Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior, 13312-13354 [2020-04328]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Rules and Regulations]
[Pages 13312-13354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04328]



[[Page 13311]]

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

[[Page 13312]]


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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, 301-796-6527, 
[email protected].

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

[[Page 13313]]

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.

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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]

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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

[[Page 13316]]

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\
---------------------------------------------------------------------------

    \6\ Available at https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of.
---------------------------------------------------------------------------

    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,

[[Page 13317]]

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.

[[Page 13318]]

    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

[[Page 13319]]

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

[[Page 13320]]

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

[[Page 13321]]

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

[[Page 13322]]

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

[[Page 13323]]

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).

[[Page 13324]]

    (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,

[[Page 13325]]

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

[[Page 13326]]

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,

[[Page 13327]]

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

[[Page 13328]]

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 
commenter explains that current would have to be applied across the 
brain to induce seizures, FDA notes that the biochemical pathways that 
contribute to seizures are not well understood. As such and given the 
dearth of research on the effects of ESDs, FDA continues to regard 
seizures as a possible additional risk, but we agree that this is not a 
well-established risk. Since we weighed the evidence in part according 
to its source and the degree of support in the scientific literature, 
we did not accord this information significant weight, and it does not 
significantly affect our evaluation of the benefit-risk profile of ESDs 
for SIB or AB.
    With regard to the evidence of the risk of heart palpitations, FDA 
believes the evidence is somewhat stronger but acknowledges the risk 
also has not been well studied. The commenter describes the manner in 
which electrodes would have to be placed on the skin in order to cause 
palpitations as a direct result of electric current flowing through the 
heart. He states that, because ESD electrodes are not arranged in that 
way, individuals subject to ESDs should not experience palpitations. In 
contrast, an individual who was subject to ESDs and an expert in this 
field have opined that the use of one model of ESD, a GED, presents a 
risk of heart palpitations to the patient (Ref. 15 at 63; Ref. 41, 
attachment 2).
    We note that people who manifest SIB or AB may have conditions or 
take medications that increase their predisposition for palpitations; 
however, the relationship between such a predisposition and the risk of 
this harm from the application of ESDs is speculative. As with the 
potential additional risk of seizures, the reports are anecdotal, so we 
did not accord them significant weight, and they do not significantly 
affect our evaluation of the benefit-risk profile.
    (Comment 25) One comment objects to FDA's reliance on JRC's policy 
document listing possible collateral effects of ESDs because this 
document was created in response to a requirement from the NYSED 
through Corrective Action Requests to include a discussion of the 
collateral effects of aversive interventions in its policies, and there 
is no evidence ESDs caused any of these collateral effects.
    (Response) FDA disagrees. The discussion of possible AEs that JRC 
included in its documents is consistent with the literature and NYSED's 
reports. It is also consistent with information identified by and 
submitted to FDA by individuals formerly at JRC and their parents. 
Specifically, NYSED received reports of AEs, which NYSED refers to as 
collateral effects, from the use of these devices, such as increases in 
aggression and increases in escape behaviors or emotional reactions. 
Also included were ``numerous reports of

[[Page 13329]]

students who have incurred physical injuries (burns, reddened marks on 
their skin) as a result of being shocked and for whom parents and 
students themselves have reported short-term and long-term trauma 
effects as a result of use of such devices or watching other students 
being shocked (e.g., loss of hair, loss of appetite, suicidal 
ideation),'' (see Ref. 22).
    In addition, based on its site visit, the NYSED criticized JRC for 
inadequate monitoring for AEs, which partially precipitated the 
Corrective Action Requests. Without adequate monitoring, JRC's 
statement is not persuasive when it says that ``no evidence'' shows the 
use of ESDs caused the ``collateral effects.'' Adequate monitoring is 
necessary to instill confidence in such claims. Given the reasons NYSED 
required the statements, the consistency with the literature and 
anecdotal reports, and the fact that JRC ultimately included the 
statements in its documents, we continue to regard this information as 
evidence of risks.
    (Comment 26) A comment questions the validity of FDA's concerns 
regarding AEs and underreporting because the commenter asserts it can 
confidently state that no treatment with an ESD has ever resulted in a 
patient death or serious injury. The comment argues that FDA's position 
on AEs is speculative and not backed by data and that underreporting 
would pertain to other alternative treatments for SIB or AB.
    (Response) FDA disagrees. As discussed in the proposed rule, FDA 
believes that the scientific literature suffers from various 
limitations and has likely underreported AEs associated with ESDs for a 
number of reasons (see 81 FR 24386 at 24935). Perhaps most importantly, 
the devices have been studied only on a very small number of subjects, 
many of whom would have difficulty communicating or otherwise 
demonstrating AEs, including injuries. Although FDA did not identify 
death as a risk of ESD use, we have reason to doubt the commenter's 
confidence about the lack of serious injuries related to ESD use.
    For example, JRC provided no data regarding AEs in the resident 
summaries it submitted, and the submission includes no information to 
assess whether AEs were systematically planned for, tracked, or 
documented in any of the clinical data. A qualified clinician should 
have inquired about AEs with open-ended questioning at predefined times 
after each use of the GED; there is no indication this occurred. 
Therefore, these data are inconclusive regarding whether AEs occurred. 
As we stated in the proposed rule, 66 patient case histories spanning a 
23-year period did not report any AEs, which is highly unusual over 
such a long time. For instance, FDA expected to read about a known case 
of skin damage in these histories; however, there is no mention of that 
event. This may be because none of these case histories included 
systematically defined methods for short- or long-term AE monitoring.
    In the Massachusetts hearing, JRC submitted only one paper about 
adverse effects of ESD use (Ref. 7). The paper acknowledges that few 
studies have systematically investigated adverse effects, and it does 
not include a statistical analysis because it did not collect enough 
data. Dr. McCracken testified that in the literature about the use of 
ESDs, ``there has been almost no attempt to identify or examine side 
effects'' (Ref. 14, day 9 at 604). He then stated that ``concerns me. 
In every other field of investigation of medical treatment, this would 
be considered--we go to great pains to capture all of those types of 
side effects'' (id., referring to ``reactions such as fear, panic, 
vigilance, regression, attempts to avoid the shock. Basically 
heightened anxiety, traumatic-like symptoms.''). These support FDA's 
position.
    There may also be an underreporting bias due to impairments with 
provider recognition, which is related to the difficulties individuals 
would have communicating or otherwise demonstrating to providers AEs 
including injuries (see 81 FR 24386 at 24398). SIB and AB are exhibited 
at disproportionately high rates by people with intellectual or 
developmental disabilities. Notably, many such people have difficulty 
communicating because of such disabilities. This difficulty is part of 
what makes these individuals members of a vulnerable population. 
Although some individuals were able to offer their opinions to FDA at 
the Panel Meeting, through interviews, and in the docket, most 
individuals at JRC currently subject to ESDs who have reported IQ 
scores, have scores that indicate their intellectual impairments are 
profound, severe, or moderate. This indicates that those individuals at 
JRC are, to varying degrees, vulnerable due to difficulty 
communicating. Thus, FDA cannot conclude that communicative individuals 
are representative (with respect to their communicative abilities) of 
other individuals subject to ESDs.
    The bulk of the articles describe case reports or series, employing 
only retrospective reviews of clinical experience, not prospective 
studies. Because such retrospective reviews do not systematically plan 
for the identification of AEs in advance, their assessment of such has 
limited value. In contrast, prospective studies that include plans to 
observe and record AEs from the outset generally provide greater 
confidence in their assessment of AEs. Further, most of the research 
articles were published in the 1960s and 1970s, before significant 
advances in the ability to diagnose and classify psychological AEs such 
as PTSD. Most of this dated research did not adhere to modern standards 
for AE monitoring.
    Although a ban does not require proof of harm, evidence of actual 
harm helps inform the analysis, so FDA extensively reviewed the 
available data and information for AEs associated with the use of ESDs. 
FDA relied on that data and information to understand specific risks 
and dangers that ESDs present to individuals' health (see 81 FR 24386 
at 24393). FDA considered data and information from one prospective 
case-control study and one retrospective chart review of 60 subjects 
that reported AEs. Note that the case-control study did not 
systematically assess AEs. These references reported:
     The emergence or intensification of self-restraint;
     low-intensity SIB that eventually resulted in tissue 
damage;
     temporary skin discoloration that cleared up in a few 
minutes or days; and
     ``collateral behavior'' not reported as AEs, including 
emotional behaviors, tensing of the body, and attempts to grab or 
remove the device.
    In addition, FDA considered 25 case reports or series encompassing 
66 subjects that included an assessment of AE occurrences. These 
references reported:
     Symptom substitution, including head-snapping, and 
possible symptom substitution, including increased incontinence;
     escape behavior;
     possible hostility and retaliation;
     anticipatory fear and avoidance upon observing the 
experimenter's initial movements to deliver a shock, immediately 
developing fear of the device itself, and fear (phobic response) of 
buzzing sounds;
     aggression, including accounts of surrogate retaliation, 
self-aggression, lesser aggressive action, aggression fantasies, 
threats and warnings;
     development of episodic bursts of SIB and aggression 
toward others;
     crying, increases in crying, cries of pain, whimpering;
     shivering;
     statements that the shocks were painful and grimacing;
     panic;

[[Page 13330]]

     extreme anxiety (consisting of screaming, crying, attack, 
and escape attempts);
     freezing (generalized behavior suppression) including an 
observation of pseudocatatonic sitdown;
     initial increase in self-mutilative behavior and 
emotionality;
     decrease in happiness or contentment and increased 
dependency;
     slight local tremor in the thigh due to the shock;
     arc burns to the skin;
     lesion or bruise on the skin that resolved in 1 week and 
slightly reddened areas;
     flinching;
     perspiration; and
     demonstrating other undesirable behaviors, including 
smearing feces, spitting, stamping feet, swearing and using racial 
epithets, making obscene gestures, rolling eyes, and imitating others.
    A later submission of 68 case reports revealed three subjects for 
whom AEs were noted; however, FDA is aware of at least one AE (skin 
burning) that did not appear in that set of reports (Ref. 5 at 69; Ref. 
15 at 135-36). These documents reported:
     Urinary retention;
     arm pain;
     seizure;
     injured foot;
     angioma (an abnormal growth) below the ribs that did not 
need treatment;
     lipoma on arm; and
     cloudy urine specimen.

These AEs occurred while the residents were subject to an ESD, but the 
reports do not describe an evaluation of whether the ESDs caused or 
related to the AEs. Note that FDA is not identifying all of these as 
risks of ESDs for SIB or AB.
    Ten other case reports or series did not assess AEs, and 6 
articles, encompassing 11 subjects in total, noted that the researchers 
did not observe AEs in their subject population.
    Because of the likely underreporting of AEs in the literature, FDA 
carefully considered the risks identified through other sources, which 
provide further support for the risks reported in the literature. These 
sources beyond the scientific literature indicate that ESDs are 
associated with additional risks such as suicidality, chronic stress, 
neuropathy, and injuries from falling (see 81 FR 24386 at 24399). 
Although JRC has only publicly acknowledged the risks of pain and 
erythema, its own documents provide evidence that aversive 
interventions such as ESDs are associated with several other risks, 
including nightmares, flashbacks of panic and rage, hypervigilance, 
insensitivity to fatigue or pain, changes in sleep patterns, loss of 
interest, difficulty concentrating, and withdrawal from usual activity 
(see 81 FR 24386 at 24398).
    With regard to underreporting AEs pertaining to other treatments, 
the comment specifically refers only to pharmacotherapy. However, the 
studies conducted for approval of the drugs provide a better baseline 
to understand their risks than that available for ESDs, and the studies 
supplement our understanding from spontaneous postmarket reports of 
AEs. As a result, the possibility that the pharmacotherapy poses risks 
additional to those that have been reported is much less of a concern 
in FDA's consideration of state-of-the-art treatment for SIB or AB than 
is the likelihood of underreporting of AEs associated with ESDs in 
FDA's consideration of ESD risks. For example, to obtain drug approval 
for the pharmacotherapies used in relation to SIB and AB or the 
underlying conditions, the sponsors conducted Phase I clinical trials 
that included neurotypical individuals to assess the safety profiles of 
the drugs, meaning the subjects of the study were generally better able 
to communicate AEs than the individuals on whom ESDs for SIB or AB have 
been used. Further, such trials assessed AEs according to prospectively 
determined protocols. In the Phase II and Phase III trials, AEs were 
also systematically monitored in the intended-use population. Thus, in 
the case of pharmacotherapy used for SIB or AB, the safety of the drugs 
has been studied in formal trials that provide a much better 
understanding of their risks than the much more limited data that exist 
for ESDs.
    In contrast, the safety of ESDs has not been equivalently studied. 
This is not to suggest that a finding of substantial equivalence to an 
existing device type must rely on adequate and well-controlled studies 
as if the sponsor sought new drug approval. Rather, it indicates to FDA 
that the safety profile for pharmacotherapy used in relation to SIB and 
AB or the underlying conditions is better understood than the safety 
profile of ESDs for SIB or AB, in particular that AEs are better 
understood. The data and analysis for such pharmacotherapies are more 
robust because the available data and information for ESDs suffer from 
various limitations discussed throughout this rulemaking, whereas the 
clinical studies for these drugs do not. As such, the pharmacotherapy 
premarket data provide a more complete understanding of risks, reducing 
any concern regarding underreporting of AEs.
    The commenter agrees that other state-of-the-art approaches such as 
positive behavioral treatments pose little to no risk. As discussed in 
the comment responses regarding the state of the art, the only risk 
that FDA found to be associated with positive behavioral treatments is 
the potential risk of ``extinction bursts,'' an upsurge of the actual 
undesirable behavior, which is easily recognized and quickly mitigated 
by competent therapists.
    (Comment 27) Quoting from Ref. 42 and Ref. 16, a comment states 
that ``most published accounts report few, if any, side effects from 
treatment'' and that ``overall, there was little to suggest the 
development of adverse side-effects.'' The comment argues that positive 
side effects are most often observed, including relief from other 
symptoms. The comment also argues that scientific research ``does not 
have a shelf life.''
    (Response) FDA disagrees with the characterization of the published 
accounts as well as the implication that previous scientific research 
cannot be understood in a different way over time. FDA considered the 
cited references in their entirety at the proposed rule stage, 
including in the context of ethics and treatment options prevailing at 
the time the research was conducted. We note that this comment relies 
on research from earlier decades; both references date back to 1975, 
well before the development of less-invasive behavioral treatments. 
After considering these references in light of then-prevailing ethics 
and conceptions of harm, FDA is not persuaded that these references 
speak to modern standards of care regarding ``positive side effects.''
    As to ``adverse side effects,'' we believe that these and other 
early studies underreported AEs for various reasons discussed in the 
proposed rule and other comment responses, were subject to lower peer-
review standards for observation and reporting relative to modern 
standards, and did not have the benefit of recent decades of research 
into the treatment of SIB and AB. As a result, the articles quoted by 
the commenter have various weaknesses that undermine the commenter's 
position.
    First, Ref. 42 notes that in its literature review ``only two 
articles [Refs. 40 and 43] consider in any detail the problems 
associated with aversion in self-injurious behavior or in the severely 
retarded.'' Further, ``even those accounts which have been included 
vary considerably in the adequacy of the information given; particular

