[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Proposed Rules]
[Pages 49986-49994]
[FR Doc No: 2020-17543]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2020-N-1053]

Physical Medicine Devices; Reclassification of Non-Invasive Bone
Growth Stimulators

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Proposed amendment; proposed order; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify non-invasive bone growth stimulators, postamendments class
III devices (product codes LOF and LPQ), into class II (special
controls), subject to premarket notification. FDA is also proposing a
new device classification with the name ``non-invasive bone growth
stimulators'' along with the proposed special controls that the Agency
believes are necessary to provide a reasonable assurance of safety and
effectiveness of these devices. FDA is proposing this reclassification
on its own initiative. If finalized, this order will reclassify these
devices from class III (premarket approval) to class II (special
controls) and reduce the regulatory burdens associated with these
devices, as these devices will no longer be required to submit a
premarket approval application (PMA), but are subject to premarket
notification (510(k)) requirements and general and special controls.

DATES: Submit either electronic or written comments on the proposed
order by October 16, 2020. Please see section XII of this document for
the proposed effective date when the new requirements apply and for the
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late,

untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 16, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 16, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal Rulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1053 for ``Physical Medicine Devices; Reclassification of
Non-Invasive Bone Growth Stimulators.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, 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: Jesse Muir, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (general controls and special controls),
and class III (general controls and premarket approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until: (1) FDA
reclassifies the device into class I or II or (2) FDA issues an order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. FDA determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807), subpart E, of the regulations.
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or class II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA acting by administrative
order, can reclassify the device into class I or class II on its own
initiative, or in response to a petition from the manufacturer or
importer of the device. To change the classification of the device, the
proposed new class must have sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
    Reevaluation of the data previously presented before the Agency is
an appropriate basis for subsequent action, where the reevaluation is
made in light of newly available regulatory authority (see Bell v.
Goddard, 366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762
F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in
``medical science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir.
1970)). Whether data before the Agency are old or new, the ``new
information'' to support reclassification under 513(f)(3) must be
``valid scientific evidence'', as defined in section 513(a)(3) of the
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.

1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act and Sec.  860.7(c)(2), in the
classification process to determine the level of regulation for
devices. To be considered in the reclassification process, the ``valid
scientific evidence'' upon which the Agency relies must be publicly
available. Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section
520(h)(4) of the FD&C Act provides that FDA may use, for
reclassification of a device, certain information in a PMA 6 years
after the application has been approved (Ref. 1). This includes
information from clinical and preclinical tests or studies that
demonstrate the safety or effectiveness of the device, but does not
include descriptions of methods of manufacture or product composition
and other trade secrets.
    In accordance with section 513(f)(3) of the FD&C Act, FDA is
issuing this proposed order to reclassify non-invasive bone growth
stimulator devices, postamendments class III devices, into class II
(special controls), subject to premarket notification because FDA
believes the standard in section 513(a)(1)(B) of the FD&C Act is met as
there is sufficient information to establish special controls, which in
addition to general controls, will provide reasonable assurance of the
safety and effectiveness of the device.\1\
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    \1\ In December 2019, FDA began adding the term ``Proposed
amendment'' to the ``ACTION'' caption for these documents, typically
styled ``Proposed order'', to indicate that they ``propose to
amend'' the Code of Federal Regulations. This editorial change was
made in accordance with the Office of Federal Register's (OFR)
interpretations of the Federal Register Act (44 U.S.C. chapter 15),
its implementing regulations (1 CFR 5.9 and parts 21 and 22), and
the Document Drafting Handbook.
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    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to reasonably assure the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to reasonably assure the safety and
effectiveness of non-invasive bone growth stimulator devices.
Therefore, the Agency does not intend to exempt these proposed class II
devices from premarket notification (510(k)) submission as provided
under section 510(m) of the FD&C Act.

II. Regulatory History of Non-Invasive Bone Growth Stimulator Devices

    In accordance with section 513(f)(1) of the FD&C Act, non-invasive
bone growth stimulator devices were automatically classified into class
III because they were not introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976,
and have not been found substantially equivalent to a device placed in
commercial distribution after May 28, 1976, which was subsequently
classified or reclassified into class II or class I. Therefore, the
device is subject to PMA requirements under section 515 of the FD&C Act
(21 U.S.C. 360e).
    Accordingly, on November 6, 1979, FDA approved a PMA for the Bio
Osteogen System 204 (P790002) (Ref. 2). Since that time, five
additional original PMAs have been approved for non-invasive bone
growth stimulators (P850007, P850022, P900009, P910066, and P030034).
On February 9, 2005, FDA received a reclassification petition dated
February 7, 2005, submitted by RS Medical Corporation, requesting that
FDA reclassify certain non-invasive bone growth stimulators from class
III to class II (Ref. 3). As stated in the Notice of Panel
Recommendation discussed further below, ``the petition was submitted
under section 513(e) of the act but FDA . . . review[ed] the petition
under section 513(f)(3) of the act because that section contain[ed] the
appropriate procedures for reclassification of postamendments devices''
(72 FR 1951 at 1952, January 17, 2007). FDA requested additional
information and the petitioner amended the petition on November 30,
2005 (``amended petition''). In accordance with the FD&C Act and
regulations, FDA referred the petition, as amended, to the FDA Advisory
Committee, specifically the Orthopaedic and Rehabilitation Devices
Panel (``the 2006 Panel'') for its recommendations on the requested
reclassification.
    On June 2, 2006, the 2006 Panel deliberated on the information in
RS Medical's petition; the presentations made by RS Medical, FDA, and
members of the public; and their own experience with certain non-
invasive bone growth stimulators (Ref. 4).
    The 2006 Panel identified the following risks to health associated
with non-invasive bone growth stimulators: Electric shock; burn; skin
irritation and/or allergic reaction; inconsistent or ineffective
treatment; adverse interaction with electrical implants; adverse
interactions with internal/external fixation devices; and biological
risks. The 2006 Panel did not specifically address risks associated
with ultrasound-based devices, as these were outside the scope of RS
Medical's petition; however, as discussed below, based upon FDA's
review of information since the Panel meeting, the risks identified
with ultrasound-based devices, along with their reported benefits, are
comparable to those of non-invasive bone growth stimulators
incorporating other modalities.
    The majority of the 2006 Panel recommended that non-invasive bone
growth stimulators should be retained in class III because there was
insufficient information in the petition by RS Medical to establish
that special controls in conjunction with general controls would
provide a reasonable assurance of the safety and effectiveness of the
device. Specifically, the Panel recommended that the proposed special
controls by RS Medical were sufficient to control for the risk of
electric shock, burn, skin irritation, and/or allergic reaction;
adverse interaction with electrical implants; adverse interactions with
internal/external fixation devices; and biological risks. However, the
Panel believed that there was insufficient evidence presented by RS
Medical to control for the risk of inconsistent or ineffective
treatment because there is a lack of knowledge about how waveform
characteristics (e.g., pulse duration, amplitude, power, frequency),
including potential modifications to the device, affect the clinical
response to treatment. The Panel requested additional clinical data
and/or special controls, which was not adequately devised by the
petitioner, to control for the risk of inconsistent or ineffective
treatment.
    FDA concurred with the 2006 Panel's recommendation, and similarly
believed that RS Medical's petition was inadequate in that FDA had
concerns about the petitioner's proposed special controls to control
the risk of inconsistent or ineffective treatment. In the Federal
Register of January 17, 2007 (72 FR 1951), FDA published a Notice of
Panel Recommendations (``the 2007 Notice''), as referenced above.
    In a letter dated April 2, 2007, RS Medical requested that its
petition be withdrawn (Ref. 5). On July 10, 2007, FDA granted RS
Medical's request for withdrawal of the petition and did not take any
further action on the petition (Ref. 6). FDA has not received any
subsequent petition requesting reclassification of these devices.
    Subsequently, as part of the Center for Devices and Radiological
Health's 2014-2015 strategic priority, ``Strike the Right Balance
Between Premarket and Postmarket Data Collection,'' a

