AIR QUALITY PROGRAM
                           301 39th Street, Bldg. #7
                           Pittsburgh, PA 15201-1811

                        Minor Source/Minor Modification
                              INSTALLATION PERMIT

Issued To:	GenOn Cheswick Generating Station 	ACHD Permit#:	0054-I005a
            Pittsburgh & Porter Streets
            Springdale, PA 15144	Date of Issuance:	February 28, 2020

                                      Amended Date		----

                                          Expiration Date:       	(See Section III.12)

Issued By:	___________________________	Prepared By:
	JoAnn Truchan, P.E.	Bernadette Lipari
	Section Chief, Engineering	Air Quality Engineer

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                               TABLE OF CONTENTS

I.	CONTACT INFORMATION	4
II.	FACILITY DESCRIPTION	5
III.	GENERAL CONDITIONS	6
IV.	SITE LEVEL TERMS AND CONDITIONS	11
V.	EMISSION UNIT LEVEL TERMS AND CONDITIONS	25
A.	Main Boiler No. 1, Stack No. 001a	25
B.	Auxiliary Boiler, Stack No. 2	30
VI.	ALTERNATIVE OPERATING SCENARIOS	33
VII.	EMISSIONS LIMITATIONS SUMMARY	34

AMENDMENTS:

DATE
SECTION(S)
11/16/21
Section IV, Removed NOX Emissions Averaging Plan; Section V, Conditions V.A.1.b.1  -  3 & V.A.1.d: Revised the NOX emissions limits; Revised the NOX monitoring requirements; Section VII: Revised the facility's emissions summary.

CONTACT INFORMATION

      Facility Location:		Cheswick Generating Station
      		Pittsburgh & Porter Street
      		Springdale, PA  15144

      Permittee/Owner:		GenOn Power Midwest LP
      		Cheswick Generating Station
		P.O. Box 65
		Cheswick, PA 15024

      Responsible Official:		Kevin P. Panzino
      Title:		Plant Manager
      Company:		GenOn Power Midwest LP
      Address:		Cheswick Generating Station
		P.O. Box 65
		Cheswick, PA 15024
      Telephone Number:<PHONE_NUMBER>
      E-Mail Address<EMAIL_ADDRESS>
      Facility Contact:		William McGraw
      Title:		Environmental and Safety Manager
      Telephone Number:<PHONE_NUMBER>
      E-mail Address<EMAIL_ADDRESS>
      Alternate Responsible Official: 	Mark Gouveia
      Title:					Senior Vice President, Plant Operations
      Company:				GenOn Energy, Inc.
      Address:				Cheswick Generating Station
      					P.O. Box 65
                              Cheswick, PA 15024
      Telephone Number:<PHONE_NUMBER>

      AGENCY ADDRESSES:

      ACHD Contact:		Chief Engineer
                              	Allegheny County Health Department
		Air Quality Program
		301 39th Street, Building #7
		Pittsburgh, PA 15201-1811

      EPA Contact:		Enforcement Programs Section (3AP12)
		USEPA Region III
		1650 Arch Street
		Philadelphia, PA 19103-2029

FACILITY DESCRIPTION

FACILITY DESCRIPTION

The Cheswick Generating Station is an electric generating facility located on Pittsburgh and Porter Streets in Springdale, PA. The plant is composed of one main boiler exhausting to one stack, which fires coal (including synfuel) as the primary fuel and natural gas as an auxiliary fuel for startup, shutdown, and during upset conditions. Pollution control equipment for the main boiler includes low NOx burners, electrostatic precipitation with flue gas conditioning, selective catalytic reduction, and flue gas desulfurization (FGD). The plant also has a No. 2 oil-fired auxiliary boiler which exhausts to a separate stack.  The facility is a major source of sulfur dioxide (SO2), nitrogen oxides (NOX), particulate matter (PM), particulate matter < 10 microns in diameter (PM10), particulate matter < 2.5 microns in diameter (PM2.5), carbon monoxide emissions (CO), hazardous air pollutants (HAPs), and volatile organic compounds (VOCs), as defined in section 2101.20 of Article XXI.

INSTALLATION DESCRIPTION

This installation permit is for inclusion of physical and operational conditions for subject facilities pursuant to Reasonable Available Control Technology (RACT) in section 2105.06 of Article XXI. There are no new units being added to the facility as part of this permitting action.

This installation permit modification revises the case-by-case RACT II analysis for the Main Boiler No. 1 by eliminating the averaging plan with the Brunot Island Generating Station (#0056) and removing the alternate limit for operation of the SCR at <600 °F.

The emission units regulated by this permit are summarized in Table II-1:

                   TABLE II-1:  Emission Unit Identification

                                     I.D.
                              SOURCE DESCRIPTION
                               CONTROL DEVICE(S)
                                    MAXIMUM
                                   CAPACITY
                                   FUEL/RAW
                                   MATERIAL
                                     STACK
                                     I.D.
                                     S-001
                     Main Boiler No.1, Tangentially Fired
               Low NOX Burners; ESP with Flue Gas Conditioning;
                                      SCR
                           6,000 MMBtu/Hr Maximum;
                                5,500 MMBtu/Hr
                                     Rated
  Bituminous and Sub-Bituminous Coal;  Synfuel ; Natural Gas (Auxiliary Fuel)
                                     S-001
                                     S-002
                 Auxiliary Boiler, No. 2 Fuel Oil Stoker Fired
                                     None
                                 160 MMBtu/Hr
                                No. 2 Fuel Oil
                                     S-002

                             DECLARATION OF POLICY

Pollution prevention is recognized as the preferred strategy (over pollution control) for reducing risk to air resources. Accordingly, pollution prevention measures should be integrated into air pollution control programs wherever possible, and the adoption by sources of cost-effective compliance strategies, incorporating pollution prevention, is encouraged. The Department will give expedited consideration to any permit modification request based on pollution prevention principles.

The permittee is subject to the terms and conditions set forth below. These terms and conditions constitute provisions of Allegheny County Health Department Rules and Regulations, Article XXI Air Pollution Control. The subject equipment has been conditionally approved for operation. The equipment shall be operated in conformity with the plans, specifications, conditions, and instructions which are part of your application, and may be periodically inspected for compliance by the Department. In the event that the terms and conditions of this permit or the applicable provisions of Article XXI conflict with the application for this permit, these terms and conditions and the applicable provisions of Article XXI shall prevail. Additionally, nothing in this permit relieves the permittee from the obligation to comply with all applicable Federal, State and Local laws and regulations.

GENERAL CONDITIONS

Prohibition of Air Pollution (§2101.11)

      It shall be a violation of this permit to fail to comply with, or to cause or assist in the violation of, any requirement of this permit, or any order or permit issued pursuant to authority granted by Article XXI. The permittee shall not willfully, negligently, or through the failure to provide and operate necessary control equipment or to take necessary precautions, operate any source of air contaminants in such manner that emissions from such source:

Exceed the amounts permitted by this permit or by any order or permit issued pursuant to Article XXI;
Cause an exceedance of the ambient air quality standards established by Article XXI §2101.10; or
May reasonably be anticipated to endanger the public health, safety, or welfare.

Nuisances (§2101.13)

      Any violation of any requirement of this Permit shall constitute a nuisance.

Definitions (§2101.20)

Except as specifically provided in this permit, terms used retain the meaning accorded them under the applicable provisions and requirements of Article XXI or the applicable federal or state regulation. Whenever used in this permit, or in any action taken pursuant to this permit, the words and phrases shall have the meanings stated, unless the context clearly indicates otherwise.

Unless specified otherwise in this permit or in the applicable regulation, the term "year" shall mean any twelve (12) consecutive months.

Certification (§2102.01)

      Any report or compliance certification submitted under this permit shall contain written certification by a responsible official as to truth, accuracy, and completeness. This certification and any other certification required under this permit shall be signed by a responsible official of the source, and shall state that, based on information and belief formed after reasonable inquiry, the statements and information in the document are true, accurate, and complete.

Operation and Maintenance (§2105.03)

      All air pollution control equipment required by this permit or Article XXI, and all equivalent compliance techniques that have been approved by the Department, shall be properly installed, maintained, and operated consistent with good air pollution control practice.

Conditions (§2102.03.c)

      It shall be a violation of this permit giving rise to the remedies provided by Article XXI §2109.02, for any person to fail to comply with any terms or conditions set forth in this permit.

