Appendix E-1   List of Potential Control Measures for 8-Hour Ozone SIP
(Cecil  SIP Analysis)

List #

Measure	Description	RACM:

Implementation  by May 2008?	RACM:  Enforceable?	RACM:

Technologically Feasible?	RACM:

Economically Feasible?	RACM:

No Adverse Impacts?	RACM:

Reductions >0.1tpd?	RACM:

Yes/No?	RACM:

Explanation

Stationary Sources

S 	1	Reductions from EGUs: OTC Model Rule	Adopt OTC Multipollutant Model
Rule for EGUs.	No	Yes	Yes	Yes	Yes	Yes	No	Will not provide reductions by
May 2008

S 	2	Reductions from EGUs Plant RACT/Technology-Based Approach	Identify
and Require Additional Power Plant-Specific Emission Reduction
Technologies.	-	Yes	Yes	-	-	Yes	No	No creditable emission reductions

S 	3	OTC Model Rule:  Distributed Generation Rule	Adopt  Rule to Require
Additional Controls on Distributed Generation Sources.	No	Yes	Yes	-	No
Yes	No	Will not provide reductions by May 2008

S 	4	OTC Model Rule:  Peaking Unit Rule	Adopt  Rule to Require
Additional Controls on EGU Peaking Units.	No	Yes	-	-	No	Yes	No	Will not
provide reductions by May 2008

S 	5	OTC Model Rule:  ICI Boiler Standards	Adopt  Rule on Standards for
Industrial, Commercial, and Institutional Boilers.  	No	Yes	Yes	Yes	No
Yes	No	Will not provide reductions by May 2008

S 	6	Control Asphalt and Concrete Facilities	Require NOx emission limits
on asphaltic concrete production facilities.	No	Yes	Yes	No	No	Yes	No
Will not provide reductions by May 2008

S 	7	Control Portland Cement Facilities	Adopt  Rule on RACT Update for
Portland Cement Facilities.	No	Yes	Yes	Yes	No	Yes	No	Will not provide
reductions by May 2008

S 	8	Mineral Products Industry Controls:  Glass and Fiberglass	Control
Glass and Fiberglass Facility Emissions.	No	Yes	Yes	Yes	Yes	No	No	Will
not provide reductions by May 2008

S 	9	Controls on Municipal Solid Waste Incinerators	Adopt  Rule on RACT
Update for MSW Incineration Facilities.	No	Yes	Yes	-	Yes	Yes	No	Will not
provide reductions by May 2008

S 	10	Control VOC Emissions from Chemical Manufacturing	Chemical
Manufacturing:  More stringent standards on the manufacture of
polystyrene, formica, polyester resin, wood and paper, other polymers,
pharmaceuticals, paints, varnishes, soaps, detergents, inks, solvents,
fuel additives, acids, fertilizers, and resins.	No	Yes	Yes	-	No	No	No
Will not provide reductions by May 2008

S 	11	Local Cap and Trade Program	Implement cap and trade program for
VOC sources in region.  Consider California RECLAIM program.	No	Yes	Yes
-	No	Yes	No	Will not provide reductions by May 2008

S 	12	Statewide Emission Registration Program	Require a mandatory
statewide registration program for all NOx and VOC emission sources.	No
Yes	Yes	No	No	Yes	No

Not economically feasible

S 	15	Emission Reduction Credit Retirement Program	Establish program to
retire emission reduction credits for stationary sources.	No	Yes	Yes	Yes
-	Yes	No	Will not provide reductions by May 2008

S 	16	Episodic Mandatory Facility Reductions	Require mandatory facility
reductions on Air Quality Action Days.  Require Curtailment Plan.	No	Yes
Yes	-	No	No	No	No creditable emission reductions

S 	17	Enhanced Enforcement/Rule Compliance at Existing Stationary
Sources	Step up enforcement of and compliance with existing rules for
emissions control by stationary sources.	Yes	Yes	Yes	No	Yes	No	No	No
creditable emission reductions

S 	18	Low NOx Fuel Oil for Stationary Sources	Require oil-burning
stationary sources to burn ThermaNOx, a low-NOx No. 2 fuel oil emulsion,
during ozone season.	No	-	Yes	-	Yes	-	No	Will not provide reductions by
May 2008

S 	19	Energy Efficiency Programs	Increase Adoption of Energy Efficient
Technology by Government and the Private Sector with Commensurate
Retirement of EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will not advance
attainment date

S 	20	Energy Efficiency:  Energy Efficiency Standards	Establish
requirements for minimum energy efficiency, with Commensurate Retirement
of EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will not advance attainment
date

S 	21	Renewable Energy:  Renewable Portfolio Standards	Increase
Purchases of Renewable Energy by Government and the Private Sector, with
Commensurate Retirement of EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will
not advance attainment date

S 	22	Renewable Energy:  Solar Photovoltaic Programs	Increase Purchases
and Installation of Renewable Energy sources by Government and the
Private Sector, with Commensurate Retirement of EGU NOx Allowances.
Consider Incentive Programs.	-	Yes	Yes	-	Yes	-	No	Will not advance
attainment date

S 	23	Renewable Energy: Wind Energy Purchases	Increase Purchases of
Renewable Energy by Government and the Private Sector, with Commensurate
Retirement of EGU NOx Allowances.	-	Yes	Yes	No	Yes	-	No	Will not advance
attainment date