retrospective review of all PMA product codes with active PMAs approved
prior to 2010 was conducted to determine whether, based on our current
understanding of the technology, certain devices could be reclassified
(down-classified). On April 29, 2015, FDA published a document in the
Federal Register identifying certain product codes as potential
candidates for reclassification (80 FR 23798), including non-invasive
bone growth stimulators under product codes LOF and LPQ, from class III
to class II (Ref. 7). One comment was received in response to this
proposal for reclassification of LOF and LPQ; this comment did not
support FDA's intention to reclassify these devices, citing the
concerns discussed during the 2006 Panel. This comment was considered
in development of this proposed order. Note that invasive bone growth
stimulators, designated under product code LOE, are outside the scope
of this proposed reclassification. As noted in the 2006 Panel, invasive
bone growth stimulator devices have added risks compared to non-
invasive bone growth stimulators, and therefore would require a
separate classification discussion. Furthermore, invasive bone growth
stimulators were also considered as a part of the aforementioned PMA
retrospective review and FDA determined that these devices should
remain as class III (Ref. 8). Therefore, FDA will continue to regulate
invasive bone growth stimulators as a class III device, subject to PMA
requirements.
    While RS Medical's petition inadequately addressed all of the risks
associated with non-invasive bone growth stimulators for
reclassification, FDA is, on its own initiative, proposing to
reclassify these devices from class III to class II, and believes that
sufficient information exists to establish special controls, as
identified in this proposed order, that, together with general
controls, can provide a reasonable assurance of safety and
effectiveness for this device type. Additionally, RS Medical in its
petition excluded use of these devices as an adjunct to cervical fusion
surgery in patients at high risk for nonfusion, as well as for use in
congenital pseudarthrosis. Based upon the review of the evidence and
FDA's ability to establish special controls, FDA believes these
indications that have been approved for currently marketed non-invasive
bone growth stimulator devices should be included in this proposed
reclassification.

III. Device Description

    Non-invasive bone growth simulators, currently designated under
product codes LOF and LPQ, are typically composed of a waveform
generator and transducer (e.g., coils, electrodes, and/or ultrasound
transducers). Patient-contacting surfaces include the transducers, lead
wires, and the device outer casing.
    Non-invasive bone growth stimulators utilize an electrical
component to produce an output electrical, magnetic, or ultrasonic
waveform that is delivered to a treatment site via a non-invasively
applied transducer (e.g., electromagnetic coil or ultrasound
transducer) or electrodes (e.g., capacitor plates). The device also
incorporates an internal means to monitor the output waveform and
delivery of treatment, and to provide visual and/or audible alarms to
alert the user of improper device function. The induced electrical and/
or magnetic fields are generated using one of the following modalities:
     Capacitive coupling (CC), in which a pair of electrodes
are placed on the skin such that a current can be driven across the
target site;
     pulsed electromagnetic fields (PEMF), in which a modulated
electromagnetic field is generated near the treatment site though an
external coil; or
     combined magnetic fields (CMF), in which a coil generates
a combination of a static and pulsed magnetic field near the treatment
site.
    The ultrasonic waveform is generated using:
     Low intensity pulsed ultrasound (LIPUS), in which pulsed
ultrasonic signals are generated using ultrasonic transducers.
    The non-invasive nature of the device obviates the need for sterile
components; however, patient-contacting surfaces should be capable of
being cleaned as needed and biocompatibility must be ensured.
    Non-invasive bone growth stimulators are generally intended to
promote osteogenesis as adjunct to primary treatments for fracture
fixation or spinal fusion. The indications for use for this device type
depend on the specific device characteristics, but have included:
     Treatment of an established non-union secondary to trauma
of the appendicular system,
     treatment of congenital pseudarthrosis,
     treatment of failed fusions of the appendicular system,
     early treatment of certain fresh fractures, and
     as an adjunct to lumbar or cervical spinal fusion.
    In addition, non-invasive bone growth stimulators are currently
prescription use only devices under Sec.  801.109 (21 CFR 801.109).

IV. Proposed Reclassification

    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR
part 860, subpart C, FDA is proposing to reclassify non-invasive bone
growth stimulator devices under product codes LOF and LPQ from class
III into class II. This includes devices that generate electrical or
magnetic fields using CC, PEMF, and CMF, and ultrasonic signals.
    FDA believes that there is sufficient information available by way
of FDA's accumulated experience with these devices from review of
premarket submissions, peer-reviewed literature, medical device reports
(MDRs), and recalls to understand the risks associated with these
devices to establish special controls that effectively mitigate the
risks to health identified in section V. In this proposed order, the
Agency has identified the special controls under section 513(a)(1)(B)
of the FD&C Act that, together with general controls, would provide a
reasonable assurance of the safety and effectiveness for non-invasive
bone growth stimulators to be in class II. Absent the special controls
identified in this proposed order, general controls applicable to this
device type are insufficient to provide reasonable assurance of safety
and effectiveness of the device.
    FDA is proposing to create a classification regulation for non-
invasive bone growth stimulators, which would include devices
designated under product codes LOF and LPQ. Under this proposed order,
if finalized, a non-invasive bone growth stimulator will be identified
as a prescription device. As such, the prescription device must satisfy
prescription labeling requirements (see Sec.  801.109, Prescription
devices). Prescription devices are exempt from the requirement for
adequate directions for use for the layperson under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of Sec.  801.109 are met. In this proposed order, if
finalized, the Agency has identified the special controls under section
513(a)(1)(B) of the FD&C Act that, together with general controls, will
provide a reasonable assurance of the safety and effectiveness for non-
invasive bone growth stimulator devices.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary

to provide reasonable assurance of the safety and effectiveness of the
device. For non-invasive bone growth stimulators, FDA has determined
that premarket notification is necessary to provide reasonable
assurance of the safety and effectiveness of the device. Therefore, FDA
does not propose to exempt these proposed class II devices from 510(k)
requirements. If this order is finalized, persons who intend to market
this type of device would need to submit to FDA a 510(k) and receive
clearance prior to marketing the device.

V. Risks to Health

    Based on available information for non-invasive bone growth
stimulators, including the 2005 reclassification petition request from
RS Medical Corp, input from the 2006 Panel, data in PMA applications
P030034, P850022/S009, and P910066/S011 available to FDA under section
520(h)(4) of the FD&C Act, published literature, and postmarket
experience associated with use of these devices, FDA identifies the
following risks to health associated with non-invasive bone growth
stimulators:
    a. Failure or delay of osteogenesis--A patient could receive
ineffective treatment, contributing to failure or delay of osteogenesis
that may lead to clinical symptoms (e.g., pain) and the need for
surgical interventions. Ineffective treatment could be a result of
various circumstances (e.g., inadequate therapeutic signal output or
device malfunction or misuse).
    b. Burn--A patient or health care professional could be burned from
the use and operation of the device. This could be a result of various
circumstances including device malfunction (e.g., electrical fault) or
misuse of the device (e.g., use while sleeping).
    c. Electrical shock--A patient or health care professional could be
shocked from the use and operation of the device. This could be a
result of various circumstances including device malfunction (e.g.,
electrical fault) or misuse of the device (e.g., use of alternating
current source during treatment).
    d. Electromagnetic interference (EMI)--A patient with electrically
powered implants (such as cardiac pacemakers, cardiac defibrillators,
and neurostimulators) could experience an adverse interaction with the
implanted electrical device via EMI or radiofrequency interference.
    e. Adverse tissue reaction--A patient could experience skin
irritation and/or allergic reaction associated with the use and
operation of the device via the use of non-biocompatible device
materials.
    f. Adverse interaction with internal/external fixation devices--The
signal output could be impacted by certain metallic internal or
external fixation devices leading to inadequate treatment signals,
device malfunction, or tissue damage.
    g. Adverse biologic effects--A patient may experience adverse
biologic effects resulting from prolonged exposure to the treatment
signal via biologic interaction with the treatment signal at a cellular
level. Excessive energy transmission could cause tissue damage or
aberrant tissue behavior if signal output parameters exceed established
safety thresholds.
    The risks to health identified within this proposed order are
consistent with those identified in the 2005 reclassification petition,
as amended. The 2006 Panel agreed with these identified risks; however,
in some cases the risk or accompanying description was reworded for
clarity in this proposed order (e.g., ``inconsistent treatment or
ineffective treatment'' is described in terms of risk to health, which
may entail ``failure or delay in osteogenesis''). Also, the risk of
adverse biologic effects previously specified risks of carcinogenicity,
genotoxicity, mutagenicity, and teratological effects. The petitioner
notes in the amended petition that ``. . . the evidence points to lack
of genotoxic, carcinogenic, and teratologic potential of the subject
waveforms,'' which is corroborated by the lack of such reports
identified in the literature. Although FDA similarly has found a lack
of such reports, it considers this risk more generally as potential
deleterious effects at the tissue or cellular level due to signal
output parameters that exceed established safety thresholds.