Transfers (§2102.03.e)

      This permit shall not be transferable from one person to another, except in accordance with Article XXI §2102.03.e and in cases of change-in-ownership which are documented to the satisfaction of the Department, and shall be valid only for the specific sources and equipment for which this permit was issued. The transfer of permits in the case of change-in-ownership may be made consistent with the administrative permit amendment procedure of Article XXI §2103.14.b.

Effect (§2102.03.g)

      Issuance of this permit shall not in any manner relieve any person of the duty to fully comply with the requirements of Article XXI or any other provision of law, nor shall it in any manner preclude or affect the right of the Department to initiate any enforcement action whatsoever for violations of Article XXI or this Permit, whether occurring before or after the issuance of such permit. Further, the issuance of this permit shall not be a defense to any nuisance action, nor shall such permit be construed as a certificate of compliance with the requirements of Article XXI or this Permit.

General Requirements (§2102.04.a)

      It shall be a violation of this Permit giving rise to the remedies set forth in Article XXI §2109 for any person to install, modify, replace, reconstruct, or reactivate any source or air pollution control equipment to which this Permit applies unless either:

The Department has first issued an Installation Permit for such source or equipment; or

Such action is solely a reactivation of a source with a current Operating Permit, which is approved under §2103.13 of Article XXI.

Conditions (§2102.04.e)

      Further, the initiation of installation, modification, replacement, reconstruction, or reactivation under this Installation Permit and any reactivation plan shall be deemed acceptance by the source of all terms and conditions specified by the Department in this permit and plan.

Revocation (§2102.04.f)

The Department may, at any time, revoke this Installation Permit if it finds that:
 Any statement made in the permit application is not true, or that material information has not been disclosed in the application;
 The source is not being installed, modified, replaced, reconstructed, or reactivated in the manner indicated by this permit or applicable reactivation plan;
 Air contaminants will not be controlled to the degree indicated by this permit;
 Any term or condition of this permit has not been complied with;
 The Department has been denied lawful access to the premises or records, charts, instruments and the like as authorized by this Permit; or

Prior to the date on which construction of the proposed source has commenced the Department may, revoke this Installation Permit if a significantly better air pollution control technology has become available for such source, a more stringent regulation applicable to such source has been adopted, or any other change has occurred which requires a more stringent degree of control of air contaminants.

Term (§2102.04.g)

      This Installation Permit shall expire in 18 months if construction has not commenced within such period or shall expire 18 months after such construction has been suspended, if construction is not resumed within such period.  In any event, this Installation Permit shall expire upon completion of construction, except that this Installation Permit shall authorize temporary operation to facilitate shakedown of sources and air cleaning devices, to permit operations pending issuance of a related subsequent Operating Permit, or to permit the evaluation of the air contamination aspects of the source.   Such temporary operation period shall be valid for a limited time, not to exceed 180 days, but may be extended for additional limited periods, each not to exceed 120 days, except that no temporary operation shall be authorized or extended which may circumvent the requirements of this Permit.

Annual Installation Permit Administrative Fee (§2102.10.c & e)

      No later than 30 days after the date of issuance of this Installation Permit and on or before the last day of the month in which this permit was issued in each year thereafter, during the term of this permit until a subsequent corresponding Operating Permit or amended Operating Permit is properly applied for, the owner or operator of such source shall pay to the Department, in addition to all other applicable emission and administration fees, an Annual Installation Permit Administration Fee in an amount of $750.

Severability Requirement (§2103.12.l)

      The provisions of this permit are severable, and if any provision of this permit is determined to by a court of competent jurisdiction to be invalid or unenforceable, such a determination will not affect the remaining provisions of this permit.

Reporting Requirements (§2103.12.k)

The permittee shall submit reports of any required monitoring at least every six (6) months. All instances of deviations from permit requirements must be clearly identified in such reports. All required reports must be certified by the Responsible Official.

Prompt reporting of deviations from permit requirements is required, including those attributable to upset conditions as defined in this permit and Article XXI §2108.01.c, the probable cause of such deviations, and any corrective actions or preventive measures taken.

All reports submitted to the Department shall comply with the certification requirements of General Condition III.4 above.

Semiannual reports required by this permit shall be submitted to the Department within 30 days of the end of the calendar half.

Quarterly reports required by this permit shall be submitted to the Department within 30 days of the end of the calendar quarter.

Reports may be emailed to the Department at<EMAIL_ADDRESS>in lieu of mailing a hard copy.

Minor Installation Permit Modifications (§2102.10.d)

      Modifications to this Installation Permit may be applied for but only upon submission of an application with a fee in the amount of $300 and where:

No reassessment of any control technology determination is required; and
No reassessment of any ambient air quality impact is required.

Violations (§2104.06)

      The violation of any emission standard established by this Permit shall be a violation of this Permit giving rise to the remedies provided by Article §2109.02.

Other Requirements Not Affected (§2105.02)

      Compliance with the requirements of this permit shall not in any manner relieve any person from the duty to fully comply with any other applicable federal, state, or county statute, rule, regulation, or the like, including, but not limited to, any applicable NSPSs, NESHAPs, MACTs, or Generally Achievable Control Technology standards now or hereafter established by the EPA, and any applicable requirement of BACT or LAER as provided by Article XXI, any condition contained in this Installation Permit and/or any additional or more stringent requirements contained in an order issued to such person pursuant to Part I of Article XXI.

Other Rights and Remedies Preserved (§2109.02.b)

      Nothing in this permit shall be construed as impairing any right or remedy now existing or hereafter created in equity, common law or statutory law with respect to air pollution, nor shall any court be deprived of such jurisdiction for the reason that such air pollution constitutes a violation of this permit

Penalties, Fines, and Interest (§2109.07.a)

      A source that fails to pay any fee required under this Permit or article XXI when due shall pay a civil penalty of 50% of the fee amount, plus interest on the fee amount computed in accordance with of Article XXI §2109.06.a.4 from the date the fee was required to be paid.   In addition, the source may have its permit revoked.

Appeals (§2109.10)

      In accordance with State Law and County regulations and ordinances, any person aggrieved by an order or other final action of the Department issued pursuant to Article XXI shall have the right to appeal the action to the Director in accordance with the applicable County regulations and ordinances.

SITE LEVEL TERMS AND CONDITIONS

Reporting of Upset Conditions (§2103.12.k.2)

      The permittee shall promptly report all deviations from permit requirements, including those attributable to upset conditions as defined in Article XXI §2108.01.c, the probable cause of such deviations, and any corrective actions or preventive measures taken.

Visible Emissions (§2104.01.a)

      Except as provided for by Article XXI §2108.01.d pertaining to a cold start, no person shall operate, or allow to be operated, any source in such manner that the opacity of visible emissions from a flue or process fugitive emissions from such source, excluding uncombined water:

Equal or exceed an opacity of 20% for a period or periods aggregating more than three (3) minutes in any sixty (60) minute period; or,
Equal or exceed an opacity of 60% at any time.

Odor Emissions (§2104.04) (County-only enforceable)

      No person shall operate, or allow to be operated, any source in such manner that emissions of malodorous matter from such source are perceptible beyond the property line.

Materials Handling (§2104.05)

      The permittee shall not conduct, or allow to be conducted, any materials handling operation in such manner that emissions from such operation are visible at or beyond the property line.

Operation and Maintenance (§2105.03)

      All air pollution control equipment required by this permit or any order under Article XXI, and all equivalent compliance techniques approved by the Department, shall be properly installed, maintained, and operated consistently with good air pollution control practice.

Open Burning (§2105.50)

      No person shall conduct, or allow to be conducted, the open burning of any material, except where the Department has issued an Open Burning Permit to such person in accordance with Article XXI §2105.50 or where the open burning is conducted solely for the purpose of non-commercial preparation of food for human consumption, recreation, light, ornament, or provision of warmth for outside workers, and in a manner which contributes a negligible amount of air contaminants.

Shutdown of Control Equipment (§2108.01.b)

In the event any air pollution control equipment is shut down for reasons other than a breakdown, the person responsible for such equipment shall report, in writing, to the Department the intent to shut down such equipment at least 24 hours prior to the planned shutdown. Notwithstanding the submission of such report, the equipment shall not be shut down until the approval of the Department is obtained; provided, however, that no such report shall be required if the source(s) served by such air pollution control equipment is also shut down at all times that such equipment is shut down.