S 	24	Renewable Energy:  Solar Hot Water Heating	Increase Use of Solar
Hot Water Heating by Government and the Private Sector, with
Commensurate Retirement of EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will
not advance attainment date

S 	25	Energy Efficiency:  Energy Performance Contracting Program
Increase Use of Energy Performance Contracts in the Public and/or
Private sector to Reduce Energy Consumption, with Commensurate
Retirement of EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will not advance
attainment date

S 	26	Energy Efficiency Programs:  LED Traffic Signal Retrofit Program
Increase Use Energy Efficient LED Traffic Signals.	-	Yes	Yes	Yes	Yes	-
No	Will not advance attainment date

S 	27	Energy Efficiency:  Green Building Code Program	Establish energy
efficiency standards for building codes, with Commensurate Retirement of
EGU NOx Allowances.	-	Yes	Yes	-	Yes	-	No	Will not advance attainment
date

S 	28	Energy Efficiency:  Ground Source Heat Pump Initiative	Increase
Purchases and Installation of Ground Source Heat Pumps in the Public
and/or Private Sector, with Commensurate Retirement of EGU NOx
Allowances.	-	Yes	Yes	-	Yes	-	No	Will not advance attainment date

S 	29	Energy Efficiency Programs:  LED Street Light Retrofit Program
Increase Use of Energy Efficient LED Street Lights.	-	Yes	-	-	Yes	-	No
Will not advance attainment date

S 	30	Energy Efficiency:  Energy Star Exit Signs	Increase market
penetration of Energy Efficient Lighting (EXIT Signs).	-	Yes	Yes	-	Yes	-
No	Will not advance attainment date

S 	31	Chemical Industry Controls	Reduce upwind NOx emissions limits in
the manufacture of chemicals.	No	Yes	-	-	-	-	No	Will not provide
reductions by May 2008

S 	33	Metallurgical Industry Controls: Iron and Steel	Control Upwind
Iron and Steel Production Emissions.	No	Yes	-	-	-	-	No	Will not provide
reductions by May 2008

S 	34	Metallurgical Industry Controls:  Lead	Control Upwind Lead Smelter
Emissions.	No	Yes	-	-	-	-	No	Will not provide reductions by May 2008

S 	35	Metallurgical Industry Controls:  Aluminum	Control Upwind Aluminum
Production Emissions.	No	Yes	-	-	-	-	No	Will not provide reductions by
May 2008

S 	36	Metallurgical Industry Controls: Zinc/Copper	Control Upwind
Zinc/Copper Smelter Emissions.	No	Yes	-	-	-	-	No	Will not provide
reductions by May 2008

S 	37	Mineral Products Industry Controls: Lime	Control Upwind Lime
Facility Emissions.	No	Yes	-	-	-	-	No	Will not provide reductions by May
2008

S 	38	Mineral Products Industry Controls: Phosphate	Control  Upwind
Phosphate Rock Plant Emissions.	No	Yes	-	-	-	-	No	Will not provide
reductions by May 2008

S 	39	Forest Product Industry Controls	Control Upwind Wood, Paper and
Pulp Production Emissions.	No	Yes	-	-	-	-	No	Will not provide reductions
by May 2008

S 	40	Upwind VOC Controls:  Plant-by-Plant BACT Controls	Identify and
Require Additional Facility-Specific Emission Reduction Technologies.	No
Yes	-	-	-	Yes	No	Will not provide reductions by May 2008

S 	41	Upwind VOC Controls:  Expand VOC RACT to Upwind Counties	Expand
VOC RACT Requirements.	No	Yes	-	Yes	Yes	Yes	No	Will not provide
reductions by May 2008

S 	42	Upwind NOx Controls:  Plant-by-Plant BACT Controls	Identify and
Require Additional Facility-Specific Emission Reduction Technologies.	No
Yes	-	-	-	Yes	No	Will not provide reductions by May 2008

S 	43	Upwind RACT Update:  Refineries	Update RACTs for Refineries in
Upwind Contributing Areas.	No	Yes	-	-	Yes	Yes	No 	Will not provide
reductions by May 2008

Area Sources

A 	2	Low-Emission Asphalt	Adopt SCAQMD Rules 1108: Cutback Asphalt (less
than 0.5% VOC evaporating at 260F) and 1108.1: Emulsified Asphalt (less
than 3% VOC evaporating at 260F).	No	Yes	-	-	Yes	No	No	De minimis

A 	3	Expand Coverage of OTC Consumer Products Rule (Phase II)	Expand
Number of Products Covered by OTC Consumer Product Rule.  Require Lower
VOC Content of Products Already Covered.	No	Yes	-	-	-	Yes	No	Will not
provide reductions by May 2008

A 	4	Expand Coverage of OTC AIMs Rule (Phase II)	Expand Number of
Products Covered by OTC AIMs Rule.  Require Lower VOC Content of
Products Already Covered.	No	Yes	-	-	-	Yes	No	Will not provide
reductions by May 2008

A 	5	Green Procurement Policy	Establish procurement policies that foster
emission reduction (paints, solvents, coatings, asphalt, roofs, building
materials, AFVs, EE office equipment, ULSD).	Yes	No	Yes	-	Yes	-	No	No
creditable emission reduction

