subject to them. The
intensity of pain from the shocks suggests that individuals are more
likely to experience trauma that may lead to psychological symptoms.
    Further, as discussed in the paragraphs that follow, regardless of
how a single shock is perceived by a particular shock recipient, FDA
believes that a series of shocks can be traumatic to the individual and
give rise to psychological harms, including anxiety, stress reactions,
learned helplessness, acute stress disorder, and even PTSD. When the
recipient does not have control over the shocks and has previously
received multiple such shocks, the risk may be yet greater, especially
in that learned helplessness may be more likely. Finally, the
vulnerability of this patient population and the circumstances of the
event, including the interpersonal nature of the trauma, the ongoing
nature of the shocks, and the fact that the device is attached to the
recipient's body, may further increase the risk of psychological harms.
    The Diagnostic and Statistical Manual of Mental Disorders (DSM)
includes diagnostic criteria for PTSD; Criterion A regards the stressor
event to which an individual is exposed. The current edition, DSM-5,
originally published in 2013, incorporates a broader definition of a
Criterion A event than previous editions: The person must be exposed to
death, threatened death, actual or threatened serious injury, or
threatened sexual violence through direct exposure, witnessing the
trauma, learning that a relative or close friend was exposed to a
trauma, or indirect exposure to aversive details, usually in the course
of professional duties.
    In criticizing FDA's explanation, the comment has apparently
misunderstood both FDA's statements and the previously cited references
with respect to how the diagnostic criteria for PTSD have evolved, and
the comment mischaracterizes the necessity of a single Criterion A
event and the literature's findings. The criteria have evolved such
that a diagnosis of PTSD may be based on a series of events rather than
a single, discrete event. Even before the DSM update, the literature
had found that people exhibited the symptoms of PTSD even when a
single, discrete event did not appear to cause the symptoms. The
explanation of the revised diagnostic criteria, from the DSM-IV to the
DSM-5, makes clear that PTSD may develop from threatened (not only
actual) harm or from a series of traumatic events (not only a single,
discrete event).
    Thus, shocks that individually may appear modestly stressful to an
observer could constitute a Criterion A stressor under the DSM-5 when
multiple such shocks are administered, even though they may not have
met Criterion A under prior iterations of the DSM. This is especially
true when the recipient is experiencing additional vulnerabilities or
circumstances discussed later in this response (e.g., the interpersonal
nature of the shock delivery, the attachment of the device serving as a
constant threat of future shocks). This change in Criterion A relates
to the argument in Ref. 26, that the previous version of Criterion A,
which contemplated a single, discrete, highly traumatic event, did not
in fact serve its intended gatekeeper function and was not a useful
criterion because people still manifested the symptoms of PTSD without
such an event as it was then defined. The revisions to the diagnostic
Criterion A for PTSD were intended to bolster its effectiveness as a
gatekeeper criterion by more comprehensively capturing the kinds of
events that can result in PTSD symptomatology. Thus, although the
commenter states that Ref. 26 ``comes to opposite conclusions,'' the
conclusions of Ref. 26 and the parallel evolution of the DSM clearly
support FDA's determination that a series of traumatic events, even
those events that may appear modestly stressful to observers, can give
rise to stress disorders, including PTSD.
    Turning to the issue of dose response, as the comment points out,
Ref. 26 empirically reviews evidence and ultimately questions the then-
current paradigm for diagnosing PTSD, based on what the reference calls
``core assumptions,'' including that PTSD has a specific etiology and
that the severity of the trauma has a strong dose-response relationship
to the severity of PTSD. The authors review the evidence regarding each
of these assumptions and conclude that the assumptions did not
adequately account for the manifestation of many cases of PTSD,
implying that the assumptions were wrong in some way.
    We agree with the commenter and the authors that the dose-response
relationship between the severity of the trauma and the stress disorder
is weak, meaning that the severity of the symptoms or resulting
disorder may not correspond with the severity of the trauma. The
authors also find that people exhibited the full symptomatology of PTSD
even if the trauma that caused the symptoms did not satisfy the then-
current (pre-DSM-5) Criterion A. While the comment agrees with these
authors and FDA that there is a weak or nonexistent dose-response
relationship, it misunderstands the implication of this, which is that
severe symptoms may manifest even if the trauma is not severe.
