[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47798-47799]
[FR Doc No: 2016-17291]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0660; FRL-9947-54-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Halogenated Solvent Cleaners/
Halogenated Hazardous Air Pollutants (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Halogenated Solvent
Cleaners/Halogenated Hazardous Air Pollutants (40 CFR part 63, subpart
T) (Renewal)'' (EPA ICR No. 1652.09, OMB Control No. 2060-0273), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
This is a proposed extension of the ICR, which is currently approved
through July 31, 2016. Public comments were requested previously via
the Federal Register (80 FR 32116) on June 5, 2015, during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 22,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0660, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP (40 CFR part 63, subpart A), and any changes,
or additions. to the Provisions are specified at 40 CFR part 63,
subpart T. Owners or operators of the affected facilities must submit
initial notification reports, performance tests, and periodic reports
and results. Owners or operators are also required to maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports, at a minimum, are
required semiannually.
    Form Numbers: None.
    Respondents/affected entities: Facilities with halogenated HAP
solvent cleaning machines.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart T).
    Estimated number of respondents: 1,431 (total).
    Frequency of response: Initially, quarterly, semiannually and
annually.

    Total estimated burden: 48,000 hours (rounded) (per year). Burden
is defined at 5 CFR 1320.3(b).
    Total estimated cost: $5,960,000 (per year), which includes
$1,010,000 in either annualized capital/startup or operation &
maintenance costs.
    Changes in the Estimates: There is an adjustment increase in
respondent labor hours in this ICR from the most recently approved ICR.
This is due to assuming all existing sources will have to re-
familiarize with the regulatory requirements each year. Additionally,
there is a small decrease in the total capital and O&M cost due to the
rounding of all calculated values to three significant digits.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2016-17291 Filed 7-21-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Page 7897]
[FR Doc No: 2022-02862]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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SUMMARY: This notice announces a meeting of the ARAC.

DATES: The meeting will be held on Thursday, March 17, 2022, from 1:00
p.m. to 4:00 p.m. Eastern Time.
    Requests to attend the meeting must be received by Monday, February
28, 2022.
    Requests for accommodations to a disability must be received by
Monday, February 28, 2022.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than Monday, February 28, 2022.

ADDRESSES: The meeting will be held virtually. Members of the public
who wish to observe the meeting must RSVP by emailing [email protected]. General committee information including copies of the
meeting minutes will be available on the FAA Committee website at
https://www.faa.gov/regulations_policies/rulemaking/committees/documents/.

FOR FURTHER INFORMATION CONTACT: Lakisha Pearson, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].
Any committee-related request should be sent to the person listed in
this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The ARAC was created under the Federal Advisory Committee Act
(FACA), in accordance with Title 5 of the United States Code (5 U.S.C.
App. 2) to provide advice and recommendations to the FAA concerning
rulemaking activities, such as aircraft operations, airman and air
agency certification, airworthiness standards and certification,
airports, maintenance, noise, and training.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Approval of Minutes
 Status Updates
    [cir] Active Working Groups
    [cir] Transport Airplane and Engine (TAE) Subcommittee
 Recommendation Reports
 FAA Updates

    Detailed agenda information will be posted on the FAA Committee
website address listed in the ADDRESSES section at least one week in
advance of the meeting.

III. Public Participation

    This virtual meeting will be open to the public on a first-come,
first-served basis. Members of the public who wish to attend are asked
to register via email by submitting the following information: Full
legal name, country of citizenship, and name of your industry
association, or applicable affiliation, to the email listed in the
ADDRESSES section. When registration is confirmed, registrants will be
provided the virtual meeting information/teleconference call-in number
and passcode. Callers are responsible for paying associated long-
distance charges.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    The FAA is not accepting oral presentations at this meeting due to
time constraints. Any member of the public may present a written
statement to the committee at any time. The public may present written
statements to ARAC by providing a copy to the Designated Federal
Officer via the email listed in the FOR FURTHER INFORMATION CONTACT
section.

    Issued in Washington, DC, on February 7, 2022.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2022-02862 Filed 2-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Proposed Rules]
[Page 48473]
[FR Doc No: 2017-22508]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0058; FRL-9969-60-Region 5]

Air Plan Approval; Michigan; Regional Haze Progress Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the regional haze progress report under the Clean Air Act as a
revision to the Michigan State Implementation Plan (SIP). Michigan has
satisfied the progress report requirements of the Regional Haze Rule.
Michigan has also met the requirements for a determination of the
adequacy of its regional haze plan with its negative declaration
submitted with the progress report.

DATES: Comments must be received on or before November 17, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2016-0058 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Gilberto Alvarez, Environmental
Scientist, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: September 29, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-22508 Filed 10-17-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 14, 2010 (Volume 75, Number 9)]
[Notices]
[Page 2127-2128]
[DOCID:fr14ja10-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 13643-000]

Basin Farm Renewable, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

January 6, 2010.
    On December 10, 2009, the Basin Farm Renewable, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Basin Farm Renewable Energy
Project Project, to be located on Saxtons River, in Westminster
Township, Windham County, Vermont.
    The proposed project would consist of: (1) A proposed stream bank
intake on

the upper pool of the twin falls; (2) a proposed five-foot-diameter,
150-foot-long penstock; (3) a proposed 25-foot x 25-foot powerhouse
containing one generating unit with a total generating capacity of 250
kW; (4) a proposed 3,000-foot-long, 12.47 kV transmission line; and (4)
a tailrace. The project would have an estimated average annual
generation of 764.0 megawatts-hours.
    Applicant Contact: Mr. James World, 55 Main Street, Lancaster, NH
03584, phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp.
    More information about this project can be viewed or printed on the
``eLibrary'' link of Commission's Web site at http://www.ferc.gov/docs-
filing/elibrary.asp. Enter the docket number (P-13643) in the docket
number field to access the document. For assistance, call toll-free 1-
866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-529 Filed 1-13-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Notices]
[Page 74146]
[FR Doc No: 2022-26238]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2022-0833; FRL-10463-01-ORD]

Availability of the IRIS Assessment Plan and Protocol for
Assessing Cancer Risk From Inhalation Exposure to Cobalt and Cobalt
Compounds; Public Science Meeting Postponement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting postponement.

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

SUMMARY: The Environmental Protection Agency (EPA) is postponing the
public science meeting to discuss the ``IRIS Assessment Plan and
Protocol for Assessing Cancer Risk from Inhalation Exposure to Cobalt
and Cobalt Compounds.'' The public science webinar originally scheduled
for November 30, 2022 will be postponed and a new meeting date will be
scheduled in early 2023. EPA will announce the public meeting date and
registration details on the EPA IRIS website (https://www.epa.gov/iris)
and via EPA's IRIS listserv. To register for the IRIS listserv, visit
IRIS website at https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

DATES: The public meeting announced in the Federal Register published
at 87 FR 68151 on November 14, 2022 is being postponed. A new meeting
date will be scheduled in early 2023. The public comment period on the
document remains unchanged.

ADDRESSES: EPA will announce the public meeting date and registration
details on the EPA IRIS website (https://www.epa.gov/iris) and via
EPA's IRIS listserv.

FOR FURTHER INFORMATION CONTACT: For technical information on the draft
IRIS Assessment Plan and Protocol for Assessing Cancer Risk From
Inhalation Exposure to Cobalt and Cobalt Compounds, contact Mr. Dahnish
Shams, CPHEA; telephone:<PHONE_NUMBER>; or email: [email protected].

