[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Page 73551]
[FR Doc No: 2022-26090]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9282-039]

Pine Valley Hydroelectric Power Company, LLC; Notice of Intent To
File License Application, Filing of Pre-Application Document, and
Approving Use of The Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 9282-039.
    c. Date Filed: September 27, 2022.
    d. Submitted by: Pine Valley Hydroelectric Power Company, LLC (Pine
Valley Hydro).
    e. Name of Project: Pine Valley Hydroelectric Project (project).
    f. Location: On the Souhegan River in Hillsborough County, New
Hampshire. No federal lands are occupied by the project works or
located within the project boundary.
    g. Filed Pursuant To: 18 CFR 5.3 and 5.5 of the Commission's
regulations.
    h. Potential Applicant Contact: Mr. Jonathan DiCesare, Pine Valley
Hydroelectric Power Company, LLC; 10 Roberts Lane, Suite 201,
Ridgefield, CT 06877;<PHONE_NUMBER>; or email at
[email protected].
    i. FERC Contact: Michael Watts at<PHONE_NUMBER>; or email at
[email protected].
    j. Pine Valley Hydro filed its request to use the Traditional
Licensing Process on September 27, 2022, and provided public notice of
its request on September 20, 2022. In a letter dated November 23 2022,
the Director of the Division of Hydropower Licensing approved Pine
Valley Hydro's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7
of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the New Hampshire State Historic Preservation
Officer, as required by section 106 of the National Historic
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Pine Valley Hydro as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. On September 27, 2022, Pine Valley Hydro filed a Pre-Application
Document (PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed and/or printed on the
Commission's website (http://www.ferc.gov), using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). At this time, the Commission has
suspended access to the Commission's Public Reference Room due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19) issued on March 13, 2020.
    o. The licensee states its unequivocal intent to submit an
application for a subsequent license for Project No. 9282. Pursuant to
18 CFR 16.20, each application for a subsequent license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by September
30, 2027.
    p. Register online at https://ferconline.ferc.gov/FERCOnline.aspx
to be notified via email of new filings and issuances related to this
or other pending projects. For assistance, contact FERC Online Support.

    Dated: November 23, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-26090 Filed 11-29-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25567-25568]
[FR Doc No: 2017-11569]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2015-0683; FRL-9962-67]
RIN 2070-AK00

Notification of Submission to the Secretaries of Agriculture and
Health and Human Services; Pesticides; Technical Amendment to Data
Requirements for Antimicrobial Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of submission to the Secretaries of Agriculture
and Health and Human Services.

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SUMMARY: This document notifies the public as required by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA
Administrator has forwarded to the Secretary of the United States
Department of Agriculture (USDA) and the Secretary of the United States
Department of Health and Human Services (HHS) a draft regulatory
document concerning Pesticides; Technical Amendment to Data
Requirements for Antimicrobial Pesticides. The draft regulatory
document is not available to the public until after it has been signed
and made available by EPA.

DATES: See Unit I. under SUPPLEMENTARY INFORMATION.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0683, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Docket (OPP Docket) in the Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    Section 25(a)(2)(A) of FIFRA requires the EPA Administrator to
provide the Secretary of USDA with a copy of any draft proposed rule at
least 60 days before signing it in proposed form for publication in the
Federal Register. Similarly, FIFRA section 21(b) requires the EPA
Administrator to provide the Secretary of HHS with a copy of any draft
proposed rule pertaining to a public health pesticide at least 60 days
before publishing it in the Federal Register. The draft proposed rule
is not available to the public until after it has been signed by EPA.
If either Secretary comments in writing regarding the draft proposed
rule within 30 days after receiving it, the EPA Administrator shall
include the comments of the Secretary and the EPA Administrator's
response to those comments with the proposed rule that publishes in the
Federal Register. If either Secretary

does not comment in writing within 30 days after receiving the draft
proposed rule, the EPA Administrator may sign the proposed rule for
publication in the Federal Register any time after the 30-day period.

II. Do any Statutory and Executive Order reviews apply to this
notification?

    No. This document is merely a notification of submission to the
Secretaries of USDA and HHS. As such, none of the regulatory assessment
requirements apply to this document.

    Dated: May 17, 2017.
Marietta Echeverria,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2017-11569 Filed 6-1-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Page 50901]
[FR Doc No: 2023-16329]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4699-DR; Docket ID FEMA-2023-0001]

California; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of California (FEMA-4699-DR), dated April 3, 2023, and
related determinations.

DATES: This amendment was issued May 25, 2023.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of California is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 3, 2023.

    Butte County for Individual Assistance (already designated for
Public Assistance).
    El Dorado, Humboldt, Lake, Marin, Napa, Nevada, Sacramento, San
Luis Obispo, Santa Barbara, Santa Clara, and Shasta Counties for
Public Assistance.
    Mono County for Public Assistance (already designated for
Individual Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-16329 Filed 8-1-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Rules and Regulations]
[Pages 26419-26422]
[FR Doc No: 2021-10133]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; EPA-HQ-SFUND-1989-0008; EPA-HQ-SFUND-1986-
0005; EPA-HQ-SFUND-1990-0010; FRL-10023-78-OLEM]

Deletions From the National Priorities List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) announces the
partial deletion of five sites from the Superfund National Priorities
List (NPL). The NPL, created under section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, as amended, is an appendix of the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP). The EPA and the states,
through their designated state agencies, have determined that all
appropriate response actions under CERCLA, other than operation and
maintenance, monitoring, and five-year reviews, where applicable, have
been completed. However, this deletion does not preclude future actions
under Superfund.

DATES: The document is effective on May 14, 2021.

ADDRESSES: Docket: EPA has established a docket for this action under
the Docket Identification included in Table 1 in the SUPPLEMENTARY
INFORMATION section of this document. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information 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 electronically through https://www.regulations.gov or
in hard copy at the corresponding Regional Records Centers. Locations,
addresses, and phone numbers of the Regional Records Centers follow.
    Regional Records Centers:
     Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA Superfund
Records Center, 1650 Arch Street, Mail code 3SD42, Philadelphia, PA
19103; 215/814-3024.
     Region 5 (IL, IN, MI, MN, OH, WI), U.S. EPA Superfund
Division Records Manager, Mail code SRC-7J, Metcalfe Federal Building,
7th Floor South, 77 West Jackson Boulevard, Chicago, IL 60604; 312/886-
4465.
     Region 7 (IA, KS, MO, NE), U.S. EPA, 11201 Renner Blvd.,
Mail code SUPRSTAR, Lenexa, KS 66219; 913/551-7956.
     Region 9 (AZ, CA, HI, NV, AS, GU, MP), U.S. EPA, 75
Hawthorne Street, Mail code SFD 6-1, San Francisco, CA 94105; 415/972-
3160.
    The EPA is temporarily suspending Regional Records Centers for
public visitors to reduce the risk of transmitting COVID-19.
Information in these repositories, including the deletion docket, may
not be updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID.

