[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Notices]
[Pages 57208-57211]
[FR Doc No: 2013-22559]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In October
2012, there were seven applications approved. This notice also includes
information on four applications, one approved in July 2012 and the
other three approved in September 2012, inadvertently left off the July
2012 and September 2012 notices, respectively. Additionally, seven
approved amendments to previously approved applications are listed.

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SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    PUBLIC AGENCY: Sanford Airport Authority, Sanford, Florida.
    APPLICATION NUMBER: 12-03-C-00-SFB.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.00.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $29,837,167.
    EARLIEST CHARGE EFFECTIVE DATE: December 1, 2012.
    ESTIMATED CHARGE EXPIRATION DATE: November 1, 2022.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S: None.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Reconstruction of taxiways L, R, C, and B4.
    Rehabilitate apron (international ramp).
    Acquire land for noise compatibility phase II.
    Acquire aircraft rescue and firefighting vehicles.
    Taxiway B extension.
    Miscellaneous runway lighting and signage improvements.
    Rehabilitate terminal building roof.
    Construct apron--north side ramp.
    Reconstruction of runway 9C/27C.
    Expand apron--east terminal ramp.
    Acquire land for noise compatibility.
    Extend runway 9R/27L (land acquisition).
    Extend runway 9R/27L (construction).
    Expand apron phase II.
    Acquire land for noise mitigation (phase 4).
    Rehabilitate runway 9L/27R.
    Extend runway 9R/27L (land acquisition--phase II).
    PFC administration costs reimbursement.
    Add/replace/reconfigure/extend baggage handling systems.
    Replace 12 passenger boarding bridges.
    DECISION DATE: July 12, 2012.

FOR FURTHER INFORMATION CONTACT: Susan Moore, Orlando Airports District
Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: Hillsborough County Aviation Authority, Tampa,
Florida.
    APPLICATION NUMBER: 12-09-C-00-TPA.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $33,030,276.

    EARLIEST CHARGE EFFECTIVE DATE: January 1, 2019.
    ESTIMATED CHARGE EXPIRATION DATE: November 1, 2019.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Air taxi/commercial operators filing FAA Form 1800-31 and operating
at Tampa International Airport (TPA).
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at TPA.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE AT A
$3.00 PFC LEVEL:
    Airside F boarding bridges.
    PFC implementation and administration costs.
    BRIEF DESCRIPTION OF PROJECT PARTIALLY APPROVED FOR COLLECTION AND
USE AT A $4.50 PFC LEVEL:
    Airside F additions and renovations.
    DETERMINATION: The following elements were determined not to meet
the requirements of Sec.  158.15 and, thus, were disapproved: Aircraft
``self-docking'' system; parking lot re-striping, landscaping, and
artwork; build-out of the concession areas and tenant support office
areas; relocation of the airline lounge; service elevator; and Wi-Fi
system upgrade.
    BRIEF DESCRIPTION OF PROJECT PARTIALLY APPROVED FOR COLLECTION AND
USE AT A $3.00 PFC LEVEL:
    Replace main terminal cooling tower.
    DETERMINATION: The redevelopment of the existing cooling tower
footprint into a covered parking and charging area for electric
maintenance vehicles does not meet the requirements of Sec.  158.15
and, thus, is not approved.
    DECISION DATE: September 26, 2012.

FOR FURTHER INFORMATION CONTACT: Susan Moore, Orlando Airports District
Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: Salt Lake City Corporation, Salt Lake City, Utah.
    APPLICATION NUMBER: 12-13-C-00-SLC.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $115,628,000.
    EARLIEST CHARGE EFFECTIVE DATE: April 1, 2013.
    ESTIMATED CHARGE EXPIRATION DATE: April 1, 2016.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Air taxi/commercial operators filing or required to file FAA Form
1800-31 and operating at Salt Lake City International Airport (SLC).
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at SLC.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE AT A
$4.50 PFC LEVEL:
    End of runway deicing program--phase 1, runway 34R.
    Taxiway S pavement reconstruction.
    Replace carousel 9 and oversized bag belt TU3.
    Terminal redevelopment program--design and associated technical
professional services.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE AT A
$3.00 PFC LEVEL:
    Apron mast lighting replacement.
    Apron reconstruction--east of spots 3 and 4.
    DECISION DATE: September 26, 2012.

FOR FURTHER INFORMATION CONTACT: Jesse Lyman, Denver Airports District
Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: Salt Lake City Corporation, Salt Lake City, Utah.
    APPLICATION NUMBER: 12-14-I-00-SLC.
    APPLICATION TYPE: Impose a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $281,119,000.
    EARLIEST CHARGE EFFECTIVE DATE: April 1, 2016.
    ESTIMATED CHARGE EXPIRATION DATE: September 1, 2022.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Air taxi/commercial operators filing or required to file FAA Form
1800-31 and operating at SLC.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at SLC.
    BRIEF DESCRIPTION OF PROJECT APPROVED FOR COLLECTION AT A $4.50 PFC
LEVEL:
    Terminal redevelopment program--consolidated terminal building.
    DECISION DATE: September 26, 2012.

FOR FURTHER INFORMATION CONTACT: Jesse Lyman, Denver Airports District
Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: County of Chemung, Elmira, New York.
    APPLICATION NUMBER: 12-05-C-00-ELM.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $77,241.
    EARLIEST CHARGE EFFECTIVE DATE: December 1, 2020.
    ESTIMATED CHARGE EXPIRATION DATE: February 1, 2021.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Nonscheduled/on-demand air carriers filing FAA Form 1800-31.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Elmira Corning Regional Airport.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    PFC program administration.
    Design taxiways A, L and B.
    BRIEF DESCRIPTION OF PROJECT APPROVED FOR COLLECTION:
    Acquire aircraft rescue and firefighting truck.
    BRIEF DESCRIPTION OF DISAPPROVED PROJECT:
    Acquire multipurpose snow removal equipment.
    DETERMINATION: Project does not meet the requirements of Sec.
158.15(b).
    DECISION DATE: October 5, 2012.

FOR FURTHER INFORMATION CONTACT: Patricia Henn, Eastern Region Airports
Division,<PHONE_NUMBER>.
    PUBLIC AGENCY: City of Killeen, Texas.
    APPLICATION NUMBER: 13-08-C-00-GRK.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $1,334,519.
    EARLIEST CHARGE EFFECTIVE DATE: April 1, 2013.
    ESTIMATED CHARGE EXPIRATION DATE: March 1, 2015.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Part 135 charter operators.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Killeen/Fort Hood, Robert Gray Airport.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Terminal hold rooms and common use space rehabilitation.
    Rehabilitate taxiways (B, B-3, C, D, and E).

    Terminal hold room and common use area passenger accommodation.
    Rehabilitate terminal access road.
    Administration fees.
    DECISION DATE: October 18, 2012.

FOR FURTHER INFORMATION CONTACT: Steven Cooks, Texas Airports
Development Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: City of Fort Smith, Arkansas.
    APPLICATION NUMBER: 12-05-C-00-FSM.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $2,412,537.
    EARLIEST CHARGE EFFECTIVE DATE: January 1, 2013.
    ESTIMATED CHARGE EXPIRATION DATE: December 1, 2019.
    CLASSES OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    (1) Air taxi/commercial operators filing FAA Form 1800-31; and (2)
commuter air carriers enplaning non-scheduled passengers filing
Department of Transportation Form 41, Schedule T-100.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that each approved
class accounts for less than 1 percent of the total annual enplanements
at Fort Smith Regional Airport.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Airport entry signs to passenger terminal.
    Passenger terminal sterile lobby expansion.
    Portable pre-conditioned air and ground power unit.
    Runway 1/19 pavement rehabilitation and marking.
    Perimeter security fence and erosion control.
    Runway closure signs.
    Wildlife habitat mitigation and drainage improvements.
    Wildlife management plan.
    Security system upgrade.
    Braking action testing equipment.
    Replace security vehicles.
    Public information systems.
    Snow removal equipment.
    Reconstruction of taxiway A west phase 2.
    Reconstruction of taxiway A west phase 3.
    PFC administration.
    DECISION DATE: October 22, 2012.