VI. Summary of Reasons for Reclassification

    FDA believes that non-invasive bone growth stimulator devices,
which are intended to promote osteogenesis as an adjunct to primary
treatments for fracture fixation or spinal fusion, should be
reclassified from class III to class II and that there is sufficient
information to establish special controls for the risks identified in
section V which, in addition to general controls, can provide
reasonable assurance of safety and effectiveness.
    Specifically, FDA proposes to require clinical performance data as
a special control to address the risk of failure or delay of
osteogenesis. FDA review of the literature suggests a high variability
of treatment efficacy, depending on therapeutic signal and anatomic
location. This would also address the main concern cited by the 2006
Panel and FDA with RS Medical's proposal, which led to the
recommendation to retain non-invasive bone growth stimulators in class
III, and various comments received in response to the 2007 Notice.
    FDA's proposal would require that clinical performance of any non-
invasive bone growth stimulator device be evaluated in support of the
intended use. Rather than prescribe specific study requirements, FDA's
proposal would allow for flexibility in study design and the level of
clinical evidence needed by taking into consideration certain
parameters, e.g., the intended use, treatment population, and
technological characteristics of the device, including any similarities
between the device and legally marketed predicate device, as
appropriate.

VII. Summary of Data Upon Which the Reclassification Is Based

    The available evidence demonstrates that there are probable health
benefits derived from the use of these devices, and that the nature and
incidence of risks are well known so that special controls can be
established to adequately mitigate the risks to health. FDA is
proposing a single device class for non-invasive bone growth
stimulators, considering that FDA did not identify any unique risks
associated with the different modalities included in this proposed
order. FDA has considered and analyzed the following: Data in PMA
applications P030034, P850022/S009, and P910066/S011 available to FDA
under section 520(h)(4) of the FD&C Act; information presented at the
2006 Panel concerning RS Medical's petition to down-classify certain
non-invasive bone growth stimulators (Ref. 3) and the 2007 Notice;
peer-reviewed articles that discussed the use of, as well as the
probable benefits and risks of these devices; reported adverse events
identified through a search of FDA's Medical Device Reporting (MDR)
system; and a review of any recalls associated with these devices
through a search of FDA's Medical Device Recall database.
    In accordance with the ``6-year rule'' described in section
520(h)(4) of the FD&C Act, FDA considered data contained in three
original PMAs or supplements, P030034, P850022/S009, and P910066/S011,
approved for non-invasive bone growth stimulators (Refs. 9 to 11).
These PMAs/supplements include three different device modalities: A
PEMF device (P030034), a CC device (P850022/S009), and a CMF device
(P910066/S011). In review of the reported clinical data in the summary
of

safety and effectiveness data documents (SSEDs), the studies conducted
in support of these devices include a total study size of 831 enrolled
subjects. The adverse event profile for the devices in each study were
similar to the control group, with a similar distribution of event
types. With regards to benefit, the clinical data reported in the SSEDs
demonstrate an improved rate of bone fusion compared to placebo
controls, with an 83.6 percent vs. 68.6 percent fusion rate at 6 months
in P030034 (cervical spine), an 85 percent vs. 75 percent clinical
success shown in P850022/S009 (lumbar spine), and a 67 percent vs. 43
percent fusion rate at 9 months in P910066/S011 (lumbar spine).
    Further, FDA performed a literature review to evaluate data related
to non-invasive bone growth stimulator devices, including studies up to
the date of the 2006 Panel, as well as any new clinical information
published since the 2006 Panel.
    Literature published at the time of the 2006 Panel includes a 1953
seminal paper on the use of electrical signals to stimulate bone
formation by Yasuda, that reported bone formation in rabbits exposed to
direct current (DC) stimulation (Ref. 12). In the following decades,
other researchers expanded on this finding in animal and clinical
models. In a canine study, a DC stimulation was shown to cause complete
ossification of the femoral medullary canal (Ref. 13). The first
clinical case report demonstrated that electrical stimulation could
treat a non-union fracture (Ref. 14). An early publication regarding
the effects of DC stimulation on spinal fusion was published by Dwyer
(Ref. 15). Another early clinical study published by Becker, et al.
showed successful fracture fusion with a success rate of 77 percent
(Ref. 16).
    In the 1990s and early 2000s, several literature articles were
identified assessing the effects of non-invasive bone growth
stimulators on various anatomic locations. These studies generally
included various therapeutic modalities (magnitude, frequency,
duration, etc.) and demonstrated varying results regarding the efficacy
of these treatments. In two studies of PEMF devices, Basset and Schink-
Ascani (Ref. 17) found a 72 percent fusion rate in patients with
congenital pseudarthrosis of the tibia, and in a study of non-unions of
the scaphoid, Adams, et al. (Ref. 18) reported a fusion rate of 69
percent, as a followup to an earlier study that found a fusion rate of
80 percent. When looking at the rate of compliance of PEMF devices as a
factor of effectiveness, Garland, et al. (Ref. 19) found that fusion
rates ranged from 35.7 percent to 80 percent, depending on how often
the devices were used. In studies of CC devices, fusion rates in long
bones varied from 60 percent (Ref. 20), 68.8 percent (Ref. 21), and
72.7 percent (Ref. 22), to no difference between treatment and a
placebo-treated group in a study by Fourie and Bowerbank (Ref. 23).
While there was a large range of observed efficacies, there was no
reporting of treatment-related adverse events. These reported
variabilities in efficacy and low adverse event rates were consistent
with the findings by the 2006 Panel.
    FDA performed a systematic review of published literature to
identify any new clinical findings since the 2006 Panel. FDA identified
14 papers that included a combination of retrospective and prospective
studies. For studies that assessed medical or insurance claims
databases, radiographs were not always available to determine actual
fusion. Instead, results were presented in terms of healing rate based
on patient records or reported outcomes. When radiographs were
available and analyzed to assess union, results were reported as fusion
rate.
    Phillips, et al. (Ref. 24) looked at registry data of 2,370
subjects who were treated with OL1000 (DJO), a CMF device, at various
fracture sites and reported an average healing rate of 75.1 percent
(ranging from 57.2 percent in the humerus to 89.7 percent in the finger
phalanx). DeVries, et al. (Ref. 25) also evaluated the OL1000 device in
a retrospective analysis of 144 subjects, finding a fusion rate of 57.1
percent in tibiotalocalcaneal fusions of the ankle.
    With respect to LIPUS, Zura, et al. (Refs. 26 and 27) published two
papers evaluating subjects in the Exogen (Bioventus) Post Market
Registry. One of the studies assessed how various patient risk factors
affected healing rate in 4,190 subjects. The study demonstrated an
overall healing rate of 95.7 percent, and in another single arm study
of 767 subjects, showed a healing rate varying from 81.8 percent to
87.9 percent depending on fracture site. Nolte, et al. (Ref. 28)
evaluated the Exogen registry in conjunction with a medical claims
database to examine metatarsal fractures and reported a healing rate of
97.4 percent overall, while Elvey, et al. (Ref. 29) evaluated 26 cases
with use of Exogen in hand and wrist non-unions, and found a fusion
rate of 54 percent to 58 percent. In two smaller studies of the Exogen
device, Majeed, et al. (Ref. 30) and Mizra, et al. (Ref. 31) both
evaluated foot and ankle fractures and found 78.7 percent and 67
percent fusion rate in a 47 and 18 patient study, respectively. Biglari
(Ref. 32) also performed an observational study using the Exogen device
and found a much lower fusion rate of 32.8 percent in 60 subjects
having existing non-unions of various long bones.
    For PEMF devices, a retrospective study by Coric, et al. (Ref. 33)
on the effects of the CervicalStim (Orthofix) device on 593 subjects
showed a 73.2 percent fusion rate in the cervical spine at 6 months. In
a single arm prospective study by Assiotis, et al. (Ref. 34), a 77.3
percent fusion rate in the tibia was demonstrated with use of the
Physiostim (Orthofix). Murray and Pethica (Ref. 35) performed a 1,382-
subject retrospective study of use of the EBI device (Zimmer Biomet)
for non-unions of the scaphoid, tibia, and fibula, and while an
assessment of healing rates was not performed, the data showed
reduction in time to healing between 35 percent and 40 percent when the
device was used as prescribed.
    In addition, two randomized control studies on PEMF devices were
conducted by Foley, et al. (Ref. 36) and by Streit, et al. (Ref. 37).
Foley evaluated 323 subjects using the Orthofix CervicalStim device in
cervical fusion and found an 83.6 percent fusion rate in the treatment
group compared to a 68.6 percent fusion rate in the control group, with
no difference in pain scores or adverse events between groups. Streit,
et al. performed a small, eight subject clinical study using the EBI
device to treat non-unions of the fifth metatarsal and found the time
to fusion was reduced on average from 14.7 weeks to 8.9 weeks with the
use of the device.
    In summary, FDA's literature review resulted in findings that are
consistent with available clinical data from PMA submissions. These
studies suggest that there are probable benefits to the use of these
devices; however, differences in methodology, including differences in
devices used, treatment waveform and frequency, patient populations, as
well as anatomic location, could have had significant effects on
reported device effectiveness, which ranged from 32.8 percent to 97.4
percent. Regarding safety, the findings from these studies demonstrate
that the devices are relatively safe as the adverse event profile
associated with these devices using various modalities was similar to
controls. Overall, the studies involved 10,566 subjects (including
control subjects), with only a single report of a serious adverse event
(Biglari, Ref. 32); however, a direct link to the use of the device
could not be established for this event.