The Department shall act on all requested shutdowns as promptly as possible. If the Department does not take action on such requests within ten (10) calendar days of receipt of the notice, the request shall be deemed denied, and upon request, the owner or operator of the affected source shall have a right to appeal in accordance with the provisions of Article XI.

The prior report required by Site Level Condition IV.7.a above shall include:

 Identification of the specific equipment to be shut down, its location and permit number (if permitted), together with an identification of the source(s) affected;
 The reasons for the shutdown;
 The expected length of time that the equipment will be out of service;
 Identification of the nature and quantity of emissions likely to occur during the shutdown;
 Measures, including extra labor and equipment, which will be taken to minimize the length of the shutdown, the amount of air contaminants emitted, or the ambient effects of the emissions;
 Measures which will be taken to shut down or curtail the affected source(s) or the reasons why it is impossible or impracticable to shut down or curtail the affected source(s) during the shutdown; and
 Such other information as may be required by the Department.

Breakdowns (§2108.01.c)

In the event that any air pollution control equipment, process equipment, or other source of air contaminants breaks down in such manner as to have a substantial likelihood of causing the emission of air contaminants in violation of this permit, or of causing the emission into the open air of potentially toxic or hazardous materials, the person responsible for such equipment or source shall immediately, but in no event later than sixty (60) minutes after the commencement of the breakdown, notify the Department of such breakdown and shall, as expeditiously as possible but in no event later than seven (7) days after the original notification, provide written notice to the Department.

To the maximum extent possible, all oral and written notices required shall include all pertinent facts, including:

 Identification of the specific equipment which has broken down, its location and permit number (if permitted), together with an identification of all related devices, equipment, and other sources which will be affected.
 The nature and probable cause of the breakdown.
 The expected length of time that the equipment will be inoperable or that the emissions will continue.
 Identification of the specific material(s) which are being, or are likely to be emitted, together with a statement concerning its toxic qualities, including its qualities as an irritant, and its potential for causing illness, disability, or mortality.
 The estimated quantity of each material being or likely to be emitted.
 Measures, including extra labor and equipment, taken or to be taken to minimize the length of the breakdown, the amount of air contaminants emitted, or the ambient effects of the emissions, together with an implementation schedule.
 Measures being taken to shut down or curtail the affected source(s) or the reasons why it is impossible or impractical to shut down the source(s), or any part thereof, during the breakdown.

Notices required shall be updated, in writing, as needed to advise the Department of changes in the information contained therein. In addition, any changes concerning potentially toxic or hazardous emissions shall be reported immediately. All additional information requested by the Department shall be submitted as expeditiously as practicable.

Unless otherwise directed by the Department, the Department shall be notified whenever the condition causing the breakdown is corrected or the equipment or other source is placed back in operation by no later than 9:00 AM on the next County business day. Within seven (7) days thereafter, written notice shall be submitted pursuant to Paragraphs a and b above.

Breakdown reporting shall not apply to breakdowns of air pollution control equipment which occur during the initial startup of said equipment, provided that emissions resulting from the breakdown are of the same nature and quantity as the emissions occurring prior to startup of the air pollution control equipment.

In no case shall the reporting of a breakdown prevent prosecution for any violation of this permit or Article XXI.

Cold Start (§2108.01.d)

      In the event of a cold start on any fuel-burning or combustion equipment, except stationary internal combustion engines and combustion turbines used by utilities to meet peak load demands, the person responsible for such equipment shall report in writing to the Department the intent to perform such cold start at least 24 hours prior to the planned cold start. Such report shall identify the equipment and fuel(s) involved and shall include the expected time and duration of the startup. Upon written application from the person responsible for fuel-burning or combustion equipment which is routinely used to meet peak load demands and which is shown by experience not to be excessively emissive during a cold start, the Department may waive these requirements and may instead require periodic reports listing all cold starts which occurred during the report period. The Department shall make such waiver in writing, specifying such terms and conditions as are appropriate to achieve the purposes of Article XXI. Such waiver may be terminated by the Department at any time by written notice to the applicant.

Monitoring of Malodorous Matter Beyond Facility Boundaries (§2104.04)

      The permittee shall take all reasonable action as may be necessary to prevent malodorous matter from becoming perceptible beyond facility boundaries.   Further, the permittee shall perform such observations as may be deemed necessary along facility boundaries to insure that malodorous matter beyond the facility boundary in accordance with Article XXI §2107.13 is not perceptible and record all findings and corrective action measures taken.

Emissions Inventory Statements (§2108.01.e & g)

Emissions inventory statements in accordance with §2108.01.e shall be submitted to the Department by March 15 of each year for the preceding calendar year. The Department may require more frequent submittals if the Department determines that more frequent submissions are required by the EPA or that analysis of the data on a more frequent basis is necessary to implement the requirements of Article XXI or the Clean Air Act.

The failure to submit any report or update within the time specified, the knowing submission of false information, or the willful failure to submit a complete report shall be a violation of this permit giving rise to the remedies provided by Article XXI §2109.02.

Orders (§2108.01.f)

      In addition to meeting the requirements Site Level Conditions IV.7 through IV.11, inclusive, the person responsible for any source shall, upon order by the Department, report to the Department such information as the Department may require in order to assess the actual and potential contribution of the source to air quality. The order shall specify a reasonable time in which to make such a report.

Violations (§2108.01.g)

      The failure to submit any report or update thereof required by Site Level Conditions IV.7 through IV.12 above, inclusive, within the time specified, the knowing submission of false information, or the willful failure to submit a complete report shall be a violation of this permit giving rise to the remedies provided by Article XXI §2109.02.

Emissions Testing (§2108.02)

Orders: No later than 60 days after achieving full production or 120 days after startup, whichever is earlier, the permittee shall conduct, or cause to be conducted, such emissions tests as are specified by the Department to demonstrate compliance with the applicable requirements of this permit and shall submit the results of such tests to the Department in writing. Upon written application setting forth all information necessary to evaluate the application, the Department may, for good cause shown, extend the time for conducting such tests beyond 120 days after startup but shall not extend the time beyond 60 days after achieving full production. Emissions testing shall comply with all applicable requirements of Article XXI, §2108.02.e.

Tests by the Department: Notwithstanding any tests conducted pursuant to this permit, the Department or another entity designated by the Department may conduct emissions testing on any source or air pollution control equipment. At the request of the Department, the permittee shall provide adequate sampling ports, safe sampling platforms and adequate utilities for the performance of such tests.

Testing Requirements: No later than 45 days prior to conducting any tests required by this permit, the person responsible for the affected source shall submit for the Department's approval a written test protocol explaining the intended testing plan, including any deviations from standard testing procedures, the proposed operating conditions of the source during the test, calibration data for specific test equipment and a demonstration that the tests will be conducted under the direct supervision of persons qualified by training and experience satisfactory to the Department to conduct such tests. In addition, at least 30 days prior to conducting such tests, the person responsible shall notify the Department in writing of the time(s) and date(s) on which the tests will be conducted and shall allow Department personnel to observe such tests, record data, provide pre-weighed filters, analyze samples in a County laboratory and to take samples for independent analysis. Test results shall be comprehensively and accurately reported in the units of measurement specified by the applicable emission limitations of this permit.

Test methods and procedures shall conform to the applicable reference method set forth in this permit or Article XXI Part G, or where those methods are not applicable, to an alternative sampling and testing procedure approved by the Department consistent with Article XXI §2108.02.e.2.

Violations: The failure to perform tests as required by this permit or an order of the Department, the failure to submit test results within the time specified, the knowing submission of false information, the willful failure to submit complete results, or the refusal to allow the Department, upon presentation of a search warrant, to conduct tests, shall be a violation of this permit giving rise to the remedies provided by Article XXI §2109.02.

Abrasive Blasting (§2105.51)

Except where such blasting is a part of a process requiring an operating permit , no person shall conduct or allow to be conducted, abrasive blasting or power tool cleaning of any surface, structure, or part thereof, which has a total area greater than 1,000 square feet unless such abrasive blasting complies with all applicable requirements of Article XXI §2105.51.

In addition to complying with all applicable provisions of §2105.51, no person shall conduct, or allow to be conducted, abrasive blasting of any surface unless such abrasive blasting also complies with all other applicable requirements of Article XXI unless such requirements are specifically addressed by §2105.51.