    In an apparent attempt to alleviate concerns relating to
psychological risks from a painful shock, the commenter elsewhere
states that electrical stimulation is easily measured objectively, and
implies that a psychologically harmless level can be set. First, as
discussed earlier, due to the complexity of the interactions between
different output settings (e.g., pulse width, frequency, electrode
size) and inter-individual variability in shock perception, it is
difficult to define a cutoff stimulation for pain or trauma. The Panel
understood this and was very concerned about the impact this
variability could have. Most importantly, individuals who are subject
to ESDs are repeatedly exposed to a painful stimulus, and several
individuals have expressed that they were anxious and/or fearful about
future shocks. Further, because the dose-response relationship between
a trauma and the severity of resulting psychological symptoms is weak,
it would be even more difficult to use electrical parameters to predict
whether any eventual psychological symptoms will be mild or
nonexistent, and FDA is unaware of data demonstrating such. (See also
FDA's discussion in the proposed rule about how an individual's
perception of the trauma is not reliably predicted by the electrical
parameters, 81 FR 24386 at 24393-24394.) Regardless of the ability to
draw such a line, the GED devices currently in use pose all of the
physical and

psychological risks discussed in this rule.
    The comment also apparently misunderstands FDA's reference to an
article that in turn refers to an earlier edition of the DSM. The DSM-
III-R, originally published in 1987, specified that the person must
have witnessed or experienced a serious threat to life or physical
well-being, but the current DSM-5 contemplates a wider spectrum of
events that may be traumatic and other, more indirect ways to
experience traumatic events, thereby broadening Criterion A.
Specifically, the current version of Criterion A in the DSM-5 also
allows for ``threatened'' traumas, meaning that the event has not
actually occurred. Not only does an ESD patient experience the trauma
of a severe pain, which can be a Criterion A event, but the device is
attached to the patient's body, constantly threatening additional
trauma. FDA's reference to the article helps to illustrate the
evolution of the diagnostic criteria and supports the risk of
developing PTSD symptoms. In short, a contemporary understanding of
trauma associated with PTSD or its symptomatology supports that these
are risks of receiving shocks from the devices.
    Indeed, this commenter elsewhere quotes the American Psychiatric
Association (APA), the publisher of the DSM, which explicitly compared
the DSM-5 to the DSM-IV: ``Compared to DSM-IV, the diagnostic criteria
for DSM-5 draw a clearer line when detailing what constitutes a
traumatic event. Sexual assault is specifically included, for example,
as is a recurring exposure that could apply to police officers or first
responders'' (Ref. 28). The APA has explained that the current
diagnostic criteria now accommodate trauma stemming from repetition,
and the criteria now focus more on the symptoms the individual displays
rather than describing the individual's subjective response to a given
event. Criterion A also includes witnessing a trauma. Thus, even an
individual who witnesses another receive an ESD shock is potentially at
risk for developing acute stress disorder or PTSD from the experience,
particularly if the witness has been sensitized by the experience of
having received an ESD shock themselves. Indeed, Panel members
expressed great concern about the impact on staff of using this device
(see Ref. 15 at 310); this concern is heightened for individuals
subject to ESDs who witness traumas of others.
    The literature, including Ref. 26, discusses additional factors in
the development of PTSD symptoms, such as individual vulnerabilities
and resilience, and the literature distinguishes the manifestation of
anxiety or stress from the development of a disorder in light of such
characteristics. Psychological traumas, regardless of whether the
results are characterized and diagnosed as PTSD, are more likely for
vulnerable individuals, depend on the circumstances of the event, and
can be more severe without effective emotional support afterward (see
Ref. 26). In the case of ESDs, the individuals subject to them are
generally more vulnerable because of their cognitive impairments and,
in many cases, comorbid conditions. Many individuals subject to ESDs
have an impaired ability to associate cause and effect, which, as we
noted in the proposed rule, increases the risk of psychological harms
(see 81 FR 24386 at 24395). Such vulnerable individuals are
particularly susceptible to the risk of learned helplessness. Despite
this, JRC does not monitor for or assess PTSD or other stress disorder
symptomatology according to its records, meaning individuals are less
likely to receive adequate emotional support.
    While the commenter did not specifically address the portion of
FDA's statement regarding the lack of control over multiple shocks,
this is an additional risk factor. The risk of psychological trauma may
be greater when the recipient does not have control over the shocks and
has previously received multiple shocks, because learned helplessness
may be more likely. An individual's inability to control receiving an
aversive stimulus such as a shock from an ESD is often linked to
learned helplessness (see, e.g., Ref. 15 at 311, summarizing mentions
of learned helplessness). Further, device malfunctions and staff's
inappropriate delivery of shocks result in many noncontingent shocks
being received (Ref. 15 at 59 (summarizing 53 filed complaints), 310
(concerning JRC staff)). As a Panel member stated, ``there are multiple
episodes of non-contingent infliction, including malfunction of the
device.'' (Ref. 15 at 310.) The risk of psychological harm increases if
the shocks are delivered noncontingently or if the individual subject
to the ESD is unable to understand that the shock is related to
undesirable behavior. Panel members explained that this is the perfect
paradigm for learned helplessness (Ref. 15 at 304).