A 	6	Control Growth and Development:  Land Use Restrictions	Implement
land use restrictions to control residential, commercial, and industrial
development in the nonattainment area.	-	No	Yes	-	No	-	No	No creditable
reductions

A 	7	Control Growth and Development: Mitigate New Development	Mitigate
emissions from new development.	-	No	Yes	-	No	-	No	No creditable
reductions

A 	8	Implement Programs to Reduce the Urban Heat Island Effect:
Forestry.	Increase Urban Tree Canopy	No	No	Yes	-	Yes	No	No	No creditable
emission reduction

A 	9	Implement Programs to Reduce the Urban Heat Island Effect: Roofs.
Increase Green and Cool Roof Market Penetration	No	No	Yes	-	Yes	No	No	No
creditable emission reduction

A 	10	Implement Programs to Reduce the Urban Heat Island Effect:
Pavement.	Increase Cool Pavement Market Penetration	No	No	Yes	-	Yes	No
No	No creditable emission reduction

A 	11	Expand Stage I Vapor Recovery 	Expand Requirements for Stage I
Vapor Recovery to Upwind Counties.	No	Yes	Yes	Yes	Yes	Yes	No	Will not
provide reductions by May 2008

A 	12	Expand Stage II Vapor Recovery	Expand requirements for Stage II
Vapor Recovery to Upwind Counties.	No	Yes	Yes	Yes	Yes	Yes	No	Will not
provide reductions by May 2008

A 	13	Upwind Fuels Controls	Expand Use of Reformulated Gasoline to
Upwind Counties.  Consider OTC Regional Fuels Initiative.	No	Yes	Yes	Yes
Yes	Yes	No	Will not provide reductions by May 2008

A 	14	Expand OTC Consumer Products Rule	Expand OTC Consumer Product Rule
to Upwind Counties.	No	Yes	Yes	Yes	Yes	Yes	No	Will not provide
reductions by May 2008

A 	15	Expand OTC Mobile Equipment Repair and Refinishing Rule	Expand OTC
Mobile Equipment Repair and Refinishing Rule to Upwind Counties.	No	Yes
Yes	Yes	Yes	Yes	No	Will not provide reductions by May 2008

A 	16	Expand OTC Portable Fuel Containers Rule	Expand OTC Portable Fuel
Containers Rule to Upwind Counties.	No	Yes	Yes	Yes	Yes	Yes	No	Will not
provide reductions by May 2008

A 	17	Expand OTC Solvent Cleaning Rule	Expand OTC Solvent Cleaning Rule
to Upwind Counties.	No	Yes	Yes	Yes	Yes	Yes	No	Will not provide
reductions by May 2008

A 	18	Expand OTC AIMs Rule	Expand OTC AIMs Rule to Upwind Counties.	No
Yes	Yes	Yes	Yes	Yes	No	Will not provide reductions by May 2008

A 	19	Control Upwind Port Emissions	Pursue approaches to reduce
land-based port emissions.	No	Yes	Yes	Yes	Yes	Yes	No	Will not provide
reductions by May 2008

A 	20	Control Drycleaning Facilities	Ban transfer systems in Petroleum
Dry Cleaning.	No	Yes	Yes	-	No	Yes	No 	Will not provide reductions by May
2008

A 	21	Expand Seasonal Open Burning Restrictions	Expand prohibitions on
seasonal open burning.	No	Yes	Yes	Yes	Yes	No	No	No creditable reductions

A 	22	Enhanced Enforcement:  Environmental Partnerships/Pollution
Prevention Initiatives	Voluntary compliance audits, encourage low
emitting technology (swap out solvent machines)	Yes	No	Yes	-	Yes	No	No
No creditable emission reductions

A 	23	Control Agricultural Sources	Encourage agricultural best
practices, including those that reduce pesticide use.	Yes	No	Yes	-	No
Yes	No 	No creditable emission reduction

A 	24	RACT Update:  Control Industrial Incineration	Implement programs
to reduce emissions from industrial incineration.	No	Yes	-	-	-	-	No	Will
not provide reductions by May 2008

A 	25	Home Heating Oil Standards	Adopt rule on standards for home
heating oils.	No	Yes	Yes	-	No	-	No	Will not provide reductions by May
2008

A 	26	Control Fermentation Sources (wineries/breweries)	Reduce
evaporative VOC emissions from the fermentation process at wineries
and/or breweries.	No	Yes	Yes	-	No	-	No 	Will not provide reductions by
May 2008

A 	27	Control Landfills and Wastewater Facilities	Reduce the NOx and VOC
emission limits for flares.	No	Yes	Yes	No	Yes	No	No	De minimis

A 	28	Control Wastewater Treatment Facilities	Require capture and
control of VOC emissions from facilities treating industrial wastewater
and domestic sewage.  Adopt SCAQMD Rule 1176: Sumps and Wastewater
Separators.	No	Yes	-	-	No	-	No	Will not provide reductions by May 2008

A 	29	Control VOC Emissions from Fuel Facilities 	Reduce the VOC
emission limits for bulk plants/terminal, including storage tanks.
Adopt SCAQMD Rule 1178: Further Reductions of VOC Emissions from Storage
Tanks at Petroleum Facilities.	No	Yes	-	-	No	Yes	No	Will not provide
reductions by May 2008