Asbestos Abatement (§2105.62, §2105.63)

      In the event of removal, encasement, or encapsulation of Asbestos-Containing Material (ACM) at a facility or in the event of the demolition of any facility, the permittee shall comply with all applicable provisions of Article XXI §2105.62 and §2105.63.

Volatile Organic Compound Storage Tanks (§2105.12.a)

      No person shall place or store, or allow to be placed or stored, a volatile organic compound having a vapor pressure of 1.5 psia or greater under actual storage conditions in any aboveground stationary storage tank having a capacity equal to or greater than 2,000 gallons but less than or equal to 40,000 gallons, unless there is in operation on such tank pressure relief valves which are set to release at the higher of 0.7 psig of pressure or 0.3 psig of vacuum or at the highest possible pressure and vacuum in accordance with State or local fire codes, National Fire Prevention Association guidelines, or other national consensus standard approved in writing by the Department. Petroleum liquid storage vessels that are used to store produced crude oil and condensate prior to lease custody transfer are exempt from these requirements.

Fugitive Emissions (§2105.49)

      The person responsible for a source of fugitive emissions, in addition to complying with all other applicable provisions of this permit shall take all reasonable actions to prevent fugitive air contaminants from becoming airborne.  Such actions may include, but are not limited to:

The use of asphalt, oil, water, or suitable chemicals for dust control;
The paving and maintenance of roadways, parking lots and the like;
The prompt removal of earth or other material which has been deposited by leaks from transport, erosion or other means;
The adoption of work or other practices to minimize emissions;
Enclosure of the source; and
The proper hooding, venting, and collection of fugitive emissions.

Episode Plans (§2106.02)

      The permittee shall upon written request of the Department, submit a source curtailment plan, consistent with good industrial practice and safe operating procedures, designed to reduce emissions of air contaminants during air pollution episodes. Such plans shall meet the requirements of Article XXI §2106.02.

New Source Performance Standards (§2105.05)

It shall be a violation of this permit giving rise to the remedies provided by §2109.02 of Article XXI for any person to operate, or allow to be operated, any source in a manner that does not comply with all requirements of any applicable NSPS now or hereafter established by the EPA, except if such person has obtained from EPA a waiver pursuant to Section 111 or Section 129 of the Clean Air Act or is otherwise lawfully temporarily relieved of the duty to comply with such requirements.

Any person who operates, or allows to be operated, any source subject to any NSPS shall conduct, or cause to be conducted, such tests, measurements, monitoring and the like as is required by such standard.  All notices, reports, test results and the like as are required by such standard shall be submitted to the Department in the manner and time specified by such standard. All information, data and the like which is required to be maintained by such standard shall be made available to the Department upon request for inspection and copying.

National Emission Standards for Hazardous Air Pollutants (§2104.08)

The permittee shall comply with each applicable emission limitation, work practice standard, and operation and maintenance requirement of 40 CFR Part 63, Subpart DDDDD  -  National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers and Process Heaters, CFR Part 63, Subpart UUUUU  -  National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired electric Utility Steam Generating Units, and CFR Part 63, Subpart ZZZZ  -  National Emission Standards for Stationary Reciprocating Internal Combustion Engines.

EMISSION UNIT LEVEL TERMS AND CONDITIONS

Main Boiler No. 1, Stack No. 001a

      Process Description: 	Tangentially-Fired Boiler
      Facility ID: 		Main Boiler No.1
      Max. Design Rate: 	6,000 MMBtu/hr (maximum hourly rating); 5,500 MMBtu/hr (maximum continuous rating) coal and synfuel; 1,028 MMBtu/hr natural gas
      Fuel(s): 		Coal (primary) or synfuel; Natural gas (auxiliary)
      Control Device: 	Low NOx burners, electrostatic precipitator (ESP) with flue gas conditioning, selective catalytic reduction (SCR) & flue gas desulfurization (FGD)
      CEM:			NOX, SO2, CO2 and opacity (COM)

Restrictions:

The permittee shall continue to meet the conditions of Operating Permit No. 0054, in addition to the revisions in this permit.  [§2102.04.b.5]

Nitrogen oxide (NOX) emissions from the Main Boiler shall not exceed the following: [25 Pa. Code §129.99(b)]

 CEMS 24-hour block total, a maximum 0.090 lb/MMBtu with SCR;
 CEMS 24-hour block total, a maximum 0.27 lb/MMBtu with SCR under all operating conditions;
 CEMS rolling average emissions rate of 540 lb NOX/hr averaged over 30 valid boiler operating days. (includes all operating scenarios and all valid operating hours); and
 2,365 tons/year.

Volatile organic compound (VOC) emissions from the Main Boiler shall not exceed 0.0034 lb/MMBtu. [25 Pa. Code §129.99]

Emissions from the Main Boiler Stack-001a shall not exceed the following: [25 Pa. Code §129.99(b)]

                TABLE V-A-1:  Main Boiler Emission Limitations
POLLUTANT
                                    HOURLY
                                EMISSION LIMIT
                                    (lb/hr)
                                    ANNUAL
EMISSION LIMIT
                                (tons/year)[1]
Nitrogen Oxides
                                   540[(2)]
                                     2,365
Volatile Organic Compounds
                                     20.4
                                     82.0
        1) A year is defined as any consecutive 12-month period.
           2) CEMS rolling average emissions rate.

Testing Requirements:

             The Department reserves the right to require additional emissions testing sufficient to assure compliance with the terms and conditions of this permit. Such testing shall be performed in accordance with Article XXI §2108.02. [§2103.12.h.125 Pa. Code §129.100]

Monitoring Requirements:

The permittee shall monitor the following parameters for the selective catalytic reduction (SCR) system: [§2103.12.i, IP No. 0054-I002, Condition V.A.3.a, issued June 13, 2001, 25 Pa. Code §129.100]

 catalytic bed inlet gas temperature continuously,
 ammonia solution injection rate continuously, and
 ammonia solution concentration (receipt of certification from vendor).

The permittee shall operate and maintain the SCR equipment and monitoring instrumentation in accordance with the manufacturer's specifications and good air pollution control practice. [§2105.03, §2102.04.b.6, IP No. 0054-I002, Condition V.A.3.b, issued June 13, 2001, 25 Pa. Code §129.100]

The permittee shall certify, operate, and maintain continuous emission monitors in accordance with 40 CFR Part 75 or approved alternative for SO2, volumetric gas flowrate, NOx, and CO2 emissions from the new main boiler stack. [40 CFR 75, Article XXI §2103.22.j, §2103.50, IP No. 0054-I004b Condition V.A.3.b, 25 Pa. Code §129.100]

 Continuous monitoring systems shall comply with the Installation and Performance Specifications of appendix A of Part 75. [40 CFR 75.10(b)]

 The permittee shall determine and record the heat input for every hour or part of an hour of any fuel that is combusted per Appendix F of Part 75.  [40 CFR 75.10(b)]

 Continuous monitoring systems shall meet the minimum data availability requirements in 40 CFR part 75. [40 CFR 75]

 The NOx and SO2 CEMs shall record emissions in terms of lb/MMBtu and lb/hr for each pollutant. [§2108.03.b.4, §2102.04.b.6]

Record Keeping Requirements:

The permittee shall maintain all appropriate records to demonstrate compliance with the requirements of §2105.06 and RACT Order No. 217. Such records shall provide sufficient data and calculations to clearly demonstrate that all requirements of §2105.06 and RACT Order No. 217 are met. The permittee shall record and maintain such data and information required to determine compliance for the facility in a time frame consistent with the averaging period of the requirements of both §2105.06 and RACT Order No. 217. Such information shall include, but not be limited to, the following minimum information which shall be submitted to the Department as a written report at three month intervals: [§2108.03.d, §2105.06, RACT Order No. 217, Condition 1.4, 25 Pa. Code §129.100]

 All recording and reporting required by Section 2108.03 of Article XXI and entitled "Continuous Emission Monitoring."
 An identification of each instance during the reporting period during which emissions exceeded the applicable emission limitations rates in condition V.A.1.b above and an identification of the reasons, if known, for such exceedance. The averaging period used for making such identification shall correspond to the averaging period specified in condition V.A.1.b above.
 An identification of each period during which the continuous emission monitoring system was inoperative, except for zero and span drift checks, the reasons therefore, and the nature of repairs or adjustments performed or to be performed.
 An identification of calibrations, zero and span drift checks, and other quality assurance procedures.

