[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73620-73621]
[FR Doc No: 2014-29022]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1453]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 11, 2015.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1453, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.

    Dated: November 24, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

    I. Watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
                         Middle Coosa Watershed
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
             Calhoun County, Alabama, and Incorporated Areas
------------------------------------------------------------------------
City of Anniston.......................  City Hall, 1128 Gurnee Avenue,
                                          Anniston, AL 36201.
City of Jacksonville...................  City Hall, 320 Church Avenue
                                          Southeast, Jacksonville, AL
                                          36265.
City of Oxford.........................  City Hall, 145 Hamric Drive
                                          East, Oxford, AL 36203.

City of Piedmont.......................  City Hall, 109 North Center
                                          Avenue, Piedmont, AL 36272.
City of Weaver.........................  City Hall, 500 Anniston Street,
                                          Weaver, AL 36277.
Town of Hobson City....................  Town Hall, 715 Martin Luther
                                          King Drive, Hobson City, AL
                                          36201.
Town of Ohatchee.......................  Town Hall, 7801 Highway 77,
                                          Ohatchee, AL 36271.
Unincorporated Areas of Calhoun County.  Calhoun County EMA, 507 Francis
                                          Street West, Jacksonville, AL
                                          36265.
------------------------------------------------------------------------
            Cherokee County, Alabama, and Incorporated Areas
------------------------------------------------------------------------
City of Centre.........................  City Hall, 401 East Main
                                          Street, Centre, AL 35960.
Unincorporated Areas of Cherokee County  County Engineering Department,
                                          1875 East Main Street, Centre,
                                          AL 35960.
------------------------------------------------------------------------
             Etowah County, Alabama, and Incorporated Areas
------------------------------------------------------------------------
City of Attalla........................  City Hall, 612 North 4th
                                          Street, Attalla, AL 35954.
City of Gadsden........................  City Hall, 90 Broad Street,
                                          Gadsden, AL 35901.
City of Glencoe........................  City Hall, 201A West Chastain
                                          Boulevard, Glencoe, AL 35905.
City of Rainbow City...................  City Hall, 3700 Rainbow Drive,
                                          Rainbow City, AL 35906.
City of Southside......................  City Hall, 2255 Highway 77,
                                          Southside, AL 35907.
Town of Hokes Bluff....................  Town Hall, 3301 Alford Bend
                                          Road, Hokes Bluff, AL 35903.
Town of Reece City.....................  Reece City Town Hall, 1023
                                          Valley Drive, Attalla, AL
                                          35954.
Town of Sardis City....................  City Hall, 1335 Sardis Drive,
                                          Sardis City, AL 35956.
Unincorporated Areas of Etowah County..  Etowah County Courthouse, 800
                                          Forrest Avenue, Gadsden, AL
                                          35901.
------------------------------------------------------------------------
            St. Clair County, Alabama, and Incorporated Areas
------------------------------------------------------------------------
City of Argo...........................  City Hall, 100 Blackjack Road,
                                          Argo, AL 35173.
City of Ashville.......................  City Hall, 211 8th Street,
                                          Ashville, AL 35953.
City of Margaret.......................  City Hall, 125 School Street,
                                          Margaret, AL 35112.
City of Moody..........................  City Hall, 670 Park Avenue,
                                          Moody, AL 35004.
City of Odenville......................  City Hall, 183 Alabama Street,
                                          Odenville, AL 35120.
City of Pell City......................  City Hall, 1905 1st Avenue
                                          North, Pell City, AL 35125.
City of Riverside......................  City Hall, 379 Depot Street,
                                          Riverside, AL 35135.
City of Springville....................  City Hall, 6327 U.S. Highway
                                          11, Springville, AL 35146.
City of Trussville.....................  City Hall, 131 Main Street,
                                          Trussville, AL 35173.
Town of Ragland........................  Town Hall, 220 Fredia Street,
                                          Suite 102, Ragland, AL 35131.
Town of Steele.........................  Town Hall, 4025 Pope Avenue,
                                          Steele, AL 35987.
Unincorporated Areas of St. Clair        St. Clair County Engineering
 County.                                  Department, 31588 U.S. Highway
                                          231, Ashville, AL 35953.
------------------------------------------------------------------------
            Talladega County, Alabama, and Incorporated Areas
------------------------------------------------------------------------
City of Childersburg...................  City Hall, 201 8th Avenue
                                          Southwest, Childersburg, AL
                                          35044.
City of Lincoln........................  City Hall, 150 Magnolia Street,
                                          Lincoln, AL 35096.
City of Sylacauga......................  City Hall, 301 North Broadway
                                          Avenue, Sylacauga, AL 35150.
City of Talladega......................  City Hall, 203 South Street
                                          West, Talladega, AL 35161.
Unincorporated Areas of Talladega        Talladega County Highway
 County.                                  Department Engineering Office,
                                          500 Institute Lane, Talladega,
                                          AL 35161.
------------------------------------------------------------------------

