[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Proposed Rules]
[Page 17093-17099]
[DOCID:fr05ap10-25]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 890

[Docket No. FDA-2009-N-0493]
RIN 0910-ZA37

Neurological and Physical Medicine Devices; Designation of
Special Controls for Certain Class II Devices and Exemption From
Premarket Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
certain neurological device and physical medicine device regulations to
establish special controls for these class II devices and to exempt
some of these devices from the premarket notification requirements of
the Federal Food, Drug, and Cosmetic Act. Elsewhere in this issue of
the Federal Register, FDA is publishing a notice of availability of
draft guidance documents that would serve as special controls for each
of these devices if the rule is finalized.

DATES:  Submit written or electronic comments by July 6, 2010. See
section III of this document for the proposed effective date of a final
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0493 and/or RIN number 0910-ZA37, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [for paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions must include the agency name and
docket number and Regulatory Information Number (RIN) (if a RIN number
has been assigned) for this rulemaking. All comments will be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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. Regulatory Authority

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Device Amendments
(SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act (FDAMA) (Public Law 105-115) established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on 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 (special controls), and class III (premarket
approval).
    Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on or
after May 28, 1976 (generally referred to as postamendments devices)
are classified automatically by statute (section 513(f) of the act)
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless FDA initiates the
following procedures: (1) FDA reclassifies the device into class I or
II; (2) FDA issues an order classifying the device into class I or II
in accordance with section 513(f)(2) of the

act; or (3) FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the act, to a predicate device that
is already legally marketed. The agency determines whether new devices
are substantially equivalent to predicate devices through review of
premarket notifications under section 510(k) of the act (21 U.S.C.
360(k)). Section 510(k) of the act and the implementing regulations,
part 807 (21 CFR part 807), require persons who intend to market a new
device to submit a premarket notification report (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the act to a legally marketed device that does not require premarket
approval.
    Section 510(m)(2) of the act provides that FDA may exempt a device
from the premarket notification requirement on its own initiative or
upon petition of an interested person, if FDA determines that a 510(k)
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. This section requires FDA to publish in
the Federal Register a notice of intent to exempt a device, or of the
petition, and to provide a 30-day comment period. Within 120 days of
publication of this document, FDA must publish in the Federal Register
its final determination regarding the exemption of the device that was
the subject of the notice.

II. The Proposed Rule

A. Establishment of Special Controls

    Under section 513(a)(1)(B) of the act, as amended by SMDA, class II
devices are defined as devices for which general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance. Special controls
may include the promulgation of performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and other appropriate actions the agency
deems necessary to provide such assurance (21 CFR 860.3(c)(2)).
    Consistent with this authority, FDA is proposing to amend the
neurological devices regulations to establish special controls for
electroconductive media (Sec.  882.1275 (21 CFR 882.1275)) and the
cutaneous electrode (Sec.  882.1320 (21 CFR 882.1320)). FDA is also
proposing to amend the neurological devices regulation at Sec.
882.5890 (21 CFR 882.5890) to add paragraphs for the transcutaneous
electrical nerve stimulator for pain relief (Sec.  882.5890(a)), the
transcutaneous electrical nerve stimulator for pain relief intended for
over the counter use (Sec.  882.5890(b)), the transcutaneous electrical
nerve stimulator with limited output for pain relief (Sec.
882.5890(c)), the percutaneous electrical nerve stimulator for pain
relief (Sec.  882.5890(d)), the transcutaneous electrical stimulator
for aesthetic purposes (Sec.  882.5890(e)), and the transcutaneous
electrical stimulator with limited output for aesthetic purposes (Sec.
882.5890(f)).
    Similarly, FDA is proposing to amend the physical medicine devices
regulation at Sec.  890.5850 (21 CFR 890.5850) to add paragraphs for
the powered muscle stimulator for rehabilitation (Sec.  890.5850(a)),
the powered muscle stimulator with limited output for rehabilitation
(Sec.  890.5850(b)), the powered muscle stimulator for muscle
conditioning (Sec.  890.5850(c)), and the powered muscle stimulator
with limited output for muscle conditioning (Sec.  890.5850(d)). FDA
believes that subdividing the classification regulations for each of
these device types would provide clarity for persons referencing the
classification regulation.
    FDA is also proposing to establish special controls for each of
these device types. Elsewhere in this issue of the Federal Register,
FDA is publishing a notice of availability of the following draft
guidance documents that would serve as special controls:
    (1) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Electroconductive Media;
    (2) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Cutaneous Electrode;
    (3) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
for Pain Relief;
    (4) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
for Pain Relief Intended for Over the Counter Use;
    (5) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
with Limited Output for Pain Relief;
    (6) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Stimulator for
Aesthetic Purposes;
    (7) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Stimulator with
Limited Output for Aesthetic Purposes;
    (8) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator for
Rehabilitation;
    (9) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator with Limited
Output for Rehabilitation;
    (10) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator for Muscle
Conditioning; and
    (11) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator with Limited
Output for Muscle Conditioning.
The agency believes that the applicable special controls and general
controls will provide reasonable assurance of the safety and
effectiveness for each of the foregoing device types.