FOR FURTHER INFORMATION CONTACT: Julieann Dwyer, Arkansas/Oklahoma
Airports Development Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: Des Moines Airport Authority, Des Moines, Iowa.
    APPLICATION NUMBER: 12-13-C-00-DSM.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $3,059,891.
    EARLIEST CHARGE EFFECTIVE DATE: October 1, 2019.
    ESTIMATED CHARGE EXPIRATION DATE: December 1, 2020.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S: Part 135 air
taxi/commercial operators.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Des Moines International Airport.
    BRIEF DESCRIPTION OF PROJECT APPROVED FOR COLLECTION AND USE:
    Taxiway D reconstruction.
    DECISION DATE: October 23, 2012.

FOR FURTHER INFORMATION CONTACT: Sheila Bridges, Central Region
Airports Division,<PHONE_NUMBER>.
    PUBLIC AGENCY: City of Waterloo, Iowa.
    APPLICATION NUMBER: 12-11-C-00-ALO.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $275,900.
    EARLIEST CHARGE EFFECTIVE DATE: August 1, 2015.
    ESTIMATED CHARGE EXPIRATION DATE: August 1, 2019.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S: None.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Taxiway A east rehabilitation--construction phase.
    Taxiway B rehabilitation--construction phase.
    DECISION DATE: October 23, 2012.

FOR FURTHER INFORMATION CONTACT: Jim Johnson, Central Region Airports
Division,<PHONE_NUMBER>.
    PUBLIC AGENCY: Monterey Peninsula Airport District, Monterey,
California.
    APPLICATION NUMBER: 13-18-C-00-MRY.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $1,200,000.
    EARLIEST CHARGE EFFECTIVE DATE: February 1, 2013.
    ESTIMATED CHARGE EXPIRATION DATE: February 1, 2014.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    Nonscheduled/on-demand air carriers filing FAA Form 1800-31.
    DETERMINATION: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Monterey Peninsula Airport.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Update airport master plan study.
    Improve runway 10R/28L safety area--phase III.
    Install perimeter fence alarm.
    Apron rehabilitation--aircraft rescue and firefighting ramp.
    DECISION DATE: October 30, 2012.

FOR FURTHER INFORMATION CONTACT: Neil Kumar, San Francisco Airports
District Office,<PHONE_NUMBER>.
    PUBLIC AGENCY: County of Gunnison, Gunnison, Colorado.
    APPLICATION NUMBER: 12-06-C-00-GUC.
    APPLICATION TYPE: Impose and use a PFC.
    PFC LEVEL: $4.50.
    TOTAL PFC REVENUE APPROVED IN THIS DECISION: $452,445.
    EARLIEST CHARGE EFFECTIVE DATE: May 1, 2020.
    ESTIMATED CHARGE EXPIRATION DATE: January 1, 2023.
    CLASS OF AIR CARRIERS NOT REQUIRED TO COLLECT PFC'S:
    None.
    BRIEF DESCRIPTION OF PROJECTS APPROVED FOR COLLECTION AND USE:
    Update wildlife hazard assessment plan.
    Rehabilitate terminal building (phase I).
    Rehabilitate terminal building (phase II).
    Rehabilitate terminal building (phase III).
    Rehabilitate terminal building (phase IV).
    Rehabilitate runway 6/24.
    Rehabilitate taxiway A system.
    Rehabilitate general aviation apron areas.
    PFC administration.
    DECISION DATE: October 30, 2012.

FOR FURTHER INFORMATION CONTACT: Jesse Lyman, Denver Airports District
Office,<PHONE_NUMBER>.

                                           Amendments to PFC Approvals
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                                                                                Original         Amended
                                     Amendment       Original         Amended        estimated       estimated
   Amendment No., City, State      approved date   approved net    approved net    charge  exp.    charge  exp.
                                                    PFC revenue     PFC revenue        date            date
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10-07-C-01-RSW, Fort Myers, FL..        09/27/12     $51,877,571     $56,490,299        05/01/18        10/01/18
07-05-C-01-FSM, Fort Smith, AR..        10/04/12       1,250,500       1,310,108        04/01/13        01/01/13
06-05-C-04-MOB, Mobile, AL......        10/12/12       4,850,267       4,681,541        06/01/15        05/01/13
12-14-C-01-YKM, Yakima, WA......        10/12/12         703,801         907,615        02/01/14        03/01/15
09-07-C-02-GRK, Killeen, TX.....        10/18/12       2,565,711       3,125,711        01/01/13        04/01/13
* 07-04-C-01-ONT, Ontario, CA...        10/19/12      96,648,998      96,648,998        04/01/13        10/01/21
96-03-C-02-SJU, San Juan, PR....        10/23/12      68,223,897      62,028,587        04/01/02        04/01/02
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NOTES:
The amendment denoted by an asterisk (*) include a change to the PFC level charged from $4.50 per enplaned
  passenger to $2.00 per enplaned passenger. For Ontario, CA, this change is effective on January 1, 2013.

    Issued in Washington, DC on September 4, 2013.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2013-22559 Filed 9-16-13; 8:45 am]
BILLING CODE 4910-13-P


July 15, 2011

Via Electronic Transmission<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>EPA Docket ID. No. EPA-HQ-OAR-2002-0058
EPA Docket ID. No. EPA-HQ-OAR-2003-0119

Ms. Toni Jones & Mr. Brian Shrager
Sector Policies and Programs Division
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711

Dear Ms. Jones and Mr. Shrager:

Waste Management (WM) is pleased to provide additional data and information to inform the Agency's reconsideration of the "National Emission Standards for Hazardous Air Pollutants for Major Sources:  Industrial, Commercial, and Institutional Boilers and Process Heaters" (hereinafter the "Boiler Rule") and "Standards of Performance for New Sources and Emission Guidelines for Existing Sources:  Commercial and Industrial Solid Waste Incineration Units" (hereinafter the "CISWI Rule").  As North America's leading provider of integrated environmental solutions, WM is uniquely interested in ensuring that the Agency's final CISWI Rule and Boiler Rule upon reconsideration reflect and support ongoing and newly evolving efforts to reduce, reuse and manage waste, while recovering valuable resources and producing clean renewable energy.  In addition, these rules must not unfairly and without notice, change longstanding regulatory determinations and control standards that currently apply to landfill gas.

WM has been a constant advocate of landfill gas as a renewable alternative fuel. WM operates 131 landfill gas-to-energy projects that produce enough renewable energy to power nearly half a million homes and replace use of about 2.4 million tons of coal per year.  These projects offset criteria pollutants and hazardous air pollutants associated with coal use and also offset nearly 3 million tons of CO2e emissions each year.  While most of our renewable energy projects involve combusting landfill gas in engines or turbines to produce electricity, about twenty percent of our projects involve treating and conveying landfill gas to third parties to use as fuel in their facility boilers.  Some of our landfill gas customers include BMW, DuPont, Dow, GM, Ford, the University of New Hampshire and NASA Goddard Spaceflight Center.  These organizations have chosen to utilize landfill gas as a viable replacement for fossil fuel, and as a key element of their corporate sustainability goals.  Furthermore, investment in these projects has been strongly encouraged by Congress and EPA's Landfill Methane Outreach Program (LMOP).  Failure to harmonize the Boiler Rule and CISWI Rule standards with national renewable energy and greenhouse gas reduction goals will undermine significant sustainability investments by private companies, local governments, and federal agencies.  In addition, the imposition of new and unreasonable regulatory burdens upon the combustion of landfill gas will conflict with existing Clean Air Act regulations governing landfill gas control and use as a renewable fuel, including the Standards of Performance for Municipal Solid Waste Landfills, 40 C.F.R. Part 60, Subpart WWW (the "Landfill NSPS") and the National Emission Standards for Hazardous Air Pollutants: Municipal Solid Waste Landfills, 40 C.F.R Part 63, Subpart AAAA (the "Landfill MACT").

EPA Must Clarify that the CISWI Rule Does Not Apply to Combustion of Landfill Gas

First and foremost, EPA must clarify that the CISWI Rule does not apply to the combustion of landfill gas, either when combusted for control (as in an enclosed flare) or combusted as a fuel (as in a boiler).  WM submitted a petition for reconsideration of the final CISWI Rule, which we have appended as Attachment A.  WM's petition focused on EPA's removal of the definition of "contained gaseous material" from the final CISWI Rule, which represents a significant shift away from EPA's established interpretation of the scope of section 129 of the CAA, as it relates to the definition of "solid waste" under the Resource Conservation and Recovery Act (RCRA).