    Further, a search of FDA's MDR database was conducted to identify
all adverse events submitted to FDA up to October 31, 2019, for devices
approved under product codes LOF and LPQ. The results of the identified
reports are consistent with the risk profiles identified in both PMA
applications and literature that were reviewed. FDA's search yielded a
total of 270 unique MDRs. The most frequently reported events were
categorized as ``skin reaction/issue'' (n = 187) followed by ``pain''
(n = 59) and ``device functional issue'' (n = 21). A review of the
adverse events regarding skin reactions found that a majority were due
to irritation from the electrode adhesive or ultrasound gel used. There
was no apparent difference in risk profile across the various device
modalities, though the risk of skin irritation was primarily observed
in the skin-contacting devices (due to the electrodes in the CC device
and the gel in the LIPUS device). For cases where followup was
described, patients recovered when treatment was discontinued. In
addition, 11 reports of ``mass/tumor'' were identified; however, the
nature of the relationship between the mass/tumor to the device was
unrelated or unclear. Based upon FDA's assessment of other systematic
reviews of these devices, no other reports of mass/tumors have been
identified (Refs. 38 to 42).
    Finally, a search of FDA's Medical Device Recall database was
conducted. No recalls were found when searching the database for
devices under product code LOF. Two class 2 recalls were reported for
devices under product code LPQ; specifically, there was a recall for
the Exogen Express Bone Healing System and a recall for the Exogen
4000+ Ultrasound Bone Healing System. Both were posted on August 4,
2009, and initiated by the manufacturer because of problems with the
transducer, which may have resulted in a reduced ultrasound output.
These recalls were terminated on November 18, 2010. These recall events
reflect the risks to health identified in section V, and FDA believes
the special controls proposed, in addition to general controls, can
effectively mitigate the risks identified.

VIII. Proposed Special Controls

    Table 1 outlines the risks to health identified in section V and
the corresponding mitigation measures proposed to reasonably assure
safety and effectiveness, which are discussed in more detail below.

 Table 1--Risks to Health and Mitigation Measures for Non-Invasive Bone
                           Growth Stimulators
------------------------------------------------------------------------
       Identified risk to health               Mitigation measures
------------------------------------------------------------------------
Failure or delay of osteogenesis.......  Clinical performance data.
                                         Non-clinical performance
                                          testing.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Labeling.
Burn...................................  Non-clinical performance
                                          testing.
                                         Electrical safety testing.
                                         Labeling.
Electrical shock.......................  Electrical safety testing.
                                         Labeling.
Electromagnetic interference...........  Electromagnetic compatibility
                                          (EMC) testing.
                                         Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
                                         Labeling.
Adverse interaction with internal/       Labeling.
 external fixation devices.
Adverse biological effects.............  Non-clinical performance
                                          testing.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
------------------------------------------------------------------------

    The risk of failure or delay of osteogenesis is clinically
significant. To mitigate this risk, FDA proposes that manufacturers
provide clinical performance data to demonstrate that the device yields
positive outcomes (e.g., fusion of the non-union) in accordance with
its intended use. Further, FDA proposes non-clinical performance
testing to demonstrate that the device performs as intended under
anticipated conditions of use to achieve the identified successful
clinical performance characteristics. This would include verification
and validation of critical performance characteristics, including
characterization of the designed outputs of the device as well as the
outputs that are delivered to the patient, thermal safety and
reliability testing, reliability testing consistent with the expected
device use-life, and validation that signal characteristics are within
safe physiologic limits. Also, FDA proposes appropriate software
verification, validation, and hazard analysis to ensure that any device
software performs as intended. Lastly, FDA proposes labeling to provide
appropriate instructions (e.g., duration, frequency of use) to the end
user.
    To mitigate the risk of skin burns, FDA proposes non-clinical
performance testing of the device to verify and validate critical
performance characteristics, demonstrate thermal safety and
reliability, validate that signal characteristics are within safe
physiologic limits, and demonstrate reliability of the device
consistent with its expected use-life. FDA also proposes electrical
safety testing to minimize the risk of thermal burns to the patient,
and specific instructions regarding proper usage and specific warnings
associated with the risk of burns.
    To mitigate electrical shocks, FDA proposes electrical safety
testing to minimize the risk of shock to the patient. Furthermore, FDA
proposes labeling provisions, including instructions on appropriate
usage and maintenance, and specific warnings regarding electrical
shock.
    To mitigate electromagnetic interference, FDA proposes
electromagnetic compatibility testing and labeling to minimize the risk
of adverse interaction with other electronic devices such as implanted
electronic devices.
    To mitigate the risk of adverse tissue reactions, FDA proposes a
biocompatibility evaluation to ensure that the materials used in
patient-contacting components of the device are safe for skin contact
and labeling that includes warnings against use on compromised skin or
when there are known sensitivities, as well as instructions on
appropriate cleaning of any reusable components.
    To mitigate the risk of adverse interaction with internal/external
fixation devices, FDA proposes labeling,

specifically inclusion of appropriate warnings for patients with
implanted internal/external devices.
    To mitigate the risk of adverse biologic effects, FDA proposes non-
clinical performance testing to verify and validate critical
performance characteristics of the device, demonstrate thermal safety
and reliability, validate safety of the signal by reference to known
biological safety limits, and demonstrate reliability of the device
over the expected use-life. Furthermore, FDA proposes software
verification, validation, and hazard analysis.
    If this reclassification is finalized, non-invasive bone growth
stimulators will be reclassified into class II and would be subject to
premarket notification (510(k)) requirements under Sec.  807.81. As
discussed below, the intent is for the reclassification to be codified
in 21 CFR 890.5870. Firms submitting a 510(k) for non-invasive bone
growth stimulators will be required to comply with the particular
mitigation measures set forth in the special controls. Adherence to the
special controls, in addition to the general controls, is necessary to
provide a reasonable assurance of the safety and effectiveness of these
devices.

IX. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required. This proposed order refers
to previously approved FDA collections of information. These
collections of information are subject to review by OMB under the PRA.
The collections of information in part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

XI. Codification of Orders

    Under section 513(f)(3) of the FD&C Act, FDA may issue final orders
to reclassify devices. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as newly codified
orders. Therefore, under section 513(f)(3), in the proposed order, we
are proposing to codify non-invasive bone growth stimulators in the new
21 CFR 890.5870, under which non-invasive bone growth stimulators would
be reclassified from class III to class II.