B. Exemption From Premarket Notification Requirements

    Together with the establishment of special controls, FDA, on its
own initiative, is also proposing to exempt some of these device types
from premarket notification, subject to limitations. FDA may consider a
number of factors in determining whether premarket notification is
necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff.'' The guidance can be obtained
electronically at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm.
    FDA believes that the following class II devices are appropriate
for exemption from premarket notification, subject to the limitations
of exemptions identified in Sec. Sec.  882.9 and 890.9 (21 CFR 882.9
and 890.9), because the applicable special controls and general
controls provide reasonable assurance of safety and effectiveness if
device manufacturers follow the special controls guidances'
recommendations and, for the transcutaneous electrical nerve stimulator
with limited output for pain relief and the powered muscle stimulator
with limited output for rehabilitation, if the devices are also
restricted to sale, distribution, and use

in accordance with the prescription device requirements in Sec.
801.109 (21 CFR 801.109):
     Electroconductive media (Sec.  882.1275);
     Cutaneous electrode (Sec.  882.1320);
     Transcutaneous electrical nerve stimulator with limited
output for pain relief (Sec.  882.5890(c));
     Transcutaneous electrical stimulator with limited output
for aesthetic purposes (Sec.  882.5890(e));
     Powered muscle stimulator with limited output for
rehabilitation (Sec.  890.5850(b)); and
     Powered muscle stimulator with limited output for muscle
conditioning (Sec.  890.5850(d)).
FDA is inviting comment on these proposed exemptions.
    FDA advises that exemption from the requirement of premarket
notification does not mean that these devices would be exempt from any
other statutory or regulatory requirements, unless such exemption is
explicitly provided by order or regulation. Indeed, FDA's proposal to
exempt these device types from the requirement of premarket
notification is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements (21 CFR part 820), provide.

III. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register. If finalized, following the effective date of a final
rule, any firm intending to market the applicable device types will
need to address the issues covered in the respective special controls
guidances. Unless otherwise exempt, the firm must show in its 510(k)
that its device meets the requirements of Sec.  807.87 and complies
with the special controls.
    As discussed previously in this document, if the rule is finalized,
for six of the device types, manufacturers who follow the specific
measures recommended to address the issues identified in the special
controls guidances would be able to market their devices without being
subject to the premarket notification requirements of section 510(k) of
the act, subject to the limitations of Sec. Sec.  882.9 and 890.9.
Manufacturers of two of these six device types, transcutaneous
electrical nerve stimulator with limited output for pain relief and
powered muscle stimulator with limited output for rehabilitation, would
also be restricted to sale, distribution, and use in accordance with
the prescription device requirements in Sec.  801.109 in order to be
able to market their devices without being subject to premarket
notification. Manufacturers who choose alternative means to address one
or more of the issues identified in the applicable special controls
guidance would remain subject to the premarket notification
requirements of section 510(k) and would need to obtain marketing
clearance for their device.

IV. 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.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Classification of the devices discussed in this
proposed rule into class II with special controls will simplify the
process of bringing these devices to market. In addition, exemption
from the premarket notification requirements for six of these devices
would reduce the costs associated with bringing the devices to market.
Thus, the agency proposes to certify that the final rule will not have
a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The special controls required by this proposed rule for the 11
listed devices do not impose significant costs because they do not add
new regulatory requirements. Instead, the special controls clarify FDA
expectations and should shorten the time to market for some new or
modified devices. Manufacturers of devices exempt from the premarket
notification requirements would no longer have to wait until they
receive a substantial equivalence determination from FDA before
marketing the device. For manufacturers of devices that still require
premarket notification, the special controls clarify FDA's expectations
making compliance with the general and special controls more
straightforward and should shorten the time to prepare a submission and
for FDA review. Moreover, manufacturers of devices that become exempt
from the premarket notification requirement would also benefit from the
elimination of application preparation time and of paper, copying, and
mailing costs by not having to prepare and submit 510(k)s. These
application savings are negligible, however, relative to the total cost
of bringing a medical device to market.
    The sector of the device industry covered by the proposed rule is
part of the Electromedical and Electrotherapeutic Apparatus
Manufacturing sector, NAICS code 334510. The Small Business
Administration classifies firms in this sector as small if they have
fewer than 500 employees. About 90 percent of firms in this sector are
small, employing about 25 percent of the sector's work force. Table 1
lists the number of manufacturers for the different types of devices,
an estimate of the number of 510(k)s submitted each year (based on
historical ranges), and our best estimate of the percentage of new
devices that would be exempt from the premarket notification
requirement for each type of device.

                             Table 1.--Number of Manufacturers and 510(k)s per Year
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                                                   No. of             No. of 510(k)s per
                Device Type                   Manufacturers\1\             Year\2\            Percentage Exempt
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Electroconductive media                                       21                      0-5                   >90%
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Cutaneous electrode                                           76                     5-15                   >90%
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Transcutaneous electrical nerve stimulator                   110                    15-25                    60%
 for pain relief
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Transcutaneous electrical stimulator for                       4                      0-5                    60%
 aesthetic purposes
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Powered muscle stimulator for                                 81                    10-20                    50%
 rehabilitation
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Powered muscle stimulator for muscle                          12                      0-8                    50%
 conditioning
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\1\ Manufacturers make multiple device types.
\2\ Data from 2000-2009.

    The potential impact on small firms would be to reduce the cost of
entry by shortening the time to market for those firms who plan to
market these devices. It will impose no additional regulatory burden on
small entities, and it may permit some small potential competitors to
enter the marketplace by lowering their costs. Therefore the agency
proposes to certify that the final rule will not have a significant
economic impact on a substantial number of small entities.

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State law conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain federal requirements applicable to devices (21
U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, 128 S. Ct. 999 (2008)). If this proposed rule is made final,
the special controls established by the final rule would create
``requirements'' for specific medical devices under 21 U.S.C. 360k,
even though product sponsors have some flexibility in how they meet
those requirements (Papike v. Tambrands, Inc., 107 F.3d 737, 740-742
(9th Cir. 1997)).

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new
collection of information; however, consistent with the regulatory
impact analysis in section V of this document, we anticipate that the
exemption of 6 devices types from the premarket notification
requirements of the act will result in a reduction in burden to
existing collections of information currently approved under OMB
control number 0910-0120.
    Accordingly, with respect to the collection of information
discussed below, FDA invites comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
     This proposed rule designates guidance documents and other special
controls for certain neurological and physical medicine devices and
exempts certain of these devices from premarket notification
requirements. FDA expects an overall reduction in burden hours for
manufacturers of the six device types that FDA is proposing to exempt
from the premarket notification reporting requirements. The current
burden associated with submitting a premarket notification submission
under part 807, subpart E is 79 hours per submission at a cost of $100
per hour resulting in a total cost of $7,900 per submission. As
identified elsewhere in this document, the six device types being
exempted from the premarket notification requirements of the act will
no longer be subject to this burden. Based on FDA's estimates of annual
premarket notifications submitted for the exempted device types (table
2 of this document), FDA estimates a total burden reduction of 34.25
annual premarket notification submissions (90% of 2.5)+(90% of 10)+(60%
of 20)+(60% of 2.5)+(50% of 15)+(50% of 4)), 2,706 hours (34.25
submissions x 79 hours), and $270,600 (2,706 hours x $100 hourly rate).