A 	30	Control VOC Emissions from Construction and Maintenance	Reduce VOC
emissions from roofing kettles.	No	Yes	No	No	No	-	No	Will not provide
reductions by May 2008

A 	31	Control Residential Wood Burning	Implement voluntary program to
reduce emissions from wood-burning fireplaces and wood stoves.  	Yes	No
Yes	-	Yes	No	No	No creditable emission reduction

A 	32	Low-Emission Natural Gas Water Heaters	Adopt SCAQMD Rule 1121:
Control of NOx from Residential Type Natural Gas Fired Water Heaters.	No
No	Yes	Yes	No	No	No	De minimis

A 	33	Low-Emission Natural Gas Furnaces	Adopt SCAQMD Rule 1111: NOx
Emissions from Natural Gas Fired, Fan-Type Central Furnaces  (no more
than 40 nanograms of NOx per joule of useful heat).	No	No	Yes	Yes	No	No
No	De minimis

A 	34	Control Restaurant Sources	Implement programs to reduce emissions
from restaurants, including charbroil operations and deep fat fryers.
No	No	Yes	No	No	No	No 	Will not provide reductions by May 2008

A 	35	"Cash for Clunkers" Gasoline Containers Replacement Program
Accelerate the Replacement of Older Gasoline Cans with CARB Compliant
Containers.  Offer incentives for consumers to turn in old gas cans and
obtain new ones.	Yes	No	Yes	-	Yes	No	No	No creditable emission reduction

A 	36	Enhanced Enforcement of Area Source Regs:  Open Burning	Enhance
enforcement of seasonal open burning restrictions.	Yes	Yes	Yes	-	Yes	No
No	No creditable emission reductions

A 	37	Enhanced Enforcement of Area Source Regs: Solvent Cleaning	Enhance
enforcement of surface cleaning rules.	Yes	Yes	Yes	-	Yes	No	No	No
creditable emission reductions

A 	38	Mitigation Fees: Preempted Sources	Charge emission mitigation fee
to federally preempted sources.	No	-	Yes	-	Yes	-	No	Will not provide
reductions by May 2008

A 	39	Pesticide Application:  Best Practices	Establish best practices
for pesticide application.	Yes	-	Yes	-	No	-	No 	No creditable emission
reduction

A 	40	Control Bakeries	Adopt SCAQMD Rule 1153: Commercial Bakery Ovens.
Reduce exemption level and set standards for unregulated bakeries.	No
Yes	Yes	No	No	No	No 	Will not provide reductions by May 2008

A 	41	Government Actions (Air Quality Action day similar to snow day)
Implement a liberal leave policy for local, state and federal employees
on Air Quality Action Days, permitting employees to work from home or
take unscheduled leave.	Yes	No	Yes	Yes	Yes	Yes	No	No creditable emission
reduction

A 	42	Clean Air Partners:  Public Outreach and Education	Implement
Strategic Communication Campaigns to Increase Public Awareness (target
lawnmowers, paints, refueling).	Yes	No	Yes	Yes	Yes	Yes	No	No creditable
emission reduction

A 	43	Local Government Education Campaign	Encourage local governments to
adopt Air Quality Action Day policies (target lawnmowers, paints,
refueling).	Yes	No	Yes	Yes	Yes	Yes	No	No creditable emission reduction

A 	44	Mass Marketing Campaign	Marketing effort involving
business-to-business advertising campaign in print media and on world
wide web. 	Yes	No	Yes	Yes	Yes	Yes	No	No creditable emission reduction

A 	45	Public Outreach and Education:  Fueling	Educate to improve fueling
practices.	Yes	No	Yes	Yes	Yes	Yes	No	No creditable emission reduction

A 	46	Public Outreach and Education: Sources	Public Education on NOx and
ROG sources in Schools and Small Businesses.	Yes	No	Yes	Yes	Yes	Yes	No
No creditable emission reduction

A 	47	Episodic limits on asphalt paving and traffic marking activities
Prohibit road paving and traffic marking on Air Quality Action days.	Yes
Yes	Yes	Yes	Yes	-	No	No creditable emission reduction

A 	48	No Fuel Policy on Air Quality Action Days	Voluntary reduction in
fueling activities on Air Quality Action Days.	Yes	No	Yes	Yes	No	-	No	No
creditable emission reduction

A 	49	Episodic Pesticide Application Ban	Ban pesticide application on
Code Red Air Quality Action Days.	Yes	-	Yes	-	No	-	No	Adverse impacts

A 	50	Episodic Voluntary Pesticide Application Reduction	Encourage
voluntary restrictions on pesticide application on Code Red Air Quality
Action Days.	Yes	-	Yes	-	No	-	No	Adverse impacts

A 	51	Clean Air Partners: Air Quality Action Days	Take a variety of
actions on Air Quality Action Days to reduce emissions and improve air
quality (target lawnmowers, paints, refueling).	Yes	No	Yes	Yes	Yes	Yes
No	No creditable emission reduction

Non-road Sources

N 	1	Clean Air Construction Initiative: Road Construction Projects
Develop alternative programs for state and local governments (public
entities) to reduce on-road and off-road construction and maintenance
related emissions.  Episodic: no work or idling restrictions.
Non-episodic: Control retrofits.	Yes	No	Yes	-	-	Yes	No	No creditable
emission reduction