XII. Proposed Effective Date

    FDA proposes that any final order based on this proposal become
effective 30 days after the date of its publication in the Federal
Register.

XIII. 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

    1. *Guidance on Section 216 of the Food and Drug Administration
Modernization Act of 1997, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda.
    2. *P790002 Approval available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P790002.
    3. *RS Medical Corporation Reclassification Petition, available
at https://wayback.archive-it.org/7993/20170405072021/https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4224b1-06-TabB-RSMEDICAL-Petition.pdf.
    4. *FDA's Orthopaedic and Rehabilitation Devices Panel
transcript and other meeting materials for the June 2, 2006, meeting
are available at: https://wayback.archive-it.org/7993/20170403222246/https://www.fda.gov/ohrms/dockets/ac/cdrh06.html#orthopaedic.
    5. *Letter from RS Medical requesting withdrawal of petition,
available at https://www.regulations.gov/document?D=FDA-2005-P-0052-0007.
    6. *FDA letter granting RS Medical's withdrawal request,
available at https://www.regulations.gov/document?D=FDA-2005-P-0052-0006.
    7. *First Cohort of Results of the 2014-2015 Strategic Priority:
Strike the Right Balance Between Premarket and Postmarket Data
Collection (April 2015), available at https://www.fda.gov/media/91437/download.
    8. *Second and Final Cohort of Results of the 2014-2015
Strategic Priority: Strike the Right Balance Between Premarket and
Postmarket Data Collection (August 2016), available at https://www.fda.gov/media/99822/download.
    9. *P030034 Summary of Safety and Effectiveness, available at
https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030034B.pdf.
    10. *P850022/S009 Summary of Safety and Effectiveness, available
at https://www.accessdata.fda.gov/cdrh_docs/pdf/P850022S009B.pdf.
    11. *P910066/S011 Summary of Safety and Effectiveness, available
at https://www.accessdata.fda.gov/cdrh_docs/pdf/P910066S011B.pdf.
    12. Yasuda, I., ``The Classic: Fundamental Aspects of Fracture
Treatment.'' J. Kyoto Med. Soc., 4:395-406, 1953.
    13. Bassett, C.A., R.J. Pawluk, and R.O. Becker, ``Effects of
Electric Currents on Bone In Vivo.'' Nature, 204: 652-654, 1964.
    14. Friedenberg, Z.B., M.C. Harlow, and C.T. Brighton, ``Healing
of Nonunion of the Medial Malleolus by Means of Direct Current: A
Case Report.'' The Journal of Trauma, 11(10):883-885, 1971.
    15. Dwyer, A.F., ``The Use of Electrical Current Stimulation in
Spinal Fusion.'' The Orthopedic Clinics of North America, 6(1):265-
273, 1975.
    16. Becker, R.O., J.A. Spadaro, and A.A. Marino, ``Clinical
Experiences With Low Direct Current Stimulation of Bone Growth.''
Clinical Orthopaedics and Related Research, 124:75-83, 1977.
    17. Bassett, C.A. and M. Schink-Ascani, ``Long-Term Pulsed
Electromagnetic Field (PEMF) Results in Congenital Pseudarthrosis.''
Calcified Tissue International, 49(3):216-220, 1991.
    18. Adams, B.D., G.K. Frykman, and J. Taleisnik, ``Treatment of
Scaphoid Nonunion With Casting and Pulsed Electromagnetic Fields: A
Study Continuation.'' The Journal of Hand Surgery, 17(5):910-914,
1992.
    19. Garland, D.E., B. Moses, and W. Salyer, ``Long-Term Follow-
up of Fracture Nonunions Treated With PEMFs.'' Contemporary
Orthopaedics, 22(3):295-302, 1991.
    20. Scott, G. and J.B. King, ``A Prospective, Double-Blind Trial
of Electrical Capacitive Coupling in the Treatment of Non-Union of
Long Bones.'' The Journal of Bone and Joint Surgery. American
volume, 76(6):820-826, 1994.
    21. Abeed, R.I., M. Naseer, and E.W. Abel, ``Capacitively
Coupled Electrical Stimulation Treatment: Results from Patients With
Failed Long Bone Fracture Unions.'' Journal of Orthopaedic Trauma,
12(7):510-513, 1998.
    22. Zamora-Navas, P., A. Borras Verdera, R. Antelo Lorenzo, et
al., ``Electrical Stimulation of Bone Nonunion With the

Presence of a Gap.'' Acta Orthopaedica Belgica, 61(3):169-176, 1995.
    23. Fourie, J.A. and P. Bowerbank, ``Stimulation of Bone Healing
in New Fractures of the Tibial Shaft Using Interferential
Currents.'' Physiotherapy Research International, 2(4):255-268,
1997.
    24. Philips, M., J. Baumhauer, S. Sprague, et al., ``Use of
Combined Magnetic Field Treatment for Fracture Nonunion.'' Journal
of Long Term Effects of Medical Implants, 26(3):277-284, 2016.
    25. DeVries, J.G., G.C. Berlet, and C.F. Hyer, ``Union Rate of
Tibiotalocalcaneal Nails With Internal or External Bone
Stimulation.'' Foot and Ankle International, 33(11):969-978, 2012.
    26. Zura, R., S. Mehta, G.J. Della Rocca, et al., ``A Cohort
Study of 4,190 Patients Treated With Low-Intensity Pulsed Ultrasound
(LIPUS): Findings in the Elderly Versus All Patients.'' BioMed
Central Musculoskeletal Disorders, 16:45, 2015.
    27. Zura, R., G.J. Della Rocca, S. Mehta, et al., ``Treatment of
Chronic (>1 Year) Fracture Nonunion: Heal Rate in a Cohort of 767
Patients Treated With Low-Intensity Pulsed Ultrasound (LIPUS).''
Injury, 46(10):2036-2041, 2015.
    28. Nolte, P., R. Anderson, E. Strauss, et al., ``Heal Rate of
Metatarsal Fractures: A Propensity-Matching Study of Patients
Treated With Low-Intensity Pulsed Ultrasound (LIPUS) vs. Surgical
and Other Treatments.'' Injury, 47(11):2584-2590, 2016.
    29. Elvey, M.H., R. Miller, K.S. Khor, et al., ``The Use of Low-
Intensity Pulsed Ultrasound in Hand and Wrist Nonunions.'' Journal
of Plastic Surgery and Hand Surgery, 1-6, 2019 (published online
ahead of print, November 26, 2019).
    30. Majeed, H., T. Karim, J. Davenport, et al., ``Clinical and
Patient-Reported Outcomes Following Low Intensity Pulsed Ultrasound
(LIPUS, Exogen) for Established Post-Traumatic and Post-Surgical
Nonunion in the Foot and Ankle.'' Foot and Ankle Surgery, S1268-
7731(19)30072-4, 2019 (published online ahead of print, May 19,
2019).
    31. Mizra, Y.H., K.H. Teoh, D. Golding, et al., ``Is There a
Role for Low Intensity Pulsed Ultrasound (LIPUS) in Delayed or
Nonunion Following Arthrodesis in Foot and Ankle Surgery?'' Foot and
Ankle Surgery, 25(6):842-848, 2019.
    32. Biglari, B., T.M. Yildirim, T. Swing, et al., ``Failed
Treatment of Long Bone Nonunions With Low Intensity Pulsed
Ultrasound.'' Archives of Orthopaedic and Trauma Surgery,
136(8):1121-1134, 2016.
    33. Coric, D., D.E. Bullard, V.V. Patel, et al., ``Pulsed
Electromagnetic Field Stimulation May Improve Fusion Rates in
Cervical Arthrodesis in High-Risk Populations.'' Bone and Joint
Research, 7(2):124-130, 2018.
    34. Assiotis, A., N.P. Sachinis, and B.E. Chalidis, ``Pulsed
Electromagnetic Fields for the Treatment of Tibial Delayed Unions
and Nonunions. A Prospective Clinical Study and Review of the
Literature.'' Journal of Orthopaedic Surgery and Research, 7:24,
2012.
    35. Murray, H.B. and B.A. Pethica, ``A Follow-up Study of the
In-Practice Results of Pulsed Electromagnetic Field Therapy in the
Management of Nonunion Fractures.'' Orthopaedic Research and
Reviews, 8:67-72, 2016.
    36. Foley, K.T., T.E. Mroz, P.M. Arnold, et al., ``Randomized,
Prospective, and Controlled Clinical Trial of Pulsed Electromagnetic
Field Stimulation for Cervical Fusion.'' Spine Journal, 8(3):436-
442, 2008.
    37. Streit, A., B.C. Watson, J.D. Granata, et al., ``Effect on
Clinical Outcome and Growth Factor Synthesis With Adjunctive Use of
Pulsed Electromagnetic Fields for Fifth Metatarsal Nonunion
Fracture: A Double-Blind Randomized Study.'' Foot and Ankle
International, 37(9):919-923, 2016.
    38. Aleem, I.S., I. Aleem, N. Evaniew, et al., ``Efficacy of
Electrical Stimulators for Bone Healing: A Meta-Analysis of
Randomized Sham-Controlled Trials.'' Science Reports, 6:31724, 2016.
    39. Behrens, S.B., M.E. Deren, and K O. Monchik, ``A Review of
Bone Growth Stimulation for Fracture Treatment.'' Current Orthopedic
Practice, 24(1):84-91, 2013.
    40. Griffin, X.L., M.L. Costa, N. Parsons, et al.,
``Electromagnetic Field Stimulation for Treating Delayed Union or
Non-Union of Long Bone Fractures in Adults.'' The Cochrane Database
of Systematic Reviews, 4:CD008471, 2011.
    41. Griffin, X.L., N. Smith, N. Parsons, et al., ``Ultrasound
and Shockwave Therapy for Acute Fractures in Adults.'' The Cochrane
Database of Systematic Reviews, 2:CD008579, 2012.
    42. Hannemann, P.F., E.H.H. Mommers, J.P.M. Schots, et al.,
``The Effects of Low-Intensity Pulsed Ultrasound and Pulsed
Electromagnetic Fields Bone Growth Stimulation in Acute Fractures: A
Systematic Review and Meta-Analysis of Randomized Controlled
Trials.'' Archives of Orthopaedic and Trauma Surgery, 134(8):1093-
1106, 2014.