EPA's statements in a related rulemaking record further indicate that EPA's final CISWI rule departs significantly from EPA's established interpretation of section 129 of the CAA.  Specifically, in its Response to Comments for the Identification of Non-Hazardous Secondary Materials That Are Solid Waste Rule, published at 76 Fed. Reg. 15456 (March 21, 2011) (NHSM Rule), EPA cast significant doubt on the continued vitality of its past interpretation of "contained gaseous materials," and suggested the combustion of air emissions for pollution control may constitute the combustion of solid waste subject to the CISWI Rule.  Further, EPA stated that landfill gas may constitute "solid waste" simply because landfill gas is extracted from a waste mass, and if used as fuel would be subject to a demonstration of legitimacy under the NHSM Rule.

Taken together, these two Agency actions signal a significant shift in policy and regulatory precedent and were made without any prior notice to regulated entities, and without opportunity for comment.  For over twenty years, EPA has developed a comprehensive regulatory structure to govern the collection, control and treatment of landfill gas under the Clean Air Act  -- a structure based on the correct determination that landfill gas is not a solid waste under RCRA.  EPA's deletion of the definition of contained gaseous material and statements in the NHSM rulemaking record threaten to undercut the existing regulatory scheme established under the CAA by potentially subjecting landfill gas combustion to the CISWI Rule.  Regulation of LFG as a solid waste also threatens to undermine the market for LFG as a fuel, in direct contradiction to the stated goals of EPA's Landfill Methane Outreach Program and the administration's broader goals to encourage domestic, renewable energy sources.

It is clear from a review of the CISWI rulemaking record that the Agency did not contemplate the possibility that landfill gas combustion units may be subject to CISWI.  EPA's evaluation of regulatory impacts did not identify massive costs associated with application of the rule to thousands of landfill gas combustion sources.  Regulation of landfill gas under section 129 of the CAA would dramatically affect the cost of capture and control of landfill gas.  As an initial matter, WM anticipates that current third party users of landfill gas would discontinue using landfill gas when faced with strict emission limits.  Without an end market for the sale or transfer of gas, WM and other landfill owners /operators will be left with greater quantities of landfill gas to control.  For example, landfill gas flares (which are approved pollution control devices under the Landfill NSPS and Landfill MACT) would need to be replaced with thermal oxidizers to meet section 129 emission limits.  For WM alone, we estimate our capital costs for installation of thermal oxidizers (about $412 million) to exceed the total EPA estimated costs identified in the CISWI Rule for all its intended sources.  Based on EPA's estimated annual costs of compliance for each facility ($186,000), we estimate WM's annual compliance costs would exceed $50 million per year.  Such costs would be a significant financial burden for WM, and would be ruinous to the many local governments that own and operate MSW landfills and combust landfill gas for control or as fuel.

On May 13, 2011, the Director of the Office of Resource Conservation and Recovery wrote a letter to the American Forest and Paper Association, to provide clarification of Agency statements made in the Response to Comments Document indicating a change in interpretation of what constitutes a "contained gaseous material."  While the Office Director's letter indicates that the Agency has not changed its previous positions, and that previous statements and interpretation remain effective, the Agency has not yet issued a technical correction to the Response to Comments Document, nor has it specifically addressed and clarified the regulatory status of landfill gas.

Because EPA has not taken action to stay or amend the NHSM Rule, it is imperative that the Agency clarify the CISWI Rule by confirming the longstanding definition of "solid waste" as extending only to "contained gaseous material" and by clarifying that the combustion of gaseous emission streams does not constitute the combustion of solid waste subject to the CISWI Rule.

The Boiler Rule Should Not Deter Use of Landfill Gas as an Alternative Fuel

WM believes that the Boiler Rule, as published, creates a significant disincentive to using landfill gas as an alternative, renewable fuel.  Our primary concern is that EPA has categorized landfill gas as a Gas 2 fuel, and thereby subjected landfill gas-fired units to unreasonable emission limitations that will be cost prohibitive to meet.  Further, although EPA has created a fuel specification for "other Gas 1 fuels" by which landfill gas and other gases may qualify for Gas 1 regulatory treatment, the fuel specification does not provide a viable avenue by which landfill gas would be relieved of the regulatory burdens associated with unnecessarily stringent emission limits.  WM is encouraged that EPA has acknowledged in its National Emission Standards for Hazardous Air Pollutants; Notice of Reconsideration ("Reconsideration Notice") published at 75 Fed. Reg. 15266 (March 21, 2011) that this and other provisions of the Boiler Rule are of central relevance to the rule and arose after the period for public comment, and were impracticable to comment upon.  WM supports EPA's Reconsideration Notice on that basis and submitted a petition to the Agency to reconsider and amend the Boiler Rule.  We have appended our petition for reconsideration as Attachment B.

Specifically, WM requested that the Agency reconsider its categorization of LFG as "Gas 2" under the Boiler Rule, and amend the rule to clarify that landfill gas constitutes a "Gas 1" fuel for which the imposition of emission limits is infeasible and impracticable.  Alternatively, to the extent that landfill gas may only quality for "Gas 1" categorization through a fuel specification, WM requests that EPA revise the specification to ensure that it is established in a manner which will include landfill gas that is managed in accordance with existing Clean Air Act requirements, and which will ensure that landfill gas may be combusted without the imposition of burdensome sampling and analysis requirements.  Finally, landfill gas-fired units should not be subject to emission limits under the Boiler MACT.  The emission limits established for Gas 2 units are technically infeasible and cost prohibitive to promoting renewable sources of energy.

Landfill Gas Should be Identified as a Gas 1 Fuel

Waste Management contracted with CH2MHill to conduct a comparison of the emissions properties of boilers firing landfill gas as fuel to those of boilers firing Gas 1 fuels, and to examine the publicly available information to compare landfill gas to Gas 1 fuels, specifically natural gas and refinery gas.  (The report is appended to our comments as Attachment C.)

As described in the appended report, CH2MHill concluded that sufficient data were readily available for EPA to establish that LFG is comparable to natural gas and refinery gas with regard to HAP emissions, and that both emissions and raw gas analysis data support the conclusion that LFG should be classified as a Gas 1 fuel.  A brief summary of the report conclusions follows:

A comparison of the readily available data for landfill gas-only fueled boiler emissions indicates that the ranges of reported results for mercury, PM, CO, and dioxin/furans are within or below the ranges of these parameters for one or both of the recognized Gas 1 fuels -- natural gas and refinery gas.  No HCl data were available for refinery gas for comparison to landfill gas; however, the few HCl emissions data points available from landfill gas-fueled boilers (0.00321 to 0.00398 pounds per million British thermal units [lb/MMBTU]) are lower than the Boiler MACT emission limits for existing coal-fired units (0.035 lb/MMBTU).
Mercury levels in raw landfill gas from 15 landfills reported in EPA's BID (2008) for Revisions to the AP-42 Emission Factors for Municipal Solid Waste (MSW) Landfills indicated a range of total mercury orders of magnitude lower than the available data for mercury in natural gas.  A comparison of the constituents of raw landfill gas to the recognized Gas 1 fuels is inconclusive with respect to the other HAP and surrogate parameters because of the dearth of available data for the Gas 1 fuels.
Data developed by EPA in its 2008 BID support the conclusion that the mercury level in landfill gas is consistently much lower than the Gas 1 fuel specification level of 40ug/m[3].
EPA based its H2S fuel specification of 4 ppmv on sweetened, pipeline-quality natural gas; however, refinery gas (already categorized as Gas 1) typically contains much higher levels of H2S than the Gas 1 fuel specification.  CH2MHill noted that the H2S concentrations in refinery gas can range from 0 to 450,000 ppm.  The range of H2S concentrations in landfill gas noted in the EPA 2008 BID ranged from 0.00102 to 55.7 ppm.  Landfill gas should not be held to a higher H2S standard than refinery gas for qualification as a Gas 1 fuel, especially considering that H2S is neither a HAP, a HAP precursor nor a surrogate for HAP emissions.
Based on the above analysis, WM strongly recommends that landfill gas be categorized as Gas 1 under the Boiler Rule.  The data for mercury and H2S in landfill gas support its characterization as a Gas 1 fuel.  Further, should boiler owners switch fuel from landfill gas to one of the currently defined Gas 1 fuels, increased pollution emissions will occur.  Use of natural gas or refinery gas will increase criteria pollutant and greenhouse gas emissions compared to landfill gas.  Landfill gas has been shown to produce lower nitrous oxide emissions than natural gas, and using landfill gas lowers fossil carbon dioxide emissions as compared to both Gas 1 fuels.