FOR FURTHER INFORMATION CONTACT:
 Andrew Hass, U.S. EPA Region 3 (DE, DC, MD, PA, VA, WV),
<EMAIL_ADDRESS>215/814-2049
 Karen Cibulskis, U.S. EPA Region 5 (IL, IN, MI, MN, OH, WI),
<EMAIL_ADDRESS>312/886-1843
 David Wennerstrom, U.S. EPA Region 7 (IA, KS, MO, NE),
<EMAIL_ADDRESS>913/551-7996
 Eric Canteenwala, U.S. EPA Region 9 (AZ, CA, HI, NV, AS, GU,
MP<EMAIL_ADDRESS>415/972-3932
 Chuck Sands, U.S. EPA Headquarters<EMAIL_ADDRESS>
703/603-8857

SUPPLEMENTARY INFORMATION: Table 1 includes the portions of the site
(media and areas) to be partially deleted from the NPL.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
                                                                                Docket No.  EPA-
              Site name                    City/county, state       Media/parcels for partial   HQ-SFUND-  year-
                                                                             deletion               docket ID
----------------------------------------------------------------------------------------------------------------
Palmerton Zinc Pile.................  Palmerton, PA..............  117 parcels in OU3.........         1983-0002
North Penn--Area 6..................  Lansdale, PA...............  1.66-acres soil and                 1989-0008
                                                                    groundwater of the Second
                                                                    Administrative Parcel, 135
                                                                    East Hancock Street.
Lake Sandy Jo (M&M Landfill)........  Gary, IN...................  Soil media of Landfill              1983-0002
                                                                    Property and identified
                                                                    adjacent parcels of OU1
                                                                    land.
Midwest Manufacturing/North Farm....  Kellogg, IA................  OU 1 North Farm............         1986-0005
Fort Ord............................  Marina, CA.................  Soil media of approximately         1990-0010
                                                                    11,934 acres\1\.
----------------------------------------------------------------------------------------------------------------
Footnote 1 for Table 1: The acreage of the partial deletion for the Fort Ord Superfund site was incorrectly
  reported in the proposed rule as 11,961-acres due to an administrative error. The correct acreage is 11,934-
  acres. The names and descriptions of all parcels identified for partial deletion were correct and remain
  unchanged.

    The sites to be partially deleted from the NPL, information
concerning the proposed rule for the partial deletion including
reference documents with the rationale and data principally relied upon
by the EPA to determine that the Superfund response is complete, public
comment and Responsiveness Summary (RS) (if applicable) are included in
Table 2.

                                                                         Table 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Date, proposed
            Site name                   rule              FR citation               Public comment                   RS                   Footnote
--------------------------------------------------------------------------------------------------------------------------------------------------------
Palmerton Zinc Pile..............      11/20/2020  85 FR 74306..............  No.......................  No.......................  ....................
North Penn--Area 6...............      12/30/2020  85 FR 86525..............  Yes......................  Yes......................  1, 2, 3
Lake Sandy Jo (M&M Landfill).....      11/20/2020  85 FR 74306..............  Yes......................  Yes......................  1, 2, 3
Midwest Manufacturing/North Farm.      11/20/2020  85 FR 74306..............  No.......................  No.......................  1, 3
Fort Ord.........................      11/20/2020  85 FR 74306..............  Yes......................  Yes......................  1, 2, 3
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The NCP permits activities to occur at a deleted site or that media
or parcel of a partially deleted site, including operation and
maintenance of the remedy, monitoring, and five-year reviews. These
activities for the site are entered in Table 2 above, if applicable,
under Footnote such that; 1 = site has continued operation and
maintenance of the remedy, 2 = site receives continued monitoring, and
3 = site five-year reviews are conducted. All other Superfund site
areas and media will remain on the NPL and are not being considered for
deletion as part of this action.
    The EPA received comments on three of the sites included for
partial deletion in this final rule. EPA did not receive adverse
comments on the Palmerton Zinc Pile and Midwest Manufacturing/North
Farm sites, therefore EPA will proceed with the partial deletions. For
the North Penn--Area 6 site, the closing date for comments on the
Notice of Intent to Delete was January 29, 2021. Three public comments
were received. One comment supported the proposed deletion. One comment
was not related to the proposed rulemaking partially deleting the site
from the NPL. The third commentor questioned EPA's technical rationale
for the proposed partial deletion. EPA has determined that all
appropriate Fund-financed responses under CERCLA have been implemented
at the 1.66-acre portion of the approximately 650-acre North Penn--Area
6 site proposed for deletion, and this forms the basis for deciding
that the Second Administrative Parcel is eligible for deletion.
Response actions continue for other portions of the site which remain
on the NPL. Further details of the technical basis for partial deletion
are provided within documents in the docket. EPA reviewed soil and
groundwater data, which indicate that soil and groundwater
contamination levels do not warrant further response actions within the
Second Administrative Parcel. Remedial Action completion reports for
soils (Operable Unit 1) and groundwater (Operable Unit 3) are both
included in the deletion docket. EPA still believes the deletion action
is appropriate. A responsiveness summary was prepared and placed in the
docket, EPA-HQ-SFUND-1989-0008, on https://www.regulations.gov, and in
the Regional repository listed in the ADDRESSES section.
    For the Lake Sandy Jo (M&M Landfill) site, the closing date for
comments on the Notice of Intent to Delete was December 21, 2020. Three
public comments were received. Two residents living near the site
submitted comments. A third comment from Regulations.gov included
general comments on the content and wording of EPA's November 20, 2020
Federal Register notice. The two residents commented on multiple issues
and expressed community concerns that the site was still contaminated,
and EPA was proposing to delete the site to eliminate EPA
responsibility. EPA contacted the residents, provided additional
information, and conducted a virtual meeting to further explain the
proposed partial deletion of the land/soil portion of the Landfill
Property and identified adjacent parcels. Continued response actions
will occur at portions of the site which remain on the NPL. EPA has
determined that it is appropriate to proceed with the deletion because
all response actions at the portion of the Lake Sandy Jo site proposed
for deletion are complete and the criteria for deletion have been met.
A responsiveness summary was prepared and placed in the docket, EPA-HQ-
SFUND-1983-0002, on https://www.regulations.gov, and in the Regional
repository listed in the ADDRESSES section.

    For the Fort Ord site, the closing date for comments on the Notice
of Intent to Delete was December 21, 2020. Seven submissions from five
commenters opposing the partial deletion were received. Several
comments questioned the timing of the partial deletion proposal at the
end of the previous Administration, subsequent to the sunset of the
Fort Ord Reuse Authority in June 2020, and questioned the utility of a
partial deletion rather than a full site deletion after all response
work would be complete at the site. EPA is deleting portions of Fort
Ord from the NPL because they meet the-criteria for site deletion, that
all appropriate response actions have been implemented. EPA determined
the partial deletion was appropriate in consultation with state
agencies including the California Department of Toxic Substances
Control and the Central Coast Regional Water Quality Control Board. The
Fort Ord Reuse Authority completed their clean-up responsibilities and
the sunset of the Authority does not impact future clean-up. The Army
will remain responsible for the remaining site clean-up with EPA and
state oversight. Other comments questioned the public outreach
activities at the site for the partial deletion and dissemination of
information to new residents. The site has robust public outreach
activities, even though COVID restrictions recently imposed by the
State impacted in-person community outreach activities at Fort Ord.
Several submissions from commentors were received which included
historic information and information about other sites which were not
accurate or germane for current clean-up actions at portions of the
Fort Ord site proposed for partial deletion. Comments included concerns
about residual munitions remaining after clean-up and contamination
from lead. Lead contamination at the site is primarily found at former
small arms training ranges; 162,800 cubic yards of soil and 719,000
pounds of spent ammunition were removed from the former Site 3 Beach
Trainfire Ranges, now Fort Ord Dunes State Park. After clean-up,
bullets are occasionally found. The Fort Ord Dunes State Park personnel
collect bullets as required by state deed covenants and transfer them
to the Army for disposal. If suspected munitions or explosives of
concern are found at Fort Ord Dunes State Park, personnel notify the
County bomb squad and the Army. Several additional small areas of lead
contamination that have not yet been addressed remain on the NPL.
Concerns were expressed about per- and polyfluoroalkyl substances
(PFAS) compound contamination. The following media remain on the NPL:
Groundwater, soil gas and surface areas impacted by soil gas, and all
soil and groundwater media associated with areas under evaluation for
the potential presence of contamination from per- and polyfluoroalkyl
substances (PFAS) compounds. A responsiveness summary was prepared and
placed in the docket, EPA-HQ-SFUND-1990-0010, on https://www.regulations.gov, and in the Regional repository listed in the
ADDRESSES section.
    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

Larry Douchand,
Director, Office of Superfund Remediation and Technology Innovation.

    For reasons set out in the preamble, the EPA amends 40 CFR part 300
as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR,
1987 Comp., p. 193.