[[Page 13331]]

deficiencies being the lack of adequate clinical data about the subject 
or the results of previous treatment and the short duration and 
variability in methods of recording of baseline observations, bearing 
in mind that self-injurious behavior tends to fluctuate in intensity 
over time'' (Ref. 42). The article also notes the importance of the 
concomitant positive behavioral program in producing positive side 
effects. Finally, the article concludes: ``an answer to the problems 
associated with aversion will not reach any rapid solution and it is 
therefore essential that treated cases are properly documented and 
reported'' (Ref. 42). Thus, the commenter's reliance on this article as 
support for its position that ESDs cause ``few, if any, side effects'' 
is not persuasive.
    Similarly, the authors of Ref. 16 conclude that ``the work with 
this technique is still at a preliminary stage and the apparatus is not 
yet sufficiently trouble-free to warrant its use outside research 
settings.'' Thus, the commenter's reliance on this article as support 
for the statement that there is ``little to suggest the development of 
adverse side-effects'' is also unpersuasive.
    Other literature submitted by the commenter supports FDA's findings 
of risks. For example, Ref. 39 reports risks from other studies of 
elicited and operant aggression, other emotional responses (e.g., 
crying), decreases in appropriate behavior (``generalized response 
suppression''), escape from or avoidance of the punishing agent or 
situation, and caregivers' misuse of punishment (see also Ref. 44). 
Further, according to Ref. 39, aggression and emotional responses may 
be more likely to occur when the individual is exposed to unavoidable 
and intense aversive stimulation. Ref. 36 reports the risk of 
untargeted positive behavior being modified by the device. Ref. 40 
includes negative reaction to authority figures, the increase in 
behaviors undergoing treatment, prolonged treatment potential, 
production of undesirable emotional states, behavioral rigidity, 
general disruption of cognitive processes, production of neurotic 
syndrome, suppression effects not specific to responses punished, and 
chronic emotional maladjustment. (See also Response 19 discussing 
pseudocatatonic states and generalized behavior suppression.) Ref. 45 
discusses the risks of an unreliable apparatus, including inappropriate 
intensity of shock, inconsistent delivery of shock, inappropriate delay 
of shock, or inappropriately prolonged shocks. Ref. 46 enumerates 19 
negative side effects. Another article submitted by the commenter 
acknowledged that few studies have systematically investigated side 
effects of skin shock (Ref. 47). The few studies reporting the 
potential benefits of the devices that were published in more recent 
years similarly did not systematically report AEs or include safety 
outcome measures (see Ref. 47).
    Recent testimony from the Massachusetts hearing corroborates that 
AEs are understudied (Ref. 14, day 9 at 604 (McCracken)) and that 
certain risks are underreported and undertreated in people with 
developmental and intellectual disabilities (Ref. 14, day 26 at 1519-20 
(Miner)). Other testimony indicates that shocks are rarely used because 
of negative side effects, for example, avoidance, emotional responses, 
and perpetuation effects (see Ref. 14, exhibit 494 (Spiegler 2014)). 
Similarly, JRC's own documents state that side effects (i.e., risks) 
can include emotional reactions, aggressiveness, escape from or 
avoidance of the punishment situation, increased unwanted behaviors, 
and self-perpetuation of punishment (Ref. 38), as well as exacerbation 
of violent behaviors (Ref. 48).
    Keeping the foregoing in mind, the quotations of Refs. 42 and 16 
indicating that published accounts report few, if any, negative side 
effects do not fairly characterize the decades of research since 1975. 
In the intervening decades, clinicians have expanded what they consider 
to be negative side effects and have made significant advances in the 
ability to diagnose and classify negative psychological effects. For 
example, pain is itself a harm, yet earlier studies did not view the 
pain as a harm.
    As we have explained, providers' and researchers' concerns about 
intentionally inflicting such conditions upon a vulnerable patient 
population led to advancements in behavioral therapy (see 81 FR 24386 
at 24404). In fact, Ref. 42 advocated for active research to establish 
``alternative forms of treatment'' because he recognized the ethical 
concerns presented by this treatment, particularly in a patient 
population that cannot give consent (Ref. 42). In the case of using 
ESDs for SIB or AB, the ethics of using restrictive interventions on 
such a population contributed to the evolution of treatments and of 
understanding their attendant risks.
    While empirical findings may not have a ``shelf life,'' the 
understanding of the completeness and implications of those findings 
may change as science evolves, which it has with respect to assessment 
of risks for ESDs. Based on such evolution, for example, because the 
decades-old references did not consider pain, anxiety, or other such 
sequelae as harms--nor did researchers systematically monitor for AEs 
according to current standards--FDA continues to regard such references 
as poor indicators for the occurrence of AEs.
    (Comment 28) A comment disputes FDA's position regarding AE 
underreporting due to communication difficulties on the part of 
intellectually and developmentally disabled individuals by arguing that 
individuals subject to ESDs ``many times'' demonstrate improved 
communication, and that communication can be through nonverbal means, 
assisted by augmentative communication devices such as a picture board.
    (Response) Although FDA acknowledges that some of these individuals 
may demonstrate improved communication and that communication can be 
through nonverbal means, this does not change FDA's view that many 
individuals manifesting SIB or AB would have difficulty communicating 
AEs and injuries, verbally or otherwise, and that this likely results 
in underreporting of AEs. Behavioral interventions typically include 
elements intended to improve communication skills; this does not mean 
that all or most individuals will be able to adequately communicate 
AEs.
    We also note that, although augmentative communication devices may 
assist staff in communicating with nonverbal individuals, this is 
nevertheless evidence that those individuals have difficulty 
communicating. The comment does not explain or give examples of how 
these devices compensate for difficulties communicating AEs and 
injuries, nor does the comment present evidence contradicting the 
likelihood of atypical pain expression. FDA maintains that many 
individuals who present with SIB or AB would have difficulty 
communicating or otherwise demonstrating AEs and injuries and the Panel 
agreed (see Ref. 15 at 54, 155, 355).
    (Comment 29) One comment questions FDA's claim of researcher bias, 
and it notes that in some ``N-equals-1'' studies, the researcher is 
blinded, which eliminates the researcher's bias.
    (Response) FDA discussed numerous reasons in the proposed rule that 
researcher bias and author conflicts of interest may have influenced 
study results and conclusions, for example with respect to 
underreporting of adverse events, 81 FR 24386 at 24395,

[[Page 13332]]

and regarding poor study design, 81 FR 24386 at 24400 to 24401, and 
this comment does not address any of them. Instead, it points to the 
testimony of one of its experts regarding some blinded N-equals-1 
studies, a study design that combines information from single-subject 
trials. We note that no N-equals-1 studies have been conducted on the 
use of ESDs for SIB or AB. Thus, although some study designs may reduce 
or eliminate researcher bias, this observation does not reflect the 
state of research into ESDs used for SIB or AB, and FDA is not revising 
our views regarding bias or the reduced weight we have given biased 
evidence.
    (Comment 30) A comment asserts that JRC uses extensive measures to 
ensure ESDs are applied only to refractory patients, for example, 
evaluating each patient with a functional behavioral assessment (FBA) 
performed by a JRC clinician; first attempting PBS approaches; 
exhausting all other options; and obtaining a prior court order with 
the involvement of multiple parties. In the commenter's view, FDA fails 
to discuss and consider these measures in the assessment of risks.
    (Response) FDA disagrees with the comment's rationale on several 
points. First, FDA did consider these measures. However, as we 
explained in the proposed rule, no clinical criteria identify 
refractory patients, and no rigorous or systematically collected data 
distinguish a refractory subpopulation that does not respond to other 
available treatments (81 FR 24386 at 24406). Similarly, members of the 
Panel unanimously concluded that such a subpopulation seems to exist 
but is very difficult to define (81 FR 24386 at 24406). Thus, as we 
explained, although evidence indicates that a very small subpopulation 
of refractory individuals may exist, that subpopulation is difficult if 
not impossible to define (81 FR 24386 at 24412). We are not persuaded 
that JRC has successfully defined a refractory subpopulation by 
exhausting a selected list of options, and this undercuts the certainty 
in JRC's claim that its patients are uniquely refractory.
    Regarding exhaustion of options, we also explained that the 
available evidence casts doubt on whether JRC in fact applies the 
devices as a last resort after adequately attempting all other 
measures, and the evidence shows that some patients JRC had considered 
to be refractory were transitioned successfully to other treatments (81 
FR 24386 at 24412). As we describe in more detail in Responses 39 and 
44 to 46, additional data and information cast further doubt on the 
adequacy of JRC's attempts at alternative treatments. In other words, 
this undermines claims that ESD use can be limited to a truly 
refractory subpopulation.
    More importantly, these measures to limit use of the device to a 
specific subpopulation in no way reduce or eliminate the risks posed by 
ESDs, and the commenter does not argue they do. Even if the measures 
were effective, they would merely limit the number of vulnerable 
individuals exposed to the risks; those individuals would still be 
exposed to the same risks as they would be in the absence of such 
measures. Rather than showing risk mitigation, the commenter's 
statements about limiting the exposed population provide support for 
the severity of the risks: If as the commenter claims, the devices are 
low risk, such measures would not be needed. Thus, the use of such 
measures fails to reduce the risks even as the reliance on such 
measures tends to confirm the severity of the risks.
    Even if the risks could be limited to a very small subpopulation, 
this would not alter FDA's determinations that the risks are 
substantial and unreasonable. This is because, as discussed in the 
comments regarding effects, effectiveness has not been established in 
any population of patients exhibiting SIB or AB. Further, as discussed 
in the comments regarding the state of the art, positive behavioral 
approaches, sometimes alongside pharmacotherapy, have generally been 
successful even in the most difficult cases. However small this patient 
population may be, these vulnerable individuals, like all individuals, 
are entitled to the public health protections provided in the FD&C Act.

D. Effects of ESDs on SIB and AB

    (Comment 31) A comment states that FDA acknowledges ESDs have been 
shown to reduce SIB and AB.
    (Response) In the proposed rule, FDA acknowledged that ESDs may 
cause the immediate interruption of SIB or AB (81 FR 24386 at 24387) if 
the shock is applied while the SIB or AB is occurring. We also 
explained that some evidence suggests ESDs reduce SIB and AB in some 
individuals, but this evidence cannot be generalized because the 
studies suffer from serious limitations such as weak design, small 
size, confounding factors, outdated standards for study conduct, and 
study-specific methodological limitations (81 FR 24386 at 24400). We 
are also concerned about potential bias in some of the evidence of 
effectiveness related to lack of peer review and conflicts of interest 
(81 FR 24386 at 24401). Other evidence shows that ESDs are completely 
ineffective for certain individuals. For these reasons, FDA concluded 
that the evidence is sufficient to show that ESDs may interrupt 
behaviors when a shock is applied, but the evidence is otherwise 
inconclusive and does not establish that ESDs improve the underlying 
condition or condition individuals to achieve durable reduction of SIB 
or AB for a clinically meaningful period of time (81 FR 24386 at 24399 
to 24403).
    (Comment 32) One comment interprets FDA's statement in the proposed 
rule that, ``the possibility that some patients are refractory [to 
other treatments] does not necessarily mean that ESDs would be an 
effective treatment'' to mean that FDA believes ESDs should be banned 
because they are not effective for every individual with SIB or AB.
    (Response) FDA disagrees. The statement referred to in the comment 
only makes the point that the fact that one treatment does not work for 
a patient or group of patients does not mean that a different treatment 
will work. FDA understands that devices are not always effective for 
every individual with the condition the device is intended to treat; 
this is not a reason that FDA is banning ESDs.
    (Comment 33) A comment argues that, although there are no 
randomized controlled clinical studies of ESDs for SIB or AB, the 
available data, including over 100 published peer-reviewed articles, 
among other sources, amply provide evidence of the safety and efficacy 
of ESDs for SIB or AB. The comment provides a table summarizing 162 
references discussing the use of skin shock.
    (Response) FDA disagrees. As the comment acknowledges, these data 
have been provided to FDA and reviewed by the Agency, and FDA has also 
reviewed all of the additional information provided by commenters. We 
weighed the evidence according to factors that we explained in the 
proposed rule (see 81 FR 24386 at 24393). Where FDA has reconsidered 
the interpretation or significance of specific sources or claims in 
response to comments on the proposed rule, we have explained the 
reevaluation and how it affects the analysis in the appropriate section 
of this final rule. For example, based on additional data and 
information, we believe the proposed rule understated the harm of pain 
(see Response 13), and we no longer consider affection-seeking a risk 
of ESDs (see Response 16(c)). In other cases, we have elaborated on the 
significance of certain statements identified in the available 
information,

[[Page 13333]]

for example with respect to the potential risk of seizures (see 
Response 24).
    FDA's review of the references cited by the commenter, along with 
the corresponding comments, does not change our conclusion that, beyond 
the ability of ESDs to cause immediate interruption of the behavior at 
the time of shock, the evidence is otherwise inconclusive with regard 
to the benefits and effectiveness of ESDs for SIB or AB. We continue to 
conclude that the evidence does not establish that ESDs improve the 
underlying disorder of which SIB or AB is a symptom, or successfully 
achieve a durable reduction of SIB or AB for clinically meaningful 
periods of time by conditioning individuals' behavior.
    FDA previously reviewed 44 of the 162 references highlighted by the 
comment, which we discussed in the Executive Summary for the Panel 
Meeting and the proposed rule (see 81 FR 24386 at 24393). There were 
few comments regarding ESD effectiveness with respect to the references 
previously discussed by FDA, and FDA continues to view these as we did 
at the proposed rule stage. Note that one reference appeared twice, 
meaning the total of summarized references is 161. The references that 
FDA had not previously reviewed are:
     19 case reports, 10 of which (involving 17 total subjects) 
provide some information regarding durability of effects;
     10 literature reviews, all of which summarize literature 
that FDA has already reviewed;
     41 references with limited or no discussion of ESDs, 
including opinion pieces and miscellaneous documents that do not 
directly bear on ESD risks or effects--these have limited relevance to 
this rulemaking;
     38 reports on treating conditions other than SIB or AB--
these also have limited relevance to this rulemaking; and
     9 unpublished presentations or other documents that the 
commenter did not provide and FDA could not locate, including two 
written by JRC's former director-founder that are no longer available 
on JRC's website.

We focused our review of these references on the 64 references (45 
discussed in the proposed rule and 19 cited in comments) that discuss 
patient data from clinical studies on ESDs for SIB or AB. With the 
exception of the one case-control study discussed in the proposed rule 
(see 81 FR 24386 at 24393, discussing Ref. 17), all of the other 
studies are case reports or literature reviews pulling from these case 
reports.
    The case reports show immediate interruption of target behaviors at 
the time of shock application. One study on subjects with Lesch-Nyhan 
syndrome exhibiting SIB and AB shows no effectiveness whatsoever (Ref. 
49), and a few report ultimate failure after a period of apparent 
success. However, all of the other case reports appear to demonstrate 
immediate interruption of the behavior at the time of shock 
application. FDA continues to conclude that the evidence shows that ESD 
shocks generally cause immediate interruption of the behavior that is 
occurring when the shock is delivered, provided the individual has not 
adapted to the shock, which has been shown to occur for some 
individuals.
    More critical to the evaluation of the effectiveness of ESDs for 
SIB or AB is their ability to achieve durable effects by aversively 
conditioning behavior. A durable effect is one where an individual 
develops a conditioned response, so the target behavior, along with the 
frequency of shocks, is significantly reduced over a clinically 
meaningful period of time, either while the individual continues to 
wear the ESD or after the ESD is removed. Half of the references, 32 of 
64, include at least some information regarding durability of ESD 
effects.\7\ Several of these references report cases where there was 
some short period of reduction in target behaviors followed by failure. 
Most report a reduction in the target behavior ranging from a few 
months up to several years, particularly with continued (less frequent) 
ESD use. However, conditioned reduction of SIB or AB over clinically 
meaningful periods of time is much more difficult to demonstrate than 
immediate interruption of behaviors because, for example, data 
regarding such are more vulnerable to the errors that well-designed and 
controlled studies are intended to minimize. Establishing durable 
conditioning demands well-conducted clinical studies and data spanning 
longer periods. For example, an individual may undergo several 
different behavior modification techniques over a period of time, and 
it is more difficult to draw conclusions regarding the effectiveness of 
ESDs from a study that does not control for such confounding factors 
than from a study that did control for them. As a result of such 
weaknesses and limitations, as described in the paragraphs that follow, 
the limited data that currently exist for ESDs for SIB or AB are 
inadequate to establish durable conditioning.
---------------------------------------------------------------------------

    \7\ We had not previously discussed 10 of these references in 
the proposed rule or Panel Executive Summary, Refs. 50-59.
---------------------------------------------------------------------------

    As the comment recognizes, there are no randomized controlled 
clinical studies of ESDs for SIB or AB; there are only case reports 
and, as discussed in the proposed rule, one prospective case-control 
study on 16 subjects, 8 in the device group and 8 in the control group 
(see Ref. 17). The comment acknowledges this study has an extremely 
small sample size. The results of the case-control study are further 
limited because the study was not randomized or blinded, and it used an 
unvalidated surrogate endpoint (decrease in mechanical restraint). Case 
reports are, by definition, extremely small in size; the ones regarding 
ESDs for SIB or AB typically include fewer than five subjects, and 
often only a single subject. They have no control group, blinding, or 
randomization, do not test statistical significance, and the results 
are unlikely to be generalizable across subjects.
    The particular case reports cited in the comment suffer from 
various other shortcomings that limit the ability to draw conclusions 
from their results regarding the effectiveness of ESDs for SIB or AB. 
Perhaps most importantly, many subjects were given concomitant 
treatments such as positive reinforcement or time-outs; therefore, it 
is unclear how much, if anything, the use of ESDs contributed to the 
observed reductions in SIB or AB. Many other case studies lacked 
sufficient detail to determine whether concomitant treatments were 
given. Other information important to assessing ESD effectiveness was 
often missing, such as details regarding the subjects and their 
particular forms of SIB or AB, baseline behavior measurements, device 
output and electrode locations, and shock administration protocols.
    Further, most of the studies were conducted several decades ago and 
do not conform to current study conduct, reporting, or peer-review 
publication standards. Results were sometimes reported anecdotally and 
were not always recorded by a trained investigator, which raises 
questions regarding their reliability. Most studies lacked predefined, 
clinically meaningful endpoints, and typically study sessions and 
followup were of inadequate duration to assess effectiveness for a 
clinically meaningful time period or generalizability to the subjects' 
everyday environment. As a result of these limitations, the data are 
inadequate to draw any scientific conclusions regarding the durability 
of ESD effects on SIB and AB.