List of Subjects in 21 CFR Part 890

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 890 be amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

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

0
2. Add Sec.  890.5870 to subpart F to read as follows:

Sec.  890.5870  Non-invasive bone growth stimulator.

    (a) Identification. A non-invasive bone growth stimulator provides
stimulation through electrical, magnetic, or ultrasonic fields. The
device is for prescription use and is intended to be used externally to
promote osteogenesis as an adjunct to primary treatments for fracture
fixation or spinal fusion.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance data must support the intended use of the
device.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following must be provided:
    (i) Verification and validation of critical performance
characteristics of the device, including characterization of the
designed outputs of the device as well as the outputs that are
delivered to the patient.
    (ii) Thermal safety and thermal reliability testing.
    (iii) Validation that signal characteristics are within safe
physiologic limits.
    (iv) Reliability testing consistent with the expected use-life of
the device.
    (3) Patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the electrical safety and
electromagnetic compatibility of the device.
    (5) Appropriate software verification, validation, and hazard
analysis must be performed.
    (6) Labeling for the device must include the following:
    (i) Warning against use on compromised skin or when there are known
sensitivities;
    (ii) Appropriate warnings for patients with implanted medical
devices;
    (iii) A detailed summary of the clinical testing, which includes
the clinical outcomes associated with the use of the device, and a
summary of adverse events and complications that occurred with the
device;
    (iv) A clear description of the device;
    (v) Instructions on appropriate usage, duration, and frequency of
use;
    (vi) Instructions for maintenance and safe disposal;
    (vii) Instructions for appropriate cleaning of any reusable
components;
    (viii) Specific warnings regarding user burns, electrical shock,
and skin irritation; and
    (ix) The risks and benefits associated with use of the device.

    Dated: August 4, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17543 Filed 8-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 5, 2006 (Volume 71, Number 128)]
[Notices]
[Page 38199-38201]
[DOCID:fr05jy06-89]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54050; File No. SR-Phlx-2006-37]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Extension of a Pilot Program Concerning Split Price
Priority in Open Outcry

June 27, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 8, 2006, the Philadelphia Stock Exchange, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
filed the proposed rule change pursuant to section 19(b)(3)(A) of the
Act \3\ and Rule 19b-4(f)(6) \4\ thereunder, which renders the proposed
rule change effective upon filing with the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to extend, for a one-year period, a pilot program
(the ``pilot'') set forth in Phlx Rule 1014(g)(i)(C) relating to
priority on split-price transactions in open outcry.
    Under the pilot, a member with an order for at least 100 contracts
\5\ who buys (sells) at least 50 contracts at a particular price has
priority over all others in purchasing (selling) up to an equivalent
number of contracts of the same order at the next lower (higher) price
without being required to yield priority, including to existing
customer interest in the limit order book. The pilot also establishes
priority for in-crowd participants in split price transactions
represented in open outcry over the quotations of participants that are
not located in the crowd (i.e., out-of-crowd Streaming Quote Traders
(``SQTs'') \6\ and Remote Streaming Quote Traders (``RSQTs'') \7\) even
where the market has a bid/ask differential of one minimum trading
increment.\8\ The current pilot is scheduled to expire June 30, 2006.
The extended pilot would expire June 30, 2007. The text of the proposed
rule change is available on the Phlx Web site (http://www.phlx.com), at

the Exchange's Office of the Secretary, and at the Commission's Public
Reference Room.\9\
---------------------------------------------------------------------------

    \5\ Orders for a size of less than 100 contracts are not
affected by the current pilot and would not be affected by this
proposed rule change.
    \6\ An SQT is an Exchange Registered Options Trader (``ROT'')
who has received permission from the Exchange to generate and submit
option quotations electronically through AUTOM in eligible options
to which such SQT is assigned. (AUTOM is Phlx's Automated Options
Market.) An SQT may submit such quotations only while such SQT is
physically present on the floor of the Exchange. See Phlx Rule
1014(b)(ii)(A).
    \7\ An RSQT is an ROT that is a member or member organization
with no physical trading floor presence who has received permission
from the Exchange to generate and submit option quotations
electronically through AUTOM in eligible options to which such RSQT
has been assigned. An RSQT may submit such quotations electronically
only from off the floor of the Exchange. See Phlx Rule
1014(b)(ii)(B).
    \8\ Generally, all options on stocks, indexes, and Exchange
Traded Funds quoting in decimals at $3.00 or higher have a minimum
increment of $.10, and those quoting in decimals under $3.00 have a
minimum increment of $.05. See Phlx Rule 1034(a).
    \9\ The proposed rule change amends the current text of Phlx
Rule 1014(g)(i)(C) by changing the expiration date from June 30,
2006 to June 30, 2007.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Phlx included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Phlx has prepared summaries, set forth in sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to extend the pilot
concerning priority in split-price transactions, which by virtue of
their size and the need to execute them at multiple prices, may be
difficult to execute without a limited exception to current Exchange
priority rules, as described below. The pilot is scheduled to expire
June 30, 2006.
    The pilot was originally adopted in June 2005,\10\ and subsequently
extended

in December 2005.\11\ In May 2006, the pilot was expanded to include
priority for in-crowd participants in both trades of the split price
transaction where there is a minimum trading increment market, but only
over RSQTs and out-of-crowd SQTs in such circumstance.\12\
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release No. 51820 (June 10,
2005), 70 FR 35759 (June 21, 2005) (SR-Phlx-2005-28).
    \11\ See Securities Exchange Act Release No. 53021 (December 23,
2005), 70 FR 77435 (December 30, 2005) (SR-Phlx-2005-86).
    \12\ See Securities Exchange Act Release No. 53874 (May 25,
2006), 71 FR 32171 (June 2, 2006) (SR-Phlx-2006-18).
---------------------------------------------------------------------------