Wayne Cascio,
Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2022-26238 Filed 12-1-22; 8:45 am]
BILLING CODE 6560-50-P


  HYPERLINK "JavaScript:sortUpdate(document.sort,'8')"  Registration #
 HYPERLINK "JavaScript:sortUpdate(document.sort,'2')"  Name 	Status
HYPERLINK "JavaScript:sortUpdate(document.sort,'4')"  Restricted Use
Product 	  HYPERLINK "JavaScript:sortUpdate(document.sort,'9')"  Company
# 	  HYPERLINK "JavaScript:sortUpdate(document.sort,'5')"  Company Name
  HYPERLINK "JavaScript:sortUpdate(document.sort,'6')"  Percent Active
Ingredient 	  HYPERLINK "JavaScript:sortUpdate(document.sort,'10')"
Active Ingredient

4-382	BONIDE BONTOX MULTI-PURPOSE INSECTICIDE CONCENTRATE	Conditionally
Registered (25-Sep-1996)	N	4	BONIDE PRODUCTS, INC.	.425	Esfenvalerate

4-383	BONIDE RTU VEGETABLE INSECT SPRAY	Conditionally Registered
(04-Oct-1996)	N	4	BONIDE PRODUCTS, INC.	.0033	Esfenvalerate

4-384	BONIDE FLEA AND TICK SPRAY FOR LAWNS	Conditionally Registered
(25-Sep-1996)	N	4	BONIDE PRODUCTS, INC.	.44	Esfenvalerate

239-2624	HI-POWER INDOOR INSECT FOGGER FORMULA V	Conditionally
Registered (23-Mar-1992)	N	239	THE SCOTTS COMPANY	.167	MGK 264

239-2624	HI-POWER INDOOR INSECT FOGGER FORMULA V	Conditionally
Registered (23-Mar-1992)	N	239	THE SCOTTS COMPANY	.1	Piperonyl butoxide

239-2624	HI-POWER INDOOR INSECT FOGGER FORMULA V	Conditionally
Registered (23-Mar-1992)	N	239	THE SCOTTS COMPANY	.1	Esfenvalerate

239-2624	HI-POWER INDOOR INSECT FOGGER FORMULA V	Conditionally
Registered (23-Mar-1992)	N	239	THE SCOTTS COMPANY	.05	Pyrethrins

239-2679	ORTHO ROACH, ANT AND SPIDER KILLER	Conditionally Registered
(31-Aug-2000)	N	239	THE SCOTTS COMPANY	.3	MGK 264

239-2679	ORTHO ROACH, ANT AND SPIDER KILLER	Conditionally Registered
(31-Aug-2000)	N	239	THE SCOTTS COMPANY	.05	Esfenvalerate

239-2679	ORTHO ROACH, ANT AND SPIDER KILLER	Conditionally Registered
(31-Aug-2000)	N	239	THE SCOTTS COMPANY	.03	Prallethrin

239-2680	ORTHO CONCENTRATE BUG-B-GON MULTI-PURPOSE INSECT KILLER
Conditionally Registered (14-Aug-2001)	N	239	THE SCOTTS COMPANY	.425
Esfenvalerate

352-503	TECHNICAL ASANA INSECTICIDE	Conditionally Registered
(29-Dec-1986)	N	352	E. I. DU PONT DE NEMOURS AND CO., INC. (S300/419)
85.5	Esfenvalerate

352-515	DUPONT ASANA XL INSECTICIDE	Conditionally Registered
(25-Mar-1988)	Y	352	E. I. DU PONT DE NEMOURS AND CO., INC. (S300/419)
8.4	Esfenvalerate

352-672	DUPONT ASANA TECHNICAL AI INSECTICIDE	Conditionally Registered
(05-Mar-2007)	N	352	E. I. DU PONT DE NEMOURS AND CO., INC. (S300/419)
96.2	Esfenvalerate

432-757	TRIBUTE II XL TERMITICIDE/INSECTICIDE CONCENTRATE	Conditionally
Registered (17-May-1993)	N	432	BAYER ENVIRONMENTAL SCIENCE	24.6
Esfenvalerate

498-167	SPRAYPAK ANT & ROACH KILLER FORMULA 2	Conditionally Registered
(03-Mar-1994)	N	498	CHASE PRODUCTS CO	.06	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

498-167	SPRAYPAK ANT & ROACH KILLER FORMULA 2	Conditionally Registered
(03-Mar-1994)	N	498	CHASE PRODUCTS CO	.05	Esfenvalerate

498-167	SPRAYPAK ANT & ROACH KILLER FORMULA 2	Conditionally Registered
(03-Mar-1994)	N	498	CHASE PRODUCTS CO	.2	MGK 264

498-167	SPRAYPAK ANT & ROACH KILLER FORMULA 2	Conditionally Registered
(03-Mar-1994)	N	498	CHASE PRODUCTS CO	.12	Piperonyl butoxide

498-177	SPRAYPAK INSTUTIONAL ANT AND ROACH RESIDUAL SPRAY	Conditionally
Registered (17-Dec-1996)	N	498	CHASE PRODUCTS CO	.25	MGK 264

498-177	SPRAYPAK INSTUTIONAL ANT AND ROACH RESIDUAL SPRAY	Conditionally
Registered (17-Dec-1996)	N	498	CHASE PRODUCTS CO	.03	Prallethrin

498-177	SPRAYPAK INSTUTIONAL ANT AND ROACH RESIDUAL SPRAY	Conditionally
Registered (17-Dec-1996)	N	498	CHASE PRODUCTS CO	.05	Esfenvalerate

498-186	CHAMPION SPRAYON INDOOR INSECT FOGGER FORMULA 4	Conditionally
Registered (28-Apr-1999)	N	498	CHASE PRODUCTS CO	1	MGK 264

498-186	CHAMPION SPRAYON INDOOR INSECT FOGGER FORMULA 4	Conditionally
Registered (28-Apr-1999)	N	498	CHASE PRODUCTS CO	.1	Esfenvalerate

498-186	CHAMPION SPRAYON INDOOR INSECT FOGGER FORMULA 4	Conditionally
Registered (28-Apr-1999)	N	498	CHASE PRODUCTS CO	.2	Tetramethrin

498-191	CHAMPION SPRAY ON CRAWLING INSECT KILLER FORMULA 2	Conditionally
Registered (12-Oct-2000)	N	498	CHASE PRODUCTS CO	.05	Esfenvalerate

498-202	CHAMPION SPRAYON MULTI-PURPOSE INSECTICIDE	Conditionally
Registered (30-Nov-2006)	N	498	CHASE PRODUCTS CO	.1	Esfenvalerate

506-176	TAT ROACH & ANT SPRAY WITH RESIDUAL ACTION 2491	Conditionally
Registered (26-Sep-1991)	N	506	WALCO LINCK COMPANY	.06
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

506-176	TAT ROACH & ANT SPRAY WITH RESIDUAL ACTION 2491	Conditionally
Registered (26-Sep-1991)	N	506	WALCO LINCK COMPANY	.05	Esfenvalerate

506-176	TAT ROACH & ANT SPRAY WITH RESIDUAL ACTION 2491	Conditionally
Registered (26-Sep-1991)	N	506	WALCO LINCK COMPANY	.12	Piperonyl
butoxide

506-176	TAT ROACH & ANT SPRAY WITH RESIDUAL ACTION 2491	Conditionally
Registered (26-Sep-1991)	N	506	WALCO LINCK COMPANY	.2	MGK 264

506-181	TAT TOTAL RELEASE WATER BASED FOGGER	Conditionally Registered
(08-Mar-1999)	N	506	WALCO LINCK COMPANY	1	MGK 264

506-181	TAT TOTAL RELEASE WATER BASED FOGGER	Conditionally Registered
(08-Mar-1999)	N	506	WALCO LINCK COMPANY	.2	Tetramethrin

506-181	TAT TOTAL RELEASE WATER BASED FOGGER	Conditionally Registered
(08-Mar-1999)	N	506	WALCO LINCK COMPANY	.1	Esfenvalerate