[[Page 13334]]

    (Comment 34) A comment notes that a literature review discussed in 
the proposed rule states, ``basic findings suggest that relatively 
intense punishers may be associated with successful long-term 
outcomes'' (Ref. 60). The comment asserts this demonstrates that 
aversives are effective and durable.
    (Response) FDA disagrees. As discussed in the proposed rule, even 
though the cited article opines that research findings suggest 
sufficiently intense punishers such as ESDs may be associated with 
long-term success, it cautions that such findings suffer from various 
limitations, and the authors conclude that ``[u]ntil additional 
research on long-term maintenance is conducted, practitioners and 
caregivers should not assume punishment will remain effective over the 
long run.'' (81 FR 24386 at 24399, citing Ref. 60). The article 
explains that most of the time periods evaluated in the literature on 
punishment are brief, which may limit their applicability to treatment 
outcomes in clinical settings, and these studies have shown 
inconsistent outcomes in maintaining a reduction in target behavior 
(see, e.g., Refs. 19, 20, 61 to 64). According to this article, 
conclusions about applied findings on maintenance of effect are 
difficult to draw for a number of reasons, including that relapse cases 
are less likely to be submitted or accepted for publication than 
successful ones. Thus, the reference does not demonstrate that 
aversives such as ESDs achieve durable reduction of SIB or AB for a 
clinically meaningful period of time. Rather, the article questions 
their effectiveness, and ultimately concludes that current knowledge is 
insufficient to support clinical application.
    (Comment 35) A comment states that FDA badly mischaracterized a 
reference, Ref. 65, in the proposed rule, and that the findings in the 
reference contradict claims that ESDs cannot be successful unless 
continuously applied.
    (Response) FDA disagrees. Providing only an excerpt from the 
article's abstract in support of its assertion, the comment 
misrepresents the findings of this article, which does not purport to 
study the effects of punishers, much less reach any conclusions 
regarding ESD effectiveness. Rather, the authors studied the ability to 
terminate the use of punishment-based procedures--described as 
``multiple, `aversive' treatments'' that ``were discontinued 
abruptly''--in favor of less invasive alternatives, specifically 
multielement positive interventions. The article explained, ``The 
question posed was how do adults with developmental disabilities and 
seriously challenging behaviors respond in the long-term when they are 
no longer exposed to negative and highly invasive procedures?''
    Interventions that included contingent electric shock from ESDs 
were used for each subject prior to the positive interventions studied 
by the authors. The article acknowledges, ``[i]t is possible, of course 
that the prior invasive [restrictive] treatment contributed to the 
long-term outcomes presented in this report,'' but concludes that its 
``results are encouraging in demonstrating that punishment-based 
approaches can be terminated, alternative strategies can be 
substituted, and through a clinically responsive system of monitoring 
and decision-making, behavioral adjustment can be supported without 
having to resort to invasive forms of treatment'' (Ref. 65). In sum, 
the authors were not validating the initial use of punishers or 
evaluating their long-term effectiveness but rather studying the 
ability of multielement positive interventions (i.e., state-of-the-art 
approaches) to supplant punishment procedures, finding encouraging 
results that behavioral adjustment can be supported without invasive 
forms of treatment.
    (Comment 36) One comment states that a reference cited in the 
proposed rule, Ref. 66, included ``surprising findings'' on the use of 
shock ``pertaining to `the immediate increase in socially directed 
behavior, such as eye-to-eye contact and physical contact, as well as 
the simultaneous decrease in a large variety of inappropriate 
behaviors, such as whining, fussing, and facial grimacing . . .' '' The 
comment asserts that FDA selectively used information from this article 
for our own purposes.
    (Response) FDA disagrees. FDA referred to this article in the 
proposed rule for several reasons, including: To support some of the 
risks posed by ESDs; to support the occurrence of adaptation, wherein a 
patient grows accustomed to a particular level of shock and no longer 
responds; and to support the ability of ESDs to immediately interrupt 
behavior occurring at the time of shock. The cited article studied 
short-term treatment and reported some immediate benefits from the use 
of ESDs for SIB or AB, as stated in the proposed rule. However, 
regarding longer-term followup, it states: ``Although the immediate 
`side-effects' of punishment point in a desirable direction, one should 
be less optimistic about long-term behavioral change under certain 
conditions. We can supply few data which exceed a couple of months' 
followup, and in the case of only two children have we had the 
opportunity to conduct follow-ups for as much as 1 year, while the 
suppression of self-destruction was being maintained.'' This is 
consistent with FDA's determination that the data suggesting durable 
effectiveness of ESDs are generally weak, and the reference's statement 
is also consistent with the commenter's criticism (elsewhere in its 
comments) of this reference's ``extremely small sample size'' of three 
subjects.
    It is also important to note that this article was published in 
1969, so as explained elsewhere, we believe that it suffers from 
outdated methodology, such as a lack of systematic observation and 
reporting of AEs. Thus, the article's characterization of ``side 
effects'' as pointing in a ``desirable direction'' must be considered 
in this light. FDA considered the entire reference with regard to both 
benefits and risks and continues to regard the reference as we did for 
the proposed rule.
    (Comment 37) A comment asserts that FDA's claims that Dr. Israel's 
2008 and 2010 papers (Refs. 47 and 67) were not peer reviewed, and that 
they failed to disclose Dr. Israel's affiliation with JRC, are 
incorrect. The comment states that the copy of the 2008 review posted 
by FDA includes an apparent printing error that omitted the references 
to Dr. Israel's disclosure.
    (Response) FDA acknowledges the apparent printing error in the 
omission of Dr. Israel's disclosure in the 2008 paper. Thus, other 
readers may have been adequately notified of any potential bias. 
However, as we explained in the proposed rule, FDA was aware of the 
affiliation and took into account the possible conflicts of interest, 
which stem from the facts that Dr. Israel was the founder of JRC and, 
at the time his papers were published, was on the journal's editorial 
board and thus part of the reviewing and approving body (for his own 
papers). As such, this printing error does not affect our conclusion 
with respect to Dr. Israel's potential bias. As we stated in the 
proposed rule, possible conflicts of interest do not, on their own, 
invalidate results. However, we continue to view Dr. Israel as a 
potentially biased source and weigh this evidence accordingly.
    With regard to peer review, the commenter simply asserts without 
explanation that the papers were peer reviewed. However, as we 
explained in the proposed rule, we determined that the publications 
(both 2008 and 2010) were not peer reviewed because the articles were 
only reviewed by the journal's editorial board rather than an 
independent expert whose sole role was

[[Page 13335]]

to verify accuracy and validity (see 81 FR 24386 at 24401).
    (Comment 38) One comment asserts that all of JRC's residents' 
harmful and dangerous behaviors decreased substantially as a result of 
treatment with the GED device, as evidenced in JRC's resident case 
reports, behavior tracking charts, and analyses from the past 16 years. 
The comment asserts this data set is extraordinarily robust because the 
individuals reside at JRC and are continuously monitored. The comment 
also asserts this data and information demonstrate the effectiveness of 
ESDs for SIB or AB for refractory patients.
    (Response) FDA disagrees that this is a robust data set, and this 
information does not change FDA's assessment of the effects of ESDs for 
SIB or AB. The case reports and other information submitted by JRC 
about its residents on whom ESDs have been used appear to indicate that 
their SIB and AB decreased substantially once they began wearing the 
GED and remained at low levels for years. However, as explained in the 
paragraphs that follow, this information suffers from several serious 
methodological limitations that prevent FDA from drawing any scientific 
conclusions regarding ESD effectiveness based on it. For example, these 
are resident records, not study data, and they also suffer from the 
same limitations that generally apply to the case studies discussed in 
the literature. In addition, the manner in which the information was 
collected and documented undermines its reliability.
    In particular, these resident records are anecdotal and do not 
amount to study data. The information was collected by JRC, which did 
not take measures to minimize the impact of subjectivity and potential 
bias. Important measures that its employees did not take include having 
an investigational plan and study protocol, running an analysis to 
demonstrate scientific soundness, validating methodology and endpoints, 
and selecting qualified investigators. JRC also failed to implement 
features designed to minimize confounding factors and other types of 
bias, such as a control group, blinding, and randomization, the 
importance of which are discussed in the proposed rule and in the 
responses to other comments. These records also suffer from the 
limitations that apply to extremely small studies. Although in 2016 JRC 
submitted case summaries for 68 residents (and has applied the devices 
to close to 300 individuals over the years, including about 51 then 
subject to the devices), we consider these data to be 68 individual 
resident summaries, not a single study including all residents, because 
the records do not show, for example, that conditions were controlled 
across individuals or subgroups of individuals.
    Further, confounding factors and uncontrolled conditions make it 
very difficult to attribute JRC's observed improvements in behavior to 
the GED device or draw any conclusions about its effects. For example, 
according to these records, most of the individuals on GEDs received 
concurrent treatment with various forms of behavioral therapy, 
including positive behavioral programming and various differential 
reinforcement programs, counseling, and functional communication 
training. Without adequately controlling for, or adequately documenting 
the formulation, application, and effects of the other behavioral 
intervention components, it is difficult if not impossible to 
differentiate effects of the GED from effects of behavioral treatments. 
Additionally, these records indicate that JRC targeted different 
behaviors during different time periods. As a result, many of the 
tracking charts show highly variable behavior, in some instances 
showing some target behaviors decreasing for an individual while other 
target behaviors did not decrease for that individual, and thus shocks 
continue to be applied. This makes it difficult to assess overall ESD 
effectiveness.
    Where data represent a relatively small number of individuals, 
detailed, systematic observations are critical to reducing uncertainty 
regarding results. Yet the information submitted by JRC fails to 
include important details regarding how the data were collected and 
recorded. This creates considerable uncertainty as to its significance 
and reliability and prevents us from drawing clinically meaningful 
conclusions regarding the benefits of the GED from the limited data 
provided in the case summaries. For example, the information lacks key 
details regarding the time at which the device was applied, the 
specific behaviors targeted, behaviors that occurred prior to 
administration of shocks, criteria for counting behaviors, the number 
of electrodes and their location on the body, which ESD model was used, 
frequency and duration of data collection, who determined a behavior to 
be SIB or AB, who recorded the count data, and the medical training (if 
any) or qualifications of those recording data to evaluate the 
residents. The information submitted to FDA suggests that JRC often 
applied multiple devices at once to single individuals, but the 
submissions do not explain why this was necessary or how the number of 
devices was determined; the submissions only provide gross detail, for 
example, that shocks were indicated for ``health-dangerous behavior.'' 
Finally, the charts include little information regarding the 
individuals and their behaviors before and after ESD use, making it 
difficult to draw conclusions regarding how the devices affected the 
target behaviors.
    (Comment 39) A comment argues that the ESD shock is applied to help 
residents identify their dangerous behaviors for purposes of reducing 
the frequency of that behavior. As residents learn to identify and 
control their dangerous behaviors, the number of shocks delivered 
decreases. The comment asserts that, for a significant portion of JRC 
residents, the duration of effects from ESDs for SIB or AB is lasting 
as demonstrated by the numerous residents who have been transitioned or 
``faded'' off of the GED and no longer manifest SIB or AB.
    (Response) Although ESDs may interrupt behaviors occurring at the 
time of shock, FDA has not seen adequate evidence demonstrating that 
ESD shocks produce a conditioned response. Additionally, although the 
ability of ESDs to condition individuals not to engage in SIB or AB 
after removing the device is part of the evaluation of ESD 
effectiveness, fading itself is not demonstrative of effectiveness. 
Fading of the GED is an indication of JRC's decision to reduce or cease 
use of the device for an individual, and submissions from JRC do not 
establish that it makes such decisions consistently, much less that it 
adequately establishes that the device caused changes in behavior. 
Further, SIB and AB can exceed pre-baseline levels once an ESD is 
removed, as has been observed in the literature. This is partly why, as 
discussed in the previous comment response, FDA disagrees that the 
resident data submitted by JRC demonstrate a durable effect for ESDs 
for SIB or AB.
    With respect to individuals transitioned off of the GED, only a 
small percentage of individuals at JRC have been completely faded off 
of the GED. According to the records submitted by JRC for the 68 
residents on whom ESDs have been used, only 13 (19 percent) have been 
completely faded, and the duration of ESD use prior to fading ranges 
from 3.5 to 23 years. According to the summary information for the 189 
residents on whom ESDs have been used since 2000, which is even less 
detailed than the 68 resident records, only 58 (31 percent) had been

[[Page 13336]]

completely faded off of the GED device at least 2 weeks before 
discharge from JRC.
    Further, JRC provided no information regarding clinical protocols, 
treatment plans, or behavior frequencies for individuals after they 
left JRC. At the Massachusetts hearing, Dr. Blenkush stated that JRC 
has not systematically collected follow-up data on individuals after 
they leave JRC (Ref. 14, day 37 at 81). FDA is not suggesting JRC 
necessarily must collect followup data; however, such data are 
important to understanding the effects of ESDs. Based on the scant 
information provided, FDA is unable to determine, for example, whether 
behaviors worsened after leaving JRC or whether other non-aversive 
treatments are responsible for any successes. Overall, it is difficult 
if not impossible to evaluate the effects of ESDs, much less draw any 
conclusions regarding ESD effectiveness, from the fading data provided 
by JRC for the GED, without: (1) A standardized clinical assessment 
protocol (e.g., specific behaviors targeted, criteria for counting 
behaviors, frequency and duration of data collection, who determined a 
behavior to be SIB or AB, who recorded the data, and the medical 
training or qualifications to evaluate patients of those recording 
data); (2) controlling for or adequately documenting the formulation, 
application, and effects of the other behavioral intervention 
components that were applied according to JRC's data; and (3) well-
documented followup to determine whether behaviors worsened after ESD 
use discontinued at JRC or after leaving JRC.
    The claim that these devices produce durable conditioning is 
further undermined by the fact that, as evidenced in the resident 
records submitted by JRC, the device has been used on many individuals 
for years and even decades. As Dr. Iwata explained during the Panel 
Meeting:

[M]y understanding of the way this whole process works is that 
within a given range in terms of interventions that we use, some are 
effective and some are not, and if they're not effective, you go on 
to something else. Now, electrical stimulation is designed to be 
very effective very quickly, which means that the individual should 
not experience very many stimulations, which means that very few 
people should habituate to the stimulus. And if they do, it's not 
really habituation; that is, they haven't adapted to it. It's simply 
ineffective, and you would move on rather than to step up the 
voltage, so to speak. To use an analogy, a small amount of lemon 
juice on the tongue might be another aversive event, but if that 
doesn't work, we don't put acid on the tongue.

(Ref. 15 at 142). Regardless of whether adaptation is the correct 
characterization, even JRC has acknowledged that its strongest ESD 
sometimes loses any effects it may have had in reducing target 
behaviors, necessitating the use of an alternative method to modify 
behaviors program instead of an ESD. Dr. Blenkush highlighted ``a very 
comprehensive alternative behavior program'' at JRC that was ``very 
effective'' after adaptation to the GED-4 even for patients engaging in 
SIB that could result in serious injury to themselves (Ref. 15 at 148).
    (Comment 40) One comment states some Panel members recognized ESDs 
as potentially appropriate for certain patients and asserts that FDA 
has ignored the comments of several Panel members that there is 
evidence to demonstrate that ESDs for SIB or AB have beneficial 
effects, particularly in the refractory population treated at JRC.
    (Response) FDA agrees that some Panel members opined that ESDs 
provide benefits for some patients but disagrees that we ignored these 
comments in the proposed rule and disagrees that Panel members opined 
that the benefits would be more likely to occur in JRC's patients. As 
explained in the proposed rule, approximately half of the Panel agreed 
that there was a benefit, but they qualified their answers by 
explaining that the evidence showed a benefit from the interruption and 
immediate cessation of the behavior and noted the weaknesses in the 
evidence (81 FR 24386 at 24401). Regarding refractory individuals 
residing at JRC, when asked specifically about the subpopulation for 
whom any benefits might manifest, most panelists stated that they could 
not define that subpopulation. Further, as noted in Responses 13, 32, 
and 43, being refractory to other treatments does not mean ESDs will be 
effective. However, overall, the Panel recommended to FDA that the 
Agency ban ESDs for SIB or AB, with the members taking into 
consideration potential benefits and risks of the devices, including 
use of the device in a refractory population. Accordingly, the Panel's 
overall evaluation of ESD effectiveness is consistent with FDA's.
    (Comment 41) One comment says that expert testimony from the 
Massachusetts hearing supports JRC's argument that the GED is effective 
for the population on whom it is used at JRC.
    (Response) FDA agrees that some of the expert witnesses at the 
Massachusetts hearing testified about the beneficial effects from the 
GED for SIB or AB at JRC. For example, Dr. Susan Shnidman, a clinician, 
testified that she observed improvements in the behaviors of many JRC 
residents after beginning treatment with the GED, and Dr. Philip 
Levendusky, another clinician, acknowledged in his testimony that there 
are many examples where the GED had a positive impact on a JRC 
resident. Further, clinicians Dr. Mikkelsen stated, and Dr. Zarcone 
confirmed, that in many cases there was rapid deceleration in SIB after 
the use of the GED, with the problematic behaviors decreasing from 
hundreds per day to zero in a very short period of time.
    While expert testimony regarding observed benefits of the GED in 
many individuals at JRC is certainly relevant to this rulemaking, and 
FDA has taken this information into account in our decision-making, 
much more important is the issue of durable, clinically meaningful, 
effectiveness of ESDs for SIB or AB. On this more scientifically 
complex issue, the expert testimony from the Massachusetts hearing 
generally cuts in the opposite direction and is consistent with FDA's 
assessment that the evidence is insufficient to establish behavioral 
conditioning or durable effectiveness.
    For example, although Dr. Mikkelsen testified that the GED can 
suppress the behavior and that he has seen some residents' behaviors 
respond to the GED, he also testified that, based on JRC's spreadsheets 
regarding efficacy, the GED ``doesn't have any statistically lasting 
effect'' and that he does not believe the GED ``actually changes the 
behavior in any lasting way'' (Ref. 14, day 7 at 196). Dr. Geller 
testified, ``[t]he 168 articles represent a small number of cases that 
have extremely mixed results. . .The studies fail to show whether or 
not [contingent skin shock] is effective, if the outcome means that the 
individual could live a life without the self-injurious behaviors or 
would have aggression without shock'' (see Ref. 14, day 21 at 49-60). 
Dr. McCracken testified regarding the design weaknesses and inadequate 
duration of observation of the majority of studies on ESDs for SIB, 
which are particularly detrimental due to the fact that SIB ``waxes and 
wanes over time''; one ``could mistakenly attribute those changes to 
the treatment if you don't have a comparison group'' (Ref. 14, day 9 at 
152). Dr. McCracken summarized that, ``the use of painful electric 
shock lacks what any professional group would deem an adequate and well 
supported evidence base'' (Ref. 14, day 9 at 85-86), and that he would 
never use

[[Page 13337]]

shock even if no other treatment worked (see also Ref. 14, day 9 at 
149-50, 160).
    Further, according to hearing testimony and an exhibit from Dr. 
Geller, for nearly half of the 87 JRC residents with GEDs between 2000 
and 2014, the ``peak 12-month period'' during which they received the 
most GED shocks was after their first year using a GED at JRC. Based on 
Dr. Geller's analysis of JRC data, the average time to peak 
applications was 2.7 years, and in some cases the peak was not reached 
until they had been receiving GED shocks for 8 years or longer. Dr. 
Blenkush of JRC criticized this analysis insofar as it did not include 
pre-2000 data; however, JRC did not provide this GED application 
frequency data to FDA. According to this hearing testimony and exhibit, 
JRC's own data show that for many individuals, the frequency of GED 
shocks and hence, the frequency of SIB and AB, increased rather than 
decreased for some period of time after GED use began; for many 
individuals, the peak 12-month period was many months, and for some 
individuals, many years, after GED use began. This casts additional 
doubt on JRC's assertions that the GED very quickly decreases SIB and 
AB and produces a lasting conditioning effect, as well as on the 
ability of ESDs to achieve durable conditioning generally.