  Table 2.--Average Number of Manufacturers and Premarket Notifications (510(k)s) per Year for Proposed Exempt
                                                  Device Types
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                                                     No. of           No. of 510(k)s per
                 Device Type                    Manufacturers\1\            Year\2\           Percentage Exempt
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Electroconductive media                                         21                     2.5                 > 90%
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Cutaneous electrode                                             76                    10                   > 90%
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Transcutaneous electrical nerve stimulator                     110                    20                     60%
 for pain relief
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Transcutaneous electrical stimulator for                         4                     2.5                   60%
 aesthetic purposes
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Powered muscle stimulator for rehabilitation                    81                    15                     50%
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Powered muscle stimulator for muscle                            12                     4                     50%
 conditioning
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\1\Manufacturers make multiple device types.
\2\Data averaged from 2000-2009.

    The guidance documents designated as special controls for each of
these 11 device types do not impose significant costs because they do
not add new regulatory requirements. Instead, the special controls
clarify FDA expectations and should shorten the time to market for some
new or modified devices. For manufacturers of devices that still
require premarket notification, the special controls clarify FDA's
expectations making compliance with the general and special controls
more straightforward and should shorten the time to prepare a
submission and for FDA review. While this clarification in expectations
may reduce the actual burden associated with submitting a premarket
notification submission for these specific device types, this reduction
is negligible when accounting for the size of entire premarket
notification program. Accordingly, FDA will not be adjusting the per
submission burden estimate of 79 hours for premarket notification
submissions accounted for under OMB control number 0910-0120.

VIII. Comments

    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 paper 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 Management between 9 a.m. and 4 p.m. Monday through Friday.

List of Subjects

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 890

    Medical devices, Physical medicine 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 parts 882 and 890 be amended as follows:

PART 882--NEUROLOGICAL DEVICES

    1. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 882.1275 is amended by revising paragraph (b) to read as
follows:

Sec.  882.1275   Electroconductive media.

* * * * *
    (b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Electroconductive Media.'' See
Sec.  882.1(e) for the availability of this guidance document. The
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter, subject to the limitations in Sec.
882.9, when it follows the recommendations of the special controls
guidance.
    3. Section 882.1320 is amended by revising paragraph (b) to read as
follows:

Sec.  882.1320   Cutaneous electrode.

* * * * *
    (b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Cutaneous Electrode.'' See Sec.
882.1(e) for the availability of this guidance document. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec.  882.9, when it
follows the recommendations of the special controls guidance.
    4. Section 882.5890 is revised to read as follows:

Sec.  882.5890   Transcutaneous electrical nerve stimulator for pain
relief.

    (a) Transcutaneous electrical nerve stimulator for pain relief--(1)
Identification. A transcutaneous electrical nerve stimulator for pain
relief is an electrically powered device used to apply an electrical
current to electrodes on a patient's skin to relieve pain. This does
not include the device types classified in paragraphs (b) through (f)
of this section.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain
Relief.'' See Sec.  882.1(e) for the availability of this guidance
document; and
    (ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter.
    (b) Transcutaneous electrical nerve stimulator for pain relief
intended for over-the-counter use--(1) Identification. A transcutaneous
electrical nerve stimulator for pain relief intended for over-the-
counter use is an electrically powered device intended for over-the-
counter use and used to apply an electrical current to electrodes on a
patient's skin to relieve pain. This does not include the device types
classified in paragraphs (a) and (c) through (f) of this section.
    (2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical Nerve
Stimulator for Pain Relief Intended for Over the Counter Use.'' See
Sec.  882.1(e) for the availability of this guidance document.
    (c) Transcutaneous electrical nerve stimulator with limited output
for pain relief--(1) Identification. A transcutaneous electrical nerve
stimulator with limited output for pain relief is an electrically
powered device that is used to apply an electrical current to
electrodes on a patient's skin to relieve pain. This does not include
the device types classified in paragraphs (a) through (b) and (d)
through (f) of this section. The device utilizes a stimulus generator
that delivers, into a resistive load, which represents the worse case
of either 500 ohms or the typical load expected during normal
conditions of use, the following:
    (i) A maximum charge per phase that does not exceed Q, where Q = 20
+