    The current pilot, applicable to equity options (including options
overlying Exchange Traded Fund Shares (``ETFs'')), permits a member
with an order for at least 100 contracts \13\ who buys (sells) at least
50 contracts at a particular price to have priority over all others in
purchasing (selling) up to an equivalent number of contracts of the
same order at the next lower (higher) price without being required to
yield priority, including to existing customer interest in the limit
order book. Absent this rule, such orders would be required to yield
priority.\14\
---------------------------------------------------------------------------

    \13\ Orders for a size of less than 100 contracts are not
affected by the current pilot and would not be affected by this
proposed rule change.
    \14\ See, e.g., Phlx Rule 119(a).
---------------------------------------------------------------------------

    For example, where the market is $.25--$.35, a Floor Broker
representing an order to purchase 100 contracts that executes a
purchase of 50 of those contracts at a price of $.30 has priority over
all market participants to purchase the remaining 50 contracts in the
order at $.25. Two trades would be reported to the tape, one a purchase
of 50 contracts at $.30, and the other a purchase of 50 contracts at
$.25. The effect to that Floor Broker's customer would be a net
purchase price of $.275 for 100 contracts.
    The pilot, as recently modified,\15\ also affords priority to
members physically located in the crowd where the market has a bid/ask
differential of one minimum trading increment and the bid and/or ask
represent quotations of members located outside of the crowd (i.e.,
out-of-crowd SQTs and RSQTs).\16\ The Exchange believes that this
provision should enable it to continue to compete for order flow in
situations where Floor Brokers seek split price executions in open
outcry when the market consists of RSQT quotations and/or SQT
quotations where the SQT is located out of that trading crowd with a
bid/ask differential of one minimum trading increment.
---------------------------------------------------------------------------

    \15\ See supra, note 12.
    \16\ Clarified in telephone conference on June 21, 2006, among
Richard Rudolph, Vice President and Counsel, Phlx; and Ira
Brandriss, Special Counsel, and Mitra Mehr, Special Counsel,
Division of Market Regulation, Commission.
---------------------------------------------------------------------------

    For example, assume a Floor Broker represents an order to purchase
100 contracts in a series where the market is $.25--$.30, and both the
bid and offer represent quotations submitted by out-of-crowd SQTs \17\
or RSQTs. Under the pilot, the Floor Broker and contra-side participant
in the trading crowd are afforded priority over the out-of-crowd SQT or
RSQT at both $.25 and $.30, even though the bid/ask differential is one
minimum trading increment ($.05). This would enable the Floor Broker to
execute a split-price order at a net price ($.275) that improves the
market. According to Phlx, the effect (and ultimate benefit) to that
Floor Broker's customer would be a net purchase price of $.275 for 100
contracts. This provision applies only with respect to quotations
submitted by out-of-crowd SQTs and RSQTs, and thus does not operate to
afford priority over, for example, customer or broker-dealer orders or
in-crowd SQT quotes.
---------------------------------------------------------------------------

    \17\ The specialist and/or SQTs participating in a trading crowd
may, in response to a verbal request for a market by a Floor Broker,
state a bid or offer that is different than their electronically
submitted bid or offer, provided that such stated bid or offer is
not inferior to such electronically submitted bid or offer. See Phlx
Rule 1014, Commentary .05(c).
---------------------------------------------------------------------------

    The Exchange believes that, in situations where the market has a
bid/ask differential of one minimum trading increment, it is
potentially difficult for the Floor Broker to achieve price improvement
for the Floor Broker's customer on the Phlx. Instead, the order might
trade at another exchange that has no impediments, i.e., rules that
afford priority to in-crowd participants over out-of-crowd participants
generally, regardless of split price priority.\18\ The pilot therefore
was modified to include this provision.\19\
---------------------------------------------------------------------------

    \18\ The Phlx cites to Chicago Board Options Exchange,
Incorporated (``CBOE'') Rule 6.45A, which provides that only in-
crowd market participants are eligible to participate in open outcry
trade allocations. See Securities Exchange Act Release No. 51366
(March 14, 2005), 70 FR 13217 (March 18, 2005) (SR-CBOE-2004-75).
The Phlx notes that CBOE Rule 6.45A affords priority over out-of-
crowd participants even where there is no split price priority
situation. CBOE Rule 6.47 contains CBOE's split price provision,
which is similar to current Phlx Rule 1014(g)(i)(C).
    \19\ See supra, note 12.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act \20\ in general, and furthers the objectives of section
6(b)(5) of the Act \21\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest, enabling Floor Brokers representing split price orders in
open outcry to provide split-price executions at improved prices on
behalf of customers by establishing a limited priority rule regarding
split-price transactions.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78f(b).
    \21\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest, it
has become effective pursuant to section 19(b)(3)(A) of the Act,\22\
and Rule 19b-4(f)(6) thereunder.\23\ At any time within 60 days of the
filing of the proposed rule change the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \24\ normally
does not become operative prior to 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\25\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day pre-operative delay. The Commission
believes that such waiver is consistent with the protection

of investors and the public interest because it would allow the Phlx to
extend its pilot without interruption.\26\ For this reason, the
Commission designates the proposed rule change to be effective upon
filing with the Commission.\27\
---------------------------------------------------------------------------

    \24\ 17 CFR 240.19b-4(f)(6).
    \25\ 17 CFR 240.19b-4(f)(6)(iii).
    \26\ At the Exchange's request, the Commission has waived the
five-day pre-notice filing requirement for ``non-controversial''
proposals. See 17 CFR 240.19b-4(f)(6)(iii).
    \27\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the rule's impact on
efficiency, competition and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Phlx-2006-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

    All submissions should refer to File Number SR-Phlx-2006-37. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal office of the Phlx. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-Phlx-2006-37 and should be submitted on or before July
26, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-10416 Filed 7-3-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Rules and Regulations]
[Page 39577-39579]
[DOCID:fr19jy07-10]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2006-0305; FRL-8440-3]

Determination of Attainment, Approval and Promulgation of
Implementation Plans and Designation of Areas for Air Quality Planning
Purposes; Indiana; Redesignation of the South Bend-Elkhart 8-Hour Ozone
Nonattainment Area to Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: On May 30, 2006, the Indiana Department of Environmental
Management (IDEM) submitted a request to EPA for approval of the
redesignation of St. Joseph and Elkhart Counties to attainment of the
8-hour ozone National Ambient Air Quality Standard (NAAQS) and of an
ozone maintenance plan for St. Joseph and Elkhart Counties as revisions
to the Indiana State Implementation Plan (SIP). On April 18, 2007, EPA
proposed to approve this submission. Today, EPA is approving Indiana's
request and corresponding SIP revision. In so doing, EPA is making a
determination that St. Joseph and Elkhart Counties have attained the 8-
hour ozone NAAQS. This determination is based on three years of
complete, quality-assured ambient air quality monitoring data for the
2003-2005 ozone seasons that demonstrate that the 8-hour ozone NAAQS
has been attained in the area. In addition, quality-assured monitoring
data for 2006 show that the area continues to attain the standard.
Finally, EPA is approving, for purposes of transportation conformity,
the motor vehicle emission budgets (MVEBs) for the year 2020 that are
contained in the 14-year 8-hour ozone maintenance plan for St. Joseph
and Elkhart Counties.

DATES: This final rule is effective on July 19, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2006-0305. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some

information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at the

Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Steven Rosenthal,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Steven Rosenthal, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the following, whenever ``we,'' ``us,''
or ``our'' are used, we mean the United States Environmental Protection
Agency.

