[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27790-27792]
[FR Doc No: E9-13730]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8917-2]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (CAA or ``Act''), 42 U.S.C. 7413(g), notice is hereby given of
a proposed consent decree, to address a lawsuit filed by Association of
Irritated Residents in the United States District Court for the
Northern District of California: Association of Irritated Residents v.
EPA, No. 08-cv-05650 CW (N.D. Cal.). Plaintiff filed a deadline suit to
compel the Administrator to take action under section 110(k) of the Act
on two specific revisions to the state implementation plan (SIP)
submitted by the California Air Resources Board on behalf of the San
Joaquin Valley Unified Air Pollution Control District (``District'').
The two SIP revisions include Rule 3170, which provides for the payment
of fees by certain sources when the District fails to attain certain
air quality standards by a specified date and Rule 4570, which is
intended to reduce emissions from volatile organic compounds on certain
confined animal facilities located in the District. Under the terms of
the proposed consent decree, the parties agree that the Rule

4570 claim is moot and warrants dismissal with prejudice in light of
the state court ruling setting aside the District's adoption of Rule
4570. In addition, the proposed consent decree establishes deadlines
for EPA to take action on Rule 3170.

DATES: Written comments on the proposed consent decree must be received
by July 13, 2009.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2009-0376, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m., Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Jan Tierney, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    This proposed consent decree would resolve a lawsuit seeking to
compel action by EPA under section 110(k) of the CAA on the following
two SIP revisions submitted by the California Air Resources Board on
behalf of the San Joaquin Valley Unified Air Pollution Control District
(``District''). The two SIP revisions include Rule 3170, which provides
for the payment of fees by certain sources when the District fails to
attain certain air quality standards by a specified date and Rule 4570,
which is intended to reduce emissions from volatile organic compounds
on certain confined animal facilities located in the District. On
January 22, 2009, the Superior Court of California, upon remand from
the Court of Appeals for the State of California, in Association of
Irritated Residents v. San Joaquin Valley Unified Air Pollution Control
District, 168 Cal. App. 4th 535 (Cal. App. 5 Dist. 2008) entered a
judgment and writ of mandate which was amended on March 12, 2009,
declaring that the District failed to perform an adequate assessment of
Rule 4570's impact on the public health before its adoption as required
by California Health and Safety Code section 40724.6(e)(2). The court
ordered the District to perform the public health assessment and to set
aside the adoption of Rule 4750 pending that assessment. Under the
terms of the proposed consent decree, the parties agree that the claim
regarding Rule 4570 is moot and warrants dismissal with prejudice.
    In addition, the proposed consent decree provides that EPA will
sign for publication in the Federal Register notice of the Agency's
proposed action pursuant to CAA section 110(k) on Rule 3170 by June 30,
2009. EPA will sign notice of the Agency's final action pursuant to CAA
section 110(k) on Rule 3170 by November 13, 2009. If EPA fulfills its
obligations, Plaintiff has agreed to dismiss this suit with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will receive written comments relating to
the proposed consent decree from persons who were not named as parties
to the litigation in question. EPA or the Department of Justice may
withdraw or withhold consent to the proposed consent decree if the
comments disclose facts or considerations that indicate that such
consent is inappropriate, improper, inadequate, or inconsistent with
the requirements of the Act. Unless EPA or the Department of Justice
determines, based on any comment which may be submitted, that consent
to the consent decree should be withdrawn, the terms of the decree will
be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How Can I Get a Copy of the Consent Decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2009-0376) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov to
submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, select ``search,'' then key in the appropriate docket
identification number.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to Whom Do I Submit Comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification,

EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: June 5, 2009.
Sara Schneeberg,
Acting Associate General Counsel.
[FR Doc. E9-13730 Filed 6-10-09; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Rules and Regulations]
[Pages 5033-5035]
[FR Doc No: 2018-02202]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2018-N-0371]

Medical Devices; Neurological Devices; Classification of the
Percutaneous Nerve Stimulator for Substance Use Disorders

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the percutaneous nerve stimulator for substance use disorders into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the percutaneous nerve stimulator for substance
use disorders' classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective February 5, 2018. The classification was
applicable on November 15, 2017.

FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2684, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the percutaneous nerve stimulator
for substance use disorders as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to

the criteria under section 513(a)(1) of the FD&C Act. Although the
device was automatically placed within class III, the De Novo
classification is considered to be the initial classification of the
device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On March 17, 2017, Innovative Health Solutions, Inc., submitted a
request for De Novo classification of the NSS-2 BRIDGE. FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on November 15, 2017, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.5896. We have named
the generic type of device percutaneous nerve stimulator for substance
use disorders, and it is identified as a device that stimulates nerves
percutaneously to aid in the reduction of withdrawal symptoms
associated with substance use disorders.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Percutaneous Nerve Stimulator for Substance Use Disorders Risks
                         and Mitigation Measures
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       Identified risks                   Mitigation measures
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Adverse tissue reaction......  Biocompatibility evaluation and Labeling.
Electrical, mechanical, or     Electromagnetic compatibility testing;
 thermal hazards leading to     Electrical, mechanical, and thermal
 user discomfort or injury.     safety testing; Non-clinical performance
                                testing; Software verification,
                                validation, and hazard analysis; and
                                Labeling.
Infection....................  Sterility testing, Shelf life testing,
                                and Labeling.
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    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in part 814, subparts A through E, regarding premarket
approval, have been approved under OMB control number 0910-0231; the
collections of information in part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control number
0910-0120, and the collections of information in 21 CFR part 801,
regarding labeling, have been approved under OMB control number 0910-
0485.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

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

PART 882--NEUROLOGICAL DEVICES

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

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

0
2. Add Sec.  882.5896 to subpart F to read as follows:

Sec.  882.5896  Percutaneous nerve stimulator for substance use
disorders.

    (a) Identification. A percutaneous nerve stimulator for substance
use disorders is a device that stimulates nerves percutaneously to aid
in the reduction of withdrawal symptoms associated with substance use
disorders.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Electromagnetic compatibility and electrical, mechanical, and
thermal safety testing must be performed.
    (3) Electrical performance testing of the device and electrodes
must be conducted to validate the specified electrical output and
duration of stimulation of the device.
    (4) Software verification, validation, and hazard analysis must be
performed.
    (5) Sterility testing of the percutaneous components of the device
must be performed.
    (6) Shelf life testing must be performed to demonstrate continued

sterility, package integrity, and device functionality over the
specified shelf life.
    (7) Labeling must include the following:
    (i) A detailed summary of the device technical parameters;
    (ii) A warning stating that the device is only for use on clean,
intact skin;
    (iii) Instructions for use, including placement of the device on
the patient; and
    (iv) A shelf life.

    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02202 Filed 2-2-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55931]
[FR Doc No: 2011-23026]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3329-EM; Docket ID FEMA-2011-0001]

Virginia; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the Commonwealth of Virginia (FEMA-3329-EM), dated August 26, 2011, and
related determinations.

DATES: Effective Date: August 29, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of an emergency declaration for
the Commonwealth of Virginia is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared an emergency by the President in his declaration of
August 26, 2011.

    The counties of Essex, Gloucester, Henrico, King George, King
and Queen, Louisa, Surry, Sussex, and York and the Independent City
of Richmond for emergency protective measures (Category B),
including direct federal assistance, under the Public Assistance
program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23026 Filed 9-8-11; 8:45 am]
BILLING CODE 9111-23-P