EPA Should Revise the Gas 1 Specification

To the extent that landfill gas, or any gaseous fuel may only qualify for Gas 1 categorization through a fuel specification, WM requests that EPA revise the specification to ensure that it is established in a manner that will include landfill gas that is managed in accordance with existing CAA requirements as discussed above and in more detail in Attachment B.  For example, the Landfill MACT requires that landfill gas be routed to a treatment system that processes the gas for subsequent sale or use as fuel; this requirement would be an appropriate and adequate specification for demonstrating that landfill gas may be combusted as a Gas 1 fuel.  Alternatively, to the extent that EPA determines that an H2S specification limit must apply, any such limit should be derived from an existing landfill gas combustion-related sulfur content limit.  The NSPS (KKKK) for Stationary Turbines (40 CFR Part 60.4330) as revised in 2009, provides such a limit.

Landfill Gas Should Not be Subject to Additional Emission Limits When Used in Boilers

EPA has already evaluated, and regulated, HAP emissions that may result from the two circumstances under which landfill gas may be used in a boiler under the Landfill NSPS and the Landfill MACT.  First, landfill gas fired directly to a boiler operating as a control device is subject to the non-methane organic compounds (NMOC) emission standard that was established pursuant to the Landfill NSPS and determined under the Landfill MACT to adequately address HAP emissions.  Imposition of additional emission limits from such control devices would constitute an impermissible duplication of emission limits under Section 112 of the CAA.  Second, the Landfill NSPS and the Landfill MACT require that landfill gas used as a fuel must be treated and processed in a manner that ensures proper combustion in accordance with specifications required by the receiving combustion unit.  Imposition of emission limits under the Boiler MACT for this use of landfill gas, where natural gas and refinery gas are not subject to such limits, would create an extreme disincentive to the use of landfill gas for energy recovery. For these reasons, the Gas 2 emission limits in the Boiler Rule should not apply to landfill gas-fired boilers.

Waste Management appreciates the opportunity to share this additional information with the Agency, and looks forward to working with you as you reconsider and revise the Boiler and CISWI Rules.  If you have any questions with our comments or with the attached materials, please feel free to contact me at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>

Sincerely,

Kerry Kelly, Director
Federal Public Affairs


SIP SUBMITTAL COMPLETENESS CRITERIA CHECKLIST ( in accordance with 40 CFR Part 51  App. V)

SIP Submitted by: Stephanie R. Timmermeyer, Cabinet Secretary Date Submitted: December 1, 2005 Subject: Revision to the West Virginia State Implementation Plant Pursuant to 40 CFR Section 51.165 Nonattainment New Source Review ( 31 Dec 2002, 67 FR 80186)

Completeness Review Completed by: Rosemarie Nino Date Completed: December 8, 2005 Administrative Materials ACCEPTABLE EPA REQUIREMENT STATE SUBMITTAL ( X)

1. A formal letter of submittal from the Governor or his designee, requesting EPA approval of the plan or revision thereof. 1. Letter from Stephanie R. Timmermeyer, Cabinet Secretary,

WVDEP to Donald S. Welsh dated December 1, 2005 ( cover letter). X 2. Evidence that the State has adopted the plan in the State code or body of regulations; or issued the permit, order,

consent agreement in final form. That evidence shall include the date of adoption or final issuance as well as the effective date of the plan, if different from the adoption/ issuance date. 2. Notice of Final Filing and Adoptin of a Legislative Rule Authorized by the WV Legislature signed by the Secretary on May 20, 2005. Copy of the Final Legislative Rule 45 CSR 19 dated June 1, 2005 ( page 3 and page 5 thru page 49).. X 3. Evidence that the State has the necessary legal authority under State law to adopt and implement the plan. 3. Notice of Agency Approval of a Proposed Rule and Filing with the Legislative Rule Making Review Committee page 64 thru 116) ( no date)

WV Authority WV Code Section 22 5 4 dated August 25, 2004 ( page 56)/ X Administrative Materials EPA REQUIREMENT STATE SUBMITTAL ( X)

2 4. A copy of actual regulation, or document submitted for approval and incorporation by reference into the plan,

including indication of the changes made to the existing approved plan, where applicable. The submittal shall be a copy of the official State regulation/ document signed, stamped,

dated by the appropriate State official indicating that it is fully enforceable by the State. The effective date of the regulation/ document shall, whenever possible, be indicated in the document itself. 4. Copy of Regulation 45 CSR 19 amending the existing rule ( page 64 thru 116) ( no date)

WV Authority WV Code Section 22 5 4, Notice of Action Taken by the Legislative Rule Making Review Committee dated February 7, 2005 ( Page54 thru 57) X 5. Evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/ issuance of the plan. 5. Letter dated July 2, 2005, ( unsigned) request for a public hearing and public comment period for 45 CSR 14 and 19 dated August 2, 2004. ( page 212). X 6. Evidence that public notice was given of the proposed change consistent with procedures approved by EPA, including the date of publication of such notice. 6. Copy fo the public notice from the Charleston Newspaper dated July 2, 2004. ( page 214 thru 218) X 7. Certification that public hearings were held in accordance with the information provided in the public notice and the State's laws and constitution, if applicable. 7. Letter dated July 2, 2004 ( unsigned) request for a public hearing and public comment period for 45 SCR 14 and 19 on August 2, 2004. ( page 212). X 8. Compilation of public comments and the State's response thereto. 8. Response to comments, page 133 ( no date). X Technical Materials EPA REQUIREMENT STATE SUBMITTAL ( X)

3 1. Identification of all regulated pollutants affected by the plan. 1. See 45 CSR 14 Section 2.35a thru 2.36 Page 69 thru 70. X 2. Identification of the locations of affected sources including the EPA attainment/ nonattainment designation of the locations and the status of the attainment plan for the affected area( s). 2. Previously approved SIP see 40 CFR 81. X 3. Quantification of the changes in plan allowable emissions from the affected sources; estimates of changes in current actual emissions from affected sources or, where appropriate,

quantification of changes in actual emissions from affected sources through calculations of the differences between certain baseline levels and allowable emissions anticipated as a result of the revision. 3. NA  Previously approved.

4. The State's demonstration that the national ambient air quality standards, prevention of significant deterioration increments, reasonable further progress demonstration, and visibility, as applicable, are protected if the plan is approved and implemented. 4. NA  Previously approved.

5. Modeling information required to support the proposed revision, including input data, output data, models used,

ambient monitoring data used, meteorological data used,

justification for use of offsite data ( where used), modes of models used, assumptions, and other information relevant to the determination of adequacy of the modeling analysis. 5. NA  Previously approved.

6. Evidence, where necessary, that emission limitations are based on continuous emission reduction technology. 6. NA  Previously approved.

7. Evidence that the plan contains emission limitations, work practice standards and recordkeeping/ reporting requirements,

where necessary, to ensure emission levels. 7. NA  Previously approved. Technical Materials EPA REQUIREMENT STATE SUBMITTAL ( X)

4 8. Compliance/ enforcement strategies, including how compliance will be determined in practice. 8. NA Previously approved 9. Special economic and technological justifications required by any applicable EPA policies. ( If a policy is not appropriate,

explain why.) 9. NA 10. A Section 107 request must be accompanied by a maintenance plan demonstrating maintenance to the relevant NAAQS for at least 10 years after redesignation. 10. NA


[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11139-11140]
[FR Doc No: 2016-04496]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16]

Proposed Establishment of Class E Airspace; Harlan, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace at Harlan,
KY, to accommodate new Area Navigation (RNAV) Global Positioning System
(GPS) Standard Instrument Approach Procedures (SIAPs) serving Tucker-
Guthrie Memorial Airport. Controlled airspace is necessary for the
safety and management of instrument flight rules (IFR) operations at
the airport.

