[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52201-52203]
[FR Doc No: 2012-19252]

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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1319; Directorate Identifier 2011-NM-143-AD;
Amendment 39-17151; AD 2012-16-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-200 and -300 series airplanes equipped
with Rolls-Royce RB211 Trent 800 engines. This AD was prompted by
reports of events related to thermal damage of the thrust reverser (T/
R) inner wall on Rolls-Royce RB211 Trent 800 engines. This AD requires
replacing the bleed valve parts and tubing with new parts and tubing on
the left and right engines; and installing Aero-Engine database (AEDB)
software in the airplane information management system (AIMS) hardware.
We are issuing this AD to prevent T/R thermal damage caused by
excessive heat downstream of the 8th stage IP8 exhaust ports, which
could result in T/R structural failure. This failure could result in
large pieces of the T/R or adjacent components departing the airplane.
A separated T/R piece could result in a rejected takeoff and cause
asymmetric thrust and consequent loss of control of the airplane during
reverse thrust operations. Separated components could also cause
structural damage to the airplane, damage to other airplanes due to
debris left on the runway, or injury to people on the ground.

DATES: This AD is effective October 3, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of October 3,
2012.

ADDRESSES: For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207;
phone:<PHONE_NUMBER>, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. For Rolls-Royce service information identified
in this AD, contact Rolls-Royce plc, P.O. Box 31, Derby, DE24 8BJ,
England; telephone 011 44 1332 242424; fax 011 44 1332 249936;
Internet: https://www.aeromanager.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Margaret Langsted, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone:
425-917-6500; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on December 12, 2011 (76 FR
77157). That NPRM proposed to require replacing bleed valve parts and
tubing with new parts and tubing on the left and right Rolls-Royce
RB211 Trent 800 engines; and installing AEDB software in the airplane
AIMS hardware.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(76 FR 77157, December 12, 2011) and the FAA's response to each
comment.

Request To Use Certain Service Information

    American Airlines (American) and Boeing requested that the NPRM (76
FR 77157, December 12, 2011) allow the use of Boeing Special Attention
Service Bulletin 777-31-0177, Revision 1, dated October 13, 2011, as a
source of information to comply with the actions required by paragraph
(h) of the NPRM.
    We agree. Paragraph (h) of the NPRM (76 FR 77157, December 12,
2011) specified the use of Boeing Special Attention Service Bulletin
777-31-0177, dated September 23, 2010. We have revised paragraph (h) of
the final rule to add Boeing Special Attention Service Bulletin 777-31-
0177, Revision 1, dated October 13, 2011, as an additional source of
service information for accomplishing the actions specified in that
paragraph. Boeing Special Attention Service Bulletin 777-31-0177,
Revision 1, dated October 13, 2011, specifies updates to the concurrent
requirements paragraph.

Request To Allow Use of Service Information Revision

    American requested that the NPRM (76 FR 77157, December 12, 2011)
allow the use of Rolls-Royce Service Bulletin RB.211-75-G466, dated
November 21, 2011, as an additional source of information to accomplish
the requirements of paragraph (g) of the NPRM.
    We agree. We have changed the final rule to specify that the
actions required by paragraph (g) of the AD may be done in accordance
with the Accomplishment Instructions of Rolls-Royce Service Bulletin
RB.211-75-G466, Revision 1, including Supplement, dated June 20, 2011;
or Rolls-Royce Service Bulletin RB.211-75-G466, Revision 2, including
Supplement, dated November 21, 2011.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     [Agr]re consistent with the intent that was proposed in
the NPRM (76 FR 77157, December 12, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 77157, December 12, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 55 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement...........................  16 work-hours x $85 per          $75,000         $76,360      $4,199,800
                                         hour = $1,360.
Installation of AEDB software.........  1 work-hour x $85 per                  0              85           4,675
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2012-16-04 The Boeing Company: Amendment 39-17151; Docket No. FAA-
2011-1319; Directorate Identifier 2011-NM-143-AD.