706-105	MULTI-USE INSECTICIDE FOGGER	Conditionally Registered
(02-Feb-2004)	N	706	CLAIRE MANUFACTURING CO	.1	Esfenvalerate

706-105	MULTI-USE INSECTICIDE FOGGER	Conditionally Registered
(02-Feb-2004)	N	706	CLAIRE MANUFACTURING CO	.05	Pyrethrins

706-105	MULTI-USE INSECTICIDE FOGGER	Conditionally Registered
(02-Feb-2004)	N	706	CLAIRE MANUFACTURING CO	.167	MGK 264

706-105	MULTI-USE INSECTICIDE FOGGER	Conditionally Registered
(02-Feb-2004)	N	706	CLAIRE MANUFACTURING CO	.1	Piperonyl butoxide

706-108	CLAIRE FAST KILL RESIDUAL ROACH & ANT KILLER	Conditionally
Registered (04-Mar-2004)	N	706	CLAIRE MANUFACTURING CO	.1	Esfenvalerate

769-584	R&M FLEA & TICK FOGGER #1	Conditionally Registered (01-Jul-1992)
N	769	VALUE GARDENS SUPPLY, LLC	.2	Tetramethrin

769-584	R&M FLEA & TICK FOGGER #1	Conditionally Registered (01-Jul-1992)
N	769	VALUE GARDENS SUPPLY, LLC	.1	Esfenvalerate

769-586	R & M FLORAL & VEGETABLE SPRAY #2 .	Conditionally Registered
(23-Mar-1992)	N	769	VALUE GARDENS SUPPLY, LLC	.0033	Esfenvalerate

769-587	R&M FLORAL & VEGETABLE SPRAY CONCENTRATE	Conditionally
Registered (01-Jul-1992)	N	769	VALUE GARDENS SUPPLY, LLC	.425
Esfenvalerate

769-589	R & M LAWN SPRAY CONCENTRATE #2	Conditionally Registered
(22-Apr-1992)	N	769	VALUE GARDENS SUPPLY, LLC	.44	Esfenvalerate

1021-1562	EVERCIDE ESFENVALERATE 50% CONCENTRATE	Conditionally
Registered (01-May-1989)	N	1021	MCLAUGHLIN GORMLEY KING CO	50
Esfenvalerate

1021-1575	EVERCIDE INTERMEDIATE 2491	Conditionally Registered
(12-Sep-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	3.01
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

1021-1575	EVERCIDE INTERMEDIATE 2491	Conditionally Registered
(12-Sep-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	10	MGK 264

1021-1575	EVERCIDE INTERMEDIATE 2491	Conditionally Registered
(12-Sep-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	6	Piperonyl butoxide

1021-1575	EVERCIDE INTERMEDIATE 2491	Conditionally Registered
(12-Sep-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Esfenvalerate

1021-1582	EVERCIDE VEGETABLE AND GARDEN INSECT KILLER 2526	Conditionally
Registered (03-Apr-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	.0033
Esfenvalerate

1021-1589	EVERCIDE INTERMEDIATE 2527	Conditionally Registered
(03-Dec-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.75	Esfenvalerate

1021-1594	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523	Conditionally
Registered (11-Jun-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	.06
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

1021-1594	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523	Conditionally
Registered (11-Jun-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	.2	MGK 264

1021-1594	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523	Conditionally
Registered (11-Jun-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	.12	Piperonyl
butoxide

1021-1594	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523	Conditionally
Registered (11-Jun-1990)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Esfenvalerate

1021-1601	EVERCIDE RESIDUAL ANT & ROACH SPRAY 2543	Conditionally
Registered (23-Dec-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	.25	MGK 264

1021-1601	EVERCIDE RESIDUAL ANT & ROACH SPRAY 2543	Conditionally
Registered (23-Dec-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	.03
Prallethrin

1021-1601	EVERCIDE RESIDUAL ANT & ROACH SPRAY 2543	Conditionally
Registered (23-Dec-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Esfenvalerate

1021-1613	EVERCIDE WASP AND HORNET SPRAY 2577	Conditionally Registered
(28-Jul-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	.2	Tetramethrin

1021-1613	EVERCIDE WASP AND HORNET SPRAY 2577	Conditionally Registered
(28-Jul-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	.031	Esfenvalerate

1021-1615	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2583	Conditionally
Registered (22-Apr-1992)	N	1021	MCLAUGHLIN GORMLEY KING CO	.25
Esfenvalerate

1021-1627	EVERCIDE INTERMEDIATE 2531	Conditionally Registered
(13-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.5
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

1021-1627	EVERCIDE INTERMEDIATE 2531	Conditionally Registered
(13-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	8.33	MGK 264

1021-1627	EVERCIDE INTERMEDIATE 2531	Conditionally Registered
(13-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.67	Esfenvalerate

1021-1634	EVERCIDE CONCENTRATE 2601	Conditionally Registered
(08-Aug-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	6.43	MGK 264

1021-1634	EVERCIDE CONCENTRATE 2601	Conditionally Registered
(08-Aug-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	3.86	Piperonyl butoxide

1021-1634	EVERCIDE CONCENTRATE 2601	Conditionally Registered
(08-Aug-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.92	Pyrethrins

1021-1634	EVERCIDE CONCENTRATE 2601	Conditionally Registered
(08-Aug-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	3.85	Esfenvalerate

1021-1635	EVERCIDE TOTAL RELEASE FOGGER 2602	Conditionally Registered
(19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.167	MGK 264

1021-1635	EVERCIDE TOTAL RELEASE FOGGER 2602	Conditionally Registered
(19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Pyrethrins

1021-1635	EVERCIDE TOTAL RELEASE FOGGER 2602	Conditionally Registered
(19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Esfenvalerate

1021-1635	EVERCIDE TOTAL RELEASE FOGGER 2602	Conditionally Registered
(19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Piperonyl butoxide

1021-1641	EVERCIDE RESIDUAL INSECTICIDE CONCENTRATE 2662	Conditionally
Registered (26-Mar-1993)	N	1021	MCLAUGHLIN GORMLEY KING CO	3.48
Esfenvalerate

1021-1643	EVERCIDE EMULSIFIABLE CONCENTRATE 2667	Conditionally
Registered (27-May-1993)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1645	EVERCIDE EMULSIFIABLE CONCENTRATE 2668	Conditionally
Registered (13-May-1993)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1647	EVERCIDE CONCENTRATE 2603	Conditionally Registered
(16-May-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	27.78	MGK 264

1021-1647	EVERCIDE CONCENTRATE 2603	Conditionally Registered
(16-May-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	5.61	Tetramethrin

1021-1647	EVERCIDE CONCENTRATE 2603	Conditionally Registered
(16-May-1994)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.78	Esfenvalerate

1021-1648	EVERCIDE TOTAL RELEASE AEROSOL 2604	Registered (05-Jun-2003)	N
1021	MCLAUGHLIN GORMLEY KING CO	1	MGK 264

1021-1648	EVERCIDE TOTAL RELEASE AEROSOL 2604	Registered (05-Jun-2003)	N
1021	MCLAUGHLIN GORMLEY KING CO	.1	Esfenvalerate

1021-1648	EVERCIDE TOTAL RELEASE AEROSOL 2604	Registered (05-Jun-2003)	N
1021	MCLAUGHLIN GORMLEY KING CO	.2	Tetramethrin

1021-1652	EVERCIDE INTERMEDIATE 2666	Conditionally Registered
(29-Jul-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	10.01	Tetramethrin

1021-1652	EVERCIDE INTERMEDIATE 2666	Conditionally Registered
(29-Jul-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.57	Esfenvalerate