(28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
    (ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
    (iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
    (iv) An average direct current (dc) that does not exceed 100
microamperes when no pulses are being applied, or if the device fails;
    (v) A maximum current density that does not exceed 2 milliamperes
root mean square (rms) per square centimeter of electrode conductive
surface area; and
    (vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Transcutaneous Electrical Nerve Stimulator with
Limited Output for Pain Relief.'' See Sec.  882.1(e) for the
availability of this guidance document; and
    (ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations of exemptions in Sec.  882.9, when it
follows the recommendations of the special controls guidance and its
sale, distribution, and use are restricted to prescription use in
accordance with the prescription device requirements in Sec.  801.109
of this chapter.
    (d) Percutaneous electrical nerve stimulator for pain relief--(1)
Identification. A percutaneous electrical nerve stimulator for pain
relief is an electrically powered device used to apply an electrical
current to electrodes that pass through a patient's skin to relieve
pain. This does not include the device types classified in paragraphs
(a) through (c) and (e) through (f) of this section.
    (2) Classification. Class II (special controls). The special
control for this device is restriction of sale, distribution, and use
to prescription use in accordance with the prescription device
requirements in Sec.  801.109 of this chapter.
    (e) Transcutaneous electrical stimulator for aesthetic purposes--
(1) Identification. A transcutaneous electrical stimulator for
aesthetic purposes is an electrically powered device applied externally
to the body surface using cutaneous electrodes to deliver electrical
current into the body, and is intended to achieve aesthetic effects
through physical change to the structure of the body. This does not
include the device types classified in paragraphs (a) through (d) and
(f) of this section.
    (2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator for Aesthetic Purposes.'' See Sec.  882.1(e) for the
availability of this guidance document.
    (f) Transcutaneous electrical stimulator with limited output for
aesthetic purposes--(1) Identification. A transcutaneous electrical
stimulator with limited output for aesthetic purposes is an
electrically powered device that is applied externally to the body
surface using cutaneous electrodes to deliver electrical current into
the body, and is intended to achieve aesthetic effects through physical
change to the structure of the body. This does not include the device
types classified in paragraphs (a) through (e) of this section. The
device utilizes a stimulus generator that delivers, into a resistive
load, which represents the worse case of either 500 ohms or the typical
load expected during normal conditions of use, the following:
    (i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
    (ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
    (iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
    (iv) An average dc that does not exceed 100 microamperes when no
pulses are being applied, or if the device fails;
    (v) A maximum current density that does not exceed 2 milliamperes
rms per square centimeter of electrode conductive surface area; and
    (vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
    (2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator with Limited Output for Aesthetic Purposes.'' See Sec.
882.1(e) for the availability of this guidance document. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations of exemptions in Sec.
882.9, when it follows the recommendations of the special controls
guidance.

PART 890--PHYSICAL MEDICINE DEVICES

    5. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    6. Section 890.5850 is revised to read as follows:

Sec.  890.5850   Powered muscle stimulator.

    (a) Powered muscle stimulator for rehabilitation--(1)
Identification. A powered muscle stimulator for rehabilitation is an
electrically powered device intended for medical purposes that
repeatedly contracts muscles by passing pulsed electrical current
through cutaneous electrodes contacting the affected body area. This
does not include the powered muscle stimulators classified in
paragraphs (b) through (d) of this section.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Powered Muscle Stimulator for Rehabilitation.'' See
Sec.  890.1(e) for the availability of this guidance document; and
    (ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter.
    (b) Powered muscle stimulator with limited output for
rehabilitation--(1) Identification. A powered muscle stimulator with
limited output for rehabilitation is an electrically powered device
that is intended for medical purposes, and repeatedly contracts muscles
by passing pulsed electrical current through cutaneous electrodes
contacting the affected body area. This does not include the powered
muscle stimulators classified in paragraphs (a), (c), and (d) of this
section. The device utilizes a stimulus generator that delivers, into a
resistive load, which represents the worse case of either 500 ohms or
the typical load expected during normal conditions of use, the
following:
    (i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is

the phase duration expressed in milliseconds and measured at 50 percent
of the phase amplitude);
    (ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
    (iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
    (iv) An average direct current (dc) that does not exceed 100
microamperes when no pulses are being applied, or if the device fails;
    (v) A maximum current density that does not exceed 2 milliamperes
root mean square (rms) per square centimeter of electrode conductive
surface area; and
    (vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Powered Muscle Stimulator with Limited Output for
Rehabilitation.'' See Sec.  890.1(e) for the availability of this
guidance document; and
    (ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations of exemptions in Sec.  890.9, when it
follows the recommendations of the special controls guidance and its
sale, distribution, and use are restricted to prescription use in
accordance with the prescription device requirements in Sec.  801.109
of this chapter.
    (c) Powered muscle stimulator for muscle conditioning--(1)
Identification. A powered muscle stimulator for muscle conditioning is
an electrically powered device that repeatedly contracts muscles by
passing pulsed electrical current through cutaneous electrodes and into
the body, thereby temporarily affecting the stimulated muscles'
contractile properties, force output, and/or fatigue resistance. This
does not include the powered muscle stimulators classified in
paragraphs (a), (b), and (d) of this section.
    (2) Classification. Class II (special controls.) The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Powered Muscle Stimulator for
Muscle Conditioning.'' See Sec.  890.1(e) for the availability of this
guidance document.
    (d) Powered muscle stimulator with limited output for muscle
conditioning--(1) Identification. A powered muscle stimulator with
limited output for muscle conditioning is an electrically powered
device that repeatedly contracts muscles by passing pulsed electrical
current through cutaneous electrodes and into the body, thereby
temporarily affecting the stimulated muscles' contractile properties,
force output, and/or fatigue resistance. This does not include the
powered muscle stimulators classified in paragraphs (a) through (c) of
this section. The device utilizes a stimulus generator that delivers,
into a resistive load, which represents the worse case of either 500
ohms or the typical load expected during normal conditions of use, the
following:
    (i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
    (ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
    (iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
    (iv) An average dc that does not exceed 100 microamperes when no
pulses are being applied, or if the device fails;
    (v) A maximum current density that does not exceed 2 milliamperes
rms per square centimeter of electrode conductive surface area; and
    (vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
    (2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Powered Muscle Stimulator with
Limited Output for Muscle Conditioning.'' See Sec.  890.1(e) for the
availability of this guidance document. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter, subject to the limitations of exemptions in Sec.  890.9, when
it follows the recommendations of the special controls guidance.

    Dated: March 24, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-7637 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64505-64506]
[FR Doc No: 2012-25816]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at Southwest Power Pool Regional
Entity Trustee, Regional State Committee and Board of Directors
Meetings

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of its staff may attend the meetings of the
Southwest Power Pool, Inc. (SPP) Regional Entity Trustee (RE), Regional
State Committee (RSC) and Board of Directors, as noted below. Their
attendance is part of the Commission's ongoing outreach efforts.
    All meetings will be held at the SPP Corporate Offices, 201 Worthen
Drive, Little Rock, AR 722111. The phone number is<PHONE_NUMBER>.

SPP RE

    October 29, 2012 (8:00 a.m.-12:00 p.m.)