The permittee shall keep and maintain the following data for Main Boiler No. 1: [§2102.04.b.6, §2103.12.j, IP No. 0054-I004b Condition V.A.4.a, 25 Pa. Code §129.100]

 Type and amount of fuel used (tons of coal/day, MMscf of natural gas/day);
 Amount of synfuel used each month (tons);
 Records of the type of synfuel binder used each month and the material safety data sheets for each binder used;
 Steam load (lbs/hr, lbs/day; average daily steam load for each month);
 Total operating hours, (hours/day, monthly and 12-month);
 Records of operation, maintenance, inspection, calibration and/or replacement of combustion equipment;
 Stack test protocols and reports;
 Data specified to be monitored in Condition V.A.3 above; and
 Data required by 40 CFR Part 75 Subpart F and Condition V.A.3 above for continuous monitors. (40 CFR Part 75, Subpart F).

The permittee shall maintain records of all air pollution control system performance evaluations and all records of calibration checks, adjustments, and maintenance performed on all equipment which is subject to this permit. [IP No.0054-I002, Condition V.A.4.b, issued June 13, 2001, §2103.05, 25 Pa. Code §129.100]

The permittee shall maintain a copy of the manufacturer's specifications for the SCR air pollution control equipment on-site. [IP No.0054-I002, Condition V.A.4.c, issued June 13, 2001, 25 Pa. Code §129.100]

The permittee shall keep a record of the date, time, and cause of the malfunction of all air pollution control systems, and the action taken to correct the malfunction. [IP No.0054-I002, Condition V.A.4.d, issued June 13, 2001, §2108.01.b & §2108.01.c, 25 Pa. Code §129.100]

The permittee shall record at a minimum the following SCR control system information: [IP No. 0054-I002, Condition V.A.4.e, issued June 13, 2001, 25 Pa. Code §129.100]

 Catalytic bed inlet temperature, ammonia solution injection rate, and ammonia solution concentration (once each shift).
 All instances or episodes when the catalyst was bypassed due to boiler upset conditions and low boiler load conditions when the boiler exhaust temperature is outside of the operating range of the SCR catalyst (each occurrence).
 All instances when the catalyst is bypassed (each occurrence).

The permittee shall record all instances of non-compliance with the conditions of this permit upon occurrence along with corrective action taken to restore compliance. [§2103.12.h.1, IP No.0054-I002, Condition V.A.4.a, issued June 13, 2001, §2108.01.b & §2108.01.c, 25 Pa. Code §129.100]

The permittee shall prepare and maintain on-site a QA/QC Plan as described in 40 CFR Part 75 Appendix B. (40 CFR §75.50(a)(4)) The permittee shall also maintain a file of all measurements, data, reports, and other required information for at least five years. [40 CFR §75.54, 25 Pa. Code §129.100]

All records of all required monitoring data and support information shall be retained by the facility for at least five (5) years. Support information includes all calibration and maintenance records and all original strip-chart recordings for continuous monitoring instrumentation, and copies of all reports required by the permit.  These records shall be made available to the Department upon request for inspection and/or copying. [§2103.12.j.2, 25 Pa. Code §129.100]

All records required under this section shall be maintained by the permittee for a period of five years following the date of such record.  [§2103.12.j.2, 25 Pa. Code §129.100]

Reporting Requirements:

The permittee shall report non-compliance information required to be recorded by V.A.4.g above to the Department in accordance with General Condition III.15 above. The reports shall contain all required information for the time period of the report: [§2103.12.k.1, 25 Pa. Code §129.100]

The permittee shall submit the results of the continuous nitrogen oxides monitoring systems on a regular schedule and in a format acceptable to the Department and in compliance with the USEPA Clean Air Markets Division Part 75 requirements. [§2108.03.b.3, 25 Pa. Code §129.100]

Within 30 days of the end of each calendar quarter, the following shall be reported to the Department: [Permit No. 1065009-003-00100, issued December 8, 1981; IP No. 0054-I002, Condition V.A.5.a, issued June 13, 2001; §2103.12.k.1, IP No. 0054-I004b Condition V.A.5.c, 25 Pa. Code §129.100]

 Amount of coal fired each month (tons);
 Daily average and rolling 30-day average NOX emissions and cumulative 12-month total NOx emissions (lb/MMBtu and lb/hr; tons/year); and
 Cumulative 12-month synfuel usage for each month during the compliance period.

The permittee shall provide the Department written notice 21 days prior to dates of periodic relative accuracy testing audits per 40 CFR 75.61(a)(5). [40 CFR §75.21(d), Article XXI §2103.22.j, §2103.50, 25 Pa. Code §129.100]

Reporting instances of non-compliance does not relieve the permittee of the requirement to report breakdowns in accordance with Site Level Condition IV.8, if appropriate.  [§2103.12.k]

Work Practice Standard:

The permittee shall not, at any time, operate Main Boiler No. 1 unless the subject boiler, including the low NOX concentric firing system II, is properly operated and maintained according to good engineering and air pollution control practices. [RACT Order No. 217, Conditions 1.1 and 1.6, issued March 8, 1996; §2105.06; §2105.03, 25 Pa. Code §129.99]

All air pollution control equipment required by this Article or any permit or order under this Article, and all equivalent compliance techniques which have been approved by the Department pursuant to this Article, shall be properly installed, calibrated maintained, and operated consistent with good air pollution control practice. [§2105.03, IP No. 0054-I004b Condition V.A.6.a, 25 Pa. Code §129.99]

The permittee shall take corrective action if an out of control period occurs to a monitoring system (e.g., continuous emission monitor). [40 CFR §75.24, Article XXI §2103.22.j, §2103.50, IP No. 0054-I004b Condition V.A.6.b, 25 Pa. Code §129.100]

The failure to install and operate any continuous emissions monitoring system required by §2108.03 within the time specified, the failure to retain any data or submit any report so required, or the knowing retention or reporting of false data shall be a violation of this permit giving rise to the remedies provided by [§2109.02. §2108.03.f, IP No. 0054-I004b Condition V.A.6.c, 25 Pa. Code §129.100]

The facility shall tune the boiler to minimize NOX emissions within six (6) months of the effective date of this permit and annually thereafter, or as specified in condition V.A.6.k below. [§2105.03]

The permittee shall set the SCR at a target NOX emission rate of 0.06 lb NOX/MMBtu within the timeframe specified in condition V.A.6.k below. [§2103.12.a.2.B]

After operating the SCR with an outlet NOX emission rate set-point set in Condition V.A.6.f for twelve consecutive months, the facility shall submit an engineering study within the timeframe specified in condition V.A.6.k below that analyzes the overall environmental performance of the system at that set-point. [§2103.12.a.2.B]

During the first 60 days of each calendar year, the facility shall perform a catalyst activity test. [25 Pa. Code §129.99]

Within 60 days of receiving the results of catalyst activity test, the facility shall consult with the SCR catalyst vendor to monitor SCR performance in accordance the catalyst management plans (CMPs) developed for the SCR systems. [25 Pa. Code §129.99]

The permittee shall provide a full and complete technical and, if applicable, economic evaluation to the Department on the possibility of heating the flue gas prior to the SCR inlet to allow the SCR to operate at low load levels. The Department shall have sole discretion to determine when the evaluation is full and complete, and this must occur within the timeframe specified in condition V.A.6.k below unless an extension is granted by the Department. [25 Pa. Code §129.99]

If the permittee ceases burning coal on or before December 31, 2022, then Conditions V.A.6.e through V.A.6.g above and V.A.6.j above are not required.  If the permittee does not cease burning coal by December 31, 2022 then Conditions V.A.6.e, V.A.6.g, and V.A.6.j above will apply with a deadline of 180 days after December 31, 2022 and condition V.A.6.f will apply with a deadline of 90 days after December 31, 2022.  [25 Pa. Code §129.99]
Auxiliary Boiler, Stack No. 2

      Process Description: Oil-fired external combustion boiler
      Facility ID: Auxiliary Boiler
      Max. Design Rate: 160 MMBtu/hr
      Raw Materials: No. 2 Fuel Oil, 0.05% (wt.) sulfur content
      Control Device: None

Restrictions:

The permittee shall continue to meet the conditions of Operating Permit No. 0054, in addition to the revisions in this permit.  [§2102.04.b.5]