0
2. Amend appendix B to part 300:
0
a. In Table 1 by revising the entries for ``IA, Midwest Manufacturing/
North Farm, Kellogg''; ``IN, Lake Sandy Jo (M&M Landfill), Gary''; and
``PA, Palmerton Zinc Pile, Palmerton''; and
0
b. In Table 2 by revising the entry for ``CA, Fort Ord, Marina''.
    The revisions read as follows:

Appendix B to Part 300--National Priorities List

                                       Table 1--General Superfund Section
----------------------------------------------------------------------------------------------------------------
             State                      Site name              City/county                   Notes a
----------------------------------------------------------------------------------------------------------------
IA.............................  Midwest Manufacturing/  Kellogg...............  P
                                  North Farm.

                                                  * * * * * * *
IN.............................  Lake Sandy Jo (M&M      Gary..................  P
                                  Landfill).

                                                  * * * * * * *
PA.............................  Palmerton Zinc Pile...  Palmerton.............  P

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ * * *
P = Sites with partial deletion(s).

                                       Table 2--Federal Facilities Section
----------------------------------------------------------------------------------------------------------------
             State                      Site name              City/county                   Notes a
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
CA.............................  Fort Ord..............  Marina................  P

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
 * * * * * *
\(a)\ * * *
P = Sites with partial deletion(s).

[FR Doc. 2021-10133 Filed 5-13-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 30, 2009 (Volume 74, Number 228)]
[Rules and Regulations]
[Page 62481-62485]
[DOCID:fr30no09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0328; Directorate Identifier 2008-NE-44-AD;
Amendment 39-16103; AD 2009-24-11]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CF34-1A,
CF34-3A, and CF34-3B Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for GE
CF34-1A, CF34-3A, and CF34-3B series turbofan engines. This AD requires
removing from service certain part number (P/N) and serial number (SN)
fan blades within compliance times specified in this AD, inspecting the
fan blade abradable rub strip on certain engines for wear, inspecting
the fan blades on certain engines for cracks, inspecting the aft
actuator head hose fitting for correct position, and, if necessary,
repositioning the hose fitting. This AD results from a report of an
under-cowl fire and a failed fan blade. We are issuing this AD to
prevent failure of certain P/N and SN fan blades and aft actuator head
hoses, which could result in an under-cowl fire and subsequent damage
to the airplane.

DATES: This AD becomes effective January 4, 2010. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of January 4, 2010.

ADDRESSES: You can get the service information identified in this AD
from General Electric Company, GE-Aviation, Room 285, 1 Newmann Way,
Cincinnati, OH 45215, telephone (513) 552--3272; fax<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>The Docket Operations office is located at
Docket Management Facility, U.S. Department of Transportation, 1200 New
Jersey Avenue, SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001.

FOR FURTHER INFORMATION CONTACT: John Frost, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39
with a proposed AD. The proposed AD applies to GE CF34-1A, CF34-3A, and
CF34-3B series turbofan engines. We published the proposed AD in the
Federal Register on April 8, 2009 (74 FR 15896). That action proposed
to require removing from service certain P/N and SN fan blades within
compliance times specified in the proposed AD, inspecting the fan blade
abradable rub strip on certain engines for wear, inspecting the fan
blades on certain engines for cracks, inspecting the aft actuator head
hose fitting for correct position, and, if necessary, repositioning the
hose fitting.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is provided in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments received.

Request To Modify Wording in Compliance Paragraphs (f)(2) Through
(f)(6)(ii)

    One commenter requests that we modify the wording in proposed AD
compliance paragraphs (f)(2) through (f)(6)(ii), by adding words that
the actions required by GEAE SB CF34-AL S/B 72-0250 apply only to those
engines that have not had the actions of GEAE SB CF34-AL S/B 72-0245
performed. The commenter states that GEAE SB CF34-AL S/B 72-0250 only
applies to fan blades with SNs listed in GEAE SB CF34-AL S/B 72-0245.
    We do not agree. The proposed AD stated in paragraph (f) that only
fan blade SNs listed in GEAE SB CF34-AL S/B 72-0245 are affected. That
paragraph is now paragraph (h) in this AD, as we recodified the AD
paragraphs to add clarification in response to another comment we
received. We did not change the AD.

Request for Eddy Current Inspection (ECI) for Fan Blades That Have More
than 1,200 Cycles-In-Service (CIS)

    Bombardier Flexjet and GE Aviation request that we also include an
ECI in the AD for fan blades that have more than 1,200 CIS on the
effective date of the AD.
    We agree. We changed proposed AD paragraph from ``(g)(3) For fan
blades, P/N 6018T30P14, with more than 850 cycles-since-new (CSN), but
fewer than 1,200 CSN on the effective date of this AD, within 350 CIS
after the effective date of this AD, perform an initial ECI of the fan
blades for cracks'' to ``(k)(3) For fan blades, P/N 6018T30P14, with
more than 850 CSN, perform an initial ECI of the fan blades for cracks
within 350 CIS after the effective date of this AD'' in this AD.

Under-Cowl Fire Determination of Cause Not Consistent

    GE Aviation states that, in the Discussion section of the proposed
AD, the statement that it was not possible to determine the cause of
the under-cowl fire was not consistent with the GE fire investigation.
GE stated that their fire investigation concluded that the most
probable cause of the under-cowl fire was the separation of the
variable geometry aft actuator head hose from the fuel control.
    We do not agree. The exact cause of the fire could not be
determined due to the thermal damage. We did not change the AD.

Clarification of Gearbox Separation Statement

    GE Aviation states that, in the Discussion section of the proposed
AD, the statement that the gearbox separated from the engine needs
clarification. GE Aviation states that the gearbox is designed to
uncouple from the engine during high-load events such as a fan blade
out, and the gearbox is secured to the engine by secondary restraint
cables. This uncoupling occurred on the left-hand mount, and should not
have contributed to the hose failure if the hose was properly aligned.
    We do not agree. The wording is factually correct, and we did not
state that the separation caused the fire. We did not change the AD.

Claim That the Fire Event Was a Controlled Fire

    GE Aviation claims that the event that this AD results from was a
``controlled fire'' as the fire had been put out and did not create a
hazard for the airplane.
    We do not agree. The fire continued to burn unabated until the
unidentified fuel source was exhausted. We did not change the AD.

Recommendation To Include GE Remote Diagnostics

    GE Aviation and Mesaba Airlines recommend that GE Remote
Diagnostics be included in proposed AD compliance paragraph (f)(6) as
an alternate method of compliance (AMOC) for monitoring blade health.
GE Aviation also recommends that we allow a recurrent ECI at 600-cycle
intervals for consistency between the Regional Jet and Business Jet
operators. GE Aviation states that the fan blade tang cracking
algorithms developed by GE have been validated analytically, as well as
in the field, and contributed substantially to finding three cracked
blades during 2008.
    We do not agree. We cannot include the GE Remote Diagnostics
program, because it is a program outside regulatory control. Further,
the program cannot replace a visual inspection to verify fan blade
cracks. Finally, no GE service bulletin requirement or FAA requirement
exists for ECI of the fan blades operating in engines in the Regional
Jet operations. We did not change the AD.

Request To Revise the Wording in Proposed AD Compliance Paragraphs (f)
and (g)

    GE Aviation requests that we revise the wording in proposed AD
compliance paragraphs (f) and (g) to clarify our instructions related
to operators who fly a Regional Jet with a CF34-3A1 engine in a
Business jet application. The commenter states that GEAE SB CF34-AL S/B
72-0245 and SB CF34-AL S/B 72-0250 apply to a small number of Business
Jet operators with the CF34-3A1 engine, who fly under the Regional jet
manual.
    We agree. We changed the compliance section in this AD by adding
the requested information and by recodifying the paragraphs.

Request To Correct a Typographical Error

    GE Aviation requests that we correct a service bulletin issue date
in paragraph (f), to be July 30, 2008.
    We agree. We corrected the date in the AD, which is now in
paragraph (h).