DATES: Comments must be received on or before April 18, 2016.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg Ground Floor, Rm W12-140, Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2016-3108; Airspace Docket No. 15-ASO-16, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.
    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 29591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish Class E airspace at Tucker-Guthrie Memorial
Airport, Harlan, KY.

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2016-3108; Airspace Docket No. 15-ASO-16) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2016-3108; Airspace Docket No. 15-ASO-16.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace
Designations and Reporting Points, dated August 6, 2015, and effective
September 15, 2015. FAA Order 7400.9Z is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.9Z lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace extending
upward from 700 feet above the surface within a 13-mile radius of
Tucker-Guthrie Memorial Airport, Harlan, KY, providing the controlled
airspace required to support the new RNAV (GPS) standard instrument
approach procedures for Tucker-Guthrie Memorial Airport. Controlled
airspace is necessary for IFR operations.
    Class E airspace designations are published in Paragraph 6005, of
FAA Order 7400.9Z, dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore; (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) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9Z, Airspace Designations and Reporting
Points, dated August 6, 2015, effective September 15, 2015, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO KY E Harlan, KY [New]

Tucker-Guthrie Memorial Airport, KY
    (Lat. 36[deg]51'36'' N., long. 83[deg]21'31'' W.)

    That airspace extending upward from 700 feet above the surface
within a 13-mile radius of Tucker-Guthrie Memorial Airport.

    Issued in College Park, Georgia, on February 23, 2016.
Ryan W. Almasy,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2016-04496 Filed 3-2-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Rules and Regulations]
[Page 23362-23367]
[DOCID:fr30ap08-20]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 171, 173, and 175

[Docket No. PHMSA-2006-25446 (HM-243)]
RIN 2137-AE19

Hazardous Materials: Fuel Cell Cartridges and Systems Transported
on Board Passenger Aircraft in Carry-On Baggage

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

ACTION: Final rule.

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

SUMMARY: PHMSA is amending the Hazardous Materials Regulations (HMR) to
permit certain fuel cell cartridges and fuel cell systems designed for
portable electronic devices to be transported by passengers and crew in
carry-on baggage on board passenger-carrying aircraft. Fuel cell
cartridges and fuel cell systems are an emerging energy technology
developed to provide a more efficient, longer-lasting, and renewable
power source for electrically operated equipment. This final rule
prescribes regulations for transporting fuel cells containing flammable
liquids, including methanol; formic acid; certain

borohydride materials; or butane that meet certain performance and
consumer use standards. PHMSA is issuing this final rule in cooperation
with the Federal Aviation Administration (FAA).

DATES: Effective date: The effective date of these amendments is
October 1, 2008.
    Voluntary Compliance Date: Voluntary compliance is authorized as of
May 30, 2008.
    Incorporation by Reference Date: The incorporation by reference of
publications listed in this final rule is approved by the Director of
the Federal Register as of October 1, 2008.

FOR FURTHER INFORMATION CONTACT: Eileen Edmonson, Office of Hazardous
Materials Standards,<PHONE_NUMBER>, Pipeline and Hazardous Materials
Safety Administration (PHMSA), 1200 New Jersey Avenue, SE., Washington,
DC 20590, facsimile telephone number<PHONE_NUMBER>, or by e-mail to
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On September 20, 2007, PHMSA published a notice of proposed
rulemaking (NPRM; 72 FR 53744) that proposed to amend the Hazardous
Materials Regulations (HMR; 49 CFR Parts 171-180) to permit certain
fuel cell cartridges and systems designed for use in portable
electronic devices to be transported in carry-on baggage on board
passenger-carrying aircraft. Consistent with the requirements adopted
by the International Civil Aviation Organization (ICAO) in section
<IP_ADDRESS>(r) of the 2007-2008 edition of the ICAO Technical Instructions
for the Safe Transport of Dangerous Goods by Air (ICAO Technical
Instructions), the NPRM proposed to permit fuel cell systems and
cartridges that contain flammable liquids (including methanol), formic
acid, and butane in carry-on baggage on board passenger-carrying
aircraft provided the fuel cells conform to the industry technical
specification governing the design and consumer use of fuel cell
cartridges, power units, and power systems developed by the
International Electrotechnical Commission (IEC)--IEC/PAS 62282-6-
1:2006(E), First Edition 2006-02, with Corrigendum 1, First Edition
2007-04. We also proposed in the NPRM, in response to petitions for
rulemaking, numbered P-1475 and P-1483, to permit fuel cell cartridges
and systems that contain certain Class 8 (corrosive) borohydride
materials to be transported in carry-on baggage on board passenger-
carrying aircraft. We agreed with the petitioners that fuel cell
cartridges and systems containing these materials pose similar safety
risks and will operate in a similar manner as those containing formic
acid. We also proposed to require that fuel cell cartridges and systems
containing certain borohydride materials conform to the same IEC
technical specification described earlier.
    The IEC specification contains detailed manufacturing, safety, and
testing requirements to address conditions that may be encountered
during use, misuse, and consumer transportation. One design requirement
of the IEC specification is that the fuel cell systems' outputs do not
exceed 60 volts and 240 watts. To ensure the capability of the fuel
cell and cartridge to withstand normal conditions of consumer handling
and transportation, the specification requires various design-type
tests such as pressure differential, vibration, temperature cycling,
high temperature exposure, drop, compressive loading, connection
cycling, external short circuit, and long-term storage.
    Under the NPRM, we proposed to limit the amount of fuel per
cartridge to a maximum quantity of 200 mL (6.76 ounces) for liquids,
200 mL (6.76 ounces) for metal fuel cell cartridges containing butane,
120 mL (4.0 ounces) for non-metallic fuel cell cartridges containing
butane, and 200 g (7 ounces) for solids. Because the IEC specification
states Class 8 borohydride fuels may be liquid or solid (see Figure
E1.4 and Sections E<IP_ADDRESS>, E<IP_ADDRESS>, and E1.3.46), and establishes a
200 g limit for solid fuel per fuel cell cartridge (see Sections
E<IP_ADDRESS>.3 and E<IP_ADDRESS>.3), we proposed this same limit for solid
fuel in the NPRM. We also proposed to limit aircraft passengers to two
spare fuel cell cartridges per person.
    We proposed in the NPRM to permit fuel cells containing the
following types of materials to be transported in carry-on baggage on
passenger aircraft: (1) Gases meeting the criteria for classification
as Division 2.1 (flammable gases), (2) solids meeting the criteria for
classification as Division 4.3 (dangerous when wet), and (3) liquids
meeting the criteria for classification as Class 3 (flammable) or Class
8 (corrosive) material. We unintentionally omitted from the NPRM's
preamble text that the proposed rulemaking also considered solid fuels
meeting the criteria for classification as Class 8 material. PHMSA
worked closely with FAA to evaluate the transportation safety risks
presented by these fuel cell cartridges and systems and determined that
they may be transported safely in the cabin of a passenger-carrying
aircraft.

II. Comments on the NPRM

    PHMSA received comments from the Methanol Institute, MTI MicroFuel
Cells, Inc., the U.S. Fuel Cell Council, and Lilliputian Systems. The
commenters unanimously support adoption of the proposed rule. Several
offered more specific comments on particular aspects of the proposal,
as addressed in detail below.

A. Limitation on Fuel Cells Used To Charge Batteries or Devices

    In the NPRM, we proposed to limit fuel cell cartridges and systems
carried by passengers and crew members to a type and design that will
not continue to charge batteries when the device being powered is not
in use. This proposed limitation is consistent with restrictions
adopted by ICAO.
    The Methanol Institute and MTI MicroFuel Cells, Inc., suggest that
this restriction is inconsistent with HMR requirements applicable to
other energy producing devices such as lithium metal or lithium ion
batteries, which are not subject to operating limitations when carried
in the passenger cabin of an aircraft. Although the function of fuel
cell cartridges and devices may be similar to those of other energy
producing devices permitted in transportation under the HMR, we
disagree with the commenters that the risks posed by these devices are
similar. We determined through our technical review that fuel cell
cartridges and systems designed solely to energize devices or that
energize devices that are not in use have the potential to overwhelm
the safety systems contained in the device, posing a risk of
overheating, electric shock, or fuel product release. We will continue
to work with the industry and international agencies to evaluate the
safety of these fuel cell cartridges and systems as the technology
evolves and to consider whether additional rulemaking may be
appropriate.