The permittee shall limit the heat input rate to the Auxiliary Boiler to less than 140,160 MMBtu per twelve (12) consecutive month period (10 percent annual capacity factor). [§2103.12.a.2.B, §2105.06.b, §63.7575, 25 Pa. Code §129.99]

Nitrogen oxide (NOX) emissions from the Auxiliary Boiler shall not exceed 0.12 lb/MMBtu. [§2102.04.b.5, 25 Pa. Code §129.97(g)(1)(ii), 25 Pa. Code §129.99]

All fuel oil purchased by the permittee beginning July 1, 2016 for the Auxiliary Boiler shall meet ASTM specifications for No.2 fuel oil and have a maximum sulfur content at or less than 0.05% by weight at all times. Commercial fuel oil that was stored in this Commonwealth by the ultimate consumer prior to July 1, 2016, which met the applicable maximum allowable sulfur content at the time it was stored, may be used by the ultimate consumer in this Commonwealth on and after July 1, 2016. [§2103.12.h.1, Permit No. 106509-003-00600, issued May 2, 1995; PA Code  25 123.22(d)(2)(ii), PA Code  25 123.22(d)(2)(iii), 25 Pa. Code §129.100]

Emissions from The Auxiliary Boiler shall not exceed the following at any time: [25 Pa. Code §129.97(g)(1)(ii), 25 Pa. Code §129.99]

              TABLE V-B-1:  Auxiliary Boiler Emission Limitations
POLLUTANT
                                    HOURLY
                                EMISSION LIMIT
                                    (lb/hr)
                                    ANNUAL
EMISSION LIMIT
                                (tons/year)[1]
Nitrogen Oxides
                                     19.2
                                      8.4
Volatile Organic Compounds
                                      0.3
                                     0.13
            (1) A year is defined as any 12 consecutive months.

Testing Requirements:

The permittee shall perform nitrogen oxides emissions testing on the Auxiliary Boiler at least once every five years in order to demonstrate compliance with the emission limitations of this permit. Such testing shall be conducted in accordance with U.S. EPA test method 7E or an alternative method approved by the Department and Article XXI §2108.02. [§2103.12.h.1; §2108.02.b, §2108.02.e., 25 Pa. Code §129.100]

The Department reserves the right to require additional emissions testing sufficient to assure compliance with the terms and conditions of this permit. Such testing shall be performed in accordance with Article XXI §2108.02.  [§2103.12.h.1, 25 Pa. Code §129.100]

Monitoring Requirements:

             The permittee shall operate and maintain a fuel flow meter to monitor the amount of fuel oil combusted in the Auxiliary Boiler. [§2103.12.i, 25 Pa. Code §129.100]

Record Keeping Requirements:

The permittee shall maintain all appropriate records to demonstrate compliance with the requirements of both Section 2105.06 Article XXI, and conditions V.B.1.b and V.B.6.b below.. Such records shall provide sufficient data to clearly demonstrate that all requirements of Section 2105.06 of Article XXI, and conditions V.B.1.b and V.B.6.b below, are being met. [§2105.06.g, 25 Pa. Code §129.100]

The permittee shall keep and maintain the following data for the Auxiliary Boiler: [§2103.12.h.1, §63.7525(k) , 25 Pa. Code §129.100]

 Amount of fuel oil used (daily and 12-month, gallons);
 Records of fuel oil supplier's certification of sulfur content, and fuel oil heating value (each shipment received);
 Total operating hours, (hours/day, monthly and 12-month);
 Total heat input rate (12-month, MMBtu)
 Records of operation, maintenance, inspection, calibration and/or replacement of combustion equipment.
 Stack test protocols and reports.
 Records of the annual adjustment required by V.B.6.b below.

The permittee shall record all instances of non-compliance with the conditions of this permit upon occurrence along with corrective action taken to restore compliance. [§2103.12.h.1, 25 Pa. Code §129.100]

All records shall be retained by the facility for at least five (5) years. These records shall be made available to the Department upon request for inspection and/or copying. [§2103.12.j.2, 25 Pa. Code §129.100]

Reporting Requirements:

The permittee shall report the following information to the Department in accordance with General Condition III.15 above on a semi-annual basis. The reports shall contain all required information for the time period of the report: [§2103.12.k.1, 25 Pa. Code §129.100]

Monthly and 12-month data required to be recorded by condition V.B.4.b above [25 Pa. Code §129.100];
 A statement from the permittee that the record of fuel supplier certifications required by condition V.B.4.b above represents all the fuel oil received during the reporting period; and
 Non-compliance information required to be recorded by V.B.4.c above.

Reporting instances of non-compliance does not relieve the permittee of the requirement to report breakdowns in accordance with Site Level Condition IV.8, if appropriate.  [§2103.12.k]

Work Practice Standard:

The permittee shall not, at any time, operate the Auxiliary Boiler unless the subject boiler is properly operated and maintained according to good engineering and air pollution control practices. [§2105.03, 25 Pa. Code §129.99]

The permittee shall conduct a tune-up of the Auxiliary Boiler at least once every 5 years from the date of the last tune-up. [§63.7500(a)(1): Subpart 5D Table 3, Item #1, 25 Pa. Code §129.99]

ALTERNATIVE OPERATING SCENARIOS

      No alternative operating scenarios exist for this operation.

EMISSIONS LIMITATIONS SUMMARY

The following table summarizes the estimated annual maximum potential emissions (which may not include fugitive) from the GenOn Cheswick Main Boiler No. 1 and the Auxiliary Boiler. These annual (consecutive 12 month) potential emission estimates assume that all sources operate continuously.

                  TABLE VII-1:  Emission Limitations Summary
                                   POLLUTANT
                                    ANNUAL
                          EMISSION LIMIT (tons/year)*
Nitrogen Oxides (NOX)
                                     2,365
Volatile Organic Compounds (VOC)
                                     82.1
                     * A year is defined as any consecutive 12-month period.


[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10179-10180]
[FR Doc No: 2013-03315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Center for Devices and
Radiological Health Appeals Processes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
15, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
Guidance for Industry and Food and Drug Administration Staff; Center
for Devices and Radiological Health Appeals Processes. Also include the
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry and Food and Drug Administration Staff; Center
for Devices and Radiological Health Appeals Processes--(OMB Control
Number 0910-NEW)

    The guidance for industry and FDA staff entitled ``Center for
Devices and Radiological Health (CDRH) Appeals Processes'' revises,
updates, and combines two previous guidance documents: ``Medical Device
Appeals and Complaints: Guidance for Dispute Resolution,'' dated
February 1998, and ``Resolving Scientific Disputes Concerning the
Regulation of Medical Devices, A Guide to Use of the Medical Devices
Dispute Resolution Panel; Final Guidance for Industry and FDA,'' dated
July 2001.
    The document is intended to provide clarity to internal and
external audiences regarding CDRH's appeal processes. Individuals
outside of FDA who disagree with a decision or action taken by CDRH and
wish to have it reviewed or reconsidered have several processes for
resolution from which to choose, including requests for supervisory
review of an action, petitions, and hearings. In most cases, it is up
to the party seeking resolution of an adverse action or resolution of a
difference of opinion to determine the appropriate process for a given
circumstance or issue. The guidance describes these mechanisms and
includes the following topics: (1) Appealable actions (i.e., warning
letters, post-approval study requirements, premarket decisions,
deficiency letters, or requests for additional information); (2) paths
and options available at different stages of appeals; (3) use of
expedited or ``paper'' appeals versus appeal meetings or
teleconferences; (4) recommended format for appeals; (5) appeal
authorities; (6) appeal conflicts; and (7) issues that are appropriate
for dispute resolution.
    This guidance is intended to describe the processes available to
outside stakeholders to request additional review of decisions and
actions by CDRH employees. There are several processes for resolution,
including a request for supervisory review of an action, petitions, and
hearings. The proposed information collection seeks approval for the
reporting burden associated with requests for additional review of
decisions and actions by CDRH employees under this guidance. The
guidance also refers to currently approved information collections
found in FDA regulations.
    The collections of information in 21 CFR 10.30, 10.33, and 10.35
have been approved under OMB control number 0910-0183; the collections
of information in 21 CFR part 12 have been approved under OMB control
number 0910-0184; the collections of information for 21 CFR part 807
subpart E have been approved under OMB control number 0910-0120; the
collections of information under 21 CFR part 812 have been approved
under OMB control number 0910-0078; the collections of information
under 21 CFR

part 814 have been approved under 0910-0231; and the collections of
information under 21 CFR part 900 are approved under OMB control number
0910-0309.
    In the Federal Register of December 28, 2011 (76 FR 81511), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates it will receive 50 requests annually from outside
stakeholders requesting additional review of decisions and actions by
CDRH employees. The Agency reached this estimate based on data
collected about requests received over the last 2 years. FDA estimates
it will take outside stakeholders approximately 8 hours to prepare a
request based on the Agency's experience with past requests.
    Before the proposed information collection provisions contained in
this guidance become effective, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           Guidance title                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH: Appeals Processes Guidance Document..........................              50                1               50                8              400
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................              50                1               50                8              400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associate with this collection of information.