SPP RSC

    October 29, 2012 (1:00 p.m.-5:00 p.m.)

SPP Board of Directors

    October 31, 2012 (8:00 a.m.-3:00 p.m.)
    The discussions may address matters at issue in the following
proceedings:

Docket No. ER06-451, Southwest Power Pool, Inc.
Docket No. ER08-1419, Southwest Power Pool, Inc.
Docket No. ER09-659, Southwest Power Pool, Inc.
Docket No. ER11-4105, Southwest Power Pool, Inc.
Docket No. ER12-140, Southwest Power Pool, Inc.
Docket No. ER12-550, Southwest Power Pool, Inc.
Docket No. ER12-891, Southwest Power Pool, Inc.
Docket No. ER12-909, Southwest Power Pool, Inc.
Docket No. ER12-959, Southwester Power Pool, Inc.
Docket No. ER12-1017, Southwest Power Pool, Inc.
Docket No. ER12-1018, Southwest Power Pool, Inc.
Docket No. ER12-1179, Southwest Power Pool, Inc.
Docket No. ER12-1401, Southwest Power Pool, Inc.
Docket No. ER12-1402, Southwest Power Pool, Inc.
Docket No. ER12-1586, Southwest Power Pool, Inc.
Docket No. ER12-1772, Southwest Power Pool, Inc.
Docket No. ER12-1779, Southwest Power Pool, Inc.
Docket No. ER12-1849, Southwest Power Pool, Inc.
Docket No. ER12-1974, Southwest Power Pool, Inc.
Docket No. ER12-2292, Southwest Power Pool, Inc.
Docket No. ER12-2366, Southwest Power Pool, Inc.
Docket No. ER12-2387, Southwest Power Pool, Inc.
Docket No. ER12-2505, Southwest Power Pool, Inc.
Docket No. ER12-2507, Southwest Power Pool, Inc.
Docket No. ER12-2525, Southwest Power Pool, Inc.
Docket No. ER12-2562, Southwest Power Pool, Inc.
Docket No. ER12-2648, Southwest Power Pool, Inc.
Docket No. EL12-2, Southwest Power Pool, Inc.
Docket No. EL12-47, Southwest Power Pool, Inc.
Docket No. EL12-51, Southwest Power Pool, Inc.
Docket No. EL12-60, Southwest Power Pool, Inc., et al.
Docket No. ER12-1813, The Empire District Electric Co.
Docket No. ER12-1071, Entergy Arkansas, Inc.
Docket No. EL12-59, Golden Spread Electric Cooperative, Inc.
Docket No. ER09-548, ITC Great Plains, LLC
Docket No. ER12-1826, Kansas City Power & Light Co.
Docket No. ER12-1828, KCP&L Greater Missouri Operations Co.
Docket No. ER11-3728, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER12-480, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER12-1577, Midwest Independent Transmission System Operator,
Inc.
Docket No. EL11-34, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-36, Prairie Wind Transmission, LLC
Docket No. ER12-1537, Public Service Co. of Oklahoma
Docket No. ER12-1538, Southwestern Electric Power Co.
Docket No. ER12-1970, Southwestern Electric Power Co.
Docket No. ER09-35, Tallgrass Transmission, LLC
Docket No. EL12-28, Xcel Energy Services Inc., et al.
    These meetings are open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
    Dated: October 15, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-25816 Filed 10-19-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Rules and Regulations]
[Page 2802-2805]
[DOCID:fr18ja11-6]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 101129595-0635-01]
RIN 0694-AF07

Additions and Revisions to the List of Validated End-Users in the
People's Republic of China: CSMC Technologies Corporation and Advanced
Micro Devices China, Inc.

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
amends the Export Administration Regulations (EAR) to add one end-user,
CSMC Technologies Corporation (CSMC), to

the list of validated end-users in the People's Republic of China
(PRC). With this rule, exports, reexports, and transfers (in-country)
of certain items to three CSMC facilities in the PRC are now authorized
under Authorization Validated End-User. In this rule, BIS also amends
the EAR to revise the validated end-user authorization for Advanced
Micro Devices China, Inc. (AMD) in the PRC by amending the list of
buildings associated with one of the company's approved facilities and
by updating the description of items eligible for export, reexport, or
transfer (in-country) to AMD's approved facilities.

DATES: This rule is effective January 18, 2011. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AF07, by any
of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AF07'' in
the subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Sheila Quarterman, U.S. Department
of Commerce, Bureau of Industry and Security, Regulatory Policy
Division, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, Attn: RIN 0694-AF07.

Send comments regarding the collection of information associated with
this rule, including suggestions for reducing the burden, to Jasmeet
Seehra, Office of Management and Budget (OMB), by e-mail to Jasmeet_
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>. Comments on this
collection of information should be submitted separately from comments
on the final rule (i.e., RIN 0694-AF07). All comments on the latter
should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chair, End-User
Review Committee, Office of the Assistant Secretary, Export
Administration, Bureau of Industry and Security, U.S. Department of
Commerce, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User (VEU): The List of Approved End-Users,
Eligible Items and Destinations in the PRC

    Consistent with U.S. Government policy to facilitate trade for
civilian end-users in the PRC, BIS amended the EAR in a final rule on
June 19, 2007 (72 FR 33646) by creating a new authorization for
``validated end-users'' (VEUs) located in eligible destinations to
which eligible items may be exported, reexported, or transferred under
a general authorization instead of a license, in conformance with
section 748.15 of the EAR. VEUs may obtain eligible items that are on
the Commerce Control List, set forth in Supplement No. 1 to Part 774 of
the EAR, without having to wait for their suppliers to obtain export
licenses from BIS. Eligible items may include commodities, software,
and technology, except those controlled for missile technology or crime
control reasons.
    Authorization VEU is a mechanism to facilitate increased high-
technology exports to companies in eligible destinations that have a
verifiable record of civilian end-uses for such items. The VEUs listed
in Supplement No. 7 to Part 748 of the EAR were reviewed and approved
by the U.S. Government in accordance with the provisions of section
748.15 and Supplement Nos. 8 and 9 to Part 748 of the EAR. In addition
to U.S. exporters, Authorization VEU may be used by foreign reexporters
and by persons transferring in-country, and it does not have an
expiration date. As of the date of this rule, pursuant to section
748.15(b) of the EAR, VEUs are only located in the PRC and India.