E. State of the Art for the Treatment of SIB and AB

    (Comment 42) A comment asserts that PBS is not a state-of-the-art 
treatment for individuals exhibiting SIB and AB, arguing that PBS is 
not formally defined by any authoritative professional body and that it 
has no professional credential or license. However, the comment also 
states that ESDs must be used in conjunction with positive approaches.
    (Response) FDA disagrees that the lack of PBS-specific professional 
credentialing or licensing means it is not a state-of-the-art treatment 
for SIB or AB. As explained in the preamble to the proposed rule, and 
as FDA continues to maintain, state-of-the-art treatment for 
individuals exhibiting SIB and AB generally relies on multielement 
positive interventions such as PBS (81 FR 24386 at 24403-10; see also 
section I.A.). The comment cites the hearing testimony of Dr. Zarcone, 
a psychologist and board-certified behavior analyst, to show that there 
is no educational degree or licensing for PBS. However, elsewhere in 
her testimony, Dr. Zarcone states that the use of PBS is generally 
accepted practice for the treatment of individuals who have 
intellectual and developmental disabilities and severe behavior 
problems (Ref. 14, day 13 at 98).
    As we recognized in the proposed rule, multielement positive 
methods such as PBS or dialectical behavioral therapy (DBT) span 
several categories of intervention for a wide variety of purposes 
(Refs. 68 and 69). Likewise, the term ``positive'' can apply to many 
different treatment modalities (Refs. 9 and 70). This does not, 
however, mean that positive approaches are vague or ill-defined. To the 
contrary, a large body of scholarship as well as broad institutional 
support informs the use of multielement positive approaches like PBS.
    To take PBS as an example, as we explained in the proposed rule, 
the Association for Positive Behavior Supports has adopted specific 
standards of practice for the elements that comprise PBS (Ref. 12). 
Multielement positive interventions that rely on FBAs, such as PBS, are 
described in academic journals, books, graduate training programs, and 
professional organization publications (Ref. 12). Likewise, other 
positive-only models such as DBT are well-defined and formally 
described (see Refs. 71 and 72). Although the comment here states that 
PBS is not formally defined, it elsewhere refers to techniques of PBS 
as a discrete subset of ABA techniques in which JRC employees have 
experience. Furthermore, the comment characterizes one provider, Dr. 
Zarcone, as a national expert on PBS, recognizing that PBS is a 
distinct, defined treatment approach for SIB and AB. We note that no 
professional organization publishes standards of practice for the use 
of ESDs, and no journals, graduate programs, or professional 
organizations focus on the skills necessary to use contingent electric 
shock (see Ref. 12).
    Comments from healthcare providers who have experience treating 
patients with SIB and AB explain that state-of-the-art positive 
behavioral interventions are even more advanced and effective than the 
methods that FDA described in the proposed rule (e.g., PBS). FDA 
agrees. For example, in one form of functional behavior assessment 
referred to as ``analog functional analysis,'' clinicians identify the 
antecedents and consequences that maintain problem behaviors by 
experimentally replicating the events or conditions thought to trigger, 
incentivize, or reinforce the behavior, then develop a behavior plan 
based on modifying these antecedents and consequences (Ref. 73). 
According to Dr. Zarcone, analog functional analysis is the most 
rigorous and precise level of FBA, and it is now considered to be the 
``gold standard'' in the field of applied behavior analysis for 
individuals with severe problem behaviors (see Ref. 14, day 13 at 66-
67, 71-72, 80). This is demonstrated by the exponential increase in the 
number of research studies relating to analog functional analysis in 
recent years: While there were only a handful of such studies before 
1985, there were approximately 250 in the 1990s and almost 1,000 
between 2001 and 2010 (Refs. 74 and 75).
    The comment asserting that PBS is not a state-of-the-art treatment 
for SIB or AB concedes that state-of-the-art treatments available to 
patients with SIB and AB include, among other options, positive 
behavior therapy, and that, ``PBS therapy is almost always the first 
line therapy in the treatment of numerous disorders, including AB and 
SIB, due to its limited risk profile.'' The comment goes further, 
stating that ESDs ``must always be used in conjunction with positive 
behavioral programming as part of a comprehensive care protocol 
individualized for the patient.'' These statements contradict the 
comment's assertion that approaches such as PBS are not within the 
state of the art.
    In analyzing the state of the art in a device ban, the Agency 
assesses the risks of the device being banned relative to the risks of 
other treatments used in current medical practice for the same 
purposes. Positive behavioral treatment techniques have a very low risk 
profile, and FDA did not receive any comments suggesting otherwise. 
Even this comment concedes PBS is ``low risk.'' The only risk that FDA 
found to be associated with positive behavioral treatments is one posed 
by ``extinction,'' a common component of behavioral plans (see 81 FR 
24386 at 24405). Extinction exhibits the potential risk of ``extinction 
bursts,'' an upsurge of the actual undesirable behavior, particularly 
manifested in the early stages of the intervention. If this upsurge in 
behavior poses a danger to the individual or others, then an extinction 
paradigm may not be a feasible option. The behavioral therapist would 
have to use a different treatment plan component to accomplish the same 
objective. However, extinction bursts would be easily recognized and 
quickly mitigated by competent therapists. With respect to SIB and AB, 
positive behavioral treatment alternatives present much lower risks 
than ESDs, supporting the conclusion that the risks posed by ESDs are 
unreasonable.
    (Comment 43) Some comments argue ESDs are necessary options because 
positive-only behavioral approaches such as PBS are ineffective for 
certain patients, citing literature indicating that

[[Page 13338]]

PBS is not always effective for every patient in every situation, and 
pointing out that the Panel agreed that treatment options other than 
ESDs would not be adequate for all patients. One comment asserts that 
FDA has erroneously clung to the notion that the effectiveness of PBS 
to treat SIB and AB is an absolute and that FDA was not forthright in 
the proposed rule because we treated PBS as though it has been 
universally recognized as effective.
    (Response) FDA disagrees. Citing most of the same literature cited 
by the commenter, we acknowledged in the proposed rule that positive 
behavioral approaches may not always be completely successful for all 
patients, either used alone or in conjunction with pharmacological 
treatment or other non-ESD treatment options. We also acknowledged that 
the Panel agreed that positive behavioral approaches alone are not 
adequate for all individuals who exhibit SIB or AB (81 FR 24386 at 
24405 to 24406). Further, we explained that not all providers follow a 
positive-only behavioral treatment model such as PBS (81 FR 24386 at 
24405, citing Refs. 10 and 76). For example, we discussed the sources 
cited by the commenter that showed success in 52 percent and 60 percent 
of patients where positive behavioral approaches were attempted and 
concluded that positive behavioral therapy may sometimes need to be 
supplemented with pharmacotherapy or other non-ESD treatment options 
(81 FR 24386 at 24405 to 24406). Thus, FDA has not portrayed PBS 
effectiveness as an absolute or universally recognized panacea. 
However, the literature does indicate PBS is successful for many 
individuals who exhibit SIB or AB and that substantial progress in non-
aversive approaches for the treatment of SIB and AB has been evident in 
the literature for at least 20 years. More recent literature 
corroborates FDA's position; for example, a recent meta-analysis of 
case studies in individuals with autism or developmental disabilities 
and SIB found that 77 percent of subjects had a positive outcome from 
behavioral interventions for SIB (Ref. 77).
    The commenter asserts far more research is needed regarding the 
efficacy of PBS for SIB and AB, quoting from a literature review that 
FDA cited in the proposed rule. The review states: ``in recent years, a 
number of questions have been raised regarding PBS, including questions 
regarding the efficacy of using an exclusively positive approach to 
support people with seriously challenging behavior'' (Ref. 8). Although 
this article states that further research is needed to validate the 
findings of the studies conducted, the article goes on to say its 
review of 12 published studies concludes that ``the results for 
literally hundreds of individuals who received services in different 
countries around the world appear to support the conclusion that the 
(multi-element PBS) model is effective. Specifically, PBS appears to be 
beneficial for the most severe problems (as well as less severe 
problems), for high-rate behaviour (as well as low-rate behaviour), and 
for behaviour problems exhibited by people who live in institutional 
settings (as well as for people who live in the community'' (Ref. 8). 
FDA agrees more clinical research on PBS would be helpful, but this 
does not undermine the benefits and general success of PBS that have 
been shown thus far.
    Two sources cited by the commenter that we did not discuss in the 
proposed rule provide further evidence that state-of-the-art behavioral 
techniques and psychotropic medications are not always completely 
effective for all individuals who exhibit SIB or AB, and that further 
research would be helpful (Refs. 78 and 79). Notably, one of them 
concludes that outcome measures ``suggest a high degree of 
effectiveness'' for behavioral interventions for self-injury (Ref. 79, 
noting that treatment failures may be underreported). This echoes our 
explanation in the proposed rule (81 FR 24386 at 24403 to 24410): 
Although PBS and multielement positive approaches may not be completely 
effective for every patient, the literature and the experience of 
experts in the field indicate that these are generally successful, 
sometimes alongside pharmacotherapy. This is true regardless of the 
severity of the behavior targeted, there has been substantial progress 
in non-aversive treatments for SIB and AB, and the success rate for 
such interventions continues to improve. (See, e.g., Refs. 2, 10, 12, 
68, and 80 to 88).
    As discussed in the previous comment response, comments on the 
proposed rule from healthcare providers and experts not affiliated with 
JRC indicate that positive behavioral interventions are more advanced 
and effective than described in the proposed rule, and, most 
importantly, such interventions are very low risk. Based on FDA's 
expertise, experience, and knowledge of the literature, we agree with 
the findings of Dr. McCracken, who testified that the majority of this 
patient population can be successfully treated using a combination of 
positive behavior supports and pharmacotherapy, without the use of ESDs 
(Ref. 14, day 9 at 148; day 10 at 107-08).
    Lastly, even though there are some patients for whom positive 
behavioral approaches may not be completely successful, that does not 
mean ESDs are effective for those patients. As one Panel member stated, 
the fact that other ``therapies are not completely successful or don't 
work on all patients does not mean, therefore, that electrical aversive 
stimulation is indicated.'' See section V.D. for a discussion of ESD 
effectiveness.
    (Comment 44) One comment supports its arguments regarding the 
ineffectiveness of non-ESD treatment options for certain individuals by 
asserting that, for the individuals on whom ESDs have been used at JRC, 
all other behavioral and pharmacological treatment options were 
attempted and failed.
    (Response) FDA has reason to doubt that pharmacological and 
positive behavioral treatment options were adequately attempted for the 
individuals on whom ESDs have been used at JRC based on the available 
data and information from JRC. JRC submitted resident summaries to FDA 
for 68 individuals at JRC in 2016 on whom ESDs had been used. Of those 
68 summaries, only 9 (13 percent) indicate a formal functional 
assessment was conducted by JRC, and the summaries indicate that 5 
other individuals underwent prior assessments at other facilities. JRC 
also submitted related case conference reports to FDA for 54 of those 
68 individuals. Those reports indicate that only 19 individuals (35 
percent of 54, 28 percent of 68) had either past or ongoing functional 
assessments. Therefore, based on the available data and information, 
only a fraction of individuals at JRC subject to ESDs appear to have 
undergone functional behavioral assessments.
    Further, the resident summaries and conference reports provided to 
FDA by JRC provide little to no detail regarding the functional 
assessments that had been conducted. For example, information regarding 
assessment instruments, granular results, and reassessment results is 
nonexistent, and in many cases, they do not identify the function of 
the behavior. Thus, for the minority of individuals who have undergone 
a documented assessment, the lack of any detail makes it difficult to 
identify the functions of the target behaviors, corroborate that the 
assessments met accepted standards, or even that the individuals were 
periodically reassessed.
    In his hearing testimony, JRC's Director of Research, Dr. Blenkush, 
not only acknowledged that JRC does not perform functional analyses but

[[Page 13339]]

recognized that outside observers would question why they have not. 
(Ref. 14, day 38 at 174). This is consistent with what we explained in 
the proposed rule: At least some parents who withdrew their children 
from JRC did not report any activity that would indicate the 
development of prevention or antecedent strategies, and some reported 
that facilities their children attended prior to JRC had not attempted 
such strategies or even conducted FBAs.
    As we explained in the proposed rule, a functional behavioral 
assessment is critical to developing a successful multi-element 
positive intervention or other empirically derived, individualized 
behavioral interventions (81 FR 24386 at 24403 to 24404). Failure to 
conduct a functional behavioral assessment and do so adequately may 
actually lead to harm because the resulting plan may inadvertently 
reinforce and consequently increase the problem behavior (Ref. 12). 
Similarly, inadequately performed functional assessments could reduce 
the effectiveness of the resulting behavioral intervention (Brown 
report). The failure to conduct an assessment or re-assessment 
properly, or even at all, is tantamount to a failure to attempt multi-
element positive interventions (e.g., PBS) or other interventions that 
utilize such assessments.
    Further, the resident summaries JRC submitted include diagnoses but 
do not include any information regarding how primary diagnoses were 
made, such as what clinical tests or scales were used, or any other 
information regarding past medical history. Dr. McCracken testified 
that methods of diagnosing individuals at JRC are outdated, and that 
its staff ``puts very little effort'' into properly diagnosing 
individuals; ``the [JRC] clinicians adopted a kind of cut-and-paste 
mentality from the prior evaluations and appear to not feel the need to 
more carefully assign and evaluate the presence of these overlapping 
terms in an effort to understand their clients more deeply.'' FDA 
agrees that JRC's diagnoses lack thoroughness and careful assessment 
based on our review of the summaries JRC submitted in its comment. Dr. 
McCracken further testified, and FDA agrees, that without a proper 
diagnosis, it is difficult for clinicians to develop an appropriate 
treatment plan (see Ref. 14, day 9 at 99-101, 104, 107-09, 116-17). As 
with any medical condition, improper diagnosis, treatment, and lack of 
access to specialty care limits positive outcomes. A proper diagnosis 
can greatly increase the chances of beneficial treatment; for example, 
when comorbid conditions are correctly diagnosed, they can be 
successfully treated with psychotherapies, behavioral therapies, and 
pharmacotherapies that are individualized to the patient's needs.
    With regard to the use of positive interventions prior to ESD use, 
whether at JRC or before an individual was brought to JRC, the 
available data and information lack critical details necessary to 
assess whether these treatments were adequately or appropriately 
administered. For example, the documents do not provide detail on what 
specific therapies were attempted, how long they were tried, or what 
the effects were. We cannot determine from the JRC resident charts and 
summaries which, if any, treatments were tried prior to placement at 
JRC. Critically, the documents do not provide enough information to 
determine whether the interventions were appropriately targeting 
behaviors, which is necessary to understand whether the interventions 
failed, and if so, why they failed.
    More importantly, these omissions also prevent evaluating whether 
the use of ESDs caused or contributed to different outcomes. The 
reasons provided for placement at JRC include not only unsuccessful 
treatment at previous facilities, but also aging out of previous 
facilities, rejection by previous facilities, and inability of parents 
to handle behaviors at home. For some cases, no reason is provided. Dr. 
Shnidman, a psychologist who wrote reports justifying the use of GEDs 
on JRC residents as part of the State court approval process, testified 
that in almost every case, she recommended that the GED was the most 
effective, least restrictive treatment, yet she was not aware whether 
JRC tried to use positive interventions or whether positive 
interventions were effective (see Ref. 14, day 12 at 156, 217). 
Similarly, Dr. Fox testified that he never saw an individual at JRC for 
whom an adequate workup had been conducted to establish that a GED was 
the most effective, least restrictive treatment (see Ref. 14, day 40 at 
39).
    The JRC resident summaries and the hearing testimony and exhibits 
that JRC submitted in its comments also cast doubt on JRC's assertions 
that pharmacological alternatives were adequately attempted prior to 
GED use on individuals. For example, the resident summaries excluded 
information on dosage, regimen (e.g., how many, how often, and for what 
duration), and both positive and negative effects. In certain 
instances, the summaries indicate that maximum therapeutic doses were 
not attempted. Dr. Mikkelsen testified that many of the medication 
trials he looked at closely ``were inadequate or, you know, the person 
may only have been on it for two weeks at a low dose and it's listed as 
all these medications didn't work'' (Ref. 14, day 7 at 156). Dr. Geller 
testified that, based on the charts he reviewed for individuals weaned 
off medication and put on the GED, individuals did not have sufficient 
trials of psychopharmacology (see Ref. 14, day 21 at 66).
    JRC documents indicate that JRC generally opposes the use of 
pharmacological treatments and makes little effort to attempt their use 
before or after prescribing the GED for an individual. For example, 
JRC's Policy on Psychotropic Medication states, ``it is JRC's policy to 
avoid, or at least minimize the use of psychotropic medication'' and 
explains that, for individuals on psychotropic medication prior to 
enrollment at JRC, a psychiatrist will be consulted to consider the 
benefits of psychotropic medication removal (Ref. 14, exhibit 718). Dr. 
Joseph, JRC's sole consulting psychopharmacologist, recommends 
medication removal in response to almost every JRC referral (Ref. 14, 
day 40 at 136-37). Once psychotropic medications are eliminated, the 
individual is typically discharged from Dr. Joseph's care, and no 
psychiatrist follows the individual thereafter. In the words of Dr. 
Geller, Dr. Joseph ``sees his task as removing people from all their 
psychiatric medications and then ending his contact with them'' (Ref. 
14, day 21 at 66). Of the 64 individuals with a treatment plan 
including ESD use as of June 2015, 7 had no record of any 
psychopharmacological consultations, 50 had not had 
psychopharmacological evaluations for over 5 years; of these 50, 37 had 
not had psychopharmacological evaluations for over 10 years, and 8 had 
not had psychopharmacological evaluations for over 20 years (Ref. 14, 
day 21 at 6-9, referring to impounded exhibit 662).
    Other comments and testimony indicate that non-ESD alternatives 
have been or likely would be successful for individuals on whom ESDs 
have been used at JRC. Several comments from healthcare providers 
explain that patients with severe SIB or AB at JRC present behaviors 
that are challenging to treat. However, such behaviors are no more 
challenging to treat than those exhibited by patients with similar 
conditions who are successfully treated across the country without the 
use of ESDs. This is supported by fact and expert witnesses in the 
hearing testimony cited by JRC, who testified