(a) Effective Date

    This AD is effective October 3, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200 and -300
series airplanes, certificated in any category, equipped with Rolls-
Royce RB211 Trent 800 engines, as identified in Boeing Service
Bulletin 777-75A0002, Revision 1, dated October 26, 2011.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 78, Exhaust.

(e) Unsafe Condition

    This AD was prompted by reports of events related to thermal
damage of the thrust reverser (T/R) inner wall on Rolls-Royce RB211
Trent 800 engines. We are issuing this AD to eliminate T/R thermal
damage caused by excessive heat downstream of the 8th stage IP8
exhaust ports, which could result in T/R structural failure. This
failure could result in large pieces of the T/R or adjacent
components departing the airplane. A separated T/R piece could
result in a rejected takeoff and cause asymmetric thrust and
consequent loss of control of the airplane during reverse thrust
operations. Separated components could also cause structural damage
to the airplane, damage to other airplanes due to debris left on the
runway, or injury to people on the ground.

 (f) Compliance

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

(g) Replacement of Bleed Valve Parts and Tubing

    Within 36 months after the effective date of this AD, replace
the bleed valve parts and tubing with new parts and tubing on the
left and right engines, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 777-75A0002, Revision 1,
dated October 26, 2011; Rolls-Royce Service Bulletin RB.211-75-G466,
Revision 1, including Supplement, dated June 20, 2011; or Rolls-
Royce Service Bulletin RB.211-75-G466, Revision 2, including
Supplement, dated November 21, 2011.

 (h) Concurrent Requirements

    Prior to or concurrently with doing the actions required by
paragraph (g) of this AD, install Aero-Engine database software,
software part number 3110-BCG-00R-06, media set part number
243W0033-7, in the airplane information management system hardware,
in accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-31-

0177, dated September 23, 2010; or Boeing Special Attention Service
Bulletin 777-31-0177, Revision 1, dated October 13, 2011.

 (i) Credit for Previous Actions

    This paragraph provides credit for the replacement required by
paragraph (g) of this AD, if the replacement was performed before
the effective date of this AD using Boeing Alert Service Bulletin
777-75A0002, dated January 12, 2011.

 (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

 (k) Related Information

    For more information about this AD, contact Margaret Langsted,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) under 5 U.S.C. 552(a) and 1 CFR
part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin 777-75A0002, Revision 1, dated
October 26, 2011.
    (ii) Boeing Special Attention Service Bulletin 777-31-0177,
dated September 23, 2010.
    (iii) Boeing Special Attention Service Bulletin 777-31-0177,
Revision 1, dated October 13, 2011.
    (iv) Rolls-Royce Service Bulletin RB.211-75-G466, Revision 1,
including Supplement, dated June 20, 2011. The revision level of
this document is not identified in the document.
    (v) Rolls-Royce Service Bulletin RB.211-75-G466, Revision 2,
including Supplement, dated November 21, 2011. The revision level of
this document is not identified in the document.
    (3) For Boeing service information identified in this AD,
contact For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207;
phone:<PHONE_NUMBER>, extension 1; fax:<PHONE_NUMBER>; Internet:
https://www.myboeingfleet.com.
    (4) For Rolls-Royce service information identified in this AD,
contact Rolls-Royce plc, P.O. Box 31, Derby, DE24 8BJ, England;
telephone: 011 44 1332 242424; fax: 011 44 1332 249936; Internet:
https://www.aeromanager.com.
    (5) You may review copies of the referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, Washington. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (6) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 26, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2012-19252 Filed 8-28-12; 8:45 am]
BILLING CODE 4910-13-P


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

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.

    (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,

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

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,

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

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.