B. Use of the Term ``Fuel Cell Cartridge''

    The U.S. Fuel Cell Council objects to PHMSA's use of the wording
``fuel cell cartridge.'' It states one company, ReliOn, has used the
term since the year 2000 to refer to its patented fuel cell system,
composed of multiple ``hot-swappable'' fuel cell cartridges, and to
refer to a cartridge that holds a fuel cell but not fuel. The commenter
states the use of this wording will cause confusion in the marketplace
and requests that we replace it with the wording ``fuel cartridges for
fuel cell devices.''
    We do not agree that our use of the term ``fuel cell cartridge''
will cause

confusion in the regulated community. We note that the terms ``fuel
cell cartridge'' and ``fuel cell system'' are used extensively in the
IEC Specification No. IEC/PAS 62282-6-1 and the U.S. Fuel Council's
Special Permit request, dated November 28, 2006, submitted by Dangerous
Goods Transport Consulting, Inc., on its behalf. The term ``fuel cell
cartridge'' has a well-established meaning in the industry and is not
generally used as a specific reference to the system developed by the
ReliOn Company.

III. Provisions of This Final Rule

    In this final rule, PHMSA is amending the HMR to permit the
transportation in carry-on baggage on passenger-carrying aircraft of
fuel cell cartridges and systems containing Class 3 flammable liquids,
including methanol; formic acid and borohydride materials meeting the
definition for a Class 8 material; and butane, a Division 2.1 gas.
    PHMSA is also requiring fuel cells to conform to certain rigorous
performance criteria, which are consistent with the passenger
authorizations adopted for the 2007-2008 edition of the ICAO Technical
Instructions. As stated earlier in this preamble, these criteria
include compliance with the industry technical specification and
addendum developed by the IEC governing the design and consumer use of
fuel cell cartridges, power units, and power systems (IEC Specification
No. IEC/PAS 62282-6-1:2006(E), First Edition 2006, with Corrigendum 1,
First Edition 2007). PHMSA finds the IEC technical specification
comprehensive in that it addresses design, manufacturing, testing, and
transportation specific to micro-fuel cells, as well as requirements
for valves, filling, packaging performance, failure mode analysis,
consumer refilling, materials of construction, exterior and exhaust
temperature limits, warnings, certification, markings, and
manufacturers' instructions. PHMSA and FAA also strongly support the
recent addendum to the IEC specification mandating a zero-leak standard
as a basis for successfully passing the design-type tests, which we
find is equivalent to the safety standard established for certain non-
bulk gas packagings in the HMR. Fuel cell cartridges and systems
carried by airline passengers and crew must be marked ``APPROVED FOR
CARRIAGE IN AIRCRAFT CABIN ONLY'' by the manufacturer. This marking is
the manufacturer's certification that the fuel cell cartridges and
systems conform to the performance standard established in the revised
IEC technical specification and all other applicable requirements
prescribed in the HMR.
    In addition, consistent with the standard adopted for the ICAO
Technical Instructions, in this final rule PHMSA is limiting the amount
of hazardous material that may be contained in each individual fuel
cell authorized for transportation in carry-on baggage on board
passenger-carrying aircraft to 200 mL (6.76 ounces) of liquid fuel per
cartridge, 200 mL (6.76 ounces) of liquefied gas fuel per metal
cartridge, 120 mL (4 fluid ounces) of liquefied gas fuel per non-
metallic fuel cartridge, and 200 g (7 ounces) of solid material fuel
per cartridge. Also consistent with the ICAO Technical Instructions,
each passenger or crew member will be permitted to carry up to two
spare cartridges.
    To reduce possible releases, passengers and crew members are
prohibited from refilling fuel cell cartridges and systems, except to
install a spare cartridge. In addition, fuel cell cartridges and
systems carried by passengers and crew members are limited to a type
and design that will not solely charge batteries or continue to charge
batteries when the device being powered is not in use. Again, these
prohibitions are consistent with the passenger authorizations for fuel
cells adopted under the ICAO Technical Instructions.
    PHMSA and FAA are confident that fuel cells containing flammable
liquids, including methanol; formic acid; certain borohydride
materials; or butane that are manufactured in accordance with the IEC
specification may safely be transported in the passenger cabin of an
aircraft under the conditions established in this final rule. However,
as indicated above, fuel cells are an evolving technology. PHMSA will
continue to work with the FAA's William J. Hughes Technical Center to
evaluate the safety risks posed by various types of fuel cell
cartridges and systems. We also intend to work closely with the ICAO
and other international standards-setting organizations to identify and
address safety issues associated with the transportation of fuel cells
by all modes of transportation.

VII. Transportation Security Administration

    The Department of Homeland Security's Transportation Security
Administration (TSA) is authorized to prescribe security standards for
all modes of transportation, including aviation (49 U.S.C. 114(d)).
Under this authority, TSA prohibits airline passengers from carrying
weapons, explosives, or incendiary devices and has published several
interpretative rules to provide guidance on the types of property TSA
considers subject to the prohibition (68 FR 7444; 68 FR 9902; 70 FR
9877).
    PHMSA consulted with TSA during the development of this final rule
concerning current security limitations applicable to the carriage of
fuel cells by aircraft passengers and crewmembers and shared with TSA
our technical analysis supporting this rulemaking. We understand that
TSA is continuing to consider whether or not any additional security
measures for fuel cells or fuel cell systems may be appropriate. This
final rule does not limit TSA's authority to address security concerns
related to the transportation of fuel cells or fuel cell systems.
    On September 26, 2006, TSA imposed a strict limit on liquids, gels,
and aerosols an aircraft passenger is permitted to take through a
security checkpoint in carry-on baggage. TSA limits these materials to
3-ounce (100 mL) or smaller containers placed in a clear quart-size,
zip-top plastic bag. Fuel cell cartridges and systems will be subject
to this limitation, notwithstanding the provisions adopted in this
final rule.

VIII. Rulemaking Analyses and Notices

A. Statutory/Legal Authority for This Rulemaking

    This final rule is published under the following statutory
authorities:
    1. 49 U.S.C. 5103(b) authorizes the Secretary of Transportation to
prescribe regulations for the safe transportation, including security,
of hazardous material in intrastate, interstate, and foreign commerce.
This final rule amends the HMR to promote the safe transportation of
fuel cells carried by airline passengers and crew members. To this end,
as detailed above, PHMSA is amending the HMR to limit the types and
quantities of fuel cell cartridges and fuel cell systems permitted in
carry-on baggage on passenger aircraft, prescribe specific performance-
based design and packaging criteria for these articles, and limit the
manner in which they may be used during air transportation.
    2. Section 5120 of Federal hazardous materials transportation law
(49 U.S.C. 5120), authorizes the Secretary of Transportation to
participate in the development of international standards for the
transportation of hazardous materials and grants the Secretary broad
discretion to harmonize the HMR with international standards. Section
5120(c) permits the Secretary to establish more stringent standards for
transportation in the United States as necessary in the

public interest. The amendments in this final rule will harmonize the
HMR with international requirements for fuel cell systems and
cartridges to the extent these are consistent with PHMSA's safety
objectives.

B. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This final rule is not a significant regulatory action under
section 3(f) of Executive Order 12866 and was not reviewed by the
Office of Management and Budget. This final rule is a non-significant
rule under the Regulatory Policies and Procedures of the Department of
Transportation [44 FR 11034].
    Fuel cells are an emerging technology designed to meet the growing
demand for alternative energy sources. Fuel cell technology has not yet
achieved wide-spread commercialization, but is being developed for use
in mobile phones, laptop computers, and, to a lesser extent,
camcorders, digital cameras, and personal digital assistants
(``PDAs''). In 2006, the U.S. Fuel Cell Council conducted an industry
survey and received comments from 181 respondents. The respondents
reported that sales from 2005 to 2006 of all fuel cell and fuel cell-
based systems increased by 7 percent to $353 million, and research and
development expenditures and industry employment over the same period
increased by 11 and 12 percent to $796 million and 7,074 employees,
respectively. Fuel cell cartridges and systems designed for portable
electronic devices are a small part of these reported results. The
industry projects fuel cells for portable electronic devices will
achieve significant market penetration by 2009.
    By authorizing their carriage by airline passengers and crew, the
regulatory changes addressed in this rulemaking will lift barriers to
the commercialization and distribution of fuel cell cartridges for use
in personal electronic equipment. The costs associated with this
rulemaking proposal primarily relate to the costs for testing fuel cell
designs in accordance with the IEC consensus specification. We expect
most fuel cell manufacturers will voluntarily comply with the IEC
specification as a positive marketing tool because it addresses broad
consumer safety issues and provides independent assurance that fuel
cells will meet a rigorous safety standard. Thus, the incremental costs
imposed by this final rule are expected to be minimal.