1021-1655	EVERCIDE CONCENTRATE 2625	Registered (20-Jun-1995)	N	1021
MCLAUGHLIN GORMLEY KING CO	5	Esfenvalerate

1021-1655	EVERCIDE CONCENTRATE 2625	Registered (20-Jun-1995)	N	1021
MCLAUGHLIN GORMLEY KING CO	2	Prallethrin

1021-1656	EVERCIDE NYLAR TOTAL RELEASE AEROSOL 2644	Conditionally
Registered (19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1
Esfenvalerate

1021-1656	EVERCIDE NYLAR TOTAL RELEASE AEROSOL 2644	Conditionally
Registered (19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.04
Prallethrin

1021-1656	EVERCIDE NYLAR TOTAL RELEASE AEROSOL 2644	Conditionally
Registered (19-Sep-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.6
Pyriproxyfen

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Conditionally Registered
(30-May-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	.167	MGK 264

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Conditionally Registered
(30-May-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Pyrethrins

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Conditionally Registered
(30-May-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Pyriproxyfen

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Conditionally Registered
(30-May-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Esfenvalerate

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Conditionally Registered
(30-May-1996)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Piperonyl butoxide

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Conditionally Registered
(26-Oct-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.167	MGK 264

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Conditionally Registered
(26-Oct-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Piperonyl butoxide

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Conditionally Registered
(26-Oct-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Esfenvalerate

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Conditionally Registered
(26-Oct-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.6	Pyriproxyfen

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Conditionally Registered
(26-Oct-1995)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Pyrethrins

1021-1690	EVERCIDE CONCENTRATE 2595	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	12.5	MGK 264

1021-1690	EVERCIDE CONCENTRATE 2595	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Esfenvalerate

1021-1690	EVERCIDE CONCENTRATE 2595	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.5	Prallethrin

1021-1691	EVERCIDE CRAWLING INSECT KILLER 2548	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	.3	MGK 264

1021-1691	EVERCIDE CRAWLING INSECT KILLER 2548	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Esfenvalerate

1021-1691	EVERCIDE CRAWLING INSECT KILLER 2548	Conditionally Registered
(26-Jun-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	.03	Prallethrin

1021-1692	EVERCIDE CONCENTRATE 2547	Conditionally Registered
(18-Apr-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	12	MGK 264

1021-1692	EVERCIDE CONCENTRATE 2547	Conditionally Registered
(18-Apr-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	2	Esfenvalerate

1021-1692	EVERCIDE CONCENTRATE 2547	Conditionally Registered
(18-Apr-1997)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.2	Prallethrin

1021-1697	EVERCIDE ROACH & ANT SPRAY 2622	Conditionally Registered
(30-Jan-1998)	N	1021	MCLAUGHLIN GORMLEY KING CO	.045
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

1021-1697	EVERCIDE ROACH & ANT SPRAY 2622	Conditionally Registered
(30-Jan-1998)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Esfenvalerate

1021-1697	EVERCIDE ROACH & ANT SPRAY 2622	Conditionally Registered
(30-Jan-1998)	N	1021	MCLAUGHLIN GORMLEY KING CO	.25	MGK 264

1021-1700	EVERCIDE INTERMEDIATE 2756	Conditionally Registered
(22-Jan-1998)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.67	Esfenvalerate

1021-1701	EVERCIDE PRESSURIZED ROACH & ANT SPRAY 27561	Conditionally
Registered (26-Jan-1998)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Esfenvalerate

1021-1733	EVERCIDE CONCENTRATE 2752	Conditionally Registered
(26-Mar-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.25	Esfenvalerate

1021-1734	EVERCIDE RESIDUAL SPRAY 27522	Conditionally Registered
(26-Mar-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.25	Esfenvalerate

1021-1752	EVERCIDE ESFENVALERATE 35% W.P. MUP 2787	Conditionally
Registered (23-Mar-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	35
Esfenvalerate

1021-1754	EVERCIDE INTERMEDIATE 2769	Conditionally Registered
(25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Imiprothrin

1021-1754	EVERCIDE INTERMEDIATE 2769	Conditionally Registered
(25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Esfenvalerate

1021-1754	EVERCIDE INTERMEDIATE 2769	Conditionally Registered
(25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	12.5	MGK 264

1021-1755	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27693	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Imiprothrin

1021-1755	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27693	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.25	MGK 264

1021-1755	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27693	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Esfenvalerate

1021-1756	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27692	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.075
Imiprothrin

1021-1756	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27692	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.075
Esfenvalerate

1021-1756	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27692	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.375	MGK 264

1021-1757	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27691	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1
Imiprothrin

1021-1757	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27691	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.5	MGK 264

1021-1757	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27691	Conditionally
Registered (25-Jan-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1
Esfenvalerate

1021-1762	EVERCIDE RESIDUAL ROACH & ANT SPRAY 27891	Conditionally
Registered (13-Aug-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1
Imiprothrin

1021-1762	EVERCIDE RESIDUAL ROACH & ANT SPRAY 27891	Conditionally
Registered (13-Aug-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.5	MGK 264

1021-1762	EVERCIDE RESIDUAL ROACH & ANT SPRAY 27891	Conditionally
Registered (13-Aug-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05
Esfenvalerate

1021-1763	EVERCIDE INTERMEDIATE 2789	Conditionally Registered
(20-Nov-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Imiprothrin

1021-1763	EVERCIDE INTERMEDIATE 2789	Conditionally Registered
(20-Nov-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.25	Esfenvalerate

1021-1763	EVERCIDE INTERMEDIATE 2789	Conditionally Registered
(20-Nov-2001)	N	1021	MCLAUGHLIN GORMLEY KING CO	12.5	MGK 264

1021-1764	EVERCIDE WASP & HORNET SPRAY 26011	Conditionally Registered
(20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.167	MGK 264

1021-1764	EVERCIDE WASP & HORNET SPRAY 26011	Conditionally Registered
(20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Piperonyl butoxide

1021-1764	EVERCIDE WASP & HORNET SPRAY 26011	Conditionally Registered
(20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1	Esfenvalerate

1021-1764	EVERCIDE WASP & HORNET SPRAY 26011	Conditionally Registered
(20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Pyrethrins

1021-1773	EVERCIDE RESIDUAL ANT & ROACH SPRAY 27523	Conditionally
Registered (19-Mar-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.1
Esfenvalerate

1021-1776	EVERCIDE EMULSIFIABLE CONCENTRATE 2806	Conditionally
Registered (04-Dec-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1777	EVERCIDE VEGETABLE AND GARDEN INSECT KILLER 28063
Conditionally Registered (10-Sep-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO
.0033	Esfenvalerate

1021-1778	EVERCIDE EMULSIFIABLE CONCENTRATE 28061	Conditionally
Registered (04-Dec-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1779	EVERCIDE ESFENVALERATE RTU 28062	Conditionally Registered
(24-Jul-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.025	Esfenvalerate

1021-1781	EVERCIDE(R) EMULSIFIABLE CONCENTRATE 20851	Registered
(26-May-2004)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425	Esfenvalerate

1021-1782	EVERCIDE EMULSIFIABLE CONCENTRATE 2805 MUP	Conditionally
Registered (20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1787	EVERCIDE O.B. RTU 28101	Conditionally Registered (10-Sep-2003)
N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Esfenvalerate

1021-1787	EVERCIDE O.B. RTU 28101	Conditionally Registered (10-Sep-2003)
N	1021	MCLAUGHLIN GORMLEY KING CO	.03	Prallethrin

1021-1788	EVERCIDE CONCENTRATE 2810	Conditionally Registered
(23-Jan-2003)	N	1021	MCLAUGHLIN GORMLEY KING CO	2.5	Esfenvalerate