Addition of CSMC Technologies Corporation to the List of Validated End-
Users in the PRC and CSMC Technologies Corporation's ``Eligible Items
(by ECCN)'' and ``Eligible Destinations''

    This final rule amends Supplement No. 7 to Part 748 of the EAR to
designate CSMC Technologies Corporation (CSMC) as a validated end-user,
to identify the eligible destinations of CSMC (referred to as
``Facilities''), and to identify the items that may be exported,
reexported, or transferred (in-country) to CSMC's specified eligible
facilities under Authorization VEU. The name and address of this newly
approved VEU and the names and addresses of its eligible facilities are
as follows:
Validated End-User
CSMC Technologies Corporation
Eligible Destinations for CSMC Technologies Corporation
CSMC Technologies Fab 1 Co., Ltd., 14 Liangxi Road, Wuxi, Jiangsu
214061, China.
CSMC Technologies Fab 2 Co., Ltd., Block 86, 87, Wuxi National Hi-New
Tech Industrial Development Zone, Wuxi, Jiangsu 214061, China.
Wuxi CR Semiconductor Wafers and Chips Co., Ltd., 14 Liangxi Road,
Wuxi, Jiangsu 214061, China.
Eligible Items That May Be Exported, Reexported, or Transferred (In-
Country) to the Three ``Eligible Destinations'' Under CSMC Technologies
Corporation's Validated End-User Authorization
    Items classified under Export Control Classification Numbers
1C350.c.3, 1C350.c.11, 2B230.a, 2B230.b, 2B350.f, 2B350.g, 2B350.h,
3B001.c.1.a, 3B001.c.2.a, 3B001.e, 3C002.a, 3C004.

Revisions to the Authorization for Validated End-User Advanced Micro
Devices China, Inc.

    This final rule also amends Supplement No. 7 to Part 748 of the EAR
by revising the list of Advanced Micro Devices China, Inc.'s (AMD)
eligible facilities. Specifically, this rule adds three new buildings
to the facility authorization for Advanced Micro Devices (Shanghai)
Co., Ltd. (AMD Shanghai), which is one of AMD's three approved
facilities. Accordingly, the address for AMD Shanghai has been amended
by adding three new building numbers and the revised address will
appear in Supplement No. 7 to Part 748 of the EAR. In addition, BIS is
updating the description of items eligible for export, reexport, or
transfer (in-country) to AMD's approved facilities in order to provide
clarification to persons shipping under Authorization VEU. This update
makes AMD's VEU listing in the Code of Federal Regulations as specific
as possible. The revisions to the authorization for validated end-user
AMD are as follows:
Name and Former Address of Facility
Advanced Micro Devices (Shanghai) Co., Ltd., Riverfront Harbor,
Building 48, Zhangjiang Hi-Tech Park, 1387 Zhangdong Rd., Pudong,
Shanghai, 201203.
Name and Current Address of Facility
Advanced Micro Devices (Shanghai) Co., Ltd., Buildings 46, 47, 48 & 49,
Riverfront Harbor, Zhangjiang Hi-Tech Park, 1387 Zhangdong Rd., Pudong,
Shanghai, 201203.

Eligible Items That May Be Exported, Reexported, or Transferred (In-
Country) to the Three ``Eligible Destinations'' Under Advanced Micro
Devices China, Inc., Validated End-User Authorization
    Items classified under Export Control Classification Numbers
(ECCNs) 3D002, 3D003, 3E001 (limited to ``technology'' for items
classified under 3C002 and 3C004 and ``technology'' for use during the
International Technology Roadmap for Semiconductors (ITRS) process for
items classified under ECCNs 3B001 and 3B002), 3E002 (limited to
``technology'' for use during the ITRS process for items classified
under ECCNs 3B001 and 3B002), 3E003.e (limited to the ``development''
and ``production'' of integrated circuits for commercial applications),
4D001, 4D002, 4D003 and 4E001 (limited to the ``development'' of
products under ECCN 4A003).
    The approval of CSMC as a validated end-user and revision of AMD's
VEU Authorization are expected to further facilitate exports to
civilian end-users in the PRC, and to result in significant savings of
time and resources for suppliers and the eligible facilities.
Authorization VEU eliminates the burden on exporters and reexporters of
preparing individual license applications, as exports, reexports, and
transfers (in-country) of eligible items to these facilities may now be
made under general authorization instead of under individual licenses.
Under the VEU program, exporters and reexporters can supply VEUs in the
PRC on a more timely basis, thereby enhancing the competitiveness of
exporters, reexporters, and end-users in the PRC.
    To ensure appropriate facilitation of exports and reexports, on-
site reviews of validated end-users may be warranted pursuant to
paragraph 748.15(f)(2) and section 7(iv) of Supplement No. 8 to Part
748 of the EAR. If such reviews are warranted, BIS will inform the PRC
Ministry of Commerce.
    Since August 21, 2001, the Export Administration Act (the Act) has
been in lapse and the President, through Executive Order 13222 of
August 17, 2001 (3 CFR, 2001 Comp., p. 783 (2002)), as extended most
recently by the Notice of August 12, 2010 (75 FR 50681 (August 16,
2010)), has continued the EAR in effect under the International
Emergency Economic Powers Act. BIS continues to carry out the
provisions of the Act, as appropriate and to the extent permitted by
law, pursuant to Executive Order 13222.