C. Executive Order 13132

    This final rule has been analyzed in accordance with the principles
and criteria set forth in Executive Order 13132 (``Federalism''). The
requirements that result from this final rule will preempt State,
local, and Indian tribe requirements but will not have substantial
direct effects on the States, the relationship between the national
government and the States, or the distribution of power and
responsibilities among the various levels of government. Therefore, the
consultation and funding requirements of Executive Order 13132 do not
apply.
    Federal hazardous materials transportation law (49 U.S.C. 5125(b))
expressly preempts State, local, and Indian tribe requirements on
certain covered subjects, as follows:
    (1) The designation, description, and classification of hazardous
materials;
    (2) The packing, repacking, handling, labeling, marking, and
placarding of hazardous materials;
    (3) The preparation, execution, and use of shipping documents
related to hazardous materials, and requirements related to the number,
contents, and placement of those documents;
    (4) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous materials; and
    (5) The design, manufacture, fabrication, inspection, marking,
maintenance, reconditioning, repair, or testing of a packaging or
container represented, marked, certified, or sold as qualified for use
in transporting hazardous material.
    This final rule addresses covered subject items (1), (2), (3), and
(5) above and will preempt State, local, and Indian tribe requirements
not meeting the ``substantively the same'' standard. Pursuant to 49
U.S.C. 5125(b)(2), we will deem federal preemption effective upon the
effective date of the final rule. We are making the final rule
effective on October 1, 2008.

D. Executive Order 13175

    This final rule was analyzed in accordance with the principles and
criteria set forth in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because it does not
have tribal implications and does not impose substantial direct
compliance costs, the funding and consultation requirements of
Executive Order 13175 do not apply to this final rule.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an
agency to review regulations to assess their impact on small entities,
unless the agency determines the final rule is not expected to have a
significant impact on a substantial number of small entities. This
final rule will relax regulatory barriers to the transportation of fuel
cells used in personal electronic devices and, accordingly, is expected
to have a positive impact on small businesses that manufacture,
distribute, transport, or use such items. As indicated above, we expect
the incremental costs imposed by this final rule to be minimal.
Therefore, PHMSA certifies that the amendments prescribed in this final
rule will not have a significant impact on a substantial number of
small entities.
    This final rule has been developed in accordance with Executive
Order 13272 (``Proper Consideration of Small Entities in Agency
Rulemaking'') and DOT's procedures and policies to promote compliance
with the Regulatory Flexibility Act to ensure that potential impacts of
final rules on small entities are properly considered.

F. Paperwork Reduction Act

    Section 1320.8(d), Title 5, Code of Federal Regulations, requires
PHMSA to provide interested members of the public and affected agencies
an opportunity to comment on information collection and recordkeeping
requests. This final rule does not include new information collection
or recordkeeping requirements.

G. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
April and October of each year. The RIN contained in the heading of
this document can be used to cross-reference this action with the
Unified Agenda.

H. Unfunded Mandates Reform Act

    This final rule does not impose unfunded mandates under the
Unfunded Mandates Reform Act of 1995. It does not result in costs of
$120.7 million or more to either State, local or tribal governments, in
the aggregate, or to the private sector, and is the least burdensome
alternative that achieves the objective of the rule.

I. Environmental Assessment

    The National Environmental Policy Act (NEPA), Sec. Sec.  4321-4375,
requires that federal agencies analyze regulatory actions to determine
whether the action will have a significant impact on the human
environment. The Council on

Environmental Quality (CEQ) regulations order federal agencies to
conduct an environmental review considering (1) the need for the
action, (2) alternatives to the action, (3) environmental impacts of
the action and alternatives, and (4) the agencies and persons consulted
during the consideration process. 40 CFR 1508.9(b).
    We have reviewed the risks associated with transporting fuel cell
systems and cartridges. The amount of hazardous material contained
within the fuel cells or cartridges to which this final rule applies is
minimal, limited to 200 mL or 200 g. Even if a large number of these
devices were compromised and their hazardous materials contents
released, the environmental impact of the release will not be
significant. We have determined there will be no significant
environmental impacts associated with this final rule.
Consultation and Public Comment
    As discussed above, PHMSA consulted with the IEC and many companies
representing the fuel cell industry here and abroad to prepare for U.N.
Dangerous Goods Council meetings on these devices. PHMSA also
participated in the technical review of papers prepared by these
companies explaining the potential risks and measures taken in the IEC
specification to reduce risks for each fuel the IEC specification
states may be present in a fuel cell. As discussed earlier, PHMSA also
has consulted extensively with the U.S. Fuel Council, Medis
Technologies, Ltd., and Millenium Cell, Inc., in response to their
petitions for rulemaking, P-1475 and P-1483, respectively, to permit
passengers and crew to transport in carry-on baggage on board passenger
aircraft fuel cells containing flammable liquid, formic acid, butane,
and Class 8 borohydride materials for use in portable electronic
devices. PHMSA has also received one letter signed by approximately 18
companies and 4 letters from commenters that support amending the HMR
to permit fuel cells to be transported in personal electronic devices
in carry-on luggage on board passenger-carrying aircraft.

List of Subjects

49 CFR Part 171

    Exports, Hazardous materials transportation, Hazardous waste,
Imports, Incorporation by reference, Reporting and recordkeeping
requirements.

49 CFR Part 173

    Hazardous materials transportation, Packaging and containers,
Radioactive materials, Reporting and recordkeeping requirements,
Uranium.

49 CFR Part 175

    Air carriers, Hazardous materials transportation, Incorporation by
reference, Radioactive materials, Reporting and recordkeeping
requirements.

0
In consideration of the foregoing, 49 CFR Chapter I is amended as
follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

0
1. The authority citation for part 171 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53;
Public Law 101-410 section 4 (28 U.S.C. 2461 Note); Public Law 104-
134 section 31001.

0
2. In Sec.  171.7, amend paragraph (a)(3), in the Table, by adding a
new entry for the International Electrotechnical Commission in
appropriate alphabetical order to read as follows:

Sec.  171.7  Reference material.

* * * * *
    (a) * * *
    (3) * * *

------------------------------------------------------------------------
                                                              49 CFR
               Source and name of material                   Reference
------------------------------------------------------------------------

                              * * * * * * *
International Electrotechnical Commission (IEC) 3, rue
 de Varemb[eacute], P.O. Box 131, CH--1211, GENEVA 20,
 Switzerland:
    Fuel cell technologies--Part 6-1: Micro fuel cell       Sec.  175.10
     power systems--Safety, IEC/PAS 62282-6-1:2006(E),
     First Edition 2006-02, with Corrigendum 1, First
     Edition 2007-04....................................

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

* * * * *

0
3. Sec.  171.8, three new definitions for ``fuel cell,'' ``fuel cell
cartridge,'' and ``fuel cell system'' are added in alphabetical order
to read as follows:

Sec.  171.8  Definitions and abbreviations.

* * * * *
    Fuel cell means an electrochemical device that converts the energy
of the chemical reaction between a fuel, such as hydrogen or hydrogen
rich gases, alcohols, or hydrocarbons, and an oxidant, such as air or
oxygen, to direct current (d.c.) power, heat, and other reaction
products.
    Fuel cell cartridge or Fuel cartridge means a removable article
that contains and supplies fuel to the micro fuel cell power unit or
internal reservoir, not to be refilled by the user.
    Fuel cell system means a fuel cell with an installed fuel cell
cartridge together with wiring, valves, and other attachments that
connect the fuel cell or cartridge to the device it powers. The fuel
cell or cartridge may be so constructed that it forms an integral part
of the device or may be removed and connected manually to the device.
* * * * *

PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND
PACKAGINGS

0
4. The authority citation for part 173 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45, 1.53.