    II. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Prowers County, Colorado, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Lamar..........................  Mayor, City of Lamar, 102 East
                                          Parmenter Street, Lamar, CO
                                          81052.
Town of Granada........................  Town Clerk, Town of Granada,
                                          103 South Main Street,
                                          Granada, CO 81041.
Town of Holly..........................  Administrator, Town of Holly,
                                          100 Tony Garcia Drive, Holly,
                                          CO 81047.
Town of Wiley..........................  Mayor, Town of Wiley, 304 Main
                                          Street, Wiley, CO 81092.
Unincorporated Areas of Prowers County.  Prowers County Emergency
                                          Operations Management, 301
                                          South Main Street, Lamar, CO
                                          81052.
------------------------------------------------------------------------

[FR Doc. 2014-29022 Filed 12-10-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59071-59072]
[FR Doc No: 2022-21146]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC22-115-000.
    Applicants: MN8 Energy LLC.
    Description: Supplement to August 30, 2022, Joint Application for
Authorization Under Section 203 of the Federal Power Act of MN8 Energy
LLC, et al.
    Filed Date: 9/21/22.
    Accession Number: 20220921-5099.
    Comment Date: 5 p.m. ET 9/28/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL19-58-016.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing Concerning
Certain Reserve Pricing Provisions in EL19-58 to be effective 10/1/
2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5089.
    Comment Date: 5 p.m. ET 10/13/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER22-1857-001.
    Applicants: Louisville Gas and Electric Company.
    Description: Compliance filing: OMU Settlement Compliance Filing to
be effective N/A.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5010.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2117-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2022-09-23_SA 3454 Entergy Arkansas-
Flat Fork 2nd Sub 1st Rev GIA (J907 J1434) to be effective 6/2/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5028.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2388-001.
    Applicants: Mississippi Power Company.
    Description: Compliance filing: MRA 30 Compliance Filing to be
effective 9/14/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5050.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2510-001.
    Applicants: The Narragansett Electric Company.
    Description: Tariff Amendment: Narragnsett MBR Tariff Revisions to
be effective 5/25/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5031.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2609-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2022-09-23_SA 3413 Ameren IL-Cass
County Solar Project Sub 2nd Rev GIA (J859) to be effective 7/22/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5025.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2827-001.
    Applicants: Bluegrass Solar, LLC.
    Description: Tariff Amendment: Amendment to 1 to be effective 9/23/
2022.
    Filed Date: 9/22/22.
    Accession Number: 20220922-5152.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: ER22-2921-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA, Service
Agreement No. 5220; Queue No. AD1-148 to be effective 8/24/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5008.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2922-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Silver State South Solar
Project ED&P LA TOT381-TOT405 (SA290) to be effective 9/24/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5048.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2923-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: UAMPS Const Agmt Santa Clara
BTM Resource Modeling to be effective 11/23/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5074.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2924-000.
    Applicants: RWE Supply & Trading Americas, LLC.
    Description: Baseline eTariff Filing: Application for Market Based
Rate Authority to be effective 11/1/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5079.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2925-000.
    Applicants: Jicarilla Solar 1 LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authority to be effective 11/15/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5121.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2926-000.
    Applicants: Jicarilla Storage 1 LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authority to be effective 12/1/2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5122.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2927-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Mid-Atlantic Interstate
Transmission, LLC submits tariff filing per 35.13(a)(2)(iii: MAIT
submits One ECSA, SA No. 6492 Klecknersville to be effective 11/23/
2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5141.
    Comment Date: 5 p.m. ET 10/14/22.

    Docket Numbers: ER22-2928-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: SPP-AECI JOA Revisions to
Add Provisions for Emergency Energy Assistance to be effective 9/24/
2022.
    Filed Date: 9/23/22.
    Accession Number: 20220923-5151.
    Comment Date: 5 p.m. ET 10/14/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 23, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-21146 Filed 9-28-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80424-80425]
[FR Doc No: 2015-32576]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Bravo Resource Partners, Ltd., First Potash Corp., HIP Energy
Corporation, Musgrove Minerals Corp., and Starcore International
Ventures Ltd. (a/k/a Starcore International Mines Ltd.); Order of
Suspension of Trading