1021-1788	EVERCIDE CONCENTRATE 2810	Conditionally Registered
(23-Jan-2003)	N	1021	MCLAUGHLIN GORMLEY KING CO	1.5	Prallethrin

1021-1793	EVERCIDE CONCENTRATE 26621 MUP	Conditionally Registered
(20-Nov-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	3.48	Esfenvalerate

1021-1794	EVERCIDE ESFENVALERATE 10MC	Conditionally Registered
(22-Oct-2002)	N	1021	MCLAUGHLIN GORMLEY KING CO	9.36	Esfenvalerate

1021-1804	EVERCIDE(R) INDUSTRIAL SPRAY 27524	Conditionally Registered
(12-Aug-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Esfenvalerate

1021-1810	PYROCIDE FALCON 7452	Registered (17-Sep-2004)	N	1021
MCLAUGHLIN GORMLEY KING CO	.1	Pyriproxyfen

1021-1810	PYROCIDE FALCON 7452	Registered (17-Sep-2004)	N	1021
MCLAUGHLIN GORMLEY KING CO	.2	Esfenvalerate

1021-1810	PYROCIDE FALCON 7452	Registered (17-Sep-2004)	N	1021
MCLAUGHLIN GORMLEY KING CO	3	MGK 264

1021-1810	PYROCIDE FALCON 7452	Registered (17-Sep-2004)	N	1021
MCLAUGHLIN GORMLEY KING CO	2	Piperonyl butoxide

1021-1810	PYROCIDE FALCON 7452	Registered (17-Sep-2004)	N	1021
MCLAUGHLIN GORMLEY KING CO	1	Pyrethrins

1021-1814	EVERCIDE ESFENVALERATE MC - 18%	Conditionally Registered
(09-Nov-2004)	N	1021	MCLAUGHLIN GORMLEY KING CO	18	Esfenvalerate

1021-1815	EVERCIDE ESFENVALERATE 6.4% CS	Conditionally Registered
(09-May-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	6.4	Esfenvalerate

1021-1816	EVERCIDE ESFENVALERATE 0.025% RTU CS	Conditionally Registered
(09-May-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.025	Esfenvalerate

1021-1826	EVERCIDE EMULSIFIABLE CONCENTRATE 2845 MUP	Conditionally
Registered (28-Jun-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Imiprothrin

1021-1826	EVERCIDE EMULSIFIABLE CONCENTRATE 2845 MUP	Conditionally
Registered (28-Jun-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.425
Esfenvalerate

1021-1827	EVERCIDE HOME DEFENSE 28452	Conditionally Registered
(28-Jun-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.025	Imiprothrin

1021-1827	EVERCIDE HOME DEFENSE 28452	Conditionally Registered
(28-Jun-2005)	N	1021	MCLAUGHLIN GORMLEY KING CO	.025	Esfenvalerate

1021-1852	EVERCIDE WASP & HORNET SPRAY 26012	Conditionally Registered
(27-Jul-2006)	N	1021	MCLAUGHLIN GORMLEY KING CO	.025	Pyrethrins

1021-1852	EVERCIDE WASP & HORNET SPRAY 26012	Conditionally Registered
(27-Jul-2006)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Esfenvalerate

1021-1852	EVERCIDE WASP & HORNET SPRAY 26012	Conditionally Registered
(27-Jul-2006)	N	1021	MCLAUGHLIN GORMLEY KING CO	.084	MGK 264

1021-1852	EVERCIDE WASP & HORNET SPRAY 26012	Conditionally Registered
(27-Jul-2006)	N	1021	MCLAUGHLIN GORMLEY KING CO	.05	Piperonyl butoxide

2382-122	YARD SPRAY CONCENTRATE	Conditionally Registered (17-May-1995)	N
2382	VIRBAC AH, INC.	.44	Esfenvalerate

2517-123	ZEMA ESFENVALERATE LAWN SPRAY CONCENTRATE	Conditionally
Registered (03-Jun-1992)	N	2517	SERGEANT'S PET CARE PRODUCTS, INC.	.44
Esfenvalerate

2724-583	SPEER RESIDUAL PRESSURIZED SPRAY	Registered (04-Jun-2003)	N
2724	WELLMARK INTERNATIONAL	.065	d-trans-Chrysanthemum monocarboxylic
ester of dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

2724-583	SPEER RESIDUAL PRESSURIZED SPRAY	Registered (04-Jun-2003)	N
2724	WELLMARK INTERNATIONAL	.05	Esfenvalerate

2724-583	SPEER RESIDUAL PRESSURIZED SPRAY	Registered (04-Jun-2003)	N
2724	WELLMARK INTERNATIONAL	.12	Piperonyl butoxide

2724-583	SPEER RESIDUAL PRESSURIZED SPRAY	Registered (04-Jun-2003)	N
2724	WELLMARK INTERNATIONAL	.2	MGK 264

2724-584	SPI TOTAL RELEASE AEROSOL FOGGER II	Conditionally Registered
(16-Dec-1991)	N	2724	WELLMARK INTERNATIONAL	.3	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

2724-584	SPI TOTAL RELEASE AEROSOL FOGGER II	Conditionally Registered
(16-Dec-1991)	N	2724	WELLMARK INTERNATIONAL	.05	Esfenvalerate

2724-589	SPEER YARD SPRAY II	Conditionally Registered (27-Jan-1992)	N
2724	WELLMARK INTERNATIONAL	.44	Esfenvalerate

2724-647	SPEER-IT FOGGER II TOTAL RELEASE AEROSOL	Conditionally
Registered (05-Sep-1996)	N	2724	WELLMARK INTERNATIONAL	.167	MGK 264

2724-647	SPEER-IT FOGGER II TOTAL RELEASE AEROSOL	Conditionally
Registered (05-Sep-1996)	N	2724	WELLMARK INTERNATIONAL	.1	Piperonyl
butoxide

2724-647	SPEER-IT FOGGER II TOTAL RELEASE AEROSOL	Conditionally
Registered (05-Sep-1996)	N	2724	WELLMARK INTERNATIONAL	.05	Pyrethrins

2724-647	SPEER-IT FOGGER II TOTAL RELEASE AEROSOL	Conditionally
Registered (05-Sep-1996)	N	2724	WELLMARK INTERNATIONAL	.1	Esfenvalerate

2724-662	SPEER TOTAL RELEASE AEROSOL II WITH NYLAR	Conditionally
Registered (11-Dec-1995)	N	2724	WELLMARK INTERNATIONAL	.167	MGK 264

2724-662	SPEER TOTAL RELEASE AEROSOL II WITH NYLAR	Conditionally
Registered (11-Dec-1995)	N	2724	WELLMARK INTERNATIONAL	.1	Pyriproxyfen

2724-662	SPEER TOTAL RELEASE AEROSOL II WITH NYLAR	Conditionally
Registered (11-Dec-1995)	N	2724	WELLMARK INTERNATIONAL	.1	Piperonyl
butoxide

2724-662	SPEER TOTAL RELEASE AEROSOL II WITH NYLAR	Conditionally
Registered (11-Dec-1995)	N	2724	WELLMARK INTERNATIONAL	.05	Pyrethrins

2724-662	SPEER TOTAL RELEASE AEROSOL II WITH NYLAR	Conditionally
Registered (11-Dec-1995)	N	2724	WELLMARK INTERNATIONAL	.1	Esfenvalerate

2724-664	SPEER TOTAL RELEASE AEROSOL III WITH NLAR	Conditionally
Registered (19-Sep-1995)	N	2724	WELLMARK INTERNATIONAL	.1	Esfenvalerate

2724-664	SPEER TOTAL RELEASE AEROSOL III WITH NLAR	Conditionally
Registered (19-Sep-1995)	N	2724	WELLMARK INTERNATIONAL	.6	Pyriproxyfen