[[Page 13340]]

that individuals with the most challenging SIB and AB have been 
successfully treated without the use of skin shock at various 
institutions across the country. (See, e.g., Ref. 14, day 4 at 42-43 
(Simons); day 7 at 49, 60-61, 181 (Mikkelson); day 9 at 39-40, 160 
(McCracken); day 13 at 11-12, 138 (Zarcone); day 14 at 24, 28 
(Thaler).)
    For example, Dr. McCracken, a clinician who treats individuals with 
developmental disabilities who engage in SIB and AB, testified that his 
clinic has been successful in treating the vast majority of individuals 
and has been able to help everyone, at least to some degree, without 
using skin shock (Ref. 14, day 10 at 107-08). Dr. Alfred Bacotti, 
another clinician, testified that in his 30 years as a psychologist 
treating patients, including some with SIB and AB as severe as those 
exhibited by JRC residents, he never used skin shock (Ref. 14 at 212). 
Perhaps most tellingly, Dr. Chris White, a licensed psychologist with 
over 30 years of experience in the field of behavioral therapies who 
runs a facility to which many individuals formerly on ESDs at JRC were 
transferred, testified at a Massachusetts DDS hearing in 2011 that his 
facility has been able to successfully serve these individuals without 
the use of aversives by taking a combined-treatment approach, 
emphasizing positive interventions. (See Ref. 14, exhibit 455, at 142-
43, for a partial transcript of the July 2001 hearing.)
    (Comment 45) Behavioral therapists comment that state-of-the-art 
treatments such as PBS can prevent the recurrence of SIB and AB because 
they address the underlying causes of SIB and AB and the communicative 
needs of patients, unlike ESDs.
    (Response) FDA agrees that state-of-the-art interventions such as 
PBS are generally successful because, unlike ESDs, they address the 
underlying causes of SIB and AB. As we explained in the proposed rule, 
one goal of state-of-the-art approaches such as PBS is to teach new 
behaviors that proactively displace undesirable behaviors (SIB and AB) 
by teaching individuals to express themselves with behavioral 
substitutions that will not cause harm to themselves or others (Refs. 
87 and 89). For example, functional communication training, as one 
element of an intervention, examines the communicative intent of the 
problem behaviors (what the individual is trying to communicate or 
obtain from others), and then focuses on teaching the individual a 
functionally equivalent, but non-problematic, behavior (Ref. 12). There 
has been a shift toward prevention in recent years (e.g., structured 
environment and schedule, support services at school), and prevention 
of SIB and AB is considered the best practice, particularly for those 
with intellectual and developmental disabilities (Refs. 77 and 90).
    In contrast, as these comments point out, the use of ESDs does not 
teach a person new skills or replacement behaviors, does not mitigate 
the underlying cause, and cannot achieve behavioral conditioning for 
some patients who have conditions that impair their ability to 
understand consequences and react by changing their behaviors (Ref. 8). 
Even Dr. Blenkush of JRC stated that providers there can reduce the use 
of ESDs through skill training or other procedures and that even people 
whom JRC thought could not be faded off of ESDs responded to these 
treatments (Ref. 15 at 148). These are some of the reasons that the 
field of ABA as a whole moved away from intrusive physical aversive 
conditioning techniques such as ESDs two decades ago (Ref. 9, reprinted 
from 1990, and Ref. 91).
    (Comment 46) Some parents of individuals at JRC who exhibit SIB or 
AB comment that ESDs have been the only treatment capable of reducing 
their family member's behaviors. They argue that a ban on ESDs for SIB 
or AB would force them to resort to ineffective and risky therapies 
such as restraints and medication. Another comment states that FDA has 
dismissed such parents' views on the basis that a very small minority 
claimed they were coerced or misled.
    (Response) FDA has not dismissed the views of these parents but 
rather has given their input careful consideration. As we stated in the 
proposed rule, FDA has no reason to doubt these parents' best 
intentions, the sincerity of their belief that an ESD is the best or 
perhaps only option for their loved one, or that they have tried 
alternatives without success. Whether they were opposed to or in favor 
of a ban, FDA considered each parent's comments and submissions for the 
Panel Meeting, as well as their comments submitted to the public docket 
for this rule. As explained in the proposed rule, we did not consider 
these parents' reports as scientific evidence relating to the use of 
the devices. Rather, FDA used these parents' reports to help inform our 
understanding of parents' and patients' experiences and knowledge 
regarding the risks and benefits of ESDs and the state of the art.
    As explained in the proposed rule, FDA has reason to question the 
information provided to family members by JRC. We explained how some of 
the parents' reported experiences contradicted assertions that the 
devices were only used as a last resort and indicated that other 
treatment strategies were not adequately attempted, in which case it is 
not known whether they would have been successful. In the proposed 
rule, we referred to parents' reports that, for some of their children, 
schools did not attempt all treatment options. For example, some 
schools did not use a functional behavioral assessment to develop 
prevention or antecedent strategies, strategies that are hallmarks of 
state-of-the-art interventions (81 FR 24386 at 21409). Ref. 92 also 
stated that once the family members were at JRC, none of the parents 
reported the development of prevention or antecedent strategies. None 
of the comments on the proposed rule cause us to view these reports 
differently. Taken together, these parents' reports indicate that non-
ESD interventions based on functional behavioral assessments that seek 
to prevent target behaviors were not adequately attempted for these 
individuals. As we acknowledged in the proposed rule, we understand 
that these reports are only from certain parents who volunteered to 
share negative experiences, and we cannot conclude that these reported 
experiences were shared by others or are generally representative of 
families' experiences at JRC.
    As with the parents of individuals at JRC, we have no reason to 
doubt the sincerity of the parents who removed their children from JRC. 
As one researcher noted, these individuals and their families ``have 
likely traveled a rough path'' (Ref. 12). For these individuals, ESDs 
were not in fact applied as a last resort, and their parents reported 
feelings of coercion from JRC (Ref. 92). It thus appears that at least 
some parents felt pressured to agree to the use of ESDs, and for at 
least some individuals, alternative treatments were not exhausted.
    One comment asserts these viewpoints are hearsay and criticizes FDA 
for relying on them while elsewhere rejecting articles supporting ESD 
effectiveness because they are not deemed adequately controlled 
studies. This criticism is without merit. In fact, FDA's views 
regarding the exhaustion of behavioral and pharmacological treatment 
options are informed primarily by the scientific literature regarding 
state-of-the-art treatments for SIB and AB, expert views on these 
issues, and the records provided by JRC regarding individual treatment 
prior to ESD use, which suffer from serious limitations, as discussed 
in Responses

[[Page 13341]]

38 and 44. FDA also considered the views and experiences of parents; as 
they relate to the current state of medical practice and alternative 
treatment attempts, the reports from parents who oppose the use of ESDs 
are consistent with the data and information we considered and 
explained in the proposed rule as well as the records JRC provided 
regarding its residents. Further, the vast majority of parents who 
commented on the state of the art opposed the use of ESDs.
    Again, evidence of failures of treatments other than ESDs is not 
evidence that ESDs safely or successfully treat patients. Programs 
across the nation successfully treat SIB and AB without ESDs. While 
some parents may sincerely believe in the necessity of ESDs and 
undoubtedly face serious difficulties in selecting treatment, their 
information may be incomplete, and alternatives may not have been 
adequately attempted.
    (Comment 47) Hundreds of parents of individuals who exhibit SIB or 
AB comment that positive-only approaches work even for the most severe 
manifestations of SIB or AB. Some describe a need to be supportive of 
individuals, contrasting support with the physically punitive nature of 
ESDs.
    (Response) These comments are consistent with FDA's finding that 
the state of the art for the treatment of SIB or AB relies on 
multielement positive methods, especially PBS, sometimes in conjunction 
with pharmacological treatments. ``Positive'' can apply to many 
different treatment modalities, but it does not include aversive 
interventions such as contingent skin shock (Refs. 9 and 70). State-of-
the-art, multielement, positive interventions such as PBS rely on 
functional behavior assessments to design a treatment plan for 
individual patients.
    Clinicians ordinarily try multiple positive treatment interventions 
if the initial treatment is not successful. Indeed, if a given 
intervention does not reduce or eliminate an unwanted behavior, a 
clinician would adjust the treatment on an empirical basis. As one 
expert in PBS explained, the assessment of behaviors and design of 
interventions is an iterative process, and continual adjustment of 
positive interventions will serve the patient better than substituting 
elements with the use of ESDs (Ref. 82). FDA believes that what these 
parents describe in their comments mirrors the state of the art for the 
treatment of SIB or AB. Multielement positive interventions are 
designed to support the individual by teaching skills and replacement 
behaviors, and such interventions can achieve durable success in 
community and home settings (Refs. 12, 87, and 88).
    (Comment 48) Comments assert that punishment generally, contingent 
shock, and the use of ESDs are state-of-the-art treatment options for 
patients with SIB and AB (along with PBS, pharmacotherapy, and 
restraint).
    (Response) To ban a device under section 516 of the FD&C Act, FDA 
must find that it presents substantial deception or an unreasonable and 
substantial risk of illness or injury. As we explained in the preamble 
to the proposed rule, 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. The state of the art with respect to this proposed 
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. 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 (81 FR 24386 at 24386 to 24388).
    The purpose of the analysis of the state of the art is to assess 
the risks and benefits of alternatives used in current medical practice 
to treat a particular patient population and to compare those to the 
risks and benefits of the device that is the subject of the ban, not to 
determine whether the device that is the subject of the ban is part of 
the state of the art. For these reasons, whether punishment, contingent 
shock, or ESDs are within the standard of care or state of the art is 
not an issue in this rulemaking. However, the state of current 
technical and scientific knowledge and medical practice with regard to 
the use of punishment generally and ESDs in particular on patients 
exhibiting SIB and AB may still bear some indirect relevance to the 
risk-benefit profile of ESDs as compared to alternative treatments.
    As we explained in the proposed rule, punishment techniques include 
a broad range of consequences (81 FR 24386 at 24405 to 22406). On one 
end of the spectrum, some are highly restrictive and/or painful, such 
as the use of ESDs or food deprivation, while, on the other end, some 
are less or non-intrusive, such as using ``time-outs.'' Given such a 
broad range, FDA did not attempt to define all possible punishment 
techniques relative to the state of the art.
    During the hearing, Dr. Zarcone testified that she uses punishment 
techniques such as time-outs, holds, and facial screening. However, she 
said that she distinguishes her techniques from those that cause pain 
such as the use of ESDs (Ref. 14, day 15 at 31-41). Her techniques are 
less intrusive, and in her view, teach the individual something about 
the behavior and are effective. Such techniques can be compatible with 
PBS. In contrast, painful punishments, including aversive 
interventions, are not compatible (Ref. 14, day 13 at 103-04). One 
textbook explains that electric shock can be replaced with ``more 
acceptable aversive outcomes'' such as a squirt of lemon juice or a 
reprimand (Ref. 59 at 56-79). Similarly, Dr. Daniel Bagner, a clinician 
and professor, testified that he does not teach parents to use painful 
punishment such as electric shocks or spanking, and that such 
techniques are not part of any evidence-based treatment (Ref. 14, day 
11 at 81).
    While punishment-based techniques may appear in textbooks that 
provide an overview of treatments for completeness, such references 
often caveat the use of punishment-based techniques as less beneficial 
than others. As we stated in the proposed rule, a 2008 survey of the 
members of the Association for Behavior Analysis found that providers 
generally view punishment procedures as having more negative side 
effects and being less successful than other reinforcement procedures 
(Ref. 76). The study of punishment to treat SIB and AB peaked in the 
1980s and has been declining steadily ever since (Ref. 93).
    Regarding ESDs, as we explained in the proposed rule, researchers 
have long raised ethical concerns about purposefully subjecting 
patients to the harms caused by physically aversive stimuli (see, e.g., 
Refs. 9, 60, 66, 71, and 88). Review of the current scientific 
literature confirms that, in recent decades, medical practice has 
shifted away from restrictive physical aversive conditioning techniques 
such as ESDs and toward treating patients with SIB and AB with 
positive-based behavioral interventions (see, e.g., Refs. 9, 10, and 
91; see also 81 FR 24386 at 24405). Indeed, of the 57 total published 
studies on the effectiveness of contingent skin shock, only 10 such 
studies have been published in the past 20 years, and only 1 in the 
past decade. Although a few ABA textbooks (one of which is authored by 
a JRC Board member) mention contingent skin shock as an available 
technique, they also emphasize the highly limited use of ESDs due to 
negative side effects and

[[Page 13342]]