    Dated: February 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03315 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 31 (Thursday, February 16, 2017)]
[Notices]
[Page 10924]
[FR Doc No: 2017-03122]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10306; 34-80024; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, March 9, 2017 from 9:00
a.m. until 11:55 a.m. (ET). Written statements should be received on or
before March 9, 2017.

ADDRESSES: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE., Washington, DC 20549. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Brent J. Fields, Secretary,
Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1503,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Marc Oorloff Sharma, Chief Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during that portion of the meeting reserved for an
administrative work session during lunch. Persons needing special
accommodations to take part because of a disability should notify the
contact person listed in the section above entitled FOR FURTHER
INFORMATION CONTACT.
    The agenda for the meeting includes: Remarks from Commissioners; a
discussion regarding SEC investor research initiatives, the FINRA 2016
Financial Capability Study, and academic research on financial
literacy; a discussion regarding unequal voting rights of common stock;
a report on the nonpublic administrative work session; and a nonpublic
administrative work session during lunch.

    Dated: February 13, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-03122 Filed 2-15-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Rules and Regulations]
[Pages 26603-26605]
[FR Doc No: 2011-11261]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 3, 100, and 165

[Docket No. USCG-2011-0368]
RIN 1625-ZA30

Reorganization of Sector North Carolina; Technical Amendment

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: This rule makes non-substantive amendments to reflect the
Coast Guard's reorganization of Sector North Carolina. The amendments
describe the boundaries of Sector North Carolina's Marine Inspection
Zone and Captain of the Port Zone, and provide updated contact
information.

DATES: This final rule is effective May 9, 2011.

ADDRESSES: Materials mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0368 and are available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. You may also find
this docket online at http://www.regulations.gov, inserting USCG-2011-
0368 in the ``Enter Keyword or ID'' box, and then clicking ``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail LT Kevin Sullivan, Sector North Carolina, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Regulatory History
II. Abbreviations
III. Basis and Purpose
IV. Background
V. Discussion of Changes
VI. Regulatory Analyses
    A. Executive Order 12866 and Executive Order 13563
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Regulatory History

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. The Coast Guard finds that this rule is exempt from notice
and comment rulemaking requirements under 5 U.S.C. 553(b)(A) because
the changes involve agency organization. The Coast Guard also finds
good cause exists under 5 U.S.C. 553(b)(B) for not publishing an NPRM
because the changes will have no substantive effect on the public, and
notice and comment are therefore unnecessary. For the same reasons, the
Coast Guard finds good cause under 5. U.S.C. 553(d)(3) to make the rule
effective fewer than 30 days after publication in the Federal Register.

II. Abbreviations

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
MSU Marine Safety Unit
NPRM Notice of Proposed Rulemaking
Sec.  Section symbol
U.S.C. United States Code

III. Basis and Purpose

    The Coast Guard has reorganized Sector North Carolina. The Coast
Guard has the authority to do so under 14 U.S.C. 92, which gives the
Secretary of Homeland Security the authority to establish the limits
of, consolidate, discontinue, and re-establish Coast Guard districts;
and DHS Delegation 0170.1, which delegates that authority to the Coast
Guard.
    The previous organization of Sector North Carolina was described in
regulations, which also contain contact details and other references to
Sector North Carolina. This technical amendment updates those
regulations so that they contain current information.

IV. Background

    Sector North Carolina was established by a 2007 technical amendment
that updated regulations to reflect a broad sector realignment (72 FR
36316, July 2, 2007). At that time, Sector North Carolina's office was
located in Fort Macon, NC, with a Marine Safety Unit (MSU) in
Wilmington, NC, responsible for the Cape Fear River Marine Inspection
and Captain of the Port (COTP) Zones. Various regulations addressing
marine events, safety zones, and regulated navigational areas contained
references to Sector North Carolina, MSU Wilmington, and the Cape Fear
River Marine Inspection and COTP Zones.
    The Coast Guard has now reorganized Sector North Carolina by moving
the Sector office to Wilmington, NC and by disestablishing MSU
Wilmington and the Cape Fear River Marine Inspection and COTP Zones.
This reorganization is intended to improve field-level operations in
the region and improve access to the Sector Commander for the industry
within the Port of Wilmington. The consolidation into one COTP zone
will strengthen unity of command in the Sector North Carolina area of
responsibility and provide a single interface point for state and local
officials.

V. Discussion of Changes

    This rule amends 33 CFR part 3 to reflect the new organization of
Sector North Carolina. The revised Sec.  3.25-20 indicates that Sector
North Carolina's office is located in Wilmington, NC, rather than in
Fort Macon, NC, and eliminates the separate description of the Cape
Fear River Marine Inspection and COTP Zones. The boundaries of the
Sector's Marine Inspection Zone and COTP Zone are otherwise unchanged,
except for the correction of a typographical error that previously had

placed the offshore boundary outside the exclusive economic zone.
    This rule also amends 33 CFR part 100, addressing special local
regulations for marine events in the Fifth Coast Guard District.
Specifically, it removes Sec.  100.501(d)(5), which had referred to the
Cape Fear River COTP Zone, and revises Sec.  100.501(d) to provide
updated contact information.
    This rule amends several sections of 33 CFR part 165 affecting
safety zones and a regulated navigation area. Specifically, it provides
updated contact information and updated COTP designations in Sec. Sec.
165.506, 165.514, 165.515, 165.518, 165.530, and 165.540. These changes
do not place any new requirements on the public.

VI. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

A. Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order. Because this rule involves internal agency
organization and non-substantive changes, it will not impose any costs
on the public.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
This rule does not require a general NPRM and therefore is exempt from
the requirements of the Regulatory Flexibility Act. Although this rule
is exempt, we have considered its potential impact on small entities
and found that it will not have a significant economic impact on a
substantial number of small entities.

C. Assistance for Small Entities

    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

G. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies. This rule does not use technical standards.
Therefore, we did not consider the use of voluntary consensus
standards.

M. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and

Commandant Instruction M16475.lD, which guide the Coast Guard in
complying with the National Environmental Policy Act of 1969 (NEPA) (42
U.S.C. 4321-4370f), and have concluded that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule is categorically
excluded under section 2.B.2, figure 2-1, paragraph (34)(a) of the
Instruction. This rule involves editorial or procedural regulations. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects

33 CFR Part 3

    Organization and functions (Government agencies).

33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, and Waterways.

33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR parts 3, 100, and 165 as follows:

PART 3--COAST GUARD AREAS, DISTRICTS, SECTORS, MARINE INSPECTION
ZONES, AND CAPTAIN OF THE PORT ZONES

0
1. The authority citation for part 3 continues to read as follows:

    Authority:  14 U.S.C. 92; Pub. L. 107-296, 116 Stat. 2135;
Department of Homeland Security Delegation No. 0170.1, para. 2(23).

0
2. Revise Sec.  3.25-20 to read as follows:

Sec.  3.25-20  Sector North Carolina Marine Inspection Zone and Captain
of the Port Zone.

    Sector North Carolina's office is located in Wilmington, NC. The
boundary of Sector North Carolina's Marine Inspection Zone and Captain
of the Port Zone starts at the sea on the North Carolina-Virginia
border at 36 deg 33.04 min N. latitude, 75 deg 52.05 min W. longitude,
and proceeds westerly along the North Carolina-Virginia boundary to the
Tennessee boundary; thence southwesterly along the North Carolina-
Tennessee boundary to the Georgia boundary and then to the South
Carolina boundary; thence easterly along the North Carolina-South
Carolina boundary on the sea at 33 deg 51.06 min N. latitude, 78 deg
32.46 min W. longitude. The offshore boundary starts at the North
Carolina-South Carolina border and proceeds southeasterly to the
outermost extent of the EEZ at 31 deg 42.1 min N. latitude, 74 deg
30.75 min W. longitude; thence northeasterly along the outermost extent
of the Exclusive Economic Zone to a point at 36 deg 32.99 min N.
latitude, 71 deg 29.56 min W. longitude; thence west to the North
Carolina-Virginia border at a point 36 deg 33.04 min N. latitude, 75
deg 52.05 min W. longitude.