2724-664	SPEER TOTAL RELEASE AEROSOL III WITH NLAR	Conditionally
Registered (19-Sep-1995)	N	2724	WELLMARK INTERNATIONAL	.04	Prallethrin

2724-673	SPEER ANT AND ROACH KILLER II	Conditionally Registered
(02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	.25	MGK 264

2724-673	SPEER ANT AND ROACH KILLER II	Conditionally Registered
(02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	.05	Esfenvalerate

2724-673	SPEER ANT AND ROACH KILLER II	Conditionally Registered
(02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	.03	Prallethrin

2724-676	SPEER-IT FOGGER IV TOTAL RELEASE AEROSOL	Conditionally
Registered (02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	1	MGK 264

2724-676	SPEER-IT FOGGER IV TOTAL RELEASE AEROSOL	Conditionally
Registered (02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	.2	Tetramethrin

2724-676	SPEER-IT FOGGER IV TOTAL RELEASE AEROSOL	Conditionally
Registered (02-Sep-1997)	N	2724	WELLMARK INTERNATIONAL	.1	Esfenvalerate

2724-729	ELITE LAWN SPRAY CONCENTRATE #3	Conditionally Registered
(02-Feb-1992)	N	2724	WELLMARK INTERNATIONAL	.22	Esfenvalerate

2724-730	ELITE LAWN SPRAY CONCENTRATE #4	Conditionally Registered
(27-Jan-1992)	N	2724	WELLMARK INTERNATIONAL	.44	Esfenvalerate

8848-86	BLACK JACK ROACH & ANT KILLER VI	Conditionally Registered
(22-Jul-2004)	N	8848	SAFEGUARD CHEMICAL CORP	.03	Prallethrin

8848-86	BLACK JACK ROACH & ANT KILLER VI	Conditionally Registered
(22-Jul-2004)	N	8848	SAFEGUARD CHEMICAL CORP	.25	MGK 264

8848-86	BLACK JACK ROACH & ANT KILLER VI	Conditionally Registered
(22-Jul-2004)	N	8848	SAFEGUARD CHEMICAL CORP	.05	Esfenvalerate

9444-143	CB-305 FOGGER	Conditionally Registered (16-Sep-1991)	N	9444
WATERBURY COMPANIES INC	.3	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

9444-143	CB-305 FOGGER	Conditionally Registered (16-Sep-1991)	N	9444
WATERBURY COMPANIES INC	.05	Esfenvalerate

9444-144	CB-405 FOGGER	Conditionally Registered (15-Jun-1992)	N	9444
WATERBURY COMPANIES INC	.167	MGK 264

9444-144	CB-405 FOGGER	Conditionally Registered (15-Jun-1992)	N	9444
WATERBURY COMPANIES INC	.1	Piperonyl butoxide

9444-144	CB-405 FOGGER	Conditionally Registered (15-Jun-1992)	N	9444
WATERBURY COMPANIES INC	.05	Pyrethrins

9444-144	CB-405 FOGGER	Conditionally Registered (15-Jun-1992)	N	9444
WATERBURY COMPANIES INC	.1	Esfenvalerate

9444-145	CB FOGGER IV	Conditionally Registered (18-Sep-1991)	N	9444
WATERBURY COMPANIES INC	.2	Tetramethrin

9444-145	CB FOGGER IV	Conditionally Registered (18-Sep-1991)	N	9444
WATERBURY COMPANIES INC	.1	Esfenvalerate

9444-166	CB-405 FOGGER WB	Conditionally Registered (26-Oct-1995)	N	9444
WATERBURY COMPANIES INC	.167	MGK 264

9444-166	CB-405 FOGGER WB	Conditionally Registered (26-Oct-1995)	N	9444
WATERBURY COMPANIES INC	.05	Pyrethrins

9444-166	CB-405 FOGGER WB	Conditionally Registered (26-Oct-1995)	N	9444
WATERBURY COMPANIES INC	.1	Esfenvalerate

9444-166	CB-405 FOGGER WB	Conditionally Registered (26-Oct-1995)	N	9444
WATERBURY COMPANIES INC	.1	Piperonyl butoxide

9444-168	COUNTRY VET ROACH EMBARGO WITH GROWTH INHIBITOR	Conditionally
Registered (19-Sep-1995)	N	9444	WATERBURY COMPANIES INC	.1	Esfenvalerate

9444-168	COUNTRY VET ROACH EMBARGO WITH GROWTH INHIBITOR	Conditionally
Registered (19-Sep-1995)	N	9444	WATERBURY COMPANIES INC	.6	Pyriproxyfen

9444-168	COUNTRY VET ROACH EMBARGO WITH GROWTH INHIBITOR	Conditionally
Registered (19-Sep-1995)	N	9444	WATERBURY COMPANIES INC	.04	Prallethrin

10308-25	SUMI-ALPHA TECHNICAL INSECTICIDE	Conditionally Registered
(02-Apr-1996)	N	10308	SUMITOMO CHEMICAL COMPANY, LTD.	85.5	Esfenvalerate

10308-28	SUMI-ALPHA 10MC FOR PCO USE	Conditionally Registered
(12-Dec-2001)	N	10308	SUMITOMO CHEMICAL COMPANY, LTD.	9.36	Esfenvalerate

10308-29	SUMI-ALPHA 10MC MUP	Conditionally Registered (12-Dec-2001)	N
10308	SUMITOMO CHEMICAL COMPANY, LTD.	9.36	Esfenvalerate

10807-191	MISTY FIRE ANT INJECTOR SPRAY II	Conditionally Registered
(15-Sep-1997)	N	10807	AMREP, INC	.2	Tetramethrin

10807-191	MISTY FIRE ANT INJECTOR SPRAY II	Conditionally Registered
(15-Sep-1997)	N	10807	AMREP, INC	.1	Esfenvalerate

11623-44	TOTAL RELEASE FOGGER III	Conditionally Registered (22-Feb-1999)
N	11623	APOLLO INDUSTRIES INCORPORATED	1	MGK 264

11623-44	TOTAL RELEASE FOGGER III	Conditionally Registered (22-Feb-1999)
N	11623	APOLLO INDUSTRIES INCORPORATED	.1	Esfenvalerate

11623-44	TOTAL RELEASE FOGGER III	Conditionally Registered (22-Feb-1999)
N	11623	APOLLO INDUSTRIES INCORPORATED	.2	Tetramethrin

28293-190	UNICORN LAWN SPRAY # 2	Conditionally Registered (27-May-1992)
N	28293	PHAETON CORPORATION	.44	Esfenvalerate

28293-192	UNICORN HOUSE AND CARPET SPRAY #5	Conditionally Registered
(30-Sep-1991)	N	28293	PHAETON CORPORATION	.065	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

28293-192	UNICORN HOUSE AND CARPET SPRAY #5	Conditionally Registered
(30-Sep-1991)	N	28293	PHAETON CORPORATION	.05	Esfenvalerate

28293-192	UNICORN HOUSE AND CARPET SPRAY #5	Conditionally Registered
(30-Sep-1991)	N	28293	PHAETON CORPORATION	.12	Piperonyl butoxide

28293-192	UNICORN HOUSE AND CARPET SPRAY #5	Conditionally Registered
(30-Sep-1991)	N	28293	PHAETON CORPORATION	.2	MGK 264

28293-196	UNICORN HOUSE AND CARPET SPRAY #6	Conditionally Registered
(23-Sep-1991)	N	28293	PHAETON CORPORATION	.065	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

28293-196	UNICORN HOUSE AND CARPET SPRAY #6	Conditionally Registered
(23-Sep-1991)	N	28293	PHAETON CORPORATION	.2	MGK 264