Request To Remove Inspection of Rubstrips at CSN

    Mesaba Airlines requests that we remove the requirements to inspect
the fan blade rub strips on fan blades with more than 1,200 CSN, within
20 CIS of the AD effective date, and on fan blades with fewer than
1,200 CSN, by 1,220 CSN. The commenter requests that we add a rub strip
inspection every 75 CIS or 100 hours-in-service, until the fan blades
are replaced. The commenter states that it is difficult to know the CSN
on each fan blade.
    We do not agree. To reduce the risk of fan blade failure, the rub
strips need to be inspected as required in the AD. We did not change
the AD.

Include a Process for Determining Fan Blade Cyclic Limits

    Mesaba Airlines states that the FAA should include a process for
determining cyclic limits if the fan blades CIS were not established
when the fan blades were introduced into service.
    We do not agree. If operators do not track fan blade time or CIS,
they will need to apply for an alternative method

of compliance (AMOC) to this AD. We did not change the AD.

Request for Separate ADs

    Mesaba Airlines requests that we issue separate ADs for the
Regional Jet fleet and the Business Jet fleet. The commenter feels the
proposed AD is far too complex.
    We do not agree. The compliance section in the proposed AD is
sufficiently direct. We did not change the AD.

Request To Define Terms

    Mesaba Airlines requests that we define the terms ``CSLI'' and
``HSLI'' in the proposed AD compliance section.
    In response, we note that we already did, and direct Mesaba
Airlines to paragraph (f)(6) in the proposed AD, and in this AD, to
compliance paragraph (h)(6).

Request To Not Include Service Bulletin Requirements

    Mesaba Airlines requests that we not include the requirements of
paragraph 3.A.(2)(d) of GEAE SB CF34-AL S/B 72-0250 in the AD.
    We agree. We did not include those requirements in the AD.

Conclusion

    We have carefully reviewed the available data, including the
comments received, and determined that air safety and the public
interest require adopting the AD with the changes described previously.
We have determined that these changes will neither increase the
economic burden on any operator nor increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 1,966 engines installed on
airplanes of U.S. registry. We estimate that the fan blade inspection
and replacement requirement will affect 300 of these engines, and the
actuator head hose inspection would affect 1,662 engines. We also
estimate that it will take 0.5 work-hour per engine to inspect the fan
blade abradable rub strip, 6 work-hours per engine to visually inspect
the fan blades, 11 work-hours per engine to perform an eddy current
inspection of the fan blades, and 0.25 work-hour per engine to inspect
the actuator head hose fitting, and that the average labor rate is $80
per work-hour. Required parts will cost $51,106,600. Based on these
figures, we estimate the total cost of the AD to U.S. operators to be
$51,184,000.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2009-24-11 General Electric Company: Amendment 39-16103. Docket No.
FAA-2009-0328; Directorate Identifier 2008-NE-44-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
4, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF34-1A,
CF34-3A, CF34-3A1, CF34-3A2, CF34-3B, and CF34-3B1 turbofan engines.
These engines are installed on, but not limited to, Bombardier
Canadair Models CL-600-2A12, CL-600-2B16, and CL-600-2B19 airplanes.

Unsafe Condition

    (d) This AD results from a report of an under-cowl fire and a
failed fan blade. We are issuing this AD to prevent failure of
certain part number (P/N) and serial number (SN) fan blades and aft
actuator head hoses, which could result in an under-cowl fire and
subsequent damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

CF34-3A1 and CF34-3B1 Engines

    (f) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 22,000 CSN; and
    (g) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 15,000 CSN that
are in compliance with GE Aircraft Engines (GEAE) Service Bulletin
(SB) CF34-AL S/B 72-0147, dated May 21, 2003, Revision 01, dated
October 17, 2003, Revision 02, dated August 5, 2004, or Revision 3,
dated August 28, 2003; and
    (h) For CF34-3B1 engines with fan blades, P/Ns 6018T30P14 or
4923T56G08, that have a fan blade SN listed in Appendix A of GEAE SB
CF34-AL S/B 72-0245, Revision 01, dated July 30, 2008;
    (i) Do the following for the engines meeting the criteria in
paragraph (f), (g), or (h) of this AD, as applicable:
    (1) Remove fan blades from service within 4,000 cycles-in-
service (CIS) after the effective date of this AD or by December 31,
2010, whichever occurs first.

Initial Visual Inspection of the Fan Blade Abradable Rub Strip for Wear

    (2) For fan blades with 1,200 or more cycles-since-new (CSN) on
the effective date of this AD, perform an initial visual inspection
of the fan blade abradable rub strip for wear within 20 CIS after
the effective date of this AD. Use paragraphs 3.A.(1) through
3.A.(2) of the Accomplishment

Instructions of GEAE SB CF34-AL S/B 72-0250, Revision 01, dated
November 26, 2008, to perform the inspection.
    (3) For fan blades with fewer than 1,200 CSN on the effective
date of this AD, perform an initial visual inspection of the fan
blade abradable rub strip for wear within 1,220 CSN. Use paragraphs
3.A.(1) through 3.A.(2) of the Accomplishment Instructions of GEAE
SB CF34-AL S/B 72-0250, Revision 01, dated November 26, 2008, to
perform the inspection.
    (4) If you find a continuous 360 degree rub indication, before
further flight, visually inspect the fan blades using paragraphs
3.A.(2)(a) through 3.A.(2)(b) of the Accomplishment Instructions of
GEAE SB CF34-AL S/B 72-0250, Revision 01, dated November 26, 2008.
    (5) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Repetitive Visual Inspection of the Fan Blade Abradable Rub Strip for
Wear

    (6) Within 75 cycles-since-last inspection (CSLI) or 100 hours-
since-last-inspection (HSLI), whichever occurs later, perform a
visual inspection of the fan blade abradable rub strip for wear. Use
paragraphs 3.A.(1) through 3.A.(2) of the Accomplishment
Instructions of GEAE SB CF34-AL S/B 72-0250, Revision 01, dated
November 26, 2008, to perform the inspection.
    (i) If you find a continuous 360 degree rub indication, before
further flight, visually inspect the fan blades using paragraphs
3.A.(2)(a) through 3.A.(2)(b) of the Accomplishment Instructions of
GEAE SB CF34-AL S/B 72-0250, Revision 01, dated November 26, 2008.
    (ii) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Inspection of the Aft Actuator Head Hose Fitting on CF34-3A1 and CF34-
3B1 Engines

    (7) Within 750 hours time-in-service (TIS) after the effective
date of this AD, visually inspect and, if necessary, reposition the
aft actuator head hose fitting. Use paragraph 3.A of the
Accomplishment Instructions of GEAE SB CF34-AL S/B 73-0046, Revision
02, dated August 27, 2008, to perform the inspection.

CF34-1A, CF34-3A, CF34-3A2, CF34-3B, and CF34-3A1 Engines

    (j) For CF34-3A1 engines with fan drive shaft, P/N 6036T78P02,
and airworthiness limitation section life limit of 15,000 CSN, that
are not in compliance with GEAE SB CF34-AL S/B 72-0147, dated May
21, 2003, Revision 01, dated October 17, 2003, Revision 02, dated
August 5, 2004, or Revision 3, dated August 28, 2003; and
    (k) For CF34-1A, CF34-3A, CF34-3A2, and CF34-3B engines with fan
blades, P/N 6018T30P14 or P/N 4923T56G08, that have a fan blade SN
listed in Appendix A of GEAE SB CF34-BJ S/B 72-0229, Revision 01,
dated July 30, 2008;
    (l) Do the following for the engines meeting the criteria in
paragraph (j) or (k) of this AD as applicable:
    (1) Remove fan blades, P/N 6018T30P14, from service within 2,400
CSN.
    (2) Remove fan blades, P/N 4923T56G08, from service within 1,200
CIS since the bushing repair of the fan blade hole.