    We note that, in addition to the relationship among
vulnerabilities, noncontingent delivery of shocks and psychological
risks, noncontingent delivery also undermines the effectiveness of the
punishment paradigm for ESDs. ESDs are intended to accomplish behavior
modification through punishment. This depends on consistent, contingent
delivery of shocks. Correspondingly, it also depends on the ability of
the individual to associate cause and effect, i.e., recognize the
contingency. If shocks are delivered noncontingently, or the individual
does not perceive the contingency, the treatment paradigm and potential
effectiveness of the device are undermined.
    Further, circumstances surrounding the application of shocks may
amplify the harms. In particular, the DSM-5 states that PTSD ``may be
especially severe or long-lasting when the stressor is interpersonal
and intentional (e.g., torture, sexual violence),'' (Ref. 29 at 274).
An ESD shock is interpersonal because it comes from a person the
recipient identifies as a caregiver, the shock is intentional because
the monitor must activate the device, and the shocks occur repeatedly
over a long period of time. Repeated ESD shocks, because of their
interpersonal nature, may therefore precipitate especially severe or
long-lasting symptoms.
    Based on other evidence discussed in the proposed rule and received
in comment responses, ESD use can be linked with DSM-5 criteria for
PTSD, most clearly including Criterion A, Criterion B intrusion
symptoms (intrusive distressing memories), Criterion C symptoms
(persistent avoidance of stimuli associated with the traumatic event),
and Criterion D symptoms (negative alterations in cognition and mood).
While there are eight criteria in the DSM-5 that need to be met for a
diagnosis of PTSD in a particular patient, the evidence in the record
corresponding with some of these criteria is sufficient for FDA to
conclude that ESDs for SIB or AB pose a risk of developing PTSD; actual
occurrence of a particular harm is not necessary for FDA to determine a
device presents a risk of that harm. Further, lack of information
regarding some of the criteria may be due to poor recordkeeping,
clinical oversight, and training of personnel at JRC to identify safety
and effectiveness outcomes.
    In addition to being part of a diagnosis of PTSD, the PTSD symptoms
for which we have evidence are also harms on their own. For example,
FDA has evidence that recipients of ESD shocks have experienced
nightmares, flashbacks, avoidance, startle, hypervigilance and
reexperiencing symptoms, and even the JRC training manual indicates
that the following symptoms of PTSD should be monitored for:
nightmares, flashbacks, avoidance,

startle, and hypervigilance. One patient reported nightmares,
flashbacks, and re-experiencing symptoms as a result of the ESD
administration (Ref. 15 at 63). The Panel discussed that various
symptoms of PTSD, including nightmares, flashbacks, emotional distress,
and intrusive thoughts, were found in individuals who have been subject
to ESD shocks, although no systematic psychiatric assessment using DSM
criteria was conducted for PTSD (see Ref. 15 at 154, summarizing such
symptoms in people subject to ESDs). Additionally, of 53 complaints
filed from 1993-2013 regarding ESD with the Massachusetts Disabled
Persons Protection Committee (DPPC) that FDA reviewed, negative
emotional reactions and PTSD were reported as AEs (Ref. 15 at 59). From
2010 to 2013, FDA officials were contacted by, and met with,
representatives from various national disability organizations. These
organizations reported at least four case reports of psychological
trauma and PTSD symptoms, and stressed that alternative treatments,
such as positive environmental and reinforcement strategies, have been
developed and are generally successful for severe and refractory self-
injury (see Ref. 5 at 72; see also Ref. 15 at 59).
    If shock recipients develop PTSD symptoms, they may be more
severely impacted by future shocks because they could have ``heightened
sensitivity to potential threats, including ones that are related to
the traumatic experience'' (Ref. 30 at 275). ``Symptom recurrence and
intensification may occur in response to reminders of the original
trauma, ongoing life stressors, or newly experienced traumatic events''
(Ref. 30 at 277). Reminders of past shocks, for example, seeing the
staff member(s) who administered the shocks or seeing others suffering
the same trauma, may contribute to re-traumatization. Significantly,
the ESD itself remains attached to the individual's body, presenting a
near-constant reminder of past trauma, so FDA believes there is a
meaningful potential for re-traumatization subsequent to painful and
traumatic stimuli such as the shocks delivered by ESDs. The testimony
during the Massachusetts hearing reflected such concerns. Dr. McCracken
emphasized the heightened risk of trauma from exposing a member of a
vulnerable patient population to continual, painful shocks over a
period of years, in many cases several years (Ref. 14, day 9 at 158-
59).