Rulemaking Requirements

    1. This final rule has been determined to be not significant for
the purposes of Executive Order 12866.
    2. This rule involves collections previously approved by the Office
of Management and Budget (OMB) under Control Number 0694-0088, ``Multi-
Purpose Application,'' which carries a burden hour estimate of 58
minutes to prepare and submit form BIS-748; and for recordkeeping,
reporting and review requirements in connection with Authorization VEU,
which carries an estimated burden of 30 minutes per submission. This
rule is expected to result in a decrease in license applications
submitted to BIS. Total burden hours associated with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA) and OMB Control
Number 0694-0088 are not expected to increase significantly as a result
of this rule.
    Notwithstanding any other provisions of law, no person is required
to respond nor be subject to a penalty for failure to comply with a
collection of information, subject to the requirements of the PRA,
unless that collection of information displays a currently valid OMB
Control Number.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), BIS finds good cause to waive requirements that the rule be
subject to notice and the opportunity for public comment because such
notice and comment here are unnecessary. In determining whether to
grant VEU designations, a committee of U.S. Government agencies
evaluates information about candidate companies and commitments made by
candidate companies, the nature and terms of which are set forth in 15
CFR Part 748, Supplement No. 8. The criteria for evaluation by the
committee are set forth in 15 CFR section 748.15(a)(2).
    The information, commitments, and criteria for this extensive
review were all established through the notice of proposed rulemaking
and public comment process (71 FR 38313, July 2, 2006, and 72 FR 33646,
June 19, 2007). Given the similarities between the authorizations
provided under the VEU program and export licenses (as discussed
further below), the publication of this information does not establish
new policy; in publishing this final rule, BIS is simply adding a VEU
within the established regulatory framework of the VEU program.
Further, this rule does not abridge the rights of the public or
eliminate the public's option to export under any of the forms of
authorization set forth in the EAR.
    Publication of this rule in other than final form is unnecessary
because the authorization granted in the rule is similar to that
granted to exporters for individual licenses, which do not undergo
public review. Individual license application applicants and VEU
authorization applicants both provide the U.S. Government with
confidential business information. This information is extensively
reviewed according to the criteria for VEU authorizations, as set out
in 15 CFR section 748.15(a)(2). As with individual export licenses, an
interagency committee, drawing on public and non-public sources,
including licensing data, and measured against the VEU authorization
criteria, vets VEU applications. The authorizations granted under the
VEU program, and through individual export licenses, involve
interagency deliberation according to set criteria. Given the thorough
nature of the review, and in light of the parallels between this
process and the non-public review of license applications, public
comment on this authorization prior to publication is unnecessary.
Moreover, as noted above, the criteria and process for authorizing VEUs
were developed with public comments; allowing additional public comment
on this individual VEU authorization, which was determined according to
those criteria, is therefore unnecessary.
    Section 553(d) of the APA generally provides that rules may not
take effect earlier than 30 days after they are published in the
Federal Register. However, section 553(d)(1) of the APA provides that a
substantive rule which grants or recognizes an exemption or relieves a
restriction, may take effect earlier. Today's final rule grants an
exemption from licensing procedures and thus is effective immediately.
    No other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required under the APA or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable and no regulatory flexibility analysis has been
prepared.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

    Accordingly, part 748 of the EAR (15 CFR Parts 730-774) is amended
as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR Part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 12, 2010, 75
FR 50681 (August 16, 2010).

0
2. Supplement No. 7 to Part 748 is amended:
0
a. By adding one entry, ``CSMC Technologies Corporation'', for ``China
(People's Republic of)'' in alphabetical order; and
0
b. By revising the entry for ``Advanced Micro Devices (Shanghai) Co.,
Ltd.'' for ``China (People's Republic of)'' to read as follows:

SUPPLEMENT NO. 7 TO PART 748--AUTHORIZATION VALIDATED END-USER (VEU);
LIST OF VALIDATED END-USERS, RESPECTIVE ITEMS ELIGIBLE FOR EXPORT,
REEXPORT AND TRANSFER, AND ELIGIBLE DESTINATIONS

----------------------------------------------------------------------------------------------------------------
                                                                    Eligible items (by
            Country                    Validated end-user                  ECCN)           Eligible destination
----------------------------------------------------------------------------------------------------------------
China (People's Republic of)..  Advanced Micro Devices China,     3D002, 3D003, 3E001     AMD Technologies
                                 Inc..                             (limited to             (China) Co., Ltd.,
                                                                   ``technology'' for      No. 88, Su Tong Road,
                                                                   items classified        Suzhou, China 215021.
                                                                   under 3C002 and 3C004  Advanced Micro Devices
                                                                   and ``technology''      (Shanghai) Co., Ltd.,
                                                                   for use during the      Buildings 46, 47, 48
                                                                   International           & 49, River Front
                                                                   Technology Roadmap      Harbor, Zhangjiang Hi-
                                                                   for Semiconductors      Tech Park, 1387
                                                                   (ITRS) process for      Zhangdong Rd.,
                                                                   items classified        Pudong, Shanghai,
                                                                   under ECCNs 3B001 and   201203.
                                                                   3B002), 3E002          AMD Technology
                                                                   (limited to             Development (Beijing)
                                                                   ``technology'' for      Co., Ltd., 18F, North
                                                                   use during the ITRS     Building, Raycom
                                                                   process for items       Infotech, Park Tower
                                                                   classified under        C, No. 2 Science
                                                                   ECCNs 3B001 and         Institute South Rd.,
                                                                   3B002), 3E003.e         Zhong Guan Cun,
                                                                   (limited to the         Haidian District,
                                                                   ``development'' and     Beijing, China
                                                                   ``production'' of       100190.
                                                                   integrated circuits
                                                                   for commercial
                                                                   applications), 4D001,
                                                                   4D002, 4D003 and
                                                                   4E001 (limited to the
                                                                   ``development'' of
                                                                   products under ECCN
                                                                   4A003).