Initial Eddy Current Inspection of the Fan Blades

    (3) For fan blades, P/N 6018T30P14, with more than 850 CSN,
perform an initial eddy current inspection (ECI) of the fan blades
for cracks within 350 CIS after the effective date of this AD. Use
paragraphs 3.A. or 3.B. of the Accomplishment Instructions of GEAE
SB CF34-BJ S/B 72-0229, Revision 01, dated July 30, 2008, to perform
the inspection.
    (4) For fan blades, P/N 6018T30P14, with 850 or fewer CSN on the
effective date of this AD, perform an initial ECI of the fan blades
for cracks within 1,200 CSN. Use paragraphs 3.A. or 3.B. of the
Accomplishment Instructions of GEAE SB CF34-BJ S/B 72-0229, Revision
01, dated July 30, 2008, to perform the inspection.
    (5) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Repetitive ECI of the Fan Blades

    (6) For fan blades, P/N 6018T30P14, within 600 CSLI, perform an
ECI of the fan blades for cracks. Use paragraphs 3.A. or 3.B. of the
Accomplishment Instructions of GEAE SB CF34-BJ S/B 72-0229, Revision
01, dated July 30, 2008, to perform the inspection.
    (7) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Initial Visual Inspection of the Fan Blade Abradable Rub Strip for Wear

    (8) For engines with fan blades, P/N 6018T30P14, installed that
have a fan blade SN listed in Appendix A of GEAE SB CF34-BJ S/B 72-
0229, Revision 01, dated July 30, 2008, with 1,200 or more CSN on
the effective date of this AD, and that haven't had an ECI of the
fan blades for cracks, do the following:
    (i) Perform an initial inspection of the fan blade abradable rub
strip for wear within 20 CIS after the effective date of this AD.
Use paragraph 3.A.(1) of the Accomplishment Instructions of GEAE SB
CF34-BJ S/B 72-0231, Revision 02, dated November 26, 2008, to
perform the inspection.
    (ii) If you find a continuous 360 degree rub indication, before
further flight, perform a visual inspection of the fan blades for
cracks. Use paragraphs 3.A(2)(a) or 3.A(2)(b) of the Accomplishment
Instructions of GEAE SB CF34-BJ S/B 72-0231, Revision 02, dated
November 26, 2008, to perform the inspection.
    (iii) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Repetitive Inspection of the Fan Blade Abradable Rub Strip for Wear

    (9) For engines with fan blades, P/N 6018T30P14, installed, if
you have performed an ECI of the fan blade, you don't need to
inspect the fan blade abradable rub strip for wear.
    (10) For engines with fan blades, P/N 6018T30P14, installed,
within 75 CSLI or 100 HSLI, whichever occurs later, do the
following:
    (i) Perform a visual inspection of the fan blade abradable rub
strip for wear. Use paragraph 3.A.(1) of the Accomplishment
Instructions of GEAE SB CF34-BJ S/B 72-0231, Revision 02, dated
November 26, 2008, to perform the inspection.
    (ii) If you find a continuous 360 degree rub indication, before
further flight, visually inspect the fan blades using paragraphs
3.A.(2)(a) through 3.A.(2)(b) of the Accomplishment Instructions of
GEAE SB CF34-BJ S/B 72-0231, Revision 02, dated November 26, 2008.
    (iii) If you find a crack in the retaining pin holes of the fan
blade, remove the blade from service.

Inspection of the Aft Actuator Head Hose Fitting on CF34-3A1 and CF34-
3B Engines

    (11) For CF34-3A1 engines, within 300 hours TIS after the
effective date of this AD, visually inspect and, if necessary,
reposition the aft actuator head hose fitting. Use paragraph 3.A of
the Accomplishment Instructions of GEAE SB CF34-BJ S/B 73-0062,
Revision 02, dated August 27, 2008, to perform the inspection.
    (12) For CF34-3B engines, within 400 hours TIS after the
effective date of this AD, visually inspect and, if necessary,
reposition the aft actuator head hose fitting. Use paragraph 3.A of
the Accomplishment Instructions of GEAE SB CF34-BJ S/B 73-0062,
Revision 02, dated August 27, 2008, to perform the inspection.

Credit for Previous Actions

    (m) Inspections previously performed using the following GEAE
SBs meet the requirements specified in the indicated paragraphs:
    (1) CF34-AL S/B 72-0250, dated August 15, 2008, meet the
requirements specified in paragraphs (i)(2) through (i)(4) of this
AD.
    (2) CF34-AL S/B 73-0046, Revision 01, dated July 1, 2008, or
earlier issue, meet the requirements specified in paragraph (i)(7)
of this AD.
    (3) CF34-BJ S/B 72-0229, dated April 10, 2008, meet the
requirements specified in paragraphs (l)(3) and (l)(4) of this AD.
    (4) CF34-BJ S/B 72-0231, Revision 01, dated October 1, 2008, or
earlier issue, meet the requirements specified in paragraphs
(l)(10)(i) and (l)(10)(ii) of this AD.
    (5) CF34-BJ S/B 73-0062, Revision 01, dated July 1, 2008, or
earlier issue, meet the requirements specified in paragraphs (l)(11)
and (l)(12) of this AD.

Installation Prohibitions

    (n) After the effective date of this AD:
    (1) Do not install any fan blade into any CF34-3A1 engine with
fan drive shaft, P/N 6036T78P02, with an airworthiness limitation
section life limit of 22,000 CSN if that fan blade:
    (i) Was installed in a CF34-3A1 engine with fan drive shaft, P/N
6036T78P02, with an airworthiness limitation section life limit of
15,000 CSN; and
    (ii) Is listed in Appendix A of GEAE SB CF34-BJ S/B 72-0229,
Revision 01, dated July 30, 2008; or
    (iii) Is listed in Appendix A of GEAE SB CF34-BJ S/B 72-0230,
Revision 01, dated July 30, 2008.

    (2) Do not install any fan blade into any CF34-3A1 engine with
fan drive shaft, P/N 6036T78P02, with an airworthiness limitation
section life limit of 15,000 CSN if that fan blade:
    (i) Was installed in any CF34-3A1 engine with fan drive shaft,
P/N 6036T78P02, with an airworthiness limitation section life limit
of 22,000 CSN and,
    (ii) Is listed in Appendix A of GEAE SB CF34-AL S/B 72-0245,
Revision 01, dated July 3, 2008.

Alternative Methods of Compliance

    (o) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (p) Contact John Frost, Aerospace Engineer, Engine Certification
Office, FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

Material Incorporated by Reference

    (q) You must use the GE Aircraft Engines service information
specified in the following Table 1 to do the actions required by
this AD.

                                   Table 1--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
        Service Bulletin No.                    Page               Revision                   Date
----------------------------------------------------------------------------------------------------------------
CF34-AL S/B 73-0046 Total Pages: 8..  All.....................              02  August 27, 2008.
CF34-BJ S/B 73-0062 Total Pages: 8..  All.....................              02  August 27, 2008.
CF34-BJ S/B 72-0229 Total Pages: 158  All.....................              01  July 30, 2008.
CF34-BJ S/B 72-0230 Total Pages: 153  All.....................              01  July 30, 2008.
CF34-BJ S/B 72-0231 Total Pages: 8..  All.....................              02  November 26, 2008.
CF34-AL S/B 72-0245 Total Pages: 153  All.....................              01  July 03, 2008.
CF34-AL S/B 72-0250 Total Pages: 9..  All.....................              01  November 26, 2008.
----------------------------------------------------------------------------------------------------------------

     (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
General Electric Company, GE-Aviation, Room 285, 1 Newmann Way,
Cincinnati, OH 45215, telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
e-mail<EMAIL_ADDRESS>    (3) You may review copies at the FAA, New England Region, 12 New
England Executive Park, Burlington, MA; or at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on November 18, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-28236 Filed 11-27-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44698-44699]
[FR Doc No: 2017-20389]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0128]

Pipeline Safety: Meeting of the Voluntary Information-Sharing
System Working Group

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice.