N 	2	Clean Air Construction Initiative: Off-Road Construction Projects
Develop alternative programs for state and local governments (public
entities) to reduce on-road and off-road construction and maintenance
related emissions.  Episodic: no work or idling restrictions.
Non-episodic: Control retrofits.	Yes	No	Yes	-	-	Yes	No	No creditable
emission reduction

N 	3	Clean Air Maintenance Initiative: Road Maintenance Contracts
Develop alternative programs for state and local governments (public
entities) to reduce on-road and off-road construction and maintenance
related emissions.  Episodic: no work or idling restrictions.
Non-episodic: Control retrofits.	Yes	No	Yes	-	-	Yes	No	No creditable
emission reduction

N 	4	Clean Air Construction Initiative: Preference for Low-emissions
Industrial Equipment	In bids for government contracts, award extra
points to bidders using low-emission industrial equipment.	Yes	No	Yes	-
-	Yes	No	No creditable emission reduction

N 	5	Control Construction Emissions	Limitations and Fleet Rules for
Construction Equipment.	No	Yes	-	No	No	Yes	No	Not economically feasible

N 	6	Non-Road Diesel Engine Retrofit Program:  Voluntary	Develop
voluntary program encouraging retrofit of non-road diesel equipment in
public and/or private fleets.	Yes	No	Yes	-	Yes	Yes	No	No creditable
emission reduction

N 	7	Non-Road Diesel Engine Retrofit Program:  Mandatory	Develop
mandatory program requiring retrofit of non-road diesel equipment in
public and/or private fleets.	No	Yes	Yes	-	-	Yes	No	Will not provide
reductions by May 2008

N 	8	Retrofit/Repower Locomotives	Provide financial incentives to
retrofit or repower locomotives operating in the nonattainment area for
cleaner burning diesel or alternative fuels.	Yes	No	-	-	Yes	-	No	No
creditable emission reduction

N 	9	Locomotive Idling Reduction	Support Installation of Idling
Reduction Technologies on Locomotives.	Yes	No	Yes	-	Yes	-	No	No
creditable emission reduction

N 	10	Control Off-Road Diesel Engines (smoke test)	Implement mandatory
smoke testing program for heavy-duty (>50 hp) off-road diesel engines.
No	Yes	Yes	No	Yes	-	No	Will not provide reductions by May 2008

N 	11	Airport Emission Cap	Establish Agreement with Airports Authority
to Cap or Reduce Emissions.	Yes	No	-	-	Yes	Yes	No	No creditable emission
reduction

N 	12	Airport Emissions Cap in Upwind Counties	Voluntary Agreement to
Cap Airport Emissions Outside the Nonattainment Area.	Yes	No	-	-	Yes	Yes
No	No creditable emission reduction

N 	13	Airport Electric GSE	Subsidize adoption of electric ground service
equipment.	Yes	Yes	Yes	Yes	Yes	Yes	No	Will not advance attainment date

N 	14	Airport GSE Retrofits	Subsidize the retrofit of airport ground
service equipment.	Yes	Yes	Yes	Yes	Yes	Yes	No	Will not advance
attainment date

N 	15	Airport GSE Idling Controls	Develop voluntary program to encourage
operators to limit idling of airport ground service equipment.	Yes	Yes
Yes	Yes	Yes	Yes	No	Will not advance attainment date

N 	16	Airport APU Initiatives	Seek voluntary agreement to reduce use of
aircraft APUs through use of gate-provided services or other strategies
Yes	Yes	Yes	Yes	Yes	Yes	No	Will not advance attainment date

N 	17	Locomotive Engine Standards	Encourage new federal  locomotive
engine emission standards (EPA 2012)	No	-	-	-	Yes	Yes	No	Will not
provide reductions by May 2008

N 	18	Marine Diesel Engine Standards	Encourage new federal marine engine
emission standards (EPA 2012).	No	-	-	-	Yes	Yes	No	Will not provide
reductions by May 2008

N 	19	Control Off-Road Diesel Engines (Blue Sky)	Encourage the use of
engines that are included in EPA’s voluntary “Blue Sky Series”
engine program.	Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

N 	20	Control Spark Ignition Engines	Retrofit controls and 3-way
catalyst for spark ignition engines.	-	Yes	-	-	Yes	-	No	No creditable
emission reductions

N 	21	Industrial Equipment Replacement	Subsidize replacement of
fossil-fuel fired industrial equipment with electric industrial
equipment.	Yes	No	-	-	No	-	No	No creditable emission reductions

N 	22	Light Commercial Equipment Retrofits	Require light commercial
equipment to be retrofitted with emissions controls.	No	No	-	No	-	-	No
Not economically feasible

N 	23	Control Light Commercial Equipment	Retrofit portable engines and
generators.	No	No	-	No	Yes	-	No	Not economically feasible

N 	24	Recreational Equipment Retrofits	Require recreational equipment to
be retrofitted with particulate fitlers and/or oxidation catalysts.	No
Yes	-	-	-	-	No	Not economically feasible

N 	25	Control Recreational Marine Emissions	Provide incentives for newer
boats and engines.	Yes	No	Yes	No	Yes	-	No	No creditable emission
reductions