December 22, 2015.
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Bravo Resource
Partners, Ltd. (``BRPNF'') (CIK No. 1116137), a Yukon corporation
located in Englewood, Colorado with a class of securities registered
with the Commission pursuant to Exchange Act Section 12(g) because it
is delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 10-Q for the period
ended October 31, 2011. On April 22, 2015, Corporation Finance sent a
delinquency letter to BRPNF requesting compliance with its periodic
filing requirements but BRPNF did not receive the delinquency letter
due to its failure to maintain a valid address on file with the
Commission as required by Commission rules (Rule 301 of Regulation S-T,
17 CFR 232.301 and Section 5.4 of EDGAR Filer Manual). As of December
9, 2015, the common stock of BRPNF was quoted on OTC Link, had two
market makers, and was eligible for the ``piggyback'' exception of
Exchange Act Rule 15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of First Potash Corp.
(``SALTF'') (CIK No. 1490078), a British Columbia corporation located
in Tucson, Arizona with a class of securities registered with the
Commission pursuant to Exchange Act Section 12(g) because it is
delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 20-F for the period
ended February 29, 2012. On April 28, 2015, Corporation Finance sent a
delinquency letter to SALTF requesting compliance with its periodic
filing requirements but SALTF did not receive the delinquency letter
due to its failure to maintain a valid address on file with the
Commission as required by Commission rules (Rule 301 of Regulation S-T,
17 CFR 232.301 and Section 5.4 of EDGAR Filer Manual). As of December
9, 2015, the common shares of SALTF were quoted on OTC Link, had four
market makers, and were eligible for the ``piggyback'' exception of
Exchange Act Rule 15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of HIP Energy
Corporation (``HIPCF'') (CIK No. 1123839), a British Columbia
corporation located in West Vancouver, BC, Canada with a class of
securities registered with the Commission pursuant to Exchange Act
Section 12(g) because it is delinquent in its periodic filings with the
Commission, having not filed any periodic reports since it filed a Form
20-F for the period ended November 30, 2011. On April 15, 2014,
Corporation Finance sent a delinquency letter to HIPCF requesting
compliance with its periodic filing requirements but HIPCF did not
receive the delinquency letter due to its failure to maintain a valid
address on file with the Commission as required by Commission rules
(Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of EDGAR
Filer Manual). As of December 9, 2015, the common shares of HIPCF were
quoted on OTC Link, had four market makers, and were eligible for the
``piggyback'' exception of Exchange Act Rule 15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Musgrove Minerals
Corp. (``MGSGF'') (CIK No. 1396368), a British Columbia corporation
located in Vancouver, British Columbia, Canada with a class of
securities registered with the Commission pursuant to Exchange Act
Section 12(g) because it is delinquent in its periodic filings with the
Commission, having not filed any periodic reports since it filed a Form
20-F for the period ended November 30, 2007. On April 28, 2015,
Corporation Finance sent a delinquency letter to MGSGF requesting
compliance with its periodic filing requirements but MGSGF did not
receive the delinquency letter due to its failure to maintain a valid
address on file with the Commission as required by Commission rules
(Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of EDGAR
Filer Manual). As of December 9, 2015, the common shares of MGSGF were
quoted on OTC Link, had four market makers, and were eligible for the
``piggyback'' exception of Exchange Act Rule 15c2-11(f)(3).
    It appears to the Commission that there is a lack of current and
accurate information concerning the securities of Starcore
International Ventures Ltd. (a/k/a Starcore International Mines Ltd.)
(``SHVLF'') (CIK No. 1301713), a British Columbia corporation located
in Vancouver, British Columbia, Canada with a class of securities
registered with

the Commission pursuant to Exchange Act Section 12(g) because it is
delinquent in its periodic filings with the Commission, having not
filed any periodic reports since it filed a Form 20-FR-12G on August
31, 2004. On February 19, 2015, Corporation Finance sent a delinquency
letter to SHVLF requesting compliance with its periodic filing
requirements but SHVLF did not receive the delinquency letter due to
its failure to maintain a valid address on file with the Commission as
required by Commission rules (Rule 301 of Regulation S-T, 17 CFR
232.301 and Section 5.4 of EDGAR Filer Manual). As of December 9, 2015,
the common shares of SHVLF were quoted on OTC Link, had seven market
makers, and were eligible for the ``piggyback'' exception of Exchange
Act Rule 15c2-11(f)(3).
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EST on December 22, 2015, through 11:59
p.m. EST on January 6, 2016.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-32576 Filed 12-22-15; 4:15 pm]
 BILLING CODE P


[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Notices]
[Pages 11112-11114]
[FR Doc No: 2014-04262]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0110]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Prescription Drug Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements,
including third party disclosure, contained in FDA's current
regulations on prescription drug advertisements.

DATES: Submit either electronic or written comments on the collection
of information by April 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in

the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Prescription Drug Advertisements--(OMB Control Number 0910-0686)--
Extension

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and
distributors (sponsors) who advertise prescription human and animal
drugs, including biological products for humans, disclose in
advertisements certain information about the advertised product's uses
and risks. For prescription drugs and biologics, section 502(n) of the
FD&C Act requires advertisements to contain ``* * * a true statement *
* *'' of certain information including ``* * * information in brief
summary relating to side effects, contraindications, and effectiveness
* * *'' as required by regulations issued by FDA. FDA's prescription
drug advertising regulations at Sec.  202.1 (21 CFR 202.1) describe
requirements and standards for print and broadcast advertisements.
Section 202.1 applies to advertisements published in journals,
magazines, other periodicals, and newspapers, and advertisements
broadcast through media such as radio, television, and telephone
communication systems. Print advertisements must include a brief
summary of each of the risk concepts from the product's approved
package labeling (Sec.  202.1(e)(1)). Advertisements that are broadcast
through media such as television, radio, or telephone communications
systems must disclose the major risks from the product's package
labeling in either the audio or audio and visual parts of the
presentation (Sec.  202.1(e)(1)); this disclosure is known as the
``major statement.'' If a broadcast advertisement omits the major
statement, or if the major statement minimizes the risks associated
with the use of the drug, the advertisement could render the drug
misbranded in violation of section 502(n) of the FD&C Act, section
201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing
regulations at Sec.  202.1(e).
    Advertisements subject to the requirements at Sec.  202.1 are
subject to the PRA because these advertisements disclose information to
the public. In addition, Sec.  202.1(e)(6) and (j) include provisions
that are subject to OMB approval under the PRA.

