[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Notices]
[Page 17143-17145]
[DOCID:fr05ap10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0495]

Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices; Neurological and Physical Medicine Device
Guidance Documents; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of draft special controls guidance documents for 11
neurological and physical medicine devices. FDA has developed a draft
special controls guidance document for each of the 11 devices. These
draft guidance documents describe a means by which these devices may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
proposed rule that would designate special controls for each of these
devices and would exempt six of them from the premarket notification
requirements of the Federal Food, Drug, and Cosmetic Act (the act).
These draft guidance documents are not final nor are they in effect at
this time.

DATES:  Although you can comment on any guidance documents at any time

(see 21 CFR 10.115(g)(5)), to ensure that the agency considers your
comment on any of these draft guidances before it begins work on the
final versions of the guidances, submit written or electronic comments
by July 6, 2010.

ADDRESSES:  Submit written requests for single copies of any or all of
the draft guidance documents to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4617, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft
guidance documents.
    Submit written comments concerning any of the draft guidance
documents to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. Identify
comments with the docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT:  Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002, e-
mail<EMAIL_ADDRESS>301-796-6630.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the following 11 draft
guidance documents:
    (1) ``Class II Special Controls Guidance Document:
Electroconductive Media; Draft Guidance for Industry and FDA Staff'';
    (2) ``Class II Special Controls Guidance Document: Cutaneous
Electrode; Draft Guidance for Industry and FDA Staff'';
    (3) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator for Pain Relief; Draft Guidance for
Industry and FDA Staff'';
    (4) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator for Pain Relief Intended for Over the
Counter Use; Draft Guidance for Industry and FDA Staff'';
    (5) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator with Limited Output for Pain Relief; Draft
Guidance for Industry and FDA Staff'';
    (6) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Stimulator for Aesthetic Purposes; Draft Guidance for
Industry and FDA Staff'';
    (7) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Stimulator with Limited Output for Aesthetic Purposes; Draft
Guidance for Industry and FDA Staff'';
    (8) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Rehabilitation; Draft Guidance for Industry and FDA
Staff'';
    (9) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Rehabilitation; Draft Guidance for
Industry and FDA Staff'';
    (10) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Muscle Conditioning; Draft Guidance for Industry and FDA
Staff''; and
    (11) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Muscle Conditioning; Draft Guidance
for Industry and FDA Staff.''
    Each draft special controls guidance document identifies the
classification, product code, and classification identification for
each of the respective 11 device types. In addition, they would serve
as special controls that, when followed and combined with the general
controls and any other applicable special controls, would generally
address the risks associated with these devices.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule that would designate special controls for these
devices. The rule also proposes to exempt the following six device
types from premarket notification requirements if they follow the
designated special controls, including addressing the issues identified
in the special controls guidance documents by following the guidances'
recommendations: (1) Electroconductive media; (2) cutaneous electrode;
(3) transcutaneous electrical nerve stimulator with limited output for
pain relief; (4) transcutaneous electrical stimulator with limited
output for aesthetic purposes; (5) powered muscle stimulator with
limited output for rehabilitation; and (6) powered muscle stimulator
with limited output for muscle conditioning.
    These draft guidance documents were developed to describe a means
by which these devices may comply with the requirement of special
controls for class II devices. FDA believes that special controls, when
combined with the general controls, would be sufficient to provide
reasonable assurance of the safety and effectiveness of these devices.

II. Significance of Guidance

    These draft guidance documents are being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). These draft
guidances, when finalized will reflect the agency's current thinking
regarding (1) Electroconductive media; (2) the cutaneous electrode; (3)
the transcutaneous electrical nerve stimulator for pain relief; (4) the
transcutaneous electrical nerve stimulator for pain relief intended for
over the counter use; (5) the transcutaneous electrical nerve
stimulator with limited output for pain relief; (6) the transcutaneous
electrical stimulator for aesthetic purposes; (7) the transcutaneous
electrical stimulator with limited output for aesthetic purposes; (8)
the powered muscle stimulator for rehabilitation; (9) the powered
muscle stimulator with limited output for rehabilitation; (10) the
powered muscle stimulator for muscle conditioning; and (11) the powered
muscle stimulator with limited output for muscle conditioning. They do
not create or confer any rights for or on any person and do not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the applicable statute, regulations, or both.