N 	26	Idling Restrictions for Lawn & Garden Equipment	Limit idling by
commercial lawn & garden equipment.	No	No	Yes	No	-	-	No	Not enforceable

N 	27	Agricultural Equipment Retrofits	Require agricultural equipment to
be retrofitted with emissions controls.	No	Yes	-	-	-	-	No	Will not
provide reductions by May 2008

N 	28	Agricultural Equipment Use Restrictions	Ban use of agricultural
equipment on Air Quality Action Days.	Yes	No	Yes	No	No	-	No	Not feasible

N 	29	Low-emissions Agricultural Equipment	Require sale of low-emissions
agricultural equipment in region.	No	Yes	-	No	No	-	No	Will not provide
reductions by May 2008

N 	30	Industrial Equipment Retrofits	Require industrial equipment to be
retrofitted with emissions controls.	No	Yes	-	-	No	-	No	Will not provide
reductions by May 2008

N 	31	Low-emissions Commercial and Industrial Equipment	Require sale of
low-emissions commercial and industrial equipment in region.	No	Yes	-	-
-	Yes	No	Will not provide reductions by May 2008

N 	32	Idling Restrictions for Commercial and Industrial Equipment	Limit
idling by commercial and industrial equipment.	No	No	Yes	No	Yes	Yes	No
Not economically feasible

N 	33	Control Light Commercial Equipment	Require zero emission forklifts
where feasible.	No	No	-	No	Yes	No	No	Not economically feasible

N 	34	Control Commercial Marine Sources	Tug/Push Boat Activity
Reductions.	No	Yes	Yes	No	No	-	No	Potential adverse impacts

N 	35	Biodiesel for Off-Road Equipment	Increase use of biodiesel in
off-road diesel equipment during ozone season.	Yes	No	-	-	-	-	No	No
creditable emission reduction

N	36	High Cetane Fuel	Require High Cetane Diesel Fuel for Off-road
Vehicles.	No	Yes	Yes	No	Yes	-	No	Will not provide reductions by May 2008

N 	37	Require low-NOx fuel for recreational equipment	Require
recreational equipment to use low-NOx fuel additives during ozone
season.	Yes	Yes	Yes	Yes	-	-	No	Will not advance attainment date

N 	38	Low-NOx Fuel for Lawn & Garden Equipment	Require diesel-fired lawn
& garden equipment to use low-NOx fuel additives during ozone season.	No
No	-	No	Yes	-	No	No creditable emission reduction

N 	39	Low-NOx Fuel for Recreational Marine Equipment	Require
diesel-fired recreational marine equipment to use low-NOx fuel additives
during ozone season.	Yes	Yes	Yes	Yes	Yes	-	No	No creditable emission
reduction

N 	40	Require Low-NOx Fuel for Airport GSE	Require airport GSE to use
low-NOx fuel additives during ozone season.	Yes	Yes	Yes	Yes	Yes	-	No	No
creditable emission reduction

N 	41	Require Low-NOx Fuel for Industrial Equipment	Require industrial
equipment to use low-NOx fuel additives during ozone season.	Yes	Yes	Yes
Yes	Yes	-	No	No creditable emission reduction

N 	42	Require Low-NOx Fuel for Light Commercial Equipment	Require light
commercial equipment to use low-NOx fuel during ozone season, if
applicable.	Yes	Yes	Yes	Yes	Yes	-	No	No creditable emission reduction

N 	43	Episodic Low-NOx Fuel for Construction Equipment	Require
diesel-fired construction equipment operating in region to use low-NOx
fuel additives during ozone season.	Yes	Yes	Yes	Yes	Yes	-	No	No
creditable emission reduction

N 	44	Episodic Low-NOx Fuel for Construction Equipment	Require
diesel-fired construction equipment operating on state or local
government contracts to use low-NOx fuel additives during ozone season.
Yes	Yes	Yes	Yes	Yes	-	No	No creditable emission reduction

N 	45	Episodic Low-NOx Fuel for Construction Equipment	Voluntary use of
low-NOx fuel additives by diesel-fired construction equipment during
ozone season.	Yes	Yes	Yes	Yes	Yes	-	No	No creditable emission reduction

N 	46	Control Recreational Equipment Emissions	Increase registration fee
on recreational vehicles (dedicate fee to clean air fund).	No	Yes	Yes	No
Yes	-	No	Not economically feasible

N 	47	Control Upwind Port Emissions	Emission Fee Program for
Port-Related Mobile Sources	No	Yes	Yes	-	Yes	-	No	No creditable emission
reductions

N 	48	Graduated registration fees for recreational boats	Levee
additional registration fee for registration of boats with old,
high-emission engines.	No	Yes	Yes	No	-	-	No	Will not provide reductions
by May 2008

N 	49	Airport Congestion Pricing	Charge higher aircraft landing fees
during busy times of day to reduce airport delays and congestion.	No	Yes
Yes	No	Yes	Yes	No	Not economically feasible

N 	50	Gas Tax Increase	Implement a fuel tax on off-road gasoline.	No	Yes
Yes	No	-	-	No	Not economically feasible

N 	51	Diesel Tax Increase	Implement a fuel tax on off-road diesel.	No
Yes	Yes	No	-	-	No	Not economically feasible