    FDA's review of JRC's records did not find evidence that JRC
monitors for or asks about PTSD, including assessment of the cardinal
symptoms of PTSD. Given the literature, the testimony about ESDs
specifically, and the fact that JRC does not monitor for such harms,
FDA disagrees with JRC's assertions that ESDs would not cause PTSD or
PTSD symptoms, among other psychological harms. In short, the evidence
indicates that shocks from an ESD can cause PTSD or several of its
symptoms, and once the symptoms arise, recipients may be even more
susceptible to harms from future shocks.
    In sum, the literature on PTSD has evolved to recognize situations
like the repeated use of ESDs, where a series of events together may be
traumatic enough for some individuals to develop posttraumatic
reactions, including acute stress disorder, PTSD symptomatology, and
PTSD. As we explained in the proposed rule, psychological risks also
include anxiety, panic reactions, learned helplessness, and other
stress disorders (see, e.g., 81 FR 24386 at 24393 to 24394).
Manifestations of these harms may contribute to a PTSD diagnosis, but
they are also harms on their own. Individuals subject to ESDs for SIB
or AB also have vulnerabilities that tend to increase the risks of
experiencing psychological harms. Based on the literature, modern
diagnostic criteria, and expert opinion, FDA has determined that ESDs
used for SIB or AB pose the risk of causing those psychological harms.
    (Comment 19) One comment states that the pseudocatatonic sitdown
reported in one article and described as an adverse event by FDA was an
act of self-restraint and was an improvement over previous behaviors.
    (Response) FDA disagrees with the comment. Entrance into a
pseudocatatonic state is a risk posed by the use of ESDs. The authors
of the reference proposed that the pseudocatatonic behavior was a self-
protective response to avoid punishment: They ``surmised that this
global muscular `freezing' or `melting' provided `insurance' for the
patient, preventing her from striking out and consequently being
punished for doing so'' (Ref. 31). The patient became temporarily
unresponsive, even upon receiving affection from caregivers. Thus, even
assuming the authors were correct that the pseudocatatonic state was
``insurance'' against striking out, this does not mean that the
behavior was not an adverse effect or risk. Particularly in the case of
certain aggressive, non-self-injurious behavior, this change in
behavior is not necessarily an improvement for the patient. Replacing
aggressive behaviors such as curses, threats, or striking out against
others with a lack of all responsiveness is not necessarily an
improvement in the patient's wellbeing. Indeed, a Panel member made
clear that generalized behavior suppression is a risk and occurs, i.e.,
``when experiencing a great deal of punishment, some people just stop
behaving in general'' (Ref. 15 at 305; see also id. at 312). This is
also concerning because less-invasive behavioral techniques such as
those that are within the state of the art would not provoke responses
such as a pseudocatatonic state. FDA is not persuaded that more
acceptable behavior from an outsider's perspective equates to improved
wellbeing for the patient. FDA continues to regard generalized
behavioral suppression, such as pseudocatatonic reactions, as a risk of
ESDs used for SIB or AB.
    (Comment 20) One comment states that crying decreased after use of
aversives in one instance where FDA claims that crying increased,
citing Ref. 32.
    (Response) FDA disagrees. Although Ref. 32 reports decreased crying
during one phase of the study involving contingent shock, crying
increased in the final treatment phase, which also involved contingent
shock (Ref. 32 at 621). In addition, other studies report crying as an
AE from ESDs for SIB or AB, including increases in crying during later
sessions (see, e.g., Ref. 33 at 117). Because crying, which can be
indicative of trauma, did in fact increase in the cited reference as
well as other references, FDA continues to consider increased crying as
an AE associated with the use of ESDs for SIB or AB.
    (Comment 21) One comment claims FDA incorrectly cites Ref. 34 to
support the risk that ESDs cause temporary or long-term increases in
symptoms and frequency of SIB. The comment alleges that this is a
``complete misstatement'' because in fact the authors reported a
decrease in target behaviors to zero.