28293-196	UNICORN HOUSE AND CARPET SPRAY #6	Conditionally Registered
(23-Sep-1991)	N	28293	PHAETON CORPORATION	.05	Esfenvalerate

28293-196	UNICORN HOUSE AND CARPET SPRAY #6	Conditionally Registered
(23-Sep-1991)	N	28293	PHAETON CORPORATION	.12	Piperonyl butoxide

28293-296	UNICORN VEGETABLE SPRAY EC	Conditionally Registered
(02-Jul-1999)	N	28293	PHAETON CORPORATION	.425	Esfenvalerate

44446-65	CS 101 ROACH & ANT SPRAY	Conditionally Registered (06-Aug-2001)
N	44446	QUEST CHEMICAL CORPORATION	.25	MGK 264

44446-65	CS 101 ROACH & ANT SPRAY	Conditionally Registered (06-Aug-2001)
N	44446	QUEST CHEMICAL CORPORATION	.05	Esfenvalerate

44446-65	CS 101 ROACH & ANT SPRAY	Conditionally Registered (06-Aug-2001)
N	44446	QUEST CHEMICAL CORPORATION	.03	Prallethrin

45385-93	CTX/CYBER BLAST	Conditionally Registered (25-Oct-1995)	N	45385
CTX-CENOL, INC.	.25	MGK 264

45385-93	CTX/CYBER BLAST	Conditionally Registered (25-Oct-1995)	N	45385
CTX-CENOL, INC.	.05	Esfenvalerate

45385-93	CTX/CYBER BLAST	Conditionally Registered (25-Oct-1995)	N	45385
CTX-CENOL, INC.	.03	Prallethrin

46515-32	SUPER K-GRO ALL PURPOSE GARDEN SPRAY	Conditionally Registered
(18-Jan-1991)	N	46515	CELEX, DIVISION OF UNITED INDUSTRIES CORP	.0033
Esfenvalerate

53883-135	ESTFENVALERATE AG	Conditionally Registered (17-Sep-2004)	Y
53883	CONTROL SOLUTIONS, INC.	8.4	Esfenvalerate

68543-17	BENGAL ROACH & ANT SPRAY IV	Conditionally Registered
(30-Sep-1997)	N	68543	BENGAL PRODUCTS INC	.3	MGK 264

68543-17	BENGAL ROACH & ANT SPRAY IV	Conditionally Registered
(30-Sep-1997)	N	68543	BENGAL PRODUCTS INC	.03	Prallethrin

68543-17	BENGAL ROACH & ANT SPRAY IV	Conditionally Registered
(30-Sep-1997)	N	68543	BENGAL PRODUCTS INC	.05	Esfenvalerate

71532-18	LG ESFENVALERATE TECHNICAL INSECTICIDE	Conditionally Registered
(24-Jul-2006)	N	71532	LG LIFE SCIENCES, LTD.	97.5	Esfenvalerate

71532-21	ESFENSTAR 8% EC	Conditionally Registered (24-Apr-2007)	N	71532
LG LIFE SCIENCES, LTD.	8.4	Esfenvalerate

73049-420	CROSSFIRE 10 MC	Conditionally Registered (02-Jun-2005)	N	73049
VALENT BIOSCIENCES CORPORATION	9.36	Esfenvalerate

84396-33	EVER-SECT III INSECTICIDE CONCENTRATE	Conditionally Registered
(18-Sep-1991)	N	84396	SUNGRO PRODUCTS, LLC	.425	Esfenvalerate

84396-34	EVER-SECT ORNAMENTAL AND GARDEN VEGETABLE INSECTICIDE SPRAY
Conditionally Registered (18-Sep-1991)	N	84396	SUNGRO PRODUCTS, LLC
.0033	Esfenvalerate

CA990022	DUPONT ASANA XL INSECTICIDE	Registered (25-Nov-2008)	N	352	E.
I. DU PONT DE NEMOURS AND CO., INC. (S300/419)	8.4	Esfenvalerate

GA040008	DUPONT ASANA XL INSECTICIDE	Under Review (25-Oct-2004)	N	352	E.
I. DU PONT DE NEMOURS AND CO., INC. (S300/419)	8.4	Esfenvalerate

ND030012	DUPONT ASANA XL INSECTICIDE	Under Review (12-Aug-2003)	N	352	E.
I. DU PONT DE NEMOURS AND CO., INC. (S300/419)	8.4	Esfenvalerate

WY030004	DUPONT ASANA XL INSECTICIDE	Registered (22-Jul-2003)	N	352	E.
I. DU PONT DE NEMOURS AND CO., INC. (S300/419)	8.4	Esfenvalerate

WY080003	DUPONT ASANA XL INSECTICIDE	Under Review (11-Mar-2008)	N	81417
DuPont Crop Protection	8.4	Esfenvalerate

Esfenvalerate Registrations as of 4/30/09

 PAGE

 PAGE   6


[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35842-35843]
[FR Doc No: 2015-15328]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-1297]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Vibrator for Climax Control of Premature Ejaculation;
Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; republication.

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

SUMMARY: The Food and Drug Administration (FDA) is republishing in its
entirety a final order entitled ``Medical Devices; Gastroenterology-
Urology Devices; Classification of the Vibrator for Climax Control of
Premature Ejaculation'' that published in the Federal Register on May
28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent
omission of information. FDA is classifying the vibrator for climax
control of premature ejaculation into class II (special controls). The
special controls that will apply to the device are identified in this
order and will be part of the codified language for the classification
of the vibrator for climax control of premature ejaculation. The Agency
is classifying the device into class II (special controls) in order to
provide a reasonable assurance of safety and effectiveness of the
device.

DATES: This order is effective June 23, 2015. The classification was
applicable on March 20, 2015.

FOR FURTHER INFORMATION CONTACT: Tuan Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. On
November 21, 2013, Auris Medtech Europe, Ltd., submitted a request for
classification of the ProlongTM under section 513(f)(2) of
the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1). On June 17, 2014, the request for
classification of ProlongTM was transferred from Auris
Medtech Europe, Ltd., to Ergon Medical, Ltd., through an amendment to
the request (Ref. 2).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on March 20, 2015, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.5025.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a vibrator
for climax control of premature ejaculation will need to comply with
the special controls named in this final order. The device is assigned
the generic name vibrator for climax control of premature ejaculation,
and it is identified as a device used for males who suffer from
premature ejaculation. It is designed to increase the time between
arousal and ejaculation using the stimulating vibratory effects of the
device on the penis.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the measures required
to mitigate these risks in table 1.

 Table 1--Vibrator for Climax Control of Premature Ejaculation Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Pain or Discomfort due to Misuse of      Labeling.
 Device.
Burns..................................  Electrical and Thermal Safety
                                          Testing Labeling.
Electrical Shock.......................  Electrical Safety Testing
                                          Labeling.
Adverse Skin Reactions.................  Biocompatibility Testing.
Patient Injury due to Device Breakage    Mechanical Safety Testing
 or Failure.                              Labeling.
Interference With Other Devices/         Electromagnetic Compatibility
 Electrical Equipment.                    Testing Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
     The labeling must include specific instructions regarding
the proper placement and use of the device.
     The portions of the device that contact the patient must
be demonstrated to be biocompatible.
     Appropriate analysis/testing must demonstrate
electromagnetic compatibility safety, electrical safety, and thermal
safety of the device.
     Mechanical safety testing must demonstrate that the device
will withstand forces encountered during use.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the vibrator for climax control of
premature ejaculation they intend to market.

II. 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, 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.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

    1. DEN130047: De Novo Request per 513(f)(2) from Auris Medtech
Europe Ltd., dated November 21, 2013.
    2. Amendment to De Novo Request from Auris Medtech Europe Ltd.,
dated June 17, 2014.

List of Subjects in 21 CFR Part 876

    Medical devices.