ethical and humanitarian objections (Ref. 94). FDA acknowledges that a 
number of States do not prohibit the use of ESDs for SIB or AB on their 
residents, and some States reimburse individuals for the use of ESDs on 
their residents in certain circumstances. However, according to a 2015 
survey conducted by NASDDDS, 37 of the 45 States that responded 
reported that aversive interventions are disallowed for treatment of 
people with intellectual or developmental disabilities, and none of the 
other eight States included ESDs as permissible aversives. With regard 
to the GED specifically, Dr. McCracken testified that no valid evidence 
supports the use of the GED and that its use is unethical (Ref. 14, day 
9 at 79, 85-86, 160).
    Perhaps most revealingly, as JRC acknowledges in its comments, JRC 
is currently the only facility in the country that uses ESDs for SIB or 
AB, and it uses ESDs on individuals from only 12 States.
    (Comment 49) A comment questions FDA's reliance on expert reports 
for the proposed rule because the experts are vocal advocates for PBS 
and vocal critics against the use of ESDs. The comment argues that FDA 
sought to bolster a particular point of view with biased advocates 
rather than seek information in a more neutral way, and that FDA did 
not similarly defer to the opinions of experts affiliated with the 
manufacturer.
    (Response) FDA disagrees. Although two of the three outside experts 
from whom FDA solicited reports oppose the use of ESDs and support the 
ban, the third, Dr. Smith, opposes the ban and instead argues in his 
report for allowing their continued use with new regulatory 
restrictions. In the proposed rule, we made clear these reports are 
``solicited opinions.'' The fact that we found the views of some 
experts more compelling than others does not mean we deferred to some 
and dismissed others. Rather, given their expertise and experience, we 
considered the opinions of all three experts in our analysis of the 
risks and benefits of ESDs and alternative treatments, similar to our 
consideration of the expert views of the Panel members. In evaluating 
these views, we took into account any potential biases, similar to our 
review of the literature. FDA made these solicited opinions and the 
transcript of the Panel Meeting publicly available in the docket for 
the proposed rule, so commenters had an opportunity to examine and 
respond to them.
    (Comment 50) One comment asserts that there are no pharmacologic 
treatments specifically approved for treatment of SIB and AB; thus, no 
drug has been proven effective for such uses, such uses are off-label, 
and no drug should be considered a state-of-the-art treatment for SIB 
or AB. The comment further asserts that pharmacotherapy is ineffective 
for some patients and has severe risks.
    (Response) FDA disagrees with the assertions that state-of-the-art 
treatments for SIB or AB do not include pharmacotherapy, and that there 
are no pharmacologic treatments specifically approved for the treatment 
of SIB or AB.
    It is important to understand that SIB and AB are not disorders 
themselves but rather symptoms associated with various underlying 
conditions. In clinical practice, SIB and AB are referred to as 
transdiagnostic symptoms because they can be associated with numerous, 
sometimes comorbid conditions and are not specific to a particular 
diagnosis. Examples of disorders in which patients may exhibit SIB and 
AB include, but are not limited to:
     Psychiatric disorders, which have a relatively high 
prevalence of SIB and AB, for example, attention deficit hyperactivity 
disorder (ADHD), mood disorders, psychotic disorders, PTSD, eating 
disorders, anxiety disorders, adjustment disorders, and substance use 
disorders;
     neurodevelopmental disorders (NDDs) and genetic disorders, 
which also have a relatively high prevalence of SIB and AB, for 
example, ASD (the definition of which was recently broadened in the 
DSM-5), stereotypic movement disorder, intellectual disability, Lesch-
Nyhan Syndrome, fragile X syndrome, Angelman Syndrome, and fetal 
alcohol syndrome (FAS); and
     medical diagnoses, for example, traumatic brain injury, 
cerebral palsy, and sleep disorders.
    The comment incorrectly minimizes the importance of proper 
diagnosis and treatment of underlying causes of SIB and AB. Treatment 
of moderate to severe SIB and AB is complex and should be tailored to 
the individual needs of each patient; treating the underlying condition 
often improves SIB and AB symptoms. Therefore, state-of-the-art 
treatment for SIB and AB begins with a proper diagnosis, obtained using 
a comprehensive psychiatric and medical examination by a board-
certified specialist (e.g., psychiatrist) in consultation with other 
professionals, such as psychologists, pediatricians or internists, and 
neurologists (Ref. 95). In recent years, advancements in psychiatric 
research and clinical care have improved our 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.
    The prevalence of SIB in NDD is high, as high as 50 percent in ASD 
(Ref. 96), a population representing a subset of all patients with SIB 
and AB. Two drugs are approved for treating irritability associated 
with ASD, one of which specifically includes SIB and AB among its 
approved indications. Specifically, RISPERDAL (risperidone) is FDA-
approved for the treatment of ``irritability associated with autistic 
disorder, including symptoms of aggression towards others, deliberate 
self-injuriousness, temper tantrums, and quickly changing moods,'' 
(emphasis added).\8\ As described in the proposed rule, ABILIFY 
(aripiprazole), has also been approved by FDA for the treatment of 
irritability associated with autistic disorder in children. As 
explained in the FDA-approved labeling for ABILIFY, ``The efficacy of 
ABILIFY (aripiprazole) in the treatment of irritability associated with 
autistic disorder was established in two 8-week, placebo-controlled 
trials in pediatric patients (6 to 17 years of age) who met the DSM-IV 
criteria for autistic disorder and demonstrated behaviors such as 
tantrums, aggression, self-injurious behavior, or a combination of 
these problems,'' (emphasis added).\9\ Both ABILIFY (aripiprazole) and 
RISPERDAL (risperidone) met their primary efficacy endpoint by 
demonstrating statistically significant changes in score on the 
Aberrant Behavior Checklist--Irritability scale (ABC-I), which is one 
of the most commonly used scales to measure SIB and AB in drug 
development programs. Thus, the comment is incorrect that no drugs have 
been proven effective for SIB and AB in any population.
---------------------------------------------------------------------------

    \8\ Labeling available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020272s082,020588s070,021444s056lbl.pdf.
    \9\ Labeling available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf.
---------------------------------------------------------------------------

    To date, most of the randomized clinical trials completed for the 
treatment of SIB and AB have been conducted in youth with developmental 
disabilities such as ASD (see Ref. 77 for review). In clinical 
practice, results from these clinical trials for the treatment of SIB 
and AB in ASD inform state-of-the-

[[Page 13343]]

art pharmacotherapy for SIB and AB treatment across diagnoses because 
SIB and AB are considered transdiagnostic symptoms. Therefore, 
clinicians consider data related to treatment of SIB and AB in ASD when 
determining whether to prescribe drugs for the treatment of SIB and AB 
in other psychiatric, genetic, medical and neurodevelopmental disorders 
in children and adults.
    The comment recognizes that ``pharmacotherapy may be effective in 
controlling the behaviors of certain patients.'' The comment's main 
concern seems to be that, ``pharmacotherapy is not uniformly 
effective,'' or that ``these types of drugs are not effective for all 
persons that exhibit aggressive and SIB behavior.'' FDA agrees that 
risperidone and aripiprazole are not uniformly effective for the 
treatment of SIB and AB in all patients. However, this does not 
undermine FDA's conclusion that the literature indicates that positive 
behavioral interventions, sometimes alongside pharmacotherapy, are 
generally successful for the treatment of SIB and AB, regardless of the 
severity of the behavior targeted.
    The comment highlights the side effects that drugs used to treat 
SIB and AB can cause, some of which can be severe. For example, as FDA 
pointed out in the proposed rule, the most common adverse reactions 
observed in the trials conducted for approval of RISPERDAL and ABILIFY 
were sedation, increased appetite, fatigue, constipation, vomiting, and 
drooling. Other less common serious adverse reactions with the use of 
risperidone or aripiprazole may include neuroleptic malignant syndrome, 
gynecomastia, galactorrhea, metabolic changes, and tardive dyskinesia 
(note, valbenazine (INGREZZA) and deutetrabenazine (AUSTEDO) have been 
approved for the treatment of tardive dyskinesia). FDA acknowledges the 
significance of the risks posed by pharmacotherapy, but assesses them 
together with their proven benefits. FDA determined that the benefits 
outweigh the risks in the population for which they are intended when 
we approved these drugs for irritability associated with ASD based on 
well-controlled clinical studies.
    Further, drugs that have not been approved for treatment of SIB and 
AB and thus have not been found safe and effective for this use may 
nonetheless be part of state-of-the-art treatment for SIB and AB, which 
has a specific meaning in the context of a device ban. As we explained 
in the preamble to the proposed rule, and maintain now, the state of 
the art with respect to this proposed 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 (81 FR 24386 at 24388). Elsewhere in its comments, the 
commenter recognizes that state-of-the-art treatment for this patient 
population can include pharmacotherapy, among other options, and 
asserts that a wide range of pharmacological interventions have been 
used to treat patients with SIB and AB, including mood stabilizers, 
antidepressants, and antipsychotics.
    A systematic review was recently completed of randomized, placebo-
controlled studies that measured the effect of pharmacologic treatments 
on reduction of aggressive behaviors and irritability, measured using 
the ABC-I change from baseline score in children with ASD (Ref. 97). 
Ref. 97 reports improvement on ABC-I scores for numerous drugs, 
including risperidone (Cohen's d = 0.9), aripiprazole (d = 0.8), 
clonidine (Cohen's d = 0.6), methylphenidate (d = 0.6), venlafaxine (d 
= 0.4), naltrexone (d = 0.35), and valproate (d = 0.3). Ref. 97 
illustrates that several drugs in addition to risperidone and 
aripiprazole have evidence-based support suggesting that they can 
improve symptoms of SIB and AB in ASD. As noted above, only risperidone 
and aripiprazole have FDA approval for the treatment of irritability in 
ASD.
    In evaluating the state of the art for purposes of determining 
whether to ban ESDs, FDA considered the available information regarding 
risks of these drugs used for SIB and AB, as well as the available 
information regarding their benefits in treating SIB and AB symptoms. 
The general risks of risperidone, aripiprazole, clonidine (an alpha-
agonist), and methylphenidate (a stimulant) are described elsewhere in 
this comment response. Common adverse reactions associated with 
serotonin-norepinephrine reuptake inhibitors (SNRIs) such as 
venlafaxine include headache, insomnia, diarrhea, vomiting, decreased 
appetite, hyperactivity, irritability, sexual dysfunction, muscle pain, 
and change in weight; mania, abnormal heart rhythm, and suicidal 
ideation and behavior can also occur. Valproate has FDA-approved 
indications in adults related to bipolar disorder, seizures, and 
migraine headaches. Common side effects include somnolence, dyspepsia, 
nausea, vomiting, diarrhea, dizziness, and pain. Serious adverse 
reactions can occur, including hepatoxicity, fetal malformations, 
multiorgan hypersensitivity reactions, and thrombocytopenia. Naltrexone 
is an opioid antagonist approved for the treatment of addiction and is 
associated with dyspepsia, diarrhea, nervousness, sleep problems, 
muscle pain and can cause liver injury and allergic pneumonia.
    As stated previously, other drugs may improve SIB and AB symptoms 
by treating the underlying disorder for which they are approved. Thus, 
in considering the state-of-the-art treatment for SIB and AB, FDA also 
considered these treatments of underlying disorders. For example, 
children who are impulsive with aggressive outbursts may have moderate 
to severe ADHD. FDA-approved medications can treat symptoms of ADHD, 
including impulsivity, and therefore may also reduce associated SIB and 
AB symptoms. FDA-approved medications for ADHD include stimulant and 
non-stimulant medications. Stimulants include amphetamine and 
methylphenidate drugs. Common adverse reactions with stimulant use 
include decreased appetite, trouble falling asleep, irritability, 
headaches, and stomachaches. Reduction in growth rate, sadness, 
irritability, tics, abuse, dependence, and elevation in blood pressures 
and heart rate can also occur. Sudden death, stroke, and myocardial 
infarction have been reported in otherwise healthy adults and in youth 
with heart problems taking stimulants. Non-stimulants with FDA-approval 
for ADHD include atomoxetine and alpha-agonists. Adverse reactions to 
non-stimulant medications include tiredness, insomnia, stomachaches, 
headaches, and nausea; hepatitis and suicidal thoughts can also occur. 
Thus, these drugs are not without risks, although in approving them, 
FDA determined that their risks are outweighed by their benefits in 
treating ADHD.
    Accurate diagnosis is especially important for mood disorders 
because choosing the wrong class of medications for treatment may 
worsen SIB or AB symptoms. For example, individuals who have bipolar 
disorder can be misdiagnosed with depression, especially children and 
adolescents. This is important because prescribing antidepressant 
medications to patients with bipolar disorder may induce or worsen 
symptoms of mania, which may include symptoms of irritability and 
impulsivity, both of which can be associated with SIB or AB. 
Medications approved to treat bipolar disorder include atypical 
antipsychotics, anticonvulsants, and lithium salts. Risks associated 
with these medications include but are not limited to sedation,

[[Page 13344]]

metabolic changes, rash, and other cardiovascular, endocrine, 
hematopoietic, and neurological adverse reactions. Neuroleptic 
malignant syndrome, extrapyramidal symptoms, tardive dyskinesia, and 
gynecomastia/galactorrhea can also occur.
    Some congenital and genetic disorders are also associated with SIB 
and AB symptoms. Advancements in understanding genetic and prenatal 
exposure-related causes for intellectual and developmental disabilities 
have improved diagnosis and management of these conditions, for example 
through genetic testing. This is important because some genetic 
disorders have treatments, some of which are pharmacological, that can 
improve the underlying condition and may also improve associated 
behavioral problems such as SIB and AB. For example, psychiatric and 
behavioral symptoms associated with phenylketonuria (PKU) can improve 
with diet or medications such as pegvaliase-pqpz, which received FDA 
approval for the treatment of PKU in 2018 (Ref. 98). The most common 
adverse reactions occurring in at least 15 percent of patients taking 
pegvaliase-pqpz were injection site reactions, arthralgia, 
hypersensitivity reactions, headache, pruritus, nausea, and dizziness.
    Finally, we now recognize that individuals with NDDs, intellectual 
disabilities, and other developmental disabilities can have comorbid 
psychiatric conditions that benefit from treatment. For example, 
treatment of comorbid depression, anxiety, ADHD, psychosis, or bipolar 
disorder, can improve symptoms such as irritability, psychomotor 
agitation, impulsivity, and worthlessness, which, in turn, can 
attenuate associated SIB and AB symptoms. As Dr. McCracken testified at 
the Massachusetts hearing, psychiatrists now recognize that 
developmentally disabled individuals are at high risk for a variety of 
psychological disorders and it is generally accepted medical practice 
to treat co-morbid disorders in individuals who exhibit challenging 
behaviors (Ref. 14, day 9 at 93). Patients and healthcare providers 
have numerous medication options to treat comorbid psychiatric 
diagnoses and the associated symptoms, as described earlier in this 
comment response.

F. Labeling and Correcting or Eliminating Risks

    (Comment 51) Some comments argue that the risks associated with 
ESDs for SIB or AB can be corrected or eliminated through labeling and 
other controls, such as the labeling and process JRC currently uses 
prior to using ESDs on an individual.
    (Response) FDA disagrees. FDA considered all available data and 
information, and we have determined that labeling or a change in 
labeling cannot correct or eliminate the unreasonable and substantial 
risk of illness or injury. Regardless of how the device is labeled, the 
individual subject to it will receive shocks intended to be painful and 
will continue to be subject to the physical and psychological risks we 
have described in this rulemaking. No manner of labeling will correct 
or eliminate these risks, so the device will continue to present the 
same unreasonable and substantial risk of illness or injury. The 
commenter does not offer any alternative except to limit the number of 
vulnerable individuals subject to the unreasonable and substantial 
risk.
    The Panel members who opined that the banning standard is met (a 
majority of the Panel) were asked whether labeling could correct or 
eliminate the risk of illness or injury posed by ESDs and all concluded 
that labeling could not correct or eliminate the dangers associated 
with ESDs. As we explain in Responses 14 and 18, factors outside of the 
user's control, including the psychological state of the individual 
subject to the device, can play a significant role in how an individual 
perceives any given shock or series of shocks. Further, especially for 
those with intellectual or developmental disabilities, the individual 
may not communicate or be able to communicate information for the 
device user to change the manner in which the device is used to correct 
or eliminate the risks. Because these factors are outside of the user's 
control or are difficult to ascertain or predict, labeling that 
corrects or eliminates the risks of ESDs for SIB or AB cannot be 
written.
    The only labeling suggestion the commenter offers regards labeling 
the device for use only in individuals refractory to other treatments, 
which is how JRC's GED devices are currently labeled. As explained in 
comment Response 30, if such a subpopulation does exist, it is very 
difficult to define. Even if such a subpopulation could be identified, 
specifying this limitation in the labeling would not correct or 
eliminate the risks for those individuals. Further, as discussed in the 
comment responses regarding effects, no subpopulation has been 
identified in which ESDs are more likely to be effective, and thus the 
risks of ESDs would still outweigh the benefits. Similarly, as 
recognized by the Panel members who were asked, limiting the 
indications to a subpopulation of individuals who engage in life-
threatening behaviors would not mitigate the risks for those 
individuals, and there is no evidence that the device is effective in 
such a subpopulation. Accordingly, limiting the use of the device to a 
narrower population through labeling would also not correct or 
eliminate the risks.
    (Comment 52) A comment argues that general ``treatment resistant'' 
language adequately defines the population for whom ECT devices are 
intended, which is precisely the population on whom JRC uses ESDs, and 
which language could be used in ESD labeling to limit the device's use 
to individuals who are refractory to all behavior controls except ESDs.
    (Response) FDA acknowledges that there is language regarding 
treatment resistance that does not precisely define a refractory 
subpopulation in the labeling for certain other devices that have 
different intended uses and different intended patient populations. 
However, FDA's position is not that imprecise descriptions of a 
refractory patient population are necessarily inadequate but rather 
that, in the case of ESDs used for SIB or AB, labeling stating that the 
device should only be used in a refractory subpopulation would not 
correct or eliminate the unreasonable and substantial risk of illness 
or injury to that population. This is because in the case of ESDs, the 
available data and information do not establish that the devices are 
effective for treating SIB or AB in people who are refractory to other 
approaches. Thus, given that the serious risks posed by ESDs for SIB or 
AB apply to refractory patients just as they do to others, the risks of 
this device outweigh its benefits regardless of whether other options 
may have been attempted, and labeling limiting its use to a refractory 
population would in no way change this. In contrast, for ECT, the 
available data associated with its use, including in treatment 
resistant patients, was of better quality and provided a reasonable 
assurance of safety and effectiveness.
    Further, for ECT there are better-defined hierarchies of treatment 
options prior to use of ECT, based on data demonstrating instances 
where other appropriate treatment options were tried and failed. For 
example, the APA has issued recommendations for determining when the 
use of ECT may be appropriate (Ref. 99), as has the National Institute 
for Health and Clinical Excellence in the United Kingdom (Ref. 100). 
Thus, the use of ``treatment resistant'' language for ECT, in light of 
the data and the formal,

[[Page 13345]]

evidence-based practice guidelines, reflects a much clearer consensus 
than is available for the use of ESDs for SIB or AB. As discussed in 
earlier comment responses, it is difficult to define a refractory 
population for ESDs for SIB or AB, JRC has not established that its 
residents on whom ESDs are used are refractory to other treatments, and 
the evidence shows that state-of-the-art alternatives have generally 
been successful even for the most difficult cases. Accordingly, ECT is 
distinguishable and FDA's determination remains that labeling or a 
change in labeling cannot correct or eliminate the substantial and 
unreasonable risks of illness or injury of ESDs used for SIB or AB.
    (Comment 53) A comment argues that an expert believes labeling can 
be developed to minimize the risks of ESDs. The comment refers to an 
expert whose opinion FDA solicited regarding this ban.
    (Response) FDA disagrees. Dr. Smith proposed certain restrictions, 
but none of these address labeling.