III. Electronic Access

    To receive any or all of the following 11 draft guidance documents
you may either send an e-mail request to<EMAIL_ADDRESS>to receive
an electronic copy of the document(s) or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number to identify
the guidance you are requesting: (1) ``Class II Special Controls
Guidance Document: Electroconductive Media; Draft Guidance for Industry
and FDA Staff'' (1571); (2) ``Class II Special Controls Guidance
Document: Cutaneous Electrode; Draft Guidance for Industry and FDA
Staff'' (1572); (3) ``Class II Special Controls Guidance Document:
Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft
Guidance for Industry and FDA Staff'' (1573); (4) ``Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
for Pain Relief Intended for Over the Counter Use; Draft Guidance for
Industry and FDA Staff'' (1670); (5) ``Class II Special Controls
Guidance Document:

Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain
Relief; Draft Guidance for Industry and FDA Staff'' (1574); (6) ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator for Aesthetic Purposes; Draft Guidance for Industry and FDA
Staff'' (1575); (7) ``Class II Special Controls Guidance Document:
Transcutaneous Electrical Stimulator with Limited Output for Aesthetic
Purposes; Draft Guidance for Industry and FDA Staff'' (1576); (8)
``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Rehabilitation; Draft Guidance for Industry and FDA
Staff'' (1577); (9) ``Class II Special Controls Guidance Document:
Powered Muscle Stimulator with Limited Output for Rehabilitation; Draft
Guidance for Industry and FDA Staff'' (1578); (10) ``Class II Special
Controls Guidance Document: Powered Muscle Stimulator for Muscle
Conditioning; Draft Guidance for Industry and FDA Staff'' (1579); and/
or (11) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Muscle Conditioning; Draft Guidance
for Industry and FDA Staff'' (1580).
    Persons interested in obtaining a copy of any or all of the draft
guidance documents may also do so by using the Internet. CDRH maintains
an entry on the Internet for easy access to information including text,
graphics, and files that may be downloaded to a personal computer with
Internet access. Updated on a regular basis, the CDRH home page
includes device safety alerts, Federal Register reprints, information
on premarket submissions (including lists of approved applications and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at http://www.fda.gov/MedicalDevices/default.htm. A search
capability for all CDRH guidance documents is available at http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    These 11 draft guidance documents refer to previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in part 807 (21 CFR part 807),
subpart E pertain to premarket submission requirements for any person
who intends to market certain medical devices, and have been approved
under OMB control number 0910-0120.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule that would designate special controls for each of these
devices and would exempt six of them from the premarket notification
requirements of the act. The proposed rule contains an analysis of the
paperwork burden for the proposed rule, including the anticipated
reduction in burden for manufacturers who follow the special controls
and for manufacturers of the six proposed exempt device types.
Consistent with the Paperwork Reduction Act of 1995, we solicit comment
on our revised burden estimates.

V. Comments

    The agency is specifically interested in comments on the types of
claims appropriate for devices included within these 11 classifications
and, for the devices that remain subject to premarket review, the data
sponsors should submit to support those claims. For example, under the
proposed rule, certain transcutaneous electrical stimulators for
aesthetic purposes would remain subject to 510(k). The agency is
interested in comments on the type of data sponsors should submit to
show a transcutaneous electrical nerve stimulator device achieves
``aesthetic effects through physical change to the structure of the
body'' as well as the predicate device does.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two copies of
any mailed comments, except that individuals may submit one copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 24, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-7634 Filed 4-2-10; 8:45 am]
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[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12221-12222]
[FR Doc No: 2011-4951]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Motor Vehicle Motor Theft
Prevention Standard; Toyota

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the petition of Toyota Motor
North America, Inc's., (Toyota) petition for an exemption of the
Corolla vehicle line in accordance with 49 CFR part 543, Exemption from
the Theft Prevention Standard. This petition is granted because the
agency has determined that the antitheft device to be placed on the
line as standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR part 541).

DATES: The exemption granted by this notice is effective beginning with
model year (MY) 2012.

FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, Office of
International Policy, Fuel Economy and Consumer Standards, NHTSA, W43-
443, 1200 New Jersey Avenue, SE., Washington, DC 20590. Ms. Mazyck's
phone number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated January 24, 2011, Toyota
requested an exemption from the parts-marking requirements of the theft
prevention standard (49 CFR part 541) for the Toyota Corolla vehicle
line beginning with MY 2012. The petition requested an exemption from
parts-marking pursuant to 49 CFR part 543, Exemption from Vehicle Theft
Prevention Standard, based on the installation of an antitheft device
as standard equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition, Toyota
provided a detailed description and diagram of the identity, design,
and location of the components of the antitheft device for the Corolla
vehicle line. Toyota will install a passive, transponder-based,
electronic engine immobilizer device as standard equipment on its
Corolla vehicle line beginning with MY 2012.
    Key components of the antitheft device include an engine
immobilizer, transponder key electronic control unit (ECE), assembly,
transponder key amplifier, security indicator, ignition key and
Electronic control module (ECM). The device's security indicators
provide the status of the immobilizer to users and others inside/
outside the vehicle. When the immobilizer is activated, the indicator
flashes continuously. When the immobilizer is not activated, the
indicator is turned off. The antitheft device does not incorporate an
audible or visual alarm as standard equipment. Toyota's submission is
considered a complete petition as required by 49 CFR 543.7 in that it
meets the general requirements contained in 543.5 and the specific
content requirements of 543.6.
    Toyota stated that the immobilizer is activated when the ignition
key is turned from the ``ON'' position and/or removed from the
vehicle's ignition. The device is deactivated when the ``conventional
key'' is inserted into the key cylinder and turned toward the ``ON''
position. Toyota stated that after the key is inserted into the key
cylinder, the transponder chip in the key sends