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

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

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

0
2. Republish Sec.  876.5025 to read as follows:

Sec.  876.5025  Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature
ejaculation is used for males who suffer from premature ejaculation. It
is designed to increase the time between arousal and ejaculation using
the stimulating vibratory effects of the device on the penis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling must include specific instructions regarding the
proper placement and use of the device.
    (2) The portions of the device that contact the patient must be
demonstrated to be biocompatible.
    (3) Appropriate analysis/testing must demonstrate electromagnetic
compatibility safety, electrical safety, and thermal safety of the
device.
    (4) Mechanical safety testing must demonstrate that the device will
withstand forces encountered during use.

    Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15328 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Proposed Rules]
[Pages 28944-28946]
[FR Doc No: 2011-12445]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0461; FRL-9309-4]

Revisions to the California State Implementation Plan, Placer
County Air Pollution Control District and Feather River Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing a limited approval and limited disapproval of
permitting rules submitted for the Placer County Air Pollution Control
District (PCAPCD) and Feather River Air Quality Management District
(FRAQMD) portion of the California State Implementation Plan (SIP). The
districts are required under Part D of title I of the Clean Air Act
(CAA) to adopt and implement a SIP-approved New Source Review (NSR)
permit program. These rules update and revise the District's NSR
permitting program for new and modified sources of air pollution. If
EPA finalizes the limited approval and limited disapproval action, as
proposed, then a sanctions clock would be triggered. We are taking
comments on this proposal and plan to follow with a final action.

DATES: Any comments must arrive by June 20, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0461, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. 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. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: EPA has established a docket for this action under EPA-R09-
OAR-2011-0461. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents are listed at http://www.regulations.gov, some
information

may be publicly available only at the hard copy location (e.g.,
copyrighted material, large maps, multi-volume reports), and some may
not be publicly available in either location (e.g., CBI). To inspect
the hard copy materials, please schedule an appointment during normal
business hours with the contact listed in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Proposed Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal, including the
date it was adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
                                                Rule
                Local agency                    No.               Rule title              Amended     Submitted
----------------------------------------------------------------------------------------------------------------
PCAPCD......................................      502  New Source Review..............     10/28/10      7/20/10
FRAQMD......................................     10.1  New Source Review..............      10/5/09      7/20/10
----------------------------------------------------------------------------------------------------------------

    On August 25, 2010, EPA determined that the submittal for PCAPCD
Rule 502 and FRAQMD Rule 10.1, met the completeness criteria in 40 CFR
part 51, Appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    There are no previous versions of Rule 502 in the SIP, but SIP
approved Rule 508 (New Source Review), which this rule will replace in
the SIP, was approved into the Mountain Counties and Lake Tahoe air
basin portions of the Placer County SIP, on June 23, 1982 (47 FR 27065)
and May 18, 1981 (46 FR 27115), respectively. The PCAPCD originally
adopted new Rule 502 on May 24, 1977 and has revised the rule several
times since that date, but there are no other pending SIP submittals of
Rule 502.
    There are no previous versions of Rule 10.1 in the SIP. The FRAQMD
originally adopted new Rule 10.1 on February 8, 1993, and submitted the
rule to EPA on March 23, 1993, however EPA has not taken action on this
submittal. While we can act on only the most recently submitted
version, we have reviewed materials provided with the previous
submittal.

C. What is the purpose of the submitted rules?

    Section 110(a) of the CAA requires states to submit regulations
that include a pre-construction permit program for certain new or
modified stationary sources of pollutants, including a permit program
as required by Part D of Title I of the CAA.
    The purpose of Rule 502 (New Source Review) and Rule 10.1 (New
Source Review) is to implement a federal preconstruction permit program
for new and modified sources located in nonattainment areas. Rule 502
will replace the existing SIP approved NSR programs contained in Rule
508, as approved for the Mountain Counties and Lake Tahoe air basin
potions of Placer County. These versions of Rule 508 were approved into
the SIP in 1981 and 1982 respectively. Rather than try to update these
rules, the District has instead adopted an entirely new rule to carry
out the NSR program--Rule 502. Rule 10.1 will be a new SIP rule. In
accordance with both District's May 5, 2010 (75 FR 24409)
reclassification as a severe ozone nonattainment area, the rules
establish BACT \1\ and offset applicability thresholds at 25 tpy or
more, and sets the required offset ratio at 1.3 to 1, or greater. The
rules do not contain any of the 2002 NSR Reform provisions adopted by
EPA. (67 FR 80186)
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    \1\ While the District uses the term BACT as the level of
control required, a review of the definition has shown that it is
equivalent to the requirements for federal LAER.
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II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    The relevant statutory provisions for our review of the submitted
rules include Part D of Title I of the CAA, section 110(a)(2)(C),
section 110(l) and section 182(d). Section 110(a) requires a pre-
construction permit programs for certain new or modified stationary
sources of pollutants, including a permit program as required by Part D
of Title I, while section 110(l) precludes EPA approval of SIP
revisions that would interfere with any applicable requirement
concerning attainment and reasonable further progress or any other
applicable requirement of the Act. Section 182(d) (together with
section 182(f) for NOX), requires NSR SIPs in ``severe''
nonattainment areas to define ``major sources'' and ``major
modifications'' to be sources that emit 25 tpy or more of VOC or
NOX, and have an offset ratio of at least 1.3 to 1. In
addition, we have reviewed the submitted rules for compliance with EPA
implementing regulations for NSR, including 40 CFR 51.160 through 40
CFR 51.165.

B. Do the rules meet the evaluation criteria?

    EPA has reviewed the submitted rules in accordance with the Rule
Evaluation criteria described above. The TSDs (one for each District)
for this action contain a complete discussion of our evaluation. EPA is
proposing to find that these rules meet the statutory requirements for
SIPs as specified in sections 110(a), 110(l), 182(d) and 193 of the
CAA. In addition, except for the deficiencies noted in the TSDs and
summarized in the Proposed Action section of this notice, we are
proposing to find that the rules meet the regulatory requirements of 40
CFR 51.160 through 40 CFR 51.165. EPA is proposing to find that it is
acceptable for PCAPCD and FRAQMD to not incorporate the NSR Reform
provisions of 40 CFR 51.165 into their SIP approved NSR programs,
because the same level of control will be required for modified
sources, with or without inclusion of these provisions in the SIP, and
neither of the PCAPCD and FRAQMD programs will be any less stringent
than the federal program.

C. Public Comment and Proposed Action

    For the reasons given above, under CAA section 110(k)(3) and
301(a), we are proposing a limited approval and limited disapproval of
Rule 502 and Rule 10.1 because, although each rule would strengthen the
SIP and they meet the applicable requirements for SIPs in general, they
contain certain deficiencies related to NSR SIPs in particular that
prevent our full approval. The primary deficiencies pertain to missing
definitions and missing provisions pursuant to 40 CFR 51.165(a)(5)(ii)
and 40 CFR 51.307(b)(2). Please refer to the TSD for this action for
additional information. The deficiencies can be remedied by each
District by revising their rule to provide the missing definitions, and
necessary provisions pursuant to the 40 CFR part 51 sections cited
above. If EPA finalizes the limited approval and limited disapproval
action, as proposed, then a sanctions clock, and EPA's obligation to
promulgate a Federal implementation plan, would be triggered because
the revisions to the District rule for which a limited approval and
limited disapproval is proposed is required under the 8-hour ozone
standard.
    We will accept comments from the public on this proposal for the
next 30 days. Unless we receive convincing new information during the
comment period, we intend to publish a final action that will
incorporate these rules into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: May 13, 2011.
Keith Takata,
Acting Regional Administrator, Region IX.
[FR Doc. 2011-12445 Filed 5-18-11; 8:45 am]
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