G. Legal Issues

    (Comment 54) One commenter suggests that the evidentiary standard 
for banning a device is a ``preponderance of evidence,'' meaning that 
there must be proof of harm and not just theoretical risk. The 
commenter bases this on a statement in the proposed glove powder ban 
that the preponderance of evidence suggests that use of an alternative 
reduces the incidence of certain harms (81 FR 15173, 15179, March 22, 
2016).\10\
---------------------------------------------------------------------------

    \10\ Available at https://www.federalregister.gov/documents/2016/03/22/2016-06360/banned-devices-proposal-to-ban-powdered-surgeons-gloves-powdered-patient-examination-gloves-and.
---------------------------------------------------------------------------

    (Response) FDA disagrees. As Congress explained in the legislative 
history of section 516 of the FD&C Act, and as FDA stated in the 
preamble to its banning regulations at 21 CFR part 895 and in the 
preambles to the proposed rules to ban ESDs and glove powder, 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; 81 FR 15173 at 15176; 81 FR 24386 at 24392. The proposed rule to 
ban glove powder does not state otherwise. The statement cited by the 
commenter does not address the standard for a device ban, nor does it 
imply that actual harm is required to meet the standard; it simply 
states that the evidence relevant to that proceeding indicated that 
using alternatives would more likely than not result in lower frequency 
of certain harms relative to glove powder.
    (Comment 55) One commenter claims that FDA arbitrarily and 
capriciously discounted JRC patient data in the proposed rule and 
instead relied on data that are anecdotal and that were carefully 
selected to support the Agency's position.
    (Response) FDA disagrees. As discussed in sections III.A. and V.B., 
FDA considered all available data and information, including anecdotal 
information, and weighed it appropriately in making our decision. FDA 
provided multiple opportunities for input from all stakeholders and 
notes again that the expert Panel also weighed all available evidence, 
applied its expertise and a majority supported a ban.
    (Comment 56) Commenters argue that FDA does not have authority to 
ban a device for a specific use or uses, but rather must ban a device 
for all uses. One of these commenters argues banning a device only for 
certain uses is inconsistent with section 513(i)(1)(E) of the FD&C Act, 
and another claims FDA's only previous device ban at the time banned 
implanted all hair fibers without regard to their intended uses.
    (Response) FDA disagrees. There is nothing in the FD&C Act or its 
implementing regulations that requires a ban under section 516 of the 
FD&C Act to apply to all uses of a device. To the contrary, it is 
difficult to conceive of a ban of a device divorced from its intended 
use since devices are defined and regulated not only according to their 
technological characteristics but also according to their intended 
uses. See, e.g., section 201(h) of the FD&C Act and the device 
classification regulations at 21 CFR parts 862 through 892. Thus, a 
device may be one class for one use and a different class for another 
use, see, e.g., 21 CFR 886.5916 (rigid gas permeable contact lens, 
class II if intended for daily wear, class III if intended for extended 
wear). This is clearly what Congress intended. See H.R. Rep. No. 94-853 
at 14-15 (Feb. 29, 1976) (``Finally, despite the fact that generally 
the term `device' is used in the bill to refer to an individual product 
or to a type or class of products, there may be instances in which a 
particular device is intended to be used for more than one purpose. In 
such instances, it is the Committee's intention that each use may, at 
the Secretary of Health and Human Services' (Secretary) discretion, be 
treated as constituting a different device for purposes of 
classification and other regulation.''). Similarly, a product may be 
regulated as a ``device'' for one intended use, or, if it had a 
different intended use, it may be regulated as a ``drug'' (e.g., if it 
achieved its primary intended purposes through chemical action in or on 
the human body).
    As discussed earlier, in determining whether a device presents an 
unreasonable and substantial risk of illness or injury, FDA weighs the 
device's benefits against its risks and considers the risks relative to 
the state of the art; the benefits and risks of a device and the state 
of the art are heavily impacted by the device's intended uses, 
including the patient population for whom it is intended. Thus, FDA's 
banning regulation for prosthetic hair fibers explains that these 
devices are intended for implantation into the human scalp to simulate 
natural hair or conceal baldness, 21 CFR 895.101, and the glove powder 
ban is not for any gloves or powder but, for certain powdered gloves 
intended to be worn on the hands of operating room personnel to protect 
a surgical wound from contamination and intended for medical purposes, 
that are worn on the examiner's hand or finger to prevent contamination 
between patient and examiner, and glove powder intended to be used to 
lubricate the surgeon's hand before putting on a surgeon's glove (21 
CFR 895.102, 895.103, and 895.104).
    The commenter's reliance on section 513(i)(1)(E) of the FD&C Act is 
misplaced for several reasons. First, this provision only pertains to 
review of a 510(k) and not to device bans or any other aspect of device 
regulation. Second, if the commenter's point is that harmful uses of a 
device should not prohibit its beneficial uses, this cuts against the 
commenter's position that FDA must ban a device for all uses. FDA is 
only banning ESDs for certain uses, which is consistent with the 
principles underlying section 513(i)(1)(E) of the FD&C Act. Third, if 
the commenter's point is that FDA should not prohibit use of a device 
that may be harmful if labeling can adequately mitigate such harm, the 
harmful uses of ESDs are its labeled uses, not ones outside the 
labeling, which are the target of section 513(i)(1)(E). Further, 
section 516 of the FD&C Act and its implementing regulations only 
authorize banning where FDA has determined the deception or risk cannot 
be corrected or eliminated by labeling, as FDA has done here; this is 
also consistent with the principles underlying section 513(i)(1)(E) of 
the FD&C Act.
    (Comment 57) Commenters assert that the proposed ban on ESDs would 
interfere with the practice of medicine and the doctor-patient 
relationship, specifically with respect to doctors and

[[Page 13346]]

patients at JRC, in contravention of section 1006 of the FD&C Act (21 
U.S.C. 396). One of these comments recognizes that what it refers to as 
the practice of medicine exemption does not limit FDA's ability to 
determine which devices are available to prescribe but argues that it 
means FDA cannot ban one use of a device and not others.
    (Response) FDA disagrees. Section 1006 of the FD&C Act states that 
nothing in this act shall be construed to limit or interfere with the 
authority of a health care practitioner to prescribe or administer any 
legally marketed device to a patient for any condition or disease 
within a legitimate health care practitioner-patient relationship. This 
makes clear, for example, that a doctor may prescribe an approved 
device for a use different from those for which it has been approved; 
it does not, however, in any way limit FDA's ability to determine which 
devices can be legally marketed and the uses for which they can be 
legally marketed. Indeed, the next sentence of section 1006, not cited 
by these commenters, explains that this section shall not limit any 
existing authority of the Secretary to establish and enforce 
restrictions on the sale or distribution, or in the labeling, of a 
device that are part of a determination of substantial equivalence, 
established as a condition of approval, or issued through regulations. 
Banning ESDs for SIB or AB would not violate section 1006 of the FD&C 
Act or be inconsistent with its general approach toward the practice of 
medicine. Pursuant to this ban, ESDs for SIB or AB, such as the GED 
devices manufactured and used at JRC, are adulterated under section 
501(g) of the FD&C Act, and thus are not legally marketed devices. 
FDA's issuing of this rule in no way conflicts with section 1006 of the 
FD&C Act or FDA's long-standing position regarding the practice of 
medicine.
    (Comment 58) One commenter argues that FDA does not have the 
authority to determine the state of the art and decide that one therapy 
is appropriate and another is not, and that in doing so FDA is playing 
the role of doctor, which sets a dangerous precedent that would allow 
FDA to ban any device or use of any device any time it disagrees with 
clinical practice.
    (Response) FDA disagrees. As explained in the preamble to FDA's 
banning regulations, in determining whether a device presents an 
unreasonable risk, we should assess the device's risks relative to the 
state of the art. Before banning a device, it is thus important to 
consider the current state of science and medicine relevant to the 
device and the patient population the device is intended for, including 
alternative treatments. This does not mean FDA is ``playing the role of 
doctor'' any more than it does when FDA decides whether to approve a 
medical product; in both contexts FDA must determine whether the 
applicable statutory standard is met.
    (Comment 59) One commenter argues that because these devices were 
manufactured years ago, the ban is only about the use of the device.
    (Response) FDA disagrees. As discussed above, a device is defined 
in terms of both its technological characteristics and its intended 
use(s). As discussed in section III, the ban prohibits future 
manufacturing and distribution or sale of ESDs for SIB or AB by anyone, 
and the ban also applies to any such devices already manufactured and 
being held for sale, such as the GEDs in use at JRC.
    (Comment 60) In the context of its arguments regarding the practice 
of medicine, one commenter cites section 510(g) of the FD&C Act and 21 
CFR 807.65(d), which exempt practitioners licensed by law to prescribe 
or administer devices and who manufacture devices solely for use in 
their practice from registration and listing, and consequently, 
premarket notification, requirements. The commenter asserts that FDA's 
Mobile Medical Applications Guidance (February 2015) suggests that 
licensed practitioners who develop devices solely for use in their 
professional practice and do not label or promote their product to be 
used generally by others would not be considered medical device 
manufacturers and therefore would not have to register, list, or submit 
a premarket application for their device.\11\ The commenter concludes 
that JRC is not a device manufacturer because its GED devices are used 
only for its residents and are not promoted or offered for sale at 
other institutions, and argues JRC's GED devices are outside FDA's 
jurisdiction because they are not the subject of any interstate 
commercial sale.
---------------------------------------------------------------------------

    \11\ FDA's guidance entitled ``Mobile Medical Applications,'' 
issued February 9, 2015, has been superseded by ``Policy for Device 
Software Functions and Mobile Medical Applications,'' issued 
September 27, 2019, available at https://www.fda.gov/media/80958/download.
---------------------------------------------------------------------------

    (Response) FDA disagrees. The statute, regulation, and guidance 
cited by the commenter regarding registration, listing, and premarket 
review in no way impact FDA's authority to ban a device under section 
516 of the FD&C Act, or our determinations regarding banning ESDs. FDA 
notes, however, that the GED devices are subject to FDA jurisdiction 
and are subject to this ban.
    (Comment 61) One comment argues a ban on ESDs for SIB or AB would 
discriminate against the most severely disabled and vulnerable members 
of the population, as well as their parents and guardians, by treating 
this subgroup differently from the larger disabled population as a 
whole by banning a treatment needed only by this subgroup, in violation 
of their right to equal protection of the laws under the Fourteenth 
Amendment of the Constitution.
    (Response) FDA disagrees. The Equal Protection Clause of the 
Fourteenth Amendment prohibits States from denying citizens equal 
protection of the laws. As the commenter notes, citing Tennessee v. 
Lane, 541 U.S. 509 (2004), this generally requires similarly situated 
people to be treated alike, and classifications based on disability 
must have a rational relationship to a legitimate governmental purpose 
to pass Constitutional muster. FDA notes that although the Fourteenth 
Amendment applies to the States, the courts have applied the same Equal 
Protection analysis to the Federal government via the Fifth Amendment. 
See, e.g., Buckley v. Valeo, 424 U.S. 1, 93 (1976); Weinberger v. 
Wiesenfeld, 420 U.S. 636, 638 n.2 (1975). The Equal Protection analysis 
is not applicable to this ban. FDA is banning a particular device, 
defined in part by its intended use; FDA is not classifying individuals 
on the basis of any disabilities or applying its laws any differently 
to anyone on the basis of their disability or the severity of their 
disability. According to the commenter's logic, FDA would violate the 
Equal Protection Clause, for example, every time we approve a drug or 
device for a subpopulation of a larger patient population, or when we 
deny expansion of approval of a drug approved for a subpopulation to a 
larger patient population, which is clearly not so.
    Finally, assuming for the sake of argument that Equal Protection 
analysis did apply, the commenter provides no analysis regarding how 
the ban would fail to bear a rational relationship to a legitimate 
governmental interest. Protecting patients from devices that present an 
unreasonable and substantial risk of illness or injury is a legitimate 
governmental interest. Because FDA has found this standard to be met 
specifically for ESDs for SIB or AB, as detailed in section III.A., 
application of the ban to this specific type of device, and not a 
broader or narrower category of devices, is clearly rationally related 
to this interest.

[[Page 13347]]

    (Comment 62) One commenter argues that the proposed ban would 
constitute a violation of the substantive due process rights of parents 
of students at JRC, arguing that parents have a fundamental right to 
choose ESD treatment for their children and that the ban is not 
narrowly tailored to serve a compelling government interest.
    (Response) FDA disagrees. The ban is not a violation of parents' 
substantive due process rights because their interests do not 
constitute a fundamental right, and the ban is rationally related to a 
legitimate government interest.
    The interest asserted by the commenter, parents' right to choose 
ESD treatment for their children, is not a fundamental right. The 
Supreme Court has recognized parents' fundamental right to direct the 
upbringing and education of their children. Troxel v. Granville, 530 
U.S. 57 (2000). The Court has made clear, however, that there are 
limitations to such rights and that the State has ``a wide range of 
power for limiting parental freedom and authority in things affecting 
the child's welfare.'' Prince v. Massachusetts, 321 U.S. 158, 167 
(1944). Under this rubric, the Court has upheld State interference with 
parental rights when there was a determination that the activity being 
restricted was harmful to a child's mental or physical health. See, 
e.g., Jehovah's Witnesses v. King Cty. Hosp., 278 F. Supp. 488, 504 
(W.D. Wash. 1967), aff'd., 390 U.S. 598 (1968) (per curiam) (holding 
that States may intervene when a parent refuses necessary medical care 
for a child).
    Although the Supreme Court has not addressed the specific parental 
interests asserted here, several lower courts have addressed similar 
interests and have expressly stated that parents' fundamental rights do 
not encompass the right to choose for a child a particular type of 
health or medical treatment that the state has deemed harmful. See 
Pickup v. Brown, 740 F.3d 1208 (9th Cir. 2015); Doe ex rel. Doe v. 
Governor of New Jersey, 783 F.3d 150 (3d Cir. 2015).
    The Pickup court was persuaded, in part, by the holdings of various 
courts that individuals do not have a fundamental right to choose 
specific health and medical treatments for themselves, noting that ``it 
would be odd if parents had a substantive due process right to choose 
specific treatments for their children--treatments that reasonably have 
been deemed harmful by the state--but not for themselves.'' Pickup, 740 
F.3d at 1236; see Nat'l. Ass'n. for Advancement of Psychoanalysis v. 
Cal. Bd. of Psychology, 228 F.3d 1043, 1050 (9th Cir. 2000) 
(``substantive due process rights do not extend to the choice of type 
of treatment or of a particular health care provider''); Mitchell v. 
Clayton, 995 F.2d 772, 775 (7th Cir. 1993) (``a patient does not have a 
constitutional right to obtain a particular type of treatment or to 
obtain treatment from a particular provider if the government has 
reasonably prohibited that type of treatment or provider''); Carnohan 
v. United States, 616 F.2d 1120, 1122 (9th Cir. 1980) (per curiam) 
(holding that there is no substantive due process right to obtain drugs 
that the FDA has not approved); Rutherford v. United States, 616 F.2d 
455, 457 (10th Cir. 1980) (``the decision by the patient whether to 
have a treatment or not is a protected right, but his selection of a 
particular treatment, or at least a medication, is within the area of 
governmental interest in protecting public health.''); see also Abigail 
All. for Better Access to Developmental Drugs v. von Eschenbach, 495 
F.3d 695 (D.C. Cir. 2007) (holding that terminally ill adult patients 
had no fundamental right to have access to investigational drugs that 
had not yet been approved by FDA for public use); CaretoLive v. 
Eschenbach, 525 F. Supp. 2d 952 (S.D. Ohio 2007) (holding that because 
an association of cancer patients did not have a ``fundamental liberty 
interest'' in a particular treatment, FDA's denial of the product's 
application did not violate the association's right to substantive due 
process).
    Based on these cases, we disagree with the commenter that parents 
have a fundamental right to choose as a treatment for their children 
ESDs for SIB or AB devices that FDA has determined to present an 
unreasonable and substantial risk of illness or injury. Because the 
interests asserted are not fundamental rights, and a suspect class is 
not involved, the ban is not in violation of parents' substantive due 
process rights as long as it is rationally related to a legitimate 
State interest. See Washington v. Glucksberg, 521 U.S. 702, 728 (1997). 
As discussed above in the previous response, the ban is rationally 
related to FDA's legitimate interest in protecting patients from 
devices that present an unreasonable and substantial risk of illness or 
injury.
    (Comment 63) One comment argues that the proposed ban would deprive 
the parents of students on whom ESDs are currently used at JRC of the 
procedural protections required by the Due Process Clause of the Fifth 
Amendment of the Constitution. This comment asserts that FDA's ban of 
ESDs for SIB or AB is an adjudicatory decision against JRC, its 
students, and the parents of its students, and is inappropriately 
couched as a rulemaking because in substance and effect it is 
individual in impact and condemnatory in purpose. The comment argues 
that the affected parties are thus entitled to an oral evidentiary 
hearing to resolve the myriad factual disputes at issue with the 
benefit of procedural safeguards such as live cross-examination.
    (Response) FDA disagrees. First, this ban of ESDs for SIB or AB is 
legislative, not adjudicative, in character and purpose, and as such, 
``it is not necessary that the full panoply of judicial procedures be 
used.'' Hannah v. Larche, 363 U.S. 420, 442 (1960). This ban plainly 
meets the definition of ``rule'' in the Administrative Procedure Act, 5 
U.S.C. 551(4) that an agency statement of general or particular 
applicability and future effect designed to implement, interpret, or 
prescribe law or policy. There is a presumption of procedural validity 
for the rulemaking procedure prescribed in the APA, 5 U.S.C. 553, 
utilized here, as mandated by section 516 of the FD&C Act. See American 
Airlines, Inc. v. C.A.B., 359 F.2d 624, 630 (D.C. Cir. 1966).
    The only reason the commenter provides to support its argument that 
this ban is adjudicative is that ``FDA repeatedly makes factual 
judgments and findings specifically concerning the medical care and 
treatment of a small subset of students at just one institution: JRC.'' 
To the extent the commenter is arguing that the facts and analysis 
underlying the ban only regard a subset of students at JRC, this is not 
true. As discussed throughout this final rule and the preamble to the 
proposed rule, the key analyses supporting this ban regard the risks 
and benefits posed by ESDs for SIB or AB and the state of the art of 
treatment for this patient population, which are based on evidence from 
the literature and other sources respecting patients and subjects 
treated and studied at many different institutions across the country 
over several decades. To the extent the commenter is arguing that 
banning ESDs for SIB or AB will only, as a practical matter, impact 
students at one institution, this does not render the ban adjudicatory, 
as explained in the following paragraphs.
    An administrative law treatise cited in one of the cases relied 
upon by the commenter helps clarify the distinction between 
adjudicatory and legislative Agency action:

    Adjudicative facts are the facts about the parties and their 
activities, businesses, and properties. Adjudicative facts usually 
answer the questions of who did what, where, when,

[[Page 13348]]

how, why, with what motive or intent; adjudicative facts are roughly 
the kind of facts that go to a jury in a jury case. Legislative 
facts do not usually concern the immediate parties but are general 
facts which help the tribunal decide questions of law and policy 
discretion.