Reporting to FDA

    Section 202.1(e)(6) permits a person who would be adversely
affected by the enforcement of a provision of Sec.  202.1(e)(6) to
request a waiver from FDA for that provision. The waiver request must
set forth clearly and concisely the petitioner's interest in the
advertisement, the specific provision of Sec.  202.1(e)(6) from which a
waiver is sought, a complete copy of the advertisement, and a showing
that the advertisement is not false, lacking in fair balance or
otherwise misleading, or otherwise violative of section 502(n) of the
FD&C Act.
    Section 202.1(j), which sets forth requirements for the
dissemination of advertisements subject to the standards in Sec.
202.1(e), contains the following information collection that is subject
to the PRA:
    Under Sec.  202.1(j)(1), a sponsor must submit advertisements to
FDA for prior approval before dissemination if: (1) The sponsor or FDA
has received information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage; (2) FDA has notified the sponsor that the information must be
part of the advertisements for the drug; and (3) the sponsor has failed
to present to FDA a program for assuring that such information will be
publicized promptly and adequately to the medical profession in
subsequent advertisements, or if such a program has been presented to
FDA but is not being followed by the sponsor. Under Sec.
202.1(j)(1)(iii), a sponsor must provide to FDA a program for assuring
that significant new adverse information about the drug that becomes
known (i.e., use of drug may cause fatalities or serious damage) will
be publicized promptly and adequately to the medical profession in any
subsequent advertisements. Under Sec.  202.1(j)(4), a sponsor may
voluntarily submit advertisements to FDA for comment prior to
publication.

Disclosures to the Public

    Under Sec.  202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section.
    Under Sec.  202.1(j)(1), if information that the use of a
prescription drug may cause fatalities or serious damage has not been
widely publicized in the medical literature, a sponsor must include
such information in the advertisements for that drug.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
202.1(e)(6)--Waiver request to                 1               1               1              12              12
 FDA............................
202.1(j)(1)--Submission of                     1               1               1               2               2
 advertisement to FDA for prior
 approval.......................
202.1(j)(1)(iii)--Providing a                  1               1               1              12              12
 program to FDA for assuring
 that adverse information about
 the drug will be publicized....
202.1(j)(4)--Voluntarily                     113               6             678              20          13,560
 submitting the advertisement to
 FDA prior to publication for
 comment........................
                                 -------------------------------------------------------------------------------

    Total.......................                                                                          13,586
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
202.1--Advertisements prepared               541            46.5          25,157             400      10,062,800
 in accordance with Sec.   202.1
202.1(j)(1)--Including                         1               1               1              40              40
 information about the drug's
 fatalities or serious damage in
 the advertisement..............
                                 -------------------------------------------------------------------------------
    Total.......................                                                                      10,062,840
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04262 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Rules and Regulations]
[Pages 50358-50360]
[FR Doc No: 2016-18156]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2016-0005; FRL-9949-94-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Measurement and Reporting of Condensable Particulate
Matter Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Pennsylvania. This SIP revision amends two regulations to clarify
testing and sampling methods for stationary sources of particulate
matter (PM) and adds the requirement to measure and report filterable
and condensable PM. EPA is approving this revision in accordance with
the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on August 31, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2016-0005. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through www.regulations.gov or may be viewed during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Pennsylvania Department of Environmental Protection, Bureau of Air
Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg,
Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Maria A. Pino,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On April 8, 2016 (81 FR 20598), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. In the NPR, EPA
proposed approval of amendments to chapters 121 and 139 of title 25,
Environmental Protection, of the Pennsylvania Code (25 Pa. Code). The
formal SIP revision was submitted by the Commonwealth of Pennsylvania
on June 15, 2015.

II. Summary of SIP Revision

    On June 25, 2015, the Commonwealth of Pennsylvania submitted a
formal SIP revision that amends chapters 121 and 139 of 25 Pa. Code.
Amendments to 25 Pa. Code section 121.1 in chapter 121 add definitions
for the terms ``condensable particulate matter'' and ``filterable
particulate matter.'' The amendments to 25 Pa. Code section 139.12 in
chapter 139 add the requirement to measure and report filterable and
condensable PM and explain the compliance demonstration process. The
amendment to 25 Pa. Code section 139.53 specifies to whom monitoring
reports must be submitted. Other specific requirements of chapters 121
and 139 of 25 Pa. Code and the rationale for EPA's proposed action are
explained in the NPR and will not be restated here. No public comments
were received on the NPR.

III. Final Action

    EPA is approving the June 25, 2015 Pennsylvania SIP revision that
amends specific provisions within chapters 121 and 139 of 25 Pa. Code.
The amendments clarify testing and sampling methods and reporting
requirements for stationary sources of PM and add the requirement to
measure and report filterable and condensable PM.