N 	52	Episodic Restrictions on Lawn & Garden Equipment (mandatory)
Restrict use of lawn and garden equipment during Air Quality Action
days.	No	-	Yes	-	No	Yes	No	No creditable emission reduction

N 	53	Episodic Restrictions on Recreational Equipment Use (mandatory)
Restrict use of recreational equipment during Air Quality Action days.
No	-	Yes	-	No	Yes	No	No creditable emission reduction

N 	54	Episodic Restrictions on Use of Commercial and Industrial
Equipment (mandatory)	Restrict use of commercial and industrial
equipment during Air Quality Action Days.	No	-	Yes	-	No	Yes	No	No
creditable emission reduction

N 	55	Episodic Commercial Lawn & Garden Equipment Use Restrictions
(voluntary)	Encourage restricted use of commercial lawn and garden
equipment on Air Quality Action Days.	Yes	No	Yes	-	Yes	Yes	No	No
creditable emission reduction

N 	56	Episodic Residential Lawn & Garden Equipment Use Restrictions
(voluntary)	Encourage restricted use of residential lawn & garden
equipment on Air Quality Action Days.	Yes	No	Yes	-	Yes	Yes	No	No
creditable emission reduction

N 	57	Episodic Commercial and Industrial Equipment Use Restrictions
(voluntary)	Encourage restricted use of commercial and industrial
equipment during Air Quality Action Days.	Yes	No	Yes	-	Yes	Yes	No	No
creditable emission reduction

N 	58	Episodic No Mow Policy on Code Red Days (voluntary)	Voluntary
reduction in mowing on Code Red Days.	Yes	No	Yes	-	Yes	Yes	No	No
creditable emission reduction

N 	59	Episodic Recreational Marine Equipment Use Restrictions
(mandatory)	Ban use of recreational marine equipment on Code Red Air
Quality Action Days.	Yes	Yes	Yes	No	No	-	No	Potential adverse impacts

N 	60	Episodic Recreational Marine Equipment Use Restrictions
(voluntary)	Encourage restricted use of all recreational marine
equipment on Air Quality Action Days.	Yes	No	Yes	Yes	Yes	-	No	Will not
advance attainment date

N 	61	Episodic Recreational Marine Idling Restrictions (mandatory)	Ban
idling by recreational marine equipment on Code Red Air Quality Action
Days.	Yes	Yes	Yes	No	Yes	-	No	Will not advance attainment date

N 	62	Episodic Recreational Marine Idling Restrictions (voluntary)
Encourage reduced idling by recreational marine equipment on Air Quality
Action Days.	No	No	Yes	No	Yes	-	No	No creditable emission reductions

N 	63	Episodic Recreational Marine Idling Restrictions (mandatory)	Ban
idling by recreational marine equipment during ozone season.	Yes	Yes	Yes
No	Yes	-	No	Will not advance attainment date

N 	64	Recreational Marine Idling Restrictions	Ban idling by recreational
marine equipment year-round.	Yes	Yes	Yes	No	Yes	-	No	Will not advance
attainment date

N 	65	"Cash for Clunkers" 2-cycle Engines	Implement a 2-cycle Engine
Replacement Program.	Yes	No	Yes	No	Yes	-	No	No creditable emission
reductions

N 	66	"Cash for Clunkers" Lawn & Garden Equipment	Offer cash for
consumers to turn in lawnmowers or lawn tractors and purchase electric
or push mowers.	Yes	No	Yes	No	Yes	-	No	No creditable emission reductions

N 	67	"Cash for Clunkers" Outboard Motors	Offer cash for consumers to
turn in old outboard motors and purchase new ones.	Yes	No	Yes	No	Yes	-
No	No creditable emission reductions

N 	68	"Cash for Clunkers" Recreational Equipment Program	Offer small
cash reward for owners to turn in old, high-emission recreational
equipment.	Yes	No	Yes	No	Yes	-	No	No creditable emission reductions

N 	69	Control Emissions from Lawn and Garden Equipment (xeriscaping)
Adopt measures to reduce lawn area and mower usage.  Xeriscaping.	Yes	No
Yes	Yes	Yes	-	No	No creditable emission reductions

N 	70	Agricultural Equipment Use Restrictions (voluntary)	Voluntary
moratorium on use of agricultural equipment on Air Quality Action Days.
Yes	No	Yes	No	Yes	-	No	No creditable emission reductions

N 	71	Low Maintenance Landscape Initiative	"Lawn Care for Cleaner Air":
increase use of low maintenance landscapes.	Yes	No	Yes	Yes	Yes	-	No	No
creditable emission reduction

Mobile Sources

M 	1	Voluntary Diesel Retrofit Program: Local Vehicles	Retrofit diesel
local vehicles.	Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	2	Voluntary Diesel Retrofit Program: Commercial Vehicles	Retrofit
diesel commercial vehicles.	Yes	No	Yes	-	Yes	-	No	No creditable emission
reduction

M 	3	Low-emission Vehicle Purchase Program:  Buses	Accelerate adoption
of low-emission vehicles.  Consider hydrid and CNG buses.	Yes	No	Yes	-
Yes	-	No	No creditable emission reduction