    (Response) Regarding a temporary or long-term increase in symptoms,
FDA disagrees. While the article cited states that ``[h]owever by the
fifth day of Phase 1 treatment, self-mutilative behaviors were reduced
to zero, and emotionality had returned to pretreatment levels,'' the
article concludes by noting that the subject had ``become more
incontinent during waking hours since termination of the treatment
program'' (Ref. 34). Moreover, the subject's initial reaction ``was an
increase in emotionality and in frequency of self-mutilative
behaviors'' (Ref. 34). Accordingly, FDA believes the commenter is
incorrect.
    (Comment 22) One comment argues that FDA misrepresented the
findings of Ref. 35 regarding the risk of undesirable

replacement behavior, given the statement in the article: ``Our
experience suggests that once most SIB has been eliminated, especially
if it was deliberately replaced by new, desirable behaviors, favorable
qualitative changes often took place in the behavior of the patients.''
    (Response) FDA disagrees. Although the article does state that
favorable changes often took place in the patients ``once most SIB had
been eliminated, especially if it was deliberately replaced by
desirable behaviors,'' (Ref. 35, emphasis added), this does not mean
favorable changes usually or always took place, or that most SIB was
often or usually eliminated, or, most importantly, that it was often or
usually replaced by desirable behaviors. Indeed, the article explains
that, at one of the study sites where skin shock was used, the positive
effects were temporary, and SIB returned if shocks were delivered by a
different staff member or in a different room (Ref. 35). The authors
observed, ``[o]ccasionally, when one type of SIB is reduced, another
would appear in its place,'' and, given the likelihood of reinforcement
of negative behaviors, ``the probability that a replacement behavior
will be undesirable is quite high'' (Ref. 35).
    In addition, one of the commenter's own references states that
positive behaviors that were not the targeted behavior can be modified
during treatment (Ref. 36). This information supports FDA's statement
regarding undesirable replacement behavior as a risk posed by ESDs for
SIB or AB.
    (Comment 23) One comment states that FDA misrepresented references
reporting hostility and retaliation as adverse events. The commenter
views hostility and retaliation as part of those patients' preexisting
behavioral history.
    (Response) Upon further consideration, FDA believes that additional
context will help inform the likelihood of the risk of hostility and
retaliation. In Refs. 29 and 31, the patients' hostility and aggression
were part of the patients' clinical presentation. In Ref. 29, the
researchers state ``it is difficult to know whether [the patient's]
infrequent attacks represent retaliation for the punishment,'' i.e.,
retaliation for the aversive stimulus used to reduce AB. Nevertheless,
``viewed against the long history of this kind of behavior'' and ``the
long period of time (containing many positive reinforcements) between
the infrequent aversive stimuli and the assaultive incidents,'' they
doubt the aversive stimulus provoked retaliation. Thus, the researchers
considered hostility and retaliation hypothetical risks of the use of
aversive stimuli but deemed the risks doubtful in light of additional
information.
    FDA cited Ref. 31 to support similar risks, specifically surrogate
retaliation, threats, and warnings. However, as the researchers
targeted certain aggressive behaviors, the patient progressed through
``petit' aggressions,'' less severe replacement behaviors, some of
which the authors describe as ``surrogate retaliation.'' This reference
therefore indicates that surrogate retaliation and threats to others,
while undesirable, were improvements upon the patient's state prior to
application of skin shocks.
    Taken together, in these researchers' opinions, these hostile or
retaliatory behaviors are not AEs from the use of ESDs for AB. However,
the commenter's own literature submissions support the risk of the
creation of hostility:
     Ref. 37, considerable hostility regarding the proceedings;
     Ref. 38, aggressiveness, anger, and disgust;
     Ref. 39, risk of elicited and operant aggression; and
     Ref. 40, negative reactions to authority figures.
    FDA is updating its risk analysis to reflect that hostile or
retaliatory behaviors in response to the use of ESDs may be a risk but
is not well supported. In particular, these behaviors may be difficult
to distinguish from preexisting aggression. However, this does not
change our overall conclusion regarding the substantial and
unreasonable risk of illness or injury from the use of ESDs for SIB or
AB, which FDA reaches based on our analysis of the other risks posed by
ESDs for SIB or AB such as posttraumatic reactions, pain, and other
injuries, much of which has been bolstered based on comments to the
proposed rule.
    (Comment 24) A comment questions FDA's scientific basis for
inferring that seizures or heart palpitations may result from the
application of ESDs.
    (Response) FDA agrees that the scientific literature does not
support the link between the application of ESDs and seizures.
Accordingly, FDA noted in the proposed rule that the sources for such
information were individuals who attributed their seizures to the use
of ESDs as well as advocacy groups that stated that the shock could
trigger seizures. We then explained, on the basis of such statements,
that ESDs may pose additional risks including seizures. Although this