IV. Incorporation by Reference

    In this rulemaking action, the EPA is finalizing regulatory text
that includes incorporation by reference. In accordance with
requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by
reference of the revised Pennsylvania regulations, published in the
Pennsylvania Bulletin, Vol. 44 No. 15, April 12, 2014, and effective on
April 12, 2014. The EPA has made, and will continue to make, these
documents generally available electronically through
www.regulations.gov and/or may be viewed at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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 (Pub. L. 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 CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable 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.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 30, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This rulemaking action, approving amendments to Pennsylvania's
regulations regarding testing and sampling methods for stationary
sources of PM, including filterable and condensable PM, may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: July 1, 2016.
Shawn M. Garvin,
Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (c)(1) is amended by
revising the entries ``Section 121.1'', ``Section 139.12'', and
``Section 139.53'' to read as follows:

Sec.  52.2020   Identification of plan.

* * * * *
    (c) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                                    State                               Additional explanation/
    State citation          Title/subject      effective date    EPA Approval date      Sec.   52.2063 citation
----------------------------------------------------------------------------------------------------------------
                          Title 25--Environmental Protection Article III--Air Resources
----------------------------------------------------------------------------------------------------------------
                                         Chapter 121--General Provisions
----------------------------------------------------------------------------------------------------------------
Section 121.1.........  Definitions..........      04/12/2014  8/1/16 [Insert         Adds definitions for the
                                                                Federal Register       terms ``condensable
                                                                citation].             particulate matter'' and
                                                                                ``filterable particulate
                                                                                matter.''

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Chapter 139--Sampling and Testing
                            Subchapter A--Sampling and Testing Methods and Procedures
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                               Stationary Sources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 139.12........  Emissions of               04/12/2014  8/1/16 [Insert         Amends section 139.12.
                         particulate matter.                    Federal Register
                                                                citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                               Subchapter B--Monitoring Duties of Certain Sources
                                                     General
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 139.53........  Filing monitoring          04/12/2014  8/1/16 [Insert         Amends section 139.53.
                         reports.                               Federal Register
                                                                citation].

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

* * * * *
[FR Doc. 2016-18156 Filed 7-29-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Rules and Regulations]
[Page 12067]
[FR Doc No: 2017-03848]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 230

[Release Nos. 33-10238A; 34-79161A; File No. S7-22-15]
RIN 3235-AL80

Exemptions To Facilitate Intrastate and Regional Securities
Offerings

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; technical correction.

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

SUMMARY: This document makes a technical correction to one of the final
regulations (SEC Rel. No. 33-10238) published in the Federal Register
on November 21, 2016 (81 FR 83494). Specifically, the amendments to
Rule 504 of Regulation D under the Securities Act of 1933 inadvertently
omitted the word ``or'' from the last sentence of the rule; this
correction is reflected in the text of the amendments below.

DATES: This correction is effective February 28, 2017.

FOR FURTHER INFORMATION CONTACT: Anthony G. Barone, Special Counsel, or
Jenny Riegel, Special Counsel, Division of Corporation Finance, at
(202) 551-3460.

SUPPLEMENTARY INFORMATION: We are making a technical correction to Rule
504 \1\ of Regulation D \2\ under the Securities Act of 1933.
---------------------------------------------------------------------------

    \1\ 17 CFR 230.504.
    \2\ 17 CFR 230.500 through 230.508.
---------------------------------------------------------------------------

List of Subjects in 17 CFR Part 230

    Reporting and recordkeeping requirements, Securities.

Text of the Amendments

    For the reasons set out above, title 17, chapter II of the Code of
Federal Regulations is amended as follows:

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
1. The general authority citation for part 230 continues to read as
follows:

    Authority: 15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h,
77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-
7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-
30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec. 401, 126
Stat. 313 (2012), unless otherwise noted.
* * * * *

0
2. Amend Sec.  230.504 by revising paragraph (b)(2) to read as follows:

Sec.  230.504  Exemption for limited offerings and sales of securities
not exceeding $5,000,000.

* * * * *
    (b) * * *
    (2) The aggregate offering price for an offering of securities
under this Sec.  230.504, as defined in Sec.  230.501(c), shall not
exceed $5,000,000, less the aggregate offering price for all securities
sold within the twelve months before the start of and during the
offering of securities under this Sec.  230.504 or in violation of
section 5(a) of the Securities Act.
* * * * *

    Dated: February 22, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-03848 Filed 2-27-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 16, 2010 (Volume 75, Number 73)]
[Notices]
[Page 20026-20028]
[DOCID:fr16ap10-141]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61879; File No. SR-CBOE-2010-031]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend the Title of CBOE Rule 6.8C

April 8, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on March 29, 2010, Chicago Board Options Exchange, Incorporated
(``CBOE'' or the ``Exchange'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the self-
regulatory organization. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