*1. FDA. Meeting Materials of the Neurological Devices Panel. April
24, 2014. Available at: https://wayback.archive-it.org/7993/20170405192749/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm394252.htm.
*2. Smith, T., Should the FDA Ban Aversive Conditioning Devices?, to
FDA, solicited opinion. Received June 30, 2015.
3. MacLean, W.E., Jr., R.C. Tervo, J. Hoch, et al., ``Self-Injury
Among a Community Cohort of Young Children at Risk for Intellectual
and Developmental Disabilities.'' The Journal of Pediatrics,
157(6):979-983, 2010.
*4. FDA. Roster in Meeting Materials of the Neurological Devices
Panel. April 24, 2014. Available at: https://wayback.archive-it.org/7993/20170405192749/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM394254.pdf.
*5. FDA. Executive Summary in Meeting Materials of the Neurological
Devices Panel. April 24, 2014. Available at: https://wayback.archive-it.org/7993/20170114045647/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM394256.pdf.
*6. FDA. FDA Presentation: Aversive Conditioning in Meeting
Materials of the Neurological Devices Panel. April 24, 2014.
Available at: https://wayback.archive-it.org/7993/20170405192749/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM395135.pdf.
7. van Oorsouw, W.M., M.L. Israel, R.E. von Heyn, et al., ``Side
Effects of Contingent Shock Treatment.'' Research in Developmental
Disabilities, 29(6):513-523, 2008.
8. LaVigna, G.W. and T.J. Willis, ``The Efficacy of Positive
Behavioural Support with the Most Challenging Behaviour: The
Evidence and its Implications.'' Journal of Intellectual &
Developmental Disability, 37(3):185-195, 2012.
9. Horner, R.H., G. Dunlap, R.L. Koegel, et al., ``Toward a
Technology of 'Nonaversive' Behavioral Support.'' Research &
Practice for Persons with Severe Disabilities, 30(1):3-10, 2005.
Originally published in The Journal of the Association for the
Severely Handicapped. Reprinted from 15(3), 1990.

10. Heyvaert, M., L. Saenen, J.M. Campbell, et al., ``Efficacy of
Behavioral Interventions for Reducing Problem Behavior in Persons
with Autism: An Updated Quantitative Synthesis of Single-Subject
Research.'' Research in Developmental Disabilities, 35(10):2463-
2476, 2014.
11. Matson, J.L. and S.V. LoVullo, ``A Review of Behavioral
Treatments for Self-Injurious Behaviors of Persons with Autism
Spectrum Disorders.'' Behavior Modification, 32(1):61-76, 2008.
*12. Brown, F., Patients Exhibiting Self-Injurious and Aggressive
Behavior, to FDA, solicited opinion. Received October 9, 2015.
*13. JRC, Inc., public docket comment (attachment 11), FDA-2016-N-
1111-1656 (1k0-8reg-jdp8). Received July 25, 2016.
*14. Commonwealth of Massachusetts. Judge Rotenberg Education
Center, Inc., et al. v. Commissioner of the Department of
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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


[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Page 40404]
[FR Doc No: 2012-16718]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Advanced
Qualification Program (AQP)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Advanced Qualification Program (AQP) incorporates data
driven quality control processes for validating and maintaining the
effectiveness of air carrier training program curriculum content.

DATES: Written comments should be submitted by September 7, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0701.
    Title: Advanced Qualification Program (AQP).
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Under Special Federal Aviation Regulation No. 58,
Advanced Qualification Program (AQP), the FAA provides certificated air
carriers, as well as training centers they employ, with a regulatory
alternative for training, checking, qualifying, and certifying aircrew
personnel subject to the requirements of 14 CFR parts 121 and 135. The
main goal of the AQP is to improve flight crew performance by providing
alternative means of complying with certain rules that may inhibit
innovative use of modern technology for flight crewmember training.
Data collection and analysis is a fundamental part of AQP. AQP is
continuously validated through the collection and analysis of trainee
performance. Data collection and analysis processes ensure that the
certificate holder provides performance information on its crewmembers,
flight instructors, and evaluators that will enable the certificate
holder and the FAA to determine whether the form and content of
training and evaluation activities are satisfactorily accomplishing the
overall objectives of the curriculum.
    Respondents: 18 respondents with approved Advanced Qualification
Programs.
    Frequency: Data is collected monthly.
    Estimated Average Burden per Response: 2 hours.
    Estimated Total Annual Burden: 432 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on July 2, 2012.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2012-16718 Filed 7-6-12; 8:45 am]
BILLING CODE 4910-13-P