Alaska Airlines, Inc. v. C.A.B., 545 F.2d 194, 201, n. 11 (D.C. Cir. 
1976) (quoting 1 Davis, Administrative Law Sec.  7.02 at 413 (1958)). 
The D.C. Circuit further illustrated the distinction with a passage 
from the Attorney General's Manual on the Administrative Procedure Act 
(1947) at 14-15:

    The object of the rule making proceeding is the implementation 
or prescription of law or policy for the future, rather than the 
evaluation of a respondent's past conduct . . . Conversely, 
adjudication is concerned with the determination of past and present 
rights and liabilities. Normally there is involved a decision as to 
whether past conduct was unlawful so that the proceeding is 
characterized by an accusatory flavor and may result in disciplinary 
action.

Id. at 201 n. 12.
    Applying these considerations to this device ban, it is clear this 
is legislative and not adjudicatory action. The key facts relevant to 
FDA's ban of ESDs for SIB or AB do not concern who did what, where, 
when, how, why, with what motive or intent; rather, they concern the 
risks and benefits these devices present to the intended patient 
population, and the state of the art of medical treatment for this 
patient population across the United States. The purpose of the ban is 
to prospectively prohibit future manufacturing and sale of ESDs for SIB 
or AB by anyone anywhere in the United States. The purpose of this 
rulemaking proceeding is not to evaluate JRC's or any other entity's 
past conduct, nor is it to determine the lawfulness of any past 
conduct. Although some of the relevant data and information regard 
patients at JRC, they also regard patients and subjects treated and 
studied at a number of other institutions, reported in the literature 
over decades; these are general facts that have led FDA to determine 
that the legal standard for banning a device has been met. The 
proceeding is not punitive and may not result in disciplinary action 
(although future failure to comply with the ban may result in 
enforcement action).
    In another case cited by the commenter, the Ninth Circuit described 
the primary considerations for distinguishing between legislation and 
adjudication as, ``(1) whether the government action applies to 
specific individuals or to unnamed and unspecified persons; (2) whether 
the promulgating agency considers general facts or adjudicates a 
particular set of disputed facts; and (3) whether the action determines 
policy issues or resolves specific disputes between particular 
parties.'' Gallo v. U.S. Dist. Ct. for the Dist. of Ariz., 349 F.3d 
1169 (9th Cir. 2003) (citations omitted). Although this court pointed 
out that that the line between legislation and adjudication is not 
always easy to draw, it is easy to determine that this device ban falls 
well within the legislative side of the line.
    First, it applies not only to JRC but to any entity that may wish 
to manufacture or sell ESDs for SIB or AB in the future. FDA notes that 
when we banned prosthetic hair fibers for concealing baldness, making 
it illegal for any entity to commercially distribute that product, 
there were no entities engaged in the commercial distribution of those 
products at the time of the ban (see 48 FR 25126, June 3, 1983).\12\ 
FDA has cleared 510(k)s for other ESDs unrelated to JRC, although to 
FDA's knowledge none of these are currently in commercial distribution 
or use. The fact that only one entity happens to be holding ESDs for 
SIB or AB for sale does not render this an adjudicative action.
---------------------------------------------------------------------------

    \12\ Available at https://www.govinfo.gov/content/pkg/FR-1983-06-03/pdf/FR-1983-06-03.pdf.
---------------------------------------------------------------------------

    Second, in banning ESDs for SIB or AB, FDA has considered general 
facts regarding this device type and alternative treatments for this 
patient population from the literature and a wide variety of other 
sources, not a particular set of disputed facts regarding a particular 
party.
    Third, the ban quite clearly determines general scientific and 
policy issues regarding whether ESDs for SIB or AB may be legally 
marketed in the United States, and does not resolve a dispute between 
particular parties, as did the cases cited by the commenter involving 
an adjudicative action (e.g., disputes regarding individuals' 
qualification for various types of government benefits or termination 
of their employment).
    Further, FDA has provided the public, including affected entities 
and individuals, years of notice, as well as meaningful opportunities 
to participate in the process and present evidence and views regarding 
the ban. FDA first notified the public that it was considering a ban on 
ESDs for SIB or AB on March 14, 2014 (79 FR 17155). Although not 
required by statute, FDA then held the Panel Meeting to discuss issues 
relating to a potential ban of these devices. FDA opened a public 
docket for this meeting, received hundreds of written comments from a 
wide variety of stakeholders, including JRC, JRC residents and their 
relatives, and provided an opportunity for verbal testimony, which was 
utilized by JRC, former JRC residents, and relatives of current and 
former JRC residents. FDA then issued a proposed rule to ban ESDs for 
SIB or AB on April 25, 2016, on which we received over 1,500 comments.
    FDA has carefully considered and responded to these comments in 
this final rule. Contrary to the commenter's claims that FDA has not 
revealed all the sources upon which it has relied (an assertion for 
which the commenter provides no support), the extensive sources upon 
which FDA has relied in issuing this ban are listed in section XI of 
the proposed rule, 81 FR 24386 at 24414, and in section XI, and some, 
such as the reports FDA obtained from outside experts, were included in 
full in the public docket for the proposed rule. This process satisfies 
the requirements of due process.
    The commenter argues that an evidentiary hearing with live cross-
examination of witnesses is required to satisfy due process here. The 
cases cited by the commenter, e.g., Goldberg v. Kelly, 397 U.S. 254, 
268-70 (1970) and Gray Panthers v. Schweiker, 652 F.2d 146, 167-72 
(D.C. Cir. 1980), consider the due process right to an evidentiary 
hearing in adjudicative matters, and thus are not applicable to this 
legislative action. Further, in those cases, the courts held that due 
process requires an opportunity to be heard. Here, interested parties, 
including the individuals affected by this ban, on their own or through 
their representatives, have had ample opportunity to present evidence 
and their views to FDA, and FDA has clearly explained the reasons for 
banning ESDs for SIB or AB. Unlike the circumstances in Gray Panthers, 
FDA has no financial or other interest in the outcome of this 
proceeding other than the protection of the public health. This is not 
an area where cross-examination of people submitting comments would be 
warranted.
    Indeed, this ban is much more akin to the cases cited by the 
commenter where the court found that live cross-examination was not 
required, for example, because the governmental proceeding was a 
general fact-finding investigation, not an adjudicatory proceeding, 
that would be unduly burdened by trial-like proceedings, Hannah v. 
Larche, at 451 (1960), or because the information critical to the 
decision, such as physicians' conclusions and other information from 
medical sources, is more effectively and efficiently communicated 
through

[[Page 13349]]

written than oral presentation, Mathews v. Eldridge, 424 U.S. 319, 345 
(1976). The same holds true here: key evidence underlying this ban is 
most effectively provided in written form, in particular the medical 
and scientific literature. FDA has already considered live testimony 
from over a dozen experts in the field and a wide variety of interested 
stakeholders with different views on the issues at its Panel Meeting, 
and little value would be added by a full or informal evidentiary 
hearing or live cross examination. Requiring such would place a huge 
burden on the Agency, with little, if any, benefit.
    (Comment 64) One comment alleges FDA distorted comments submitted 
by the U.S. Department of Justice Civil Rights Division (DOJ) in the 
proposed rule, 81 FR 24386 at, 24409, because FDA did not note that DOJ 
investigated JRC and took no enforcement action, which the commenter 
interprets to mean that JRC's program and use of ESDs fully complies 
with accepted professional judgment, practice, and standards. The 
commenter further asserts that FDA's reliance on DOJ's statements that 
ESDs do not conform to professional standards of care is misplaced and 
flawed, as DOJ conducted a full investigation and did not take 
enforcement action, and DOJ is not qualified to dictate healthcare 
practice.
    (Response) FDA disagrees. There are many reasons why DOJ may have 
chosen not to take enforcement action against JRC under the statutes it 
administers, which are different from those administered by FDA. The 
fact that DOJ did not do so does not mean that JRC's use of ESDs 
complies with accepted professional judgment, practice, or standards. 
Indeed, as discussed in the proposed rule, DOJ clearly explained its 
position that ESDs for SIB or AB are harmful and have uncertain 
efficacy. As explained in the proposed rule, DOJ has experience in this 
field, because it must determine relevant standards of care in 
administering the statutes under its purview, and the evidence 
submitted by DOJ pertaining to the state of the art is corroborative of 
FDA's conclusions based on other evidence.

H. Transition Time

    (Comment 65) Comments we received related to transitioning 
individuals on whom ESDs are currently used off of them supported 
making the transition time as short as possible after the ban is 
effective. One stated that if FDA allows a gradual transition, a 
definite end date must be set. However, one comment stated that 
improper transition would be potentially life-threatening and likely to 
cause a return to behaviors and result in direct and immediate harm; 
any transition must happen under the care of a physician.
    (Response) As explained in the proposed rule, this ban applies to 
future manufacture, sale, and distribution of devices as well as to 
devices already in commercial distribution and devices already sold to 
the ultimate user. For devices already in use, FDA agrees that 
transition off of ESDs should occur under the supervision of a 
physician and that the transition should end as soon as possible for 
the individual. The majority of comments suggested that use of ESDs can 
cease immediately and that an appropriate behavioral treatment plan can 
continue to address SIB or AB even without the device. As we noted in 
the proposed rule, the Massachusetts DDS and other providers have 
successfully transitioned several patients who were subject to ESDs at 
JRC to providers who do not use ESDs (81 FR 24386 at 24408 and 24411). 
We further note that JRC has implemented ``a very comprehensive 
alternative behavior program'' at its own facility that it described as 
``very successful'' on occasions it decided its most powerful ESD was 
not effective, even for severe SIB. JRC's representative also said that 
its providers were able to transition individuals off of ESDs even 
though they had initially thought a transition ``would be very 
unlikely'' (see Ref. 15 at 148). However, in light of concerns about 
thorough assessments of the behaviors' functions and corresponding 
development of appropriate treatment plans, FDA recognizes that 
affected parties may need some period of time to establish or adjust 
treatment plans. We have determined the compliance date for residents 
already subject to the device with that in mind. In determining the 
amount of transition time for compliance, we relied upon clinical 
expert opinions, such as those provided by members of the Panel Meeting 
who opined that six months should be the maximum time allowed to 
transition (see Ref. 1).

VI. Effective Date and Compliance Dates

    This rule is effective 30 days after its date of publication in the 
Federal Register (see DATES). We are establishing two compliance dates. 
For devices in use on specific individuals as of the date of 
publication and subject to a physician-directed transition plan, 
compliance is required 180 days after the date of publication of this 
rule in the Federal Register (see DATES). For all other devices, 
compliance is required 30 days after publication in the Federal 
Register. Section 501(g) of the FD&C Act provides that a device is 
adulterated if it is a banned device.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the final rule would only affect one entity that is 
not classified as small, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $154 
million, using the most current (2018) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    Under this final rule we are banning ESDs for SIB or AB. Non-
quantified benefits of the final rule include a reduction in adverse 
events, such as the risk of burns, PTSD, and other physical or 
psychological harms related to use of the device in this patient 
population.
    We expect that the final rule will only affect one entity that 
currently uses these devices on residents of its facility. The final 
rule will impose costs on this entity to read and understand the rule,

[[Page 13350]]

as well as to provide affected individuals with alternative treatments. 
Although uncertain, other treatments or care at other facilities may 
cost more than the current treatment with the banned device.
    To account for this uncertainty, we use a range of potential 
alternative treatment costs. At the lower bound, we assume that 
alternative treatments would cost the same as the current treatment. We 
use reimbursement data from the State of Massachusetts to estimate a 
potential upper bound for alternative treatments. The costs for the one 
affected entity to read and understand the rule range from around 
$1,200 to $5,200. The present value of the incremental treatment costs 
over 10 years ranges from $0 to $44 million, with a primary estimate of 
$22 million at a 3 percent discount rate, and from $0 to $38 million, 
with a primary estimate of $18.8 million at a 7 percent discount rate. 
Annualized costs range from $0 million to $5.0 million, with a primary 
estimate of $2.5 million at a 3 percent discount rate, and from $0 
million to $5.0 million, with a primary estimate of $2.5 million at a 7 
percent discount rate. The lower-bound cost estimates only include 
administrative costs to read and understand the rule with no 
incremental costs for alternative treatments. Additionally, there would 
be transfer payments between $14 million and $15 million annually 
either within the affected entity to treat the same individuals using 
alternative treatments, or between entities if affected individuals 
transfer to alternate facilities for treatment. The final rule's costs 
and benefits are summarized in table 1.
    We also examined the economic implications of the rule as required 
by the Regulatory Flexibility Act. The Regulatory Flexibility Act 
requires us to analyze regulatory options that would minimize any 
significant impact of a rule on small entities. Because the final rule 
would only affect one entity that is not classified as small, we 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.

                                                  Table 1--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
                                                        Primary                    ------------------------------------------------
             Category                Low  estimate     estimate     High  estimate                                      Period              Notes
                                       (million)       (million)       (million)     Year  dollars  Discount  rate      covered
                                                                                                          (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized.
    Monetized $millions/year.
    Annualized.
    Quantified.
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Reduction in
                                                                                                                                     physical and
                                                                                                                                     psychological
                                                                                                                                     adverse events
                                                                                                                                     related to use of
                                                                                                                                     the device.
Costs:
    Annualized....................            $0.0            $2.5            $5.0            2018               7              10  ....................
    Monetized $millions/year......             0.0             2.5             5.0            2018               3              10  ....................
    Annualized.
    Quantified.
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Transition costs to
                                                                                                                                     the affected entity
                                                                                                                                     and individuals for
                                                                                                                                     transitioning to
                                                                                                                                     alternative
                                                                                                                                     treatments.
Transfers:
    Federal.
    Annualized.
                                   ------------------------------------------------------------------------------------------------
    Monetized $millions/year......  From:
                                    To:
                                   ------------------------------------------------------------------------------------------------
    Other Annualized..............            13.8            14.2            14.6            2018               7              10  ....................
    Monetized $millions/year......            13.8            14.2            14.6            2018               3              10  ....................
                                   ------------------------------------------------------------------------------------------------
                                    From: Affected entity for current treatment
                                    To: Affected entity for other treatments or to  ..............
                                    other facilities that treat aggressive or self-
                                    injurious behavior
                                   ---------------------------------------------------------------------------------------------------------------------
Effects...........................  State, Local or Tribal Government: State expenditures may rise or fall if individuals move across State boundaries.
                                    Small Business: No effect.
                                    Wages: No effect.
                                    Growth: No effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we estimate present 
and annualized values of costs and cost savings over an infinite 
horizon. We do not estimate any cost savings due to this final rule.

                                                      Table 2--Executive Order 13771 Summary Table
                                                 [In $millions 2016 dollars, over infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary  (7%)       (7%)            (7%)        Primary  (3%)       (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $36.7              $0           $73.4           $82.5              $0          $165.0
Present Value of Cost Savings...........................              $0               0               0               0               0               0
Present Value of Net Costs..............................            36.7               0            73.4            82.5               0           165.0
Annualized Costs........................................             2.6               0             5.1             2.5               0             4.9

[[Page 13351]]

 
Annualized Cost Savings.................................               0               0               0               0               0               0
Annualized Net Costs....................................             2.6               0             5.1             2.5               0             4.9
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 101) and 
at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

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

IX. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by OMB under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    FDA has analyzed this rule in accordance with the principles set 
forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain State requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices (21 
U.S.C. 360k; see Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel 
v. Medtronic, Inc., 552 U.S. 312 (2008)). This rule creates a 
requirement under 21 U.S.C. 360k that bans ESDs for SIB or AB.

XI. References

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

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List of Subjects

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

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

PART 882--NEUROLOGICAL DEVICES

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

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


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


Sec.  882.5235  Aversive conditioning device.

* * * * *
    (b) Classification. Class II (special controls), except for 
electrical stimulation devices for self-injurious or aggressive 
behavior. Electrical stimulation devices for self-injurious or 
aggressive behavior are banned. See Sec.  895.105 of this chapter.

PART 895--BANNED DEVICES

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

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


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


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

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

    Dated: February 27, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-04328 Filed 3-4-20; 8:45 am]
 BILLING CODE 4164-01-P