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

    The Exchange proposes to make a technical amendment to change the
title of a rule. The text of the proposed rule change is available on
CBOE's Web site at http://www.cboe.org, on the Commission's Web site at
http://www.sec.gov, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    In April 2009, the Commission approved a CBOE rule change to modify
Rule 6.8C, Prohibition Against Members Functioning as Market-Makers, to
eliminate some of its restrictions. As revised, Rule 6.8C's
restrictions are now only applicable to customer orders (i.e., non-
broker-dealer orders that are not Voluntary Professional and
Professional orders), since such customer orders have priority at any
price over the bids and offers of non-customers.\5\ The restrictions
are no longer applicable to instances where a member is acting as
principal on its own behalf or is acting as agent on behalf of other
broker-dealer orders or Voluntary Professional or Professional order
[sic].
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act No. 59700 (April 2, 2009), 74 FR
16246 (April 9, 2009) (SR-CBOE-2009-009). When Rule 6.8C was amended
in April 2009, it only referenced Voluntary Professionals. In
December 2009, the Exchange received Commission approval of a rule
change related to Professionals. That rule change, among other
things, excluded Professional orders from the restrictions of Rule
6.8C in the same manner that Voluntary Professionals are excluded
from the restrictions of Rule 6.8C. See Securities Exchange Act
Release No. 61198 (December 17, 2009), 74 FR 68880 (December 29,
2009) (SR-CBOE-2009-078).
---------------------------------------------------------------------------

    The purpose of this rule change is solely to amend the title of
Rule 6.8C to better reflect the current application of the rule. In
particular, the title of Rule 6.8C will be changed from ``Prohibition
Against Members Functioning as Market-Makers'' to ``Prohibition Against
Customers Functioning as Market-Makers.''
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \6\ that an exchange have rules that
are designed to promote just and equitable principles of trade, and to
remove impediments to and perfect the mechanism for a free and open
market and a national market system, and, in general, to protect
investors and the public interest. In particular, the proposed rule
change seeks to update the title of CBOE Rule 6.8C to better reflect
the current application of the rule.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Because the foregoing proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not become operative for 30 days from the
date on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, it has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The Commission notes that the amended title of CBOE Rule 6.8C better
reflects the current application of the rule. Therefore, the Commission
designates the proposal operative upon filing.\11\
---------------------------------------------------------------------------

    \11\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2010-031 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2010-031. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent

amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2010-031 and should be submitted on or before May
7, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-8687 Filed 4-15-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 3, 2008 (Volume 73, Number 233)]
[Notices]
[Page 73648-73652]
[DOCID:fr03de08-27]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0046; FRL-8391-3]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before January 2, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at:
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to

certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed at the
end of the pesticide petition summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this document contain the data or information
prescribed in FFDCA section 408(d)(2); however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the pesticide petitions. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 8E7445. (EPA-HQ-OPP-2008-0810). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540, proposes to establish a tolerance for residues of the
insecticide spinosad, a fermentation product of Saccharopolyspora
spinosa which consists of two related active ingredients: Spinosyn A
(Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-
4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione in or on
pomegranate at 0.3 parts per million (ppm) and date at 0.1 ppm. EPA has
determined adequate analytical methods are available for enforcement
purposes for spinosad in plant and animal matrices. Methods include an
immunoassay particle-based method 97.05 and a high performance liquid
chromatography/ultraviolet (HPLC/UV) method GRM 03.15 and a suite of
specific crop methods: GRM 94.02 (cottonseed and related commodities),
GRM 95.17 (leafy vegetables), GRM 96.09 (citrus), GRM 96.14 (tree
nuts), GRM 95.04 (fruiting vegetables), GRM 94.02.S1 (cotton gin
byproducts). GRM 94.02 has a successful independent lab validation and
was submitted for inclusion in the Pesticide Analytical Manual II (PAM
II) as Method I. EPA recently concluded that for water, residues should
be estimated using total spinosad residue method (EPA, DP
316077, August 2, 2006). The Agency has concluded that spinosad are
considered toxicologically identical to another pesticide, spinetoram.
This conclusion is based on the following:
    i. Spinetoram and spinosad are large molecules with nearly
identical structures; and
    ii. The toxicological profiles for each are similar (generalized
systemic toxicity) with similar doses and endpoints chosen for human-
health risk assessment. Spinosad and spinetoram should be considered
toxicologically identical in the same manner that metabolites are
generally considered toxicologically identical to the parent. Contact:
Laura Nollen,<PHONE_NUMBER><EMAIL_ADDRESS>    2. PP 8E7450. (EPA-HQ-OPP-2008-0805). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540, proposes to establish a tolerance for residues of the
insecticide spinetoram, expressed as a combination of XDE-175-J: 1-H-
as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-
2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-
(2R,3aR,5aR,5bS,9S,13S,14R, 16aS,16bR); XDE-175-L: 1H-as-

indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-
di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R, 16aS,16bS); ND-
J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide in or on pineapple at 0.02 ppm; pomegranate at
0.3 ppm; date at 0.1 ppm; spice, subgroup 19B, except black pepper at
1.7 ppm; hop, dry cones at 22 ppm; and pineapple, process residue at
0.08 ppm. Per the Federal Register of October 10, 2007 (72 FR 57492)
(FRL-8149-9) supported by DP  325387, August 9, 2008, EPA has
determined adequate analytical methods are available for enforcement
purposes for spinetoram in plant and animal matrices. The methods were
noted as efficient and well-documented. The independent laboratory
validation data were acceptable. Spinetoram and its metabolites are
determined using liquid chromatography with positive-ion atmospheric
pressure chemical ionization tandem mass spectrometry (LC/MS/MS). The
limit of detection (LOD) and limit of quantitation (LOQ) in crop and
animal matrices are typically 0.003 g/g and 0.01 g/g, respectively.
Contact: Laura Nollen,<PHONE_NUMBER><EMAIL_ADDRESS>    3. PP 8F7456. (EPA-HQ-OPP-2008-0811). Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a
tolerance for residues of the herbicide mesotrione, in or on soybeans
at 0.01 ppm. Practical and specific analytical method RAM 366/01 is
available for detecting and measuring the level of mesotrione in or on
various crop commodities. Contact: James M. Stone,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Amendment to Existing Tolerances