0
5. In Sec.  173.230, paragraph (a) is revised and new paragraph (d) is
added, to read as follows:

Sec.  173.230  Fuel cell cartridges containing flammable liquids.

    (a) A fuel cell cartridge must be designed and constructed to
prevent the fuel it contains from leaking during normal conditions of
transportation and be free of electric charge generating components.
* * * * *
    (d) Fuel cells intended for transportation in carry-on baggage on
board passenger aircraft must also meet the applicable provisions
prescribed in Sec.  175.10 of this subchapter.

PART 175--CARRIAGE BY AIRCRAFT

0
6. The authority citation for part 175 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45, 1.53.

0
7. In Sec.  175.10, new paragraph (a)(18) is added to read as follows:

Sec.  175.10  Exceptions for passengers, crew members, and air
operators.

    (a) * * *
    (18) Portable electronic devices (for example, cameras, cellular
phones, laptop computers, and camcorders) powered by fuel cell systems,
and not more than two spare fuel cell cartridges per passenger or crew
member, when transported in carry-on baggage by aircraft under the
following conditions:
    (i) Fuel cell cartridges may contain only Class 3 flammable liquids
(including methanol), Class 8 formic acid, Class 8 borohydride
materials, or Division 2.1 butane;
    (ii) The maximum quantity of fuel in any fuel cell cartridge may
not exceed:
    (A) 200 mL (6.76 ounces) for liquids,
    (B) 120 mL (4 fluid ounces) for liquefied gases in non-metallic
fuel cell cartridges, or 200 mL for liquefied gases in metal fuel cell
cartridges;
    (C) 200 g (7 ounces) for solids;
    (iii) No more than two spare fuel cell cartridges may be carried by
a passenger;
    (iv) Fuel cell systems containing fuel and fuel cell cartridges
including spare cartridges are permitted in carry-on baggage only;
    (v) Fuel cell cartridges may not be refillable by the user.
Refueling of fuel cell systems is not permitted except that the
installation of a spare cartridge is allowed. Fuel cell cartridges that
are used to refill fuel cell systems but that are not designed or
intended to remain installed (fuel cell refills) in a portable
electronic device are not permitted;
    (vi) Fuel cell systems and fuel cell cartridges must conform to
IEC/PAS 62282-6-1 (IBR; see Sec.  171.7 of this subchapter);
    (vii) Interaction between fuel cells and integrated batteries in a
device must conform to IEC/PAS 62282-6-1. Fuel cell systems for which
the sole function is to charge a battery in the device are not
permitted;
    (viii) Fuel cell systems must be of a type that will not charge
batteries when the portable electronic device is not in use; and
    (ix) Each fuel cell cartridge and system that conforms to the
requirements in this paragraph (a)(18) must be durably marked by the
manufacturer with the wording: ``APPROVED FOR CARRIAGE IN AIRCRAFT
CABIN ONLY'' to certify that the fuel cell cartridge or system meets
the specifications in IEC/PAS 62282-6-1 and all other applicable
requirements of this subchapter.
* * * * *

    Issued in Washington, DC, on April 22, 2008, under the authority
delegated in 49 CFR part 1.
Carl T. Johnson,
Administrator.
[FR Doc. E8-9203 Filed 4-29-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37069-37070]
[FR Doc No: 2023-11943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0861]

Cover Letter Attachments for Controlled Correspondence and
Abbreviated New Drug Application Submissions; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Cover
Letter Attachments for Controlled Correspondence and ANDA
Submissions.'' This guidance is intended to assist prospective
applicants, applicants, and holders of abbreviated new drug
applications (ANDAs) with optional attachments that can be used when
preparing cover letters that accompany controlled correspondence,
original ANDAs, amendments to ANDAs, and supplements to approved ANDAs
submitted to FDA. This guidance finalizes the draft guidance of the
same title issued on December 13, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on June 6, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2021-D-0861 for ``Cover Letter Attachments for Controlled
Correspondence and ANDA Submissions.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/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 https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan Hughes, Office of Generic
Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Rm. 1668, Silver Spring, MD
20993-0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Cover Letter Attachments for Controlled Correspondence and
ANDA Submissions.'' This guidance is intended to assist prospective
applicants, applicants, and holders of ANDAs with optional attachments
that can be used when preparing cover letters that accompany controlled
correspondence, original ANDAs, amendments to ANDAs, and supplements to
approved ANDAs submitted to FDA.
    A cover letter is generally included with controlled correspondence
to the Office of Generic Drugs and submissions to an ANDA file. While a
cover letter is not required content for an ANDA, the cover letter is a
part of the electronic common technical document hierarchy and is
included in Module 1 of an ANDA submission.
    The cover letter provides an overview of the submission and helps
FDA ensure that the submission is properly triaged and assigned to the
appropriate assessors. In an effort to ensure that submissions are
effectively managed by FDA and acted upon within the performance review
goal dates reflected in the Generic Drug User Fee Amendments (GDUFA)
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2023-2027 commitment letter (GDUFA III Commitment Letter),\1\ FDA has
developed cover letter attachments to accompany, not replace,
applicants' cover letters for common submissions, including controlled
correspondence, original ANDAs, and amendments to ANDAs, as well as
supplements to approved ANDAs. These cover letter attachments have been
designed as a checklist to reflect common types of information
applicants are expected to address in their cover letters. The
attachments are intended both to serve as a useful guide to help
applicants prepare their cover letters and to assist FDA in the triage
and management of submissions.
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/media/153631/download.
---------------------------------------------------------------------------

    This guidance finalizes the draft guidance entitled ``Cover Letter
Attachments for Controlled Correspondence and ANDA Submissions'' issued
on December 13, 2021 (86 FR 70849). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include clarifying that use of the cover
letter attachments are voluntary; defining several terms that may have
been ambiguous (e.g., ``administrative general correspondence'' and
``approved citizen petitions''); and adding updated information on
labeling carve-outs and requests for reconsideration. In addition,
editorial changes were made to improve clarity, such as adding lines to
denote where information should be filled in by the applicant and minor
reformatting of the attachments in the appendices.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cover Letter Attachments for Controlled
Correspondence and ANDA Submissions.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 (including subpart C) for to the
content and format of ANDAs, including original ANDAs, amendments to
ANDAs, and supplements to approved ANDAs, submitted by applicants and
approved by FDA have been approved under OMB control number 0910-0001.
The collections of information for Form FDA 356h (NDA and ANDA cover
letter) have been approved under OMB control number 0910-0338.
    Applicants submit to FDA controlled correspondence along with cover
letters related to generic drug development and FDA approval. The
collections of information for such submissions have been approved
under OMB control number 0910-0797. The collections of information in
21 CFR part 11 for electronic records and electronic signatures have
been approved under OMB control number 0910-0303. The collections of
information in 21 CFR part 211 about the manufacture of the drug have
been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the final guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11943 Filed 6-5-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Notices]
[Page 68148-68149]
[DOCID:fr04de07-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12904-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

November 26, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12904-000.
    c. Date filed: July 30, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Dashields Locks & Dam Hydroelectric Project.
    f. Location: Ohio River in Allegheny County, Pennsylvania. It would
use the U.S. Army Corps of Engineers' Dashields Locks & Dam.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12904-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in 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.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Dashields Locks & Dam and operated in a run-of-
river mode would consist of: (1) A new 200-foot long, 200-foot wide,
50-foot high concrete powerhouse; (2) a new intake channel and tailrace
channel on the northeastern side of the river opposite the existing
locks structure; (3) five turbine/generator units with a combined
installed capacity of 25 megawatts; (4) a new 11,500-foot long above
ground transmission line extending from the switchyard near the
powerhouse to an interconnection point with an existing transmission
line located northwest of the powerhouse; and (5) appurtenant
facilities. The proposed Dashields Locks & Dam Project would have an
average annual generation of 120 gigawatt-hours.
    l. This filing 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 last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.
    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide

whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23435 Filed 12-3-07; 8:45 am]

BILLING CODE 6717-01-P