the ID codes to the Transponder Key ECU assembly to verify the code.
When the key code has been verified, the immobilizer allows the ECM to
start the engine.
    Toyota also stated that there will be position switches installed
in the vehicle to protect the hood and doors. The sensors will trigger
the antitheft device when it detects inappropriate opening of the hood
(i.e., from outside the vehicle, instead of using the interior release)
and inappropriate opening of the door (i.e., when the doors are opened
without using a key or wireless switch/key FOB).
    In addressing the specific content requirements of 543.6, Toyota
provided information on the reliability and durability of its proposed
device. To ensure reliability and durability of the device, Toyota
conducted tests based on its own specified standards. Toyota provided a
detailed list of the tests conducted (i.e., high and low temperature,
strength, impact, vibration, electro-magnetic interference, etc.).
Toyota stated that it believes that its device is reliable and durable
because it complied with its own specific design standards and it is
installed in other vehicle lines for which the agency has granted a
parts-marking exemption. Additionally, Toyota stated that there are
approximately 20,000 combinations for the key cylinders and key plates
for its outer gutter keys and approximately 10,000 for its inner gutter
keys, making it very difficult to unlock the doors without valid keys.
    Toyota informed the agency that its Corolla vehicle line has been
equipped with the device beginning with its MY 2005 vehicles. Toyota
referenced NHTSA published theft rate data for several years before and
after the Corolla vehicle line was equipped with a standard
immobilizer. Toyota stated that the average theft rate for the Corolla
dropped to 2.1 per 1,000 cars produced between MYs 2005-2008 (with a
standard immobilizer) from 4.0 per 1,000 cars produced between MYs
1996-1999 (without a standard immobilizer). Toyota stated that this
represents approximately a 47.5% decrease in the theft rate with
installation of a standard immobilizer for the Toyota Corolla vehicle
line when compared to the average for the Corolla when it was parts
marked. Toyota believes that installing the immobilizer as standard
equipment reduces the theft rate and therefore would be more effective
than parts-marking labels. Toyota also revealed that the Toyota Camry
and Lexus LS and GS vehicle lines have all been granted parts-marking
exemptions by the agency. The theft rates for the Toyota Camry and
Lexus LS and GS vehicle lines using an average of three model years
data are 1.6742, 1.3567 and 1.0961 respectively. Therefore, Toyota has
concluded that the antitheft device proposed for its vehicle line is no
less effective than those devices in the lines for which NHTSA has
already granted full exemption from the parts-marking requirements.
    Based on the evidence submitted by Toyota, the agency believes that
the antitheft device for the Corolla vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR 541).
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of part
541, either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that Toyota has provided adequate reasons for its belief that the
antitheft device for the Toyota Corolla vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR part 541). This conclusion is based on the information Toyota
provided about its device.
    The agency concludes that the device will provide four or five of
the types of performance listed in Sec.  543.6(a)(3): Promoting
activation; attract attention to the efforts of an unauthorized person
to enter or move a vehicle by means other than a key; preventing defeat
or circumvention of the device by unauthorized persons; preventing
operation of the vehicle by unauthorized entrants; and ensuring the
reliability and durability of the device
    For the foregoing reasons, the agency hereby grants in full
Toyota's petition for exemption for the Toyota Corolla vehicle line
from the parts-marking requirements of 49 CFR part 541, beginning with
the 2012 model year vehicles. The agency notes that 49 CFR part 541,
Appendix A-1, identifies those lines that are exempted from the Theft
Prevention Standard for a given model year. 49 CFR 543.7(f) contains
publication requirements incident to the disposition of all part 543
petitions. Advanced listing, including the release of future product
nameplates, the beginning model year for which the petition is granted
and a general description of the antitheft device is necessary in order
to notify law enforcement agencies of new vehicle lines exempted from
the parts marking requirements of the Theft Prevention Standard.
    If Toyota decides not to use the exemption for this line, it should
formally notify the agency. If such a decision is made, the line must
be fully marked according to the requirements under 49 CFR 541.5 and
541.6 (marking of major component parts and replacement parts).
    NHTSA notes that if Toyota wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Part 543.7(d) states that a part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Sec.
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: March 1, 2011.
Joseph S. Carra,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2011-4951 Filed 3-3-11; 8:45 am]
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