                                                  * * * * * * *
                                CSMC Technologies Corporation...  1C350.c.3, 1C350.c.11,  CSMC Technologies Fab
                                                                   2B230.a, 2B230.b,       1 Co., Ltd., 14
                                                                   2B350.f, 2B350.g,       Liangxi Road, Wuxi,
                                                                   2B350.h, 3B001.c.1.a,   Jiangsu 214061,
                                                                   3B001.c.2.a, 3B001.e,   China.
                                                                   3C002.a, 3C004.        CSMC, Technologies Fab
                                                                                2 Co., Ltd., Block
                                                                                86, 87, Wuxi National
                                                                                Hi-New Tech
                                                                                Industrial
                                                                                Development Zone,
                                                                                Wuxi, Jiangsu 214061,
                                                                                China.
                                                                                Wuxi CR Semiconductor
                                                                                Wafers and Chips Co.,
                                                                                Ltd., 14 Liangxi
                                                                                Road, Wuxi, Jiangsu
                                                                                214061, China.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    Dated: January 11, 2011.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2011-920 Filed 1-14-11; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Page 30938]
[FR Doc No: 2022-10870]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-017]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed May 9, 2022 10 a.m. EST Through May 16, 2022 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20220069, Draft, FERC, LA, Driftwood Line 200 and Line 300,
Comment Period Ends: 07/05/2022, Contact: Office of External Affairs
866-208-3372.
EIS No. 20220070, Final, DOE, ID, Versatile Test Reactor Environmental
Impact Statement, Review Period Ends: 06/21/2022, Contact: James
Lovejoy<PHONE_NUMBER>.
EIS No. 20220071, Draft Supplement, USFS, MT, Telegraph Vegetation
Project Supplemental Environmental Impact Statement, Comment Period
Ends: 07/05/2022, Contact: Katherine Bushnell<PHONE_NUMBER>.
EIS No. 20220072, Final, Caltrans, CA, El Camino Real Roadway Renewal
Project, Contact: Yolanda Rivas<PHONE_NUMBER>. Pursuant to 23 U.S.C.
139(n)(2), Caltrans has issued a single FEIS and ROD. Therefore, the
30-day wait/review period under NEPA does not apply to this action.

Amended Notice

EIS No. 20220052, Draft, FHWA, IN, Mid-States Corridor Tier 1, Comment
Period Ends: 06/14/2022, Contact: Michelle Allen<PHONE_NUMBER>. Revision
to FR Notice Published 04/15/2022; Extending the Comment Period from
05/31/2022 to 06/14/2022.

    Dated: May 17, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-10870 Filed 5-19-22; 8:45 am]
BILLING CODE 6560-50-P


PAPERWORK REDUCTION ACT SUBMISSION SAN 4380 Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Air Quality Planning and Standards 2. OMB control number b. X None a OMB Comment Number 2060 0500 3. Type of information collection ( check one)

a.

New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one)

a.

Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes

No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.

Three years from approval date b. G Other Specify: / /___

7. Title NESHAP for Taconite Iron Ore Processing ( 40 CFR Part 63 subpart RRRRR) ( Final Rule)

8. Agency form number( s) 2050.02 9. Keywords Taconite iron ore, Taconite, NESHAP, recordkeeping, reporting 10. Abstract All owners and operators of taconite iron ore processing plants will develop and submit an operation and maintenance plan, a startup shutdown and malfunction plan, a fugitive dust emissions control plan, and a site specific monitoring plan. Sources must submit initial notifications. Sources must also keep and maintain records of supporting material used in development of their plans. Plants without title V permits and plants choosing representative testing of units must develop and submit a testing plan. Sources must conduct initial performance tests to demonstrate initial compliance with particulate matter emission limits for each ore crushing and handling operation, ore dryer, indurating furnace, and finished pellet handling operation.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 8 b. Total annual responses 8 1. Percentage of these responses collected electronically 0 % c. Total hours requested 1,272 d. Current OMB inventory 0 e. Difference 1,272 f. Explanation of difference 1. Program Change 1,272 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 393 b. Total annual costs ( O& M) $ 117 c. Total annualized cost requested $ 510 d. Current OMB inventory $ 0 e. Difference $ 510 f. Explanation of difference 1. Program change $ 510 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply)

a.

Recordkeeping b. Q Third party disclosure c.

Reporting 1.

On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5.

Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Conrad Chin Phone: ( 919) 541 1512 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official,

Office of Air and Radiation Date Signature of Senior Official or designee Doreen Sterling , Acting Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Notices]
[Page 74165]
[FR Doc No: 2023-23919]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas and Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP24-50-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Sec.  4(d) Rate Filing: Termination of APP Contract
No. 246682 to be effective 11/23/2023.
    Filed Date: 10/23/23.
    Accession Number: 20231023-5177.
    Comment Date: 5 p.m. ET 11/6/23.

    Docket Numbers: RP24-51-000.
    Applicants: Discovery Gas Transmission LLC.
    Description: Sec.  4(d) Rate Filing: Title Page Update to be
effective 11/24/2023.
    Filed Date: 10/24/23.
    Accession Number: 20231024-5018.
    Comment Date: 5 p.m. ET 11/6/23.

    Docket Numbers: RP24-52-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.24.23 Negotiated Rates--
Mercuria Energy America, LLC R-7540-02 to be effective 11/1/2023.
    Filed Date: 10/24/23.
    Accession Number: 20231024-5020.
    Comment Date: 5 p.m. ET 11/6/23.

    Docket Numbers: RP24-53-000.
    Applicants: OkTex Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Requests for Service to be
effective 12/20/2023.
    Filed Date: 10/24/23.
    Accession Number: 20231024-5043.
    Comment Date: 5 p.m. ET 11/6/23.

    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP23-1115-000.
    Applicants: Northwest Pipeline LLC.
    Description: Report Filing: Requested Effective Date Revision for
RP23-1115 to be effective N/A.
    Filed Date: 10/23/23.
    Accession Number: 20231023-5138.
    Comment Date: 5 p.m. ET 11/6/23.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: October 24, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-23919 Filed 10-27-23; 8:45 am]
BILLING CODE 6717-01-P