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

SUMMARY: This notice announces a public meeting of the Voluntary
Information-Sharing System (VIS) Working Group. The VIS Working Group
will convene to continue the discussion on the need for, and the
identification of, a voluntary information-sharing system.

DATES: The VIS Working Group will meet on November 29, 2017, from 8:30
a.m. to 5:00 p.m. and on November 30, 2017, from 8:30 a.m. to 5:00
p.m., ET. Members of the public who wish to attend in person are asked
to register no later than November 19, 2017. Individuals requiring
accommodations, such as sign language interpretation or other ancillary
aids, are asked to notify the working group by November 22, 2017. For
additional information see the ADDRESSES section.

ADDRESSES: The meeting will be held at the Hilton Arlington, 950 North
Stafford Street, Arlington, Virginia 22203. The meeting agenda and any
additional information will be published on the following VIS Working
Group and registration page at: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=126.
    The meeting will not be web cast; however, any documents presented
will be available on the meeting Web site and posted on the E-Gov Web
site: http://www.regulations.gov under docket number PHMSA-2016-0128
within 30 days following the meeting.

Public Participation

    This meeting will be open to the public. Members of the public who
wish to attend in person are asked to register at: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=126 to facilitate entry
and guarantee seating. Members of the public who attend in person will
also be provided an opportunity to make a statement during the meeting.
    Services for Individuals with Disabilities: The public meeting will
be physically accessible to people with disabilities. Individuals
requiring accommodations, such as sign language interpretation or other
ancillary aids, are asked to notify Cheryl Whetsel at
<EMAIL_ADDRESS>    Written comments: Written comments on the meeting may be submitted
to the docket in the following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2016-0128 at the
beginning of your comments. Note that all comments received will be
posted without change to www.regulations.gov, including any personal
information provided. You should know that anyone is able to search the
electronic form of all comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
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Therefore, you may want to review DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000, (65 FR 19477) or
view the Privacy Notice at www.regulations.gov before submitting any
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    Docket: For access to the docket or to read background documents or
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comments, please include a self-addressed, stamped postcard with the
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    DOT may solicit comments from the public regarding certain general
notices. DOT posts these comments, without edit, including any personal
information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL- 14 FDMS), which can
be reviewed at www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The VIS Working Group is a recently created advisory committee
established in accordance with Section 10 of the Protecting our
Infrastructure of Pipelines and Enhancing Safety Act of 2016 (Pub. L.
114-183), the Federal Advisory Committee Act of 1972 (5 U.S.C., App. 2,
as amended), and 41 CFR 102-3.50(a). On December 15, 2016, the
Secretary of Transportation (the Secretary) appointed 24 members to the
committee. The first committee meeting convened on December 19, 2016,
to conduct committee and staff introductions, review the mandate
requirements, review the committee charter and bylaws, introduce the
concept of voluntary information-sharing, and discuss plans for future
meetings. The last committee meeting was on June 29-30, 2017, to
discuss existing integrity management regulations, assessment types and
tools, geographic information system pipeline data, operator
implementation, and the potential need for short-term subcommittees.

II. Meeting Details and Agenda

    The VIS Working Group agenda will include briefings on topics such
as the mission and objective of the VIS effort, best practices,
examples of existing information-sharing systems, safety management
systems, and the establishment of subcommittees. As part of its work,
the committee will ultimately provide recommendations to

the Secretary, as required and specifically outlined in Section 10 of
Public Law 114-183, addressing:
    (a) The need for, and the identification of, a system to ensure
that dig verification data are shared with in-line inspection operators
to the extent consistent with the need to maintain proprietary and
security-sensitive data in a confidential manner to improve pipeline
safety and inspection technology;
    (b) Ways to encourage the exchange of pipeline inspection
information and the development of advanced pipeline inspection
technologies and enhanced risk analysis;
    (c) Opportunities to share data, including dig verification data
between operators of pipeline facilities and in-line inspector vendors
to expand knowledge of the advantages and disadvantages of the
different types of in-line inspection technology and methodologies;
    (d) Options to create a secure system that protects proprietary
data while encouraging the exchange of pipeline inspection information
and the development of advanced pipeline inspection technologies and
enhanced risk analysis;
    (e) Means and best practices for the protection of safety and
security-sensitive information and proprietary information; and
    (f) Regulatory, funding, and legal barriers to sharing the
information described in paragraphs (a) through (d).
    The Secretary will publish the VIS Working Group's recommendations
on a publicly available DOT Web site. The VIS Working Group will
fulfill its purpose once its recommendations are published online.
    The agenda will be published on the PHMSA meeting page https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=126, once it is
finalized.

    Issued in Washington, DC on September 19, 2017, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2017-20389 Filed 9-22-17; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Notices]
[Page 42795]
[DOCID:fr23jy08-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

July 17, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP00-70-019.
    Applicants: Algonquin Gas Transmission Company.
    Description: Algonquin Gas Transmission, LLC submits its FERC Gas
Tariff, Fifth Revised Volume 1 effective 5/1/08.
    Filed Date: 07/15/2008.
    Accession Number: 20080716-0139.
    Comment Date: 5 p.m. Eastern Time on Monday, July 28, 2008.

    Docket Numbers: RP05-422-028.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Company submits Second Revised
Volume 1A et al. effective 5/1/08.
    Filed Date: 07/15/2008.
    Accession Number: 20080716-0138.
    Comment Date: 5 p.m. Eastern Time on Monday, July 28, 2008.

    Docket Numbers: RP96-272-078.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Co submits Third Revised Sheet
66B.07 to its FERC Gas Tariff, Fifth Revised Volume 1.
    Filed Date: 07/15/2008.
    Accession Number: 20080716-0140.
    Comment Date: 5 p.m. Eastern Time on Monday, July 28, 2008.

    Docket Numbers: RP08-444-000.
    Applicants: MGI Supply Ltd.
    Description: Petition of MGI Supply Ltd for Clarification or Waiver
pursuant to Rule 207 of the Commission's Rules of Practice and
Procedure 18 CFR Section 207 etc.
    Filed Date: 07/14/2008.
    Accession Number: 20080715-0199.
    Comment Date: 5 p.m. Eastern Time on Monday, July 28, 2008.

    Docket Numbers: RP08-445-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Cash Out Activity Report.
    Filed Date: 07/16/2008.
    Accession Number: 20080716-5022.
    Comment Date: 5 p.m. Eastern Time on Monday, July 28, 2008.

    Docket Numbers: CP08-406-002.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits a
compliance filing to cancel Rate Schedules X-53, X-82, X-87, X-92 and
X-101.
    Filed Date: 07/11/2008.
    Accession Number: 20080715-0005.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 22, 2008.

    Docket Numbers: CP07-32-006.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits Substitute
Fourtheenth Revised Sheet No. 20 et al. to FERC Gas Tariff, Sixth
Revised Volume No. 1, to be effective 6/1/08.
    Filed Date: 07/15/2008.
    Accession Number: 20080716-0137.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 22, 2008.

    Docket Numbers: CP00-6-015.
    Applicants: Gulfstream Natural Gas Company, LLC.
    Description: Gulfstream Natural Gas Company, LLC submits Second
Revised Sheets 5 and 6 to their FERC Gas Tariff, Original Volume 1.
    Filed Date: 07/15/2008.
    Accession Number: 20080716-0141.
    Comment Date: 5 p.m. Eastern Time Tuesday, July 22, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.
Deputy Secretary.
 [FR Doc. E8-16816 Filed 7-22-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74368-74372]
[FR Doc No: 2016-25852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]
RIN 0910-AH36

Use of Ozone-Depleting Substances

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its regulation on uses of ozone-depleting substances
(ODSs), including chlorofluorocarbons (CFCs), to remove the designation
for certain products as ``essential uses'' under the Clean Air Act.
Essential-use products are exempt from the ban by FDA on the use of
CFCs and other ODS propellants in FDA-regulated products and from the
ban by the Environmental Protection Agency (EPA) on the use of ODSs in
pressurized dispensers. This action, if finalized, will remove the
essential-use exemption for anesthetic drugs for topical use on
accessible mucous membranes of humans where a cannula is used for
application. FDA is proposing this action because these products are no
longer being marketed in approved versions that contain ODSs and
because alternative products that do not use ODSs are now available.