    1. PP 8E7445. (EPA-HQ-OPP-2008-0810). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540, proposes to amend the tolerances in 40 CFR 180.495 (a) to
increase the levels of existing tolerances for residues of the
insecticide spinosad, a fermentation product of Saccharopolyspora
spinosa which consists of two related active ingredients: Spinosyn A
(Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-
pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-
4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione in or on
nut, tree, group 14 and pistachio from 0.02 to 0.08 ppm; and almond,
hulls from 2.0 ppm to 9.0 ppm. A reduction to a 1-day pre-harvest
interval (PHI) is supported with new MOR data for the increased
tolerances in tree nuts. EPA has determined adequate analytical methods
are available for enforcement purposes for spinosad in plant and animal
matrices. Methods include an immunoassay particle-based method 97.05
and a high performance liquid chromatography/ultraviolet (HPLC/UV)
method GRM 03.15 and a suite of specific crop methods: GRM 94.02
(cottonseed and related commodities), GRM 95.17 (leafy vegetables), GRM
96.09 (citrus), GRM 96.14 (tree nuts), GRM 95.04 (fruiting vegetables),
GRM 94.02.S1 (cotton gin byproducts). GRM 94.02 has a successful
independent lab validation and was submitted for inclusion in the
Pesticide Analytical Manual II (PAM II) as Method I. EPA recently
concluded that for water, residues should be estimated using total
spinosad residue method. The Agency has concluded that spinosad are
considered toxicologically identical to another pesticide, spinetoram.
This conclusion is based on the following:
    i. Spinetoram and spinosad are large molecules with nearly
identical structures; and
    ii. The toxicological profiles for each are similar (generalized
systemic toxicity) with similar doses and endpoints chosen for human-
health risk assessment. Spinosad and spinetoram should be considered
toxicologically identical in the same manner that metabolites are
generally considered toxicologically identical to the parent. Contact:
Laura Nollen,<PHONE_NUMBER><EMAIL_ADDRESS>    2. PP 8E7450. (EPA-HQ-OPP-2008-0805). Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540, proposes to amend the tolerances in 40 CFR 180.635 to increase
the levels of existing tolerances for residues of the insecticide
spinetoram, expressed as a combination of XDE-175-J: 1-H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-
di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b, 6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-
(2R,3aR,5aR,5bS,9S,13S,14R, 16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-
L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,
10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R, 16aS,16bS); ND-
J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide in or on nut, tree, group 14 and pistachio from
0.04 to 0.08 ppm; and almond, hulls from 2.0 ppm to 9.0 ppm. A
reduction to a 1-day pre-harvest interval (PHI) is supported with new
MOR data for the increased tolerances in tree nuts. EPA has determined
adequate analytical methods are available for enforcement purposes for
spinosad in plant and animal matrices. Methods include an immunoassay
particle-based method 97.05 and a high performance liquid
chromatography/ultraviolet (HPLC/UV) method GRM 03.15 and a suite of
specific crop methods: GRM 94.02 (cottonseed and related commodities),

GRM 95.17 (leafy vegetables), GRM 96.09 (citrus), GRM 96.14 (tree
nuts), GRM 95.04 (fruiting vegetables), GRM 94.02.S1 (cotton gin
byproducts). GRM 94.02 has a successful independent lab validation and
was submitted for inclusion in the Pesticide Analytical Manual II (PAM
II) as Method I. EPA recently concluded that for water, residues should
be estimated using total spinosad residue method (EPA, DP
316077, August 2, 2006). The Agency has concluded that spinosad are
considered toxicologically identical to another pesticide, spinetoram.
This conclusion is based on the following:
    i. Spinetoram and spinosad are large molecules with nearly
identical structures; and
    ii. The toxicological profiles for each are similar (generalized
systemic toxicity) with similar doses and endpoints chosen for human-
health risk assessment. Spinosad and spinetoram should be considered
toxicologically identical in the same manner that metabolites are
generally considered toxicologically identical to the parent. Contact:
Laura Nollen,<PHONE_NUMBER><EMAIL_ADDRESS>    3. PP 8F7454. (EPA-HQ-OPP-2008-0806). Y-TEX Corporation, 1825 Big
Horn Avenue, P.O. Box 1450, Cody, WY 82414, proposes to amend the
tolerances in 40 CFR 180.449 by increasing the combined residues of the
insecticide avermectin B1 (a mixture of avermectins
containing greater than or equal to 80% avermectin B1a(5-O-
demethyl avermectin A1) and less than or equal to 20%
avermectin B1b(5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1)) and its delta-8,9-isomer in or
on cattle, fat from 0.015 ppm to 0.03 ppm and cattle, meat byproducts
from 0.02 ppm to 0.06 ppm. Avermectin B1 is referred to as
simply abamectin throughout this document. The analytical method is
titled ``Determination of Macrocyclic Lactone Residues in Bovine and
Ovine Tissues,'' referenced as Method No. AATM-R-53. The method
involves maceration of the tissue sample with acetonitrile,
homogenization, filtration, partition, extraction and cleanup with
analysis by high performance liquid chromatography (HPLC) -
fluorescence detection. The method is sufficiently sensitive to detect
residues at a limit of detection of 0.002 ppm and a limit of
quantification of 0.005 ppm. Both levels are below the tolerances
proposed. The method has undergone independent laboratory validation as
required by PR Notice 96-1. Contact: Thomas Harris,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    4. PP 8F7452. (EPA-HQ-OPP-2008-0813). Bayer CropScience, 2 T.W.
Alexander Drive, Research Triangle Park, NC 27709, proposes to reduce
the tolerance for residues of the herbicide tembotrione, 2-[2-chloro-4-
methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
cyclohexanedione, and its metabolite (M5), 2-[2-chloro-4-
(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-4,6-
dihydroxy-1,3-cyclohexanedione in or on corn, sweet, forage at 0.09
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn,
sweet, stover at 0.15 ppm. Independently validated, analytical methods
for plants, plant products and animal matrices, suitable for
enforcement purposes, have been submitted for measuring tembotrione and
all significant metabolites. Typically, residues are extracted from
plant or animal using accelerated solvent extraction. Following
concentration, quantitation is by liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) using deuterated internal
standards. AE 1392936 requires additional clean-up by anion exchange,
solid phase extraction prior to quantitation. Determination of AE
1417268 in ruminant samples requires a hexane wash prior to
quantitation. Contact: Michael Walsh,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
New Exemptions from an Inert Tolerance