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
3. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
4. Amend Sec.  100.501 by revising paragraph (d)(4) to read as follows
and removing paragraph (d)(5).

Sec.  100.501  Special Local Regulations; Marine Events in the Fifth
Coast Guard District.

* * * * *
    (d) * * *
    (4) Coast Guard Sector North Carolina--Captain of the Port Zone,
North Carolina:<PHONE_NUMBER> or<PHONE_NUMBER>.
* * * * *

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
5. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
6. Amend Sec.  165.506 to revise paragraph (c)(4) to read as follows:

Sec.  165.506  Safety Zones; Fifth Coast Guard District Fireworks
Displays.

* * * * *
    (c) * * *
    (4) Coast Guard Sector North Carolina--Captain of the Port Zone,
Wilmington, NC:<PHONE_NUMBER> or<PHONE_NUMBER>.
* * * * *

0
7. Amend Sec.  165.514 as follows:
0
a. In paragraph (b) introductory text and paragraph (c)(1), remove the
word ``Wilmington'' wherever it appears and add, in its place, the
words ``North Carolina''; and
0
b. Revise the last sentence in paragraph (d) to read as follows:

Sec.  165.514  Safety Zone: Atlantic Intracoastal Waterway and
connecting waters, vicinity of Marine Corps Base Camp Lejeune, North
Carolina.

* * * * *
    (d) * * * The Captain of the Port may be contacted at Sector North
Carolina by telephone at<PHONE_NUMBER> or<PHONE_NUMBER>.

0
8. Amend Sec.  165.515 as follows:
0
a. In paragraph (b), remove the word ``Wilmington,''; and
0
b. Revise the first sentence after the italic heading in paragraph (c)
to read as follows:

Sec.  165.515  Safety Zone: Cape Fear River, Wilmington, North
Carolina.

* * * * *
    (c) * * * The Captain of the Port and the Command Duty Officer at
Sector North Carolina can be contacted at telephone number (877) 229-
0770 or<PHONE_NUMBER>. * * *
* * * * *

Sec.  165.518  [Amended]

0
9. In Sec.  165.518(c)(7), remove the text ``Wilmington:<PHONE_NUMBER>
or<PHONE_NUMBER>'' and add, in its place, the text ``North Carolina:
(877) 229-0770 or<PHONE_NUMBER>''.
0
10. Amend Sec.  165.530 as follows:
0
a. In paragraph (a), remove the word ``Wilmington'';
0
b. Revise the first sentence of paragraph (b)(1) to read as follows;
and
0
c. Revise paragraph (b)(3) to read as follows:

Sec.  165.530  Safety Zone: Cape Fear and Northeast Cape Fear Rivers,
NC.

* * * * *
    (b) * * *
    (1) The Captain of the Port and the Command Duty Officer at Sector
North Carolina can be contacted at telephone number<PHONE_NUMBER> or
(910) 772-2200. * * *
* * * * *
    (3) Sector North Carolina will notify the maritime community of
periods during which this safety zone will be in effect by providing
advance notice of scheduled arrivals and departures of loaded hazardous
materials vessels via a marine Broadcast Notice to Mariners.
* * * * *

Sec.  165.540  [Amended]

0
11. In Sec.  165.540(f)(10), remove the word ``Wilmington'' and add, in
its place, the words ``North Carolina''.

    Dated: May 4, 2011.
Kathryn A. Sinniger,
Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
[FR Doc. 2011-11261 Filed 5-6-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Page 42547]
[FR Doc No: 2012-17614]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Suspected
Unapproved Parts Notification

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on May 9, 2012, vol. 77, no. 90, page 27271. The information
collected on the FAA Form 8120-11 is used by those who wish to report
suspected unapproved parts to the FAA for review.

DATES: Written comments should be submitted by August 20, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0552.
    Title: Suspected Unapproved Parts Notification.
    Form Numbers: FAA Form 8120-11.
    Type of Review: Renewal of an information collection.
    Background: 49 U.S.C. 44701 empowers the Administrator of the FAA
to provide reasonable rules and regulations for minimum standards
governing the design, materials, construction, and performance of
aircraft, engines, and propellers as may be required to ensure safety
in air transportation. Submission of the Suspected Unapproved Parts
Report, FAA Form 8120-11, is necessary to ensure that only FAA-approved
parts are installed on type certificated aircraft, and that continued
airworthiness is maintained.
    Respondents: Approximately 150 manufacturers, repair stations,
aircraft owner/operators, and air carriers.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 30 minutes.
    Estimated Total Annual Burden: 75 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on July 12, 2012.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2012-17614 Filed 7-18-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32481-32482]
[DOCID:fr08jn10-106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0276]

Guidance for Industry: Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Enforcement Policy
Concerning Rotational Warning Plans for Smokeless Tobacco Products.''
The guidance is intended to provide information relating to FDA's
enforcement policy concerning section 3 of the Comprehensive Smokeless
Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the
Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act). This guidance will be implemented immediately, but remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).

DATES:  Submit either electronic or written comments on this guidance
at any time. General comments on agency guidance documents are welcome
at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco Products'' to the Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229. Send one self-addressed adhesive label to
assist that office in processing your request or include a fax number
to which the guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to guidance.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229,<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act grants FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect public health generally and to reduce
tobacco use by minors. Section 204 of the Tobacco Control Act amended
section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe
new requirements for health warning labels that must appear on
smokeless tobacco product packages and advertising, and to require that
rotational warning plans for packaging and advertising for smokeless
tobacco products be submitted to FDA, rather than to the Federal Trade
Commission (FTC).
    The new warning labels required by section 3 of the Smokeless
Tobacco Act must begin to rotate in advertising for smokeless tobacco
products beginning on June 22, 2010, and must be distributed and
displayed on the packaging of smokeless tobacco products manufactured
on or after June 22, 2010, as set forth in section 3(b)(3) of the
Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and
section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after
July 22, 2010, manufacturers may not introduce any smokeless tobacco
product into

domestic commerce unless its packaging complies with section 3 of the
Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3)
is that the rotation of label statements on packaging and advertising
for each brand of smokeless tobacco must be ``in accordance with a plan
submitted by the tobacco product manufacturer, importer, distributor,
or retailer'' to, and approved by, FDA (Id.).
    At this time, as an exercise of enforcement discretion, FDA does
not intend to commence or recommend enforcement of the requirement that
a smokeless tobacco manufacturer, distributor, importer, or retailer
must have an FDA-approved rotational warning plan, so long as a
rotational warning plan has been submitted to FDA by July 22, 2010. FDA
believes that allowing additional time for the review of rotational
warning plans will permit an orderly transition of regulatory authority
from FTC to FDA to review and approve rotational warning plans. During
such transition between June 22, 2010, and July 22, 2010, affected
companies may wish to contact FDA to discuss the submission of their
rotational warning plans in order to make the subsequent approval
process more orderly and efficient. FDA intends to provide further
public notice prior to revising or rescinding this enforcement policy
after the transition from FTC to FDA has been accomplished for the
submission and review of rotational warning plans. This enforcement
policy pertains only to the requirement that smokeless tobacco
manufacturers, distributors, importers, or retailers must have an FDA-
approved rotational warning plan. FDA expects compliance with regard to
all other requirements of section 3 of the Smokeless Tobacco Act,
including the requirements relating to size, formatting, location, and
use of required warning statements.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulations (21 CFR
10.115). This guidance is being implemented immediately without prior
public comment under 10.115(g)(2) because the agency has determined
that prior public participation is not feasible or appropriate. This
document provides guidance on statutory provisions that take effect
June 22, 2010. It is important that FDA explain its enforcement policy
concerning the submission and approval of rotational warning plans for
smokeless tobacco products before that date.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    An electronic version of this guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13819 Filed 6-4-10; 4:15 pm]
BILLING CODE 4160-01-S