DATES: Submit either electronic or written comments on the proposed
rule by December 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-1355 for ``Use of Ozone-Depleting Substances.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6246, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Production of ODSs has been phased out worldwide under the terms of
the Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol) (September 16, 1987, S. Treaty Doc. No. 10, 100th
Cong., 1st sess., 26 I.L.M. 1541 (1987)). In accordance with the
provisions of the Montreal Protocol, under authority of Title VI of the
Clean Air Act (section 601 et seq.), the manufacture of ODSs, including
CFCs, in the United States was generally banned as of January 1, 1996.
To receive permission to manufacture CFCs in the United States after
the phase-out date, manufacturers must obtain an exemption from the
phase-out requirements from the parties to the Montreal Protocol.
Procedures for securing an essential-use exemption under the Montreal
Protocol are described in a request by EPA for applications for
exemptions (60 FR 54349, October 23, 1995).
    Firms that wished to use ODSs manufactured after the phase-out date
in medical devices (as defined in section 601(8) of the Clean Air Act
(42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42
U.S.C. 7671i) must receive exemptions for essential uses under the
Montreal Protocol. EPA regulations implementing the provisions of
section 610 of the Clean Air Act contain a general ban on the use of
ODSs in pressurized dispensers, such as metered-dose inhalers (MDIs)
(40 CFR 82.64(c) and 82.66(d)). These EPA regulations exempt from the
general ban ``medical devices'' that FDA considers essential and that
are listed in Sec.  2.125(e) (21 CFR 2.125(e)). Section 601(8) of the
Clean Air Act defines ``medical device'' as any device (as defined in
the Federal Food, Drug & Cosmetic Act (the FD&C Act) (21 U.S.C. 321)),
diagnostic product, drug (as defined in the FD&C Act), and drug
delivery system, if such device, diagnostic product, drug, or drug
delivery system uses a class I or class II ODS for which no safe and
effective alternative has been developed (and, where necessary, has
been approved by the Commissioner of Food and Drugs), and if such
device, diagnostic product, drug, or drug delivery system has, after
notice and opportunity for public comment, been

approved and determined to be essential by the Commissioner in
consultation with the Administrator of EPA. Class I substances include
CFCs, halons, carbon tetrachloride, methyl chloroform, methyl bromide,
and other chemicals not relevant to this document (see 40 CFR part 82,
appendix A to subpart A). Class II substances include
hydrochlorofluorocarbons (see 40 CFR part 82, appendix B to subpart A).
    A drug, device, cosmetic, or food contained in an aerosol product
or other pressurized dispenser that releases a CFC or other ODS
propellant generally is not considered an essential use of the ODS
under the Clean Air Act except as provided in Sec.  2.125(c) and (e).
This prohibition is based on scientific research indicating that CFCs
and other ODSs reduce the amount of ozone in the stratosphere and
thereby increase the amount of ultraviolet radiation reaching the
Earth. An increase in ultraviolet radiation will increase the incidence
of skin cancer, and produce other adverse effects of unknown magnitude
on humans, animals, and plants (80 FR 36937, June 29, 2015). Sections
2.125(c) and (e) provide exemptions for essential uses of ODSs for
certain products containing ODS propellants that FDA determines provide
unique health benefits that would not be available without the use of
an ODS.
    Faced with the statutorily mandated phase-out of the production of
ODSs, drug manufacturers have developed alternatives to MDIs and other
self-pressurized drug dosage forms that do not contain ODSs. Examples
of these alternative dosage forms are MDIs that use non-ODSs as
propellants and dry-powder inhalers. The availability of alternatives
to ODSs means that certain drug products listed in Sec.  2.125(e) are
no longer essential uses of ODSs. Therefore, due to lack of marketing
of an approved product containing an ODS, and the availability of
alternative products that do not contain an ODS, FDA is proposing to
amend its regulations to remove the essential-use designation for
anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application (Sec.
2.125(e)(4)(iii)).
    On June 29, 2015, FDA published a notice and request for comment
concerning its tentative conclusion that anesthetic drugs for topical
use on accessible mucous membranes of humans where a cannula is used
for application no longer constitute an essential use under the Clean
Air Act (June 2015 notice). FDA requested comment concerning its
tentative finding that anesthetic drugs for topical use on accessible
mucous membranes of humans where a cannula is used for application are
no longer being sold in an approved ODS formulation. Under Sec.
2.125(g)(1), an active moiety may no longer constitute an essential use
(Sec.  2.125(e)) if it is no longer marketed in an approved ODS
formulation. The failure to market indicates nonessentiality because
the absence of a demand sufficient for even one company to market the
product is highly indicative that the use is not essential.

II. Comment on the June 2015 Notice and FDA Response

    FDA received one comment concerning its tentative finding that
anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application are no longer marketed
in an approved ODS formulation and, therefore, no longer constitute an
essential use (see June 2015 notice). On August 21, 2015, Cetylite
Industries, Inc. (Cetylite) submitted a comment stating that ``FDA's
belief that no products are marketed under this exemption is
incorrect'' (Comment 1). According to the comment, Cetylite
manufactures Cetacaine Spray (CETACAINE), a topical anesthetic spray
with an active ingredient combination of benzocaine, tetracaine HCl,
and butamben that uses a blend of CFCs as the propellant under the
essential-use exemption found in Sec.  2.125(e)(4)(iii). However,
CETACAINE is not an approved drug product and does not qualify as an
essential use under Sec.  2.125(e)(4)(iii). As described in Sec.
2.125(c), an aerosol drug product or other pressurized dispenser that
releases an ODS is an essential use of the ODS under the Clean Air Act
only if it is listed in Sec.  2.125(e) and if an investigational
application or an approved marketing application is in effect.
    Cetylite states that CETACAINE has been marketed continuously since
the mid-1950s under a request for a Drug Efficacy Study Implementation
(DESI) review that was submitted in 1976. FDA published a DESI notice
(DESI 8076 (Docket No. 75N-0203) in the Federal Register of December 9,
1975 (40 FR 57379)) in which the Agency offered an opportunity for a
hearing on a proposal to withdraw approval of a combination drug
product containing two of the three ingredients contained in CETACAINE.
In response to this DESI notice, Cetylite requested a hearing regarding
the effectiveness of CETACAINE. While FDA's review of the product's
effectiveness has been pending, Cetylite has been marketing CETACAINE
without an approved new drug application.
    In 1979, based on a citizen petition submitted by Cetylite
regarding its CETACAINE product, FDA proposed that anesthetic drugs for
topical use on accessible mucous membranes of humans where a cannula is
used for application were essential uses of ODSs (44 FR 33114, June 8,
1979) (1979 Proposed Rule). In the preamble to the 1979 Proposed Rule,
FDA noted that its tentative finding as to CETACAINE's essentiality
under Sec.  2.125 was ``conditional'' on the product being found
effective. Similarly, in the preamble to the Final Rule amending Sec.
2.125, FDA stated that ``the determination in this document that
CETACAINE Aerosol is an essential use of a chlorofluorocarbon is also
conditional'' on a finding that CETACAINE is effective for the use
described in Sec.  2.125(e)(4)(iii) (45 FR 22902, April 4, 1980).
    To date, FDA has not made a finding that CETACAINE is effective for
the use described in Sec.  2.125(e)(4)(iii). There is no
investigational new drug application or approved marketing application
in effect for the ODS formulation of CETACAINE, as required for a
finding of essentiality under Sec.  2.125(c). Accordingly, CETACAINE
does not meet the conditions to qualify as an essential use of ODSs
under Sec.  2.125(e)(4)(iii), and FDA believes that its proposed
finding that anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application are no
longer marketed in an approved ODS formulation remains correct.
Moreover, alternative products for the same use that do not use ODSs,
such as lidocaine, are now available, further suggesting that
anesthetic drugs for topical use are no longer an essential use of
ODSs. In addition, a recently completed laboratory study demonstrated
that lidocaine may be a safer alternative to benzocaine (Ref. 1). The
study found that benzocaine was substantially more likely than
lidocaine to form methemoglobin, the cause of the serious blood
disorder called methemoglobinemia.

III. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563

direct us to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). We have developed a comprehensive
Economic Analysis of Impacts that assesses the impacts of the proposed
rule. We believe that this proposed rule is not a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. We propose to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Need for the Regulation

    This rule is necessary to comply with the Montreal Protocol under
authority of Title VI of the Clean Air Act (section 601 et seq.), which
banned the manufacture of ODSs, including CFCs, to reduce the depletion
of the ozone layer in the United States as of January 1, 1996. EPA
regulations exempted from the ban medical devices, diagnostic products,
drugs, and drug delivery systems that FDA considered essential and that
are listed in Sec.  2.125(e) when they use a class I or class II ODS
for which no safe and effective alternative has been developed.
    Anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application are not available in the
product market in an approved ODS formulation. Because the product is
not marketed under an investigational new drug (IND), new drug
application (NDA), or abbreviated new drug application (ANDA) and
alternative products for the same use that do not use ODSs, such as
lidocaine, are now available, the product is nonessential under Sec.
2.125(g)(1). With the adoption of this rule, any potential
manufacturers of these anesthetic drugs will have notice about their
requirements to comply with the ban of products from containing ODSs.

C. Costs and Benefits

1. Number of Affected Entities
    There are no affected entities covered by this rule because there
are no current manufacturers of approved products that would qualify as
``essential'' products under the current regulation.
2. Costs
    ODS-containing anesthetic products for topical use on accessible
mucous membranes of humans where a cannula is used for application are
not marketed under an IND, NDA, or ANDA and would not qualify as
``essential'' products under the current regulation; consequently,
removal of the exemption for such drugs would not present the public,
consumers, insurers, or producers with any costs.
3. Health Benefits
    The proposed rule would implement the requirements of the Clean Air
Act that ban the use of products containing ODSs that no longer meet
the requirements for essential use. The benefits stem from preventing
the ODSs that would have been emitted by potential market entrants. The
social benefits of the proposed rule derive from greater compliance
with the Clean Air Act. Because there will not be any change in
exposure and any resulting risk from the proposed rule, there will not
be any direct public health benefits.

D. Economic Summary

    The proposed rule, if finalized, will remove the essential-use
exemption for anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application. The
primary public health benefit from adoption of the proposed rule is to
reduce the depletion of the ozone layer to decrease human exposure to
ultraviolet radiation. Because anesthetic drugs for topical use are not
currently sold in the market in an approved form, there would be no
health benefit or social cost for removing the exemption for such
products from the ban.

IV. Regulatory Flexibility Analysis

    FDA has examined the economic implications of the proposed rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. We propose to certify that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
This analysis, together with other relevant sections of this document,
serves as the proposed regulatory flexibility analysis.

V. Analysis of Environmental Impacts

    We have determined under 21 CFR 25.30(h) 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.

VI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

VIII. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also
available electronically at http://www.regulations.gov.

1. Hartman, N. R., J. J. Mao, H. Zhou, et al., ``More Methemoglobin
is Produced by Benzocaine Treatment Than Lidocaine Treatment in
Human In Vitro Systems.'' Regulatory Toxicology and Pharmacology,
70:182-188, 2014.

List of Subjects

In 21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR part 2 be amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

0
1. The authority citation for part 2 continues to read as follows:

    Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342,
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42
U.S.C. 7671 et seq.

Sec.  2.125  [Amended]

0
2. In Sec.  2.125, remove and reserve paragraph (e)(4)(iii).

    Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25852 Filed 10-25-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 13, 2007 (Volume 72, Number 155)]
[Notices]
[Page 45241-45242]
[DOCID:fr13au07-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12574-002]

Santiam Water Control District; Notice of Application Tendered
for Filing With the Commission, Soliciting Additional Study Requests,
Intent To Waive Pre-Filing Consultation Provisions, and Establishing
Deadline for Submission of Final Amendments

August 7, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Conversion of the conduit exemption
application filed by the Santiam Water Control District on February 1,
2005, under P-12574-001 to an application for a small hydro (less than
5 MW) exemption.
    b. Project No.: P-12574-002.
    c. Date Filed: June 18, 2007, and supplemented on July 18, 2007,
pursuant to Order Denying Rehearing (119 FERC ] 61,159).
    d. Applicant: Santiam Water Control District.
    e. Name of Project: Stayton Hydroelectric Project.
    f. Location: On the Stayton Ditch near the Town of Stayton, Marion
County, Oregon. The project would not occupy United States land.
    g. Filed Pursuant to: Public Utilities Regulatory Policies Act of
1978, 16 U.S.C. Sec. Sec.  2705, 2708.
    h. Applicant Contact: Larry Trosi, Manager, Santiam Water Control
District, 284 East Water Street, Stayton, OR 97383,<PHONE_NUMBER>.
    i. FERC Contact: Tom Dean,<PHONE_NUMBER>.
    j. Cooperating Agencies: We are asking Federal, state, and local
agencies and Indian tribes with jurisdiction and/or special expertise
with respect to environmental issues to cooperate with us in the
preparation of the environmental document. Agencies who would like to
request cooperating status should follow the instructions for filing
comments described in item l below.
    k. Pursuant to Sec.  4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: September 17, 2007.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Additional study requests and requests for cooperating agency
status may be filed electronically via the Internet in lieu of paper.
The Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at (http://www.ferc.gov) under the ``eFiling'' link.

    m. This application is not ready for environmental analysis at this
time.

    n. Santiam Water Control District proposes to restore operation to
the Stayton Project which was operated by Pacific Power until 1992. As
proposed, the Stayton Project would consist of: (1) An existing 24-
foot-long by 12-foot-high intake structure equipped with 24.6-foot-long
by 12-foot-high 3-inch bar spacing trashracks; (2) an existing 40-foot-
long V-type spillway weir and integral powerhouse containing a single
600-kilowatt generating unit; (3) an existing 24-foot-long by 12-foot-
high outlet structure; (4) an existing 100-foot-long, 2,400-kilovolt
transmission line; and (5) appurtenant facilities. The project would
have an average annual generation of 4,320 megawatt-hours.
    Additional project facilities may include the existing: (1) Power
canal head gate structure and fish ladder, and the fish screen and 28-
inch-diameter, 600-foot-long juvenile fish bypassed return pipe located
on the Stayton Ditch; (2) the tailrace fish barrier; (3) the Spill dam
and fish ladder located on the North Channel of the Santiam River just
upstream of the power canal head gate structure; and (4) the North
Channel of the Santiam River including the Upper and Lower Bennett dams
and fish ladders.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>. A copy is also available
for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    p. With this notice, we are initiating consultation with the Oregon
State Historic Preservation Officer (SHPO), as required by section 106,
National Historic Preservation Act, and the regulations of the Advisory
Council on Historic Preservation, 36 CFR 800.4.
    q. Waiver of Pre-filing Consultation: We intend to use the
consultation that has occurred on this project for the previous conduit
exemption application supplemented with National Environmental Policy
Act scoping as a means to conduct further consultation with resource
agencies and interested entities. Therefore, we intend to waive pre-
filing consultation sections 4.38(a)-(g) which requires, among other
things, holding a joint meeting, and distributing and consulting on a
draft exemption application.
    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15797 Filed 8-10-07; 8:45 am]

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