Table of Contents

I. What Is the Background for This Rule?
II. What Comments Did We Receive on the Proposed Action?
III. What Are Our Final Actions?
IV. Statutory and Executive Order Review

I. What Is the Background for This Rule?

    The background for today's action is discussed in detail in EPA's
April 18, 2007 proposal (72 FR 19413). In that rulemaking, we noted
that, under EPA regulations at 40 CFR part 50, the 8-hour ozone
standard is attained when the 3-year average of the annual fourth-
highest daily maximum 8-hour average ozone concentrations is less than
or equal to 0.08 ppm. (See 69 FR 23857 (April 30, 2004) for further
information). The data completeness requirement is met when the average
percent of days with valid ambient monitoring data is greater than 90%,
and no single year has less than 75% data completeness, as determined
in accordance with Appendix I of Part 50.
    Under the Clean Air Act (CAA), EPA may redesignate nonattainment
areas to attainment if sufficient complete, quality-assured data are
available to determine that the area has attained the standard and that
it meets the other CAA redesignation requirements in section
107(d)(3)(E).
    On May 30, 2006, Indiana submitted a request for the redesignation
of St. Joseph and Elkhart Counties to attainment for the 8-hour ozone
standard. The request included three years of complete, quality-assured
data for the period of 2003 through 2005, indicating the 8-hour NAAQS
for ozone had been achieved. The data satisfy the applicable CAA
requirements discussed above. The April 18, 2007, proposed rule
provides a detailed discussion of how Indiana met these requirements.
    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-
hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (D.C.Cir. 2006). On June
8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No.
04-1201, in response to several petitions for rehearing, the D.C.
Circuit clarified that the Phase 1 Rule was vacated only with regard to
those parts of the rule that had been successfully challenged.
Therefore, the Phase 1 Rule provisions related to classifications for
areas currently classified under subpart 2 of Title I, part D of the
Act as 8-hour nonattainment areas, the 8-hour attainment dates and the
timing for emissions reductions needed for attainment of the 8-hour
ozone NAAQS remain effective. The June 8 decision left intact the
Court's rejection of EPA's reasons for implementing the 8-hour standard
in certain nonattainment areas under subpart 1 in lieu of subpart 2. By
limiting the vacatur, the Court let stand EPA's revocation of the 1-
hour standard and those anti-backsliding provisions of the Phase 1 Rule
that had not been successfully challenged. The June 8 decision
reaffirmed the December 22, 2006, decision that EPA had improperly
failed to retain four measures required for 1-hour nonattainment areas
under the anti-backsliding provisions of the regulations: (1)
Nonattainment area New Source Review (NSR) requirements based on an
area's 1-hour nonattainment classification; (2) Section 185 penalty
fees for 1-hour severe or extreme nonattainment areas; (3) measures to
be implemented pursuant to section 172(c)(9) or 182(c)(9) of the Act,
on the contingency of an area not making reasonable further progress
toward attainment of the 1-hour NAAQS, or for failure to attain that
NAAQS; and, (4) certain transportation conformity requirements for
certain types of Federal actions. The June 8 decision clarified that
the Court's reference to conformity requirements was limited to
requiring the continued use of 1-hour motor vehicle emissions budgets
until 8-hour budgets were available for 8-hour conformity
determinations.
    For the reasons set forth in the proposal, EPA does not believe
that the Court's rulings alter any requirements relevant to this
redesignation action so as to preclude redesignation, and does

not prevent EPA from finalizing this redesignation. EPA believes that
the Court's December 22, 2006, and June 8, 2007, decisions impose no
impediment to moving forward with redesignation of this area to
attainment, because even in light of the Court's decisions,
redesignation is appropriate under the relevant redesignation
provisions of the Act and longstanding policies regarding redesignation
requests.
    With respect to the requirement for transportation conformity under
the 1-hour standard, the Court in its June 8 decision clarified that
for those areas with 1-hour motor vehicle emissions budgets in their
maintenance plans, anti-backsliding requires only that those 1-hour
budgets must be used for 8-hour conformity determinations until
replaced by 8-hour budgets. To meet this requirement, conformity
determinations in such areas must comply with the applicable
requirements of EPA's conformity regulations at 40 CFR part 93.

II. What Comments Did We Receive on the Proposed Action?

    EPA provided a 30-day review and comment period. The only comment
that we received was from a resident of Elkhart, Indiana, who stated
that the redesignation recognized the region's efforts to improve air
quality.

III. What Are Our Final Actions?

    EPA is taking several related actions. First, EPA is making a
determination that St. Joseph and Elkhart Counties have attained the 8-
hour ozone standard. EPA is also approving the State's request to
change the legal designation of St. Joseph and Elkhart Counties from
nonattainment to attainment of the 8-hour ozone NAAQS. Further, EPA is
approving Indiana's maintenance plan SIP revision for St. Joseph and
Elkhart Counties (such approval being one of the CAA criteria for
redesignation to attainment status). The maintenance plan is designed
to keep St. Joseph and Elkhart Counties in attainment for ozone through
2020. Finally, as supported by and consistent with the ozone
maintenance plan, EPA is approving the 2020 volatile organic content
and oxides of nitrogen MVEBs for St. Joseph and Elkhart Counties for
transportation conformity purposes.
    In accordance with 5 U.S.C. 553(d), EPA finds that there is good
cause for these actions to become effective immediately upon
publication. This is because a delayed effective date is unnecessary
due to the nature of a redesignation to attainment, which relieves the
area from certain CAA requirements that would otherwise apply to it.
The immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3) which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30-day waiting period
prescribed in 553(d) is to give affected parties a reasonable time to
adjust their behavior and prepare before the final rule takes effect.
Today's rule, however, does not create any new regulatory requirements
such that affected parties would need time to prepare before the rule
takes effect. Rather, today's rule relieves the State of planning
requirements for these 8-hour ozone nonattainment areas. For these
reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Review

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, therefore, is
not subject to review by the Office of Management and Budget.

Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Redesignation of an area to attainment under
section 107(d)(3)(E) of the CAA does not impose any new requirements on
small entities. Redesignation is an action that affects the status of a
geographical area and does not impose any new regulatory requirements
on sources. Accordingly, the Administrator certifies that this rule
will not have a significant economic impact on a substantial number of
small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Redesignation is an action that merely affects the status of
a geographical area, and does not impose any new requirements on
sources, or allows a state to avoid adopting or implementing additional
requirements, and does not alter the relationship or distribution of
power and responsibilities established in the Clean Air Act.

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
state to use voluntary consensus

standards (VCS), EPA has no authority to disapprove a SIP submission
for failure to use VCS. It would thus be inconsistent with applicable
law for EPA, when it reviews a SIP submission, to use VCS in place of a
SIP submission that otherwise satisfies the provisions of the Clean Air
Act. Redesignation is an action that affects the status of a
geographical area but does not impose any new requirements on sources.
Thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 17, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review, nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to force its requirements. (See Section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Volatile
organic compounds.

40 CFR Part 81

    Air pollution control, Environmental protection, National parks,
Wilderness areas.

    Dated: July 5, 2007.
Bharat Mathur,
Acting Regional Administrator, Region 5.

0
Parts 52 and 81, chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart P--Indiana

0
2. Section 52.777 is amended by adding paragraph (hh) to read as
follows:

Sec.  52.777  Control strategy: photochemical oxidants (hydrocarbons).

* * * * *
    (hh) Approval--On May 30, 2006, Indiana submitted a request to
redesignate St. Joseph and Elkhart Counties to attainment of the 8-hour
ozone National Ambient Air Quality Standard. As part of the
redesignation request, the State submitted a maintenance plan as
required by section 175A of the Clean Air Act. Elements of the section
175 maintenance plan include a contingency plan and an obligation to
submit a subsequent maintenance plan revision in eight years as
required by the Clean Air Act. Also included were motor vehicle
emission budgets to determine transportation conformity in St. Joseph
and Elkhart Counties. The 2020 motor vehicle emission budgets are 6.64
tons per day for volatile organic compounds and 7.73 tons per day for
oxides of nitrogen.

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. Section 81.315 is amended by revising the entry for South Bend-
Elkhart, IN: Elkhart and St. Joseph Counties in the table entitled
``Indiana Ozone (8-Hour Standard)'' to read as follows:

Sec.  81.315  Indiana.

* * * * *

                                                                      Indiana Ozone
                                                                    [8-hour standard]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Designation \a\                                         Classification
             Designated area             ---------------------------------------------------------------------------------------------------------------
                                            Date \1\                      Type                      Date\1\                       Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
South Bend-Elkhart, IN:                       7/19/07  Attainment...............................
     Elkhart County.....................
     St. Joseph County..................

                                                                     * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

[FR Doc. E7-13797 Filed 7-18-07; 8:45 am]

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