    1. PP 8E7362. (EPA-HQ-OPP-2008-0601). Ag-Chem Consulting, 12208
Quinque Lane, Clifton, VA 21024 on behalf of Caltex Inc., 2 Market
Street, Sydney Australia, proposes to establish an exemption from the
requirement of a tolerance in 40 CFR 180.920 for residues of the
ultraviolet (UV) stabilizer Phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-
4-methyl (CAS No. 23328-53-2) when used as a pesticide inert ingredient
in pesticide spray oil formulations at a maximum concentration of 0.6%
in or on Adzuki beans, canola, chickpeas, cotton, faba beans, field
peas, lentils, linola, linseed, lucerne, lupins, mungbeans, navy beans,
pigeon peas, safflower, sunflower, and vetch. Because this petition is
a request for an exemption from the requirement of a tolerance, no
analytical method is required. Contact: Karen Samek,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    2. PP 8E7363. (EPA-HQ-OPP-2008-0602). Ag-Chem Consulting, 12208
Quinque Lane, Clifton, VA 21024 on behalf of Caltex Inc., 2 Market
Street, Sydney Australia, proposes to establish an exemption from the
requirement of a tolerance in 40 CFR 180.920 for residues of the
ultraviolet (UV) stabilizer 2-(2'-hydroxy-3',5'-di-t-amylphenyl)-
benzotriazole (CAS No. 25973-55-1) when used as a pesticide inert
ingredient in pesticide spray oil formulations at a maximum
concentration of 0.6% in or on Adzuki beans, canola, chickpeas, cotton,
faba beans, field peas, lentils, linola, linseed, lucerne, lupins,
mungbeans, navy beans, pigeon peas, safflower, sunflower, and vetch.
Because this petition is a request for an exemption from the
requirement of a tolerance, no analytical method is required. Contact:
Karen Samek,<PHONE_NUMBER><EMAIL_ADDRESS>    3. PP 8E7387. (EPA-HQ-OPP-2008-0671). Loveland Products, Inc., P.O.
Box 1286, Greeley, CO 80632-1286, proposes to establish an exemption
from the requirement of a tolerance in 40 CFR 180.920 for residues of
the choline chloride (CAS No. 67-48-1) when used as a pesticide inert
ingredient as a solvent in pesticide formulations. Because this
petition is a request for an exemption from the requirement of a
tolerance, no analytical method is required. Contact: Karen Samek,
(703) 347-8825<EMAIL_ADDRESS>    4. PP 8E7421. (EPA-HQ-OPP-2008-0794). Akzo Nobel Surface Chemistry,
LLC, 525 West Van Buren Street, Chicago, IL 60607-3823, proposes to
establish an exemption from the requirement of a tolerance in 40 CFR
180.960 for residues of formaldehyde, polymer with 2-methyloxirane and
4-nonylphenol (CAS No. 37523-33-4) when used as a pesticide inert
ingredient in pesticide formulations. Akzo Nobel submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA) requesting an
exemption from the requirements of a tolerance. This petition requests
the elimination of the need to establish a maximum permissible level
for residues of formaldehyde, polymer with 2-methyloxirane and 4-
nonylphenol in or on all raw agricultural commodities. Because this
petition is a request for an exemption from the requirement of a
tolerance, no analytical method is required. Contact: Alganesh Debesai,
(703) 308-8353<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: November 25, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E8-28668 Filed 12-2-08; 8:45 am]

BILLING CODE 6560-50-S