M 	4	Low-emission Vehicle Purchase Program: Refuse Haulers	Accelerate
Adoption of Low-emission Vehicles.  Consider CNG refuse haulers instead
of new diesel.	Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	5	Voluntary Diesel Retrofit Program: School Buses	Retrofit diesel
school buses.	Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	6	Voluntary Diesel Retrofit Program: State Vehicles	Retrofit diesel
state vehicles.	Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	7	Voluntary Diesel Retrofit Program: International Green Diesel
Retrofit	Fit transit buses running on ultra low sulfur diesel with a
quad-catalytic filter.	Yes	No	Yes	-	Yes	-	No	No creditable emission
reduction

M 	8	Low-emission Vehicle Purchase Program: State and Local Fleets
Accelerate adoption of low-emission vehicles, including hybrids. Focus
on state and local fleets.	Yes	No	Yes	Yes	Yes	-	No	Will not advance
attainment date

M 	9	Low-emission Vehicle Purchase Program: Private Owners Fleet
Accelerate adoption of low-emission vehicles. Consider use of tax
incentives.	Yes	No	Yes	-	Yes	-	No	Will not advance attainment date

M 	10	Electric Vehicle Tax Incentives	Establish incentives to purchase
electric vehicles.  	Yes	No	Yes	-	Yes	-	No	Not enforceable

M 	11	Low-emission Vehicle Purchase Program: Rental Cars	Accelerate
Adoption of Low-emission Vehicles.  Target rental car fleets.  	Yes	No
Yes	-	Yes	-	No	No creditable emission reduction

M 	12	Low-emission Vehicle Purchase Program: Taxicabs	Accelerate
Adoption of Low-emission Vehicles.  Target taxicab fleets.  	Yes	No	Yes
-	Yes	-	No	No creditable emission reduction

M	13	OTC Corridor Strategy	Implement truck stop electrification projects
and Heavy-Duty Engine Engine Control Module (ECM) Recalibration (chip
reflash) along the I-95 corridor.	Yes	No	Yes	-	Yes	-	No	Will not advance
attainment date

M 	14	Truck Idling Reduction: Truck Stop Electrification (TSE)	Implement
projects to electrify truck stops.	Yes	No	Yes	-	Yes	-	No	Will not
advance attainment date

M 	15	Truck Idling Reduction: Auxilliary Power Units (APU)	Increase
market penetration of APUs to reduce truck idling.	Yes	No	Yes	Yes	Yes	-
No	Will not advance attainment date

M 	16	Control Bus Emissions	Provide electrified parking spaces or APUs
for tour buses.  	Yes	No	-	-	Yes	-	No	Will not advance attainment date

M 	17	Smart Growth and Infill Development Programs	Encourage
development/redevelopment of land in designated growth areas,
encouraging local governments to place greater emphasis on land
development near transit stations.	Yes	No	Yes	-	Yes	No	No	No creditable
emission reductions

M 	18	Incentives for Mixed Use at Transit Centers	Include incentives for
mixed-use development at transit centers to reduce sprawl and VMT.	No
Yes	Yes	-	Yes	Yes	No	Will not provide reductions by May 2008

M 	19	Infill Development	Implement an infill development program
throughout the Washington region.	No	No	Yes	-	Yes	-	No	Will not provide
reductions by May 2008

M 	20	Convenience Commercial Centers in Residential Areas	Change zoning
ordinances to allow neighborhood-serving retail establishments in
residential areas.	No	Yes	Yes	-	No	-	No	Will not provide reductions by
May 2008

M 	21	Control Growth and Development	Encourage mixed-use development.
Yes	No	Yes	-	Yes	Yes	No	No creditable emission reductions

M 	22	Proximity Commute:  Job Swap	Encourage employees of the same firm
to swap jobs, permitting each to work at a location closer to home.	Yes
No	Yes	-	Yes	-	No	No creditable emission reductions

M 	23	Proximity Commute: Live Near Your Work	Provides financial
incentives to homebuyers moving to designated neighborhoods near their
workplaces.	Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	24	Telecommuting Centers and Telework Program	Telecommuting centers,
including marketing activity, consultant support, commuter and employer
information and assistance.	Yes	No	Yes	-	Yes	-	No	No creditable emission
reductions

M 	25	Telecourses at Local Colleges and Universities	Encourage local
colleges and universities to offer telecourses to reduce vehicle trips.
Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	26	Safe Routes to School Program	Implement a safe pedestrian and
bicycle routes to school program to reduce VMT.	-	No	Yes	-	Yes	No	No	No
creditable emission reduction

M 	27	Commuter Operations Center	Provides commuter assistance services,
including carpool and vanpool ridematching.	Yes	No	Yes	-	Yes	-	No	No
creditable emission reductions

M 	28	Guaranteed Ride Home	Provides free rides home in event of
unexpected emergency or unscheduled overtime to commuters using public
transport.	Yes	No	Yes	-	Yes	-	No	Will not advance attainment date

M 	29	Access to Jobs Program	Identifies gaps in transit service between
places of residence and places of work for low wage workers.	-	No	Yes	-
Yes	No	No	No creditable emission reduction

M 	30	Integrated Rideshare	Provides transit, park & ride, and telecenter
information to all commuters on a match list.	Yes	No	Yes	-	Yes	-	No	No
creditable emission reductions

M 	31	Interactive Rideshare Kiosks	Transportation Information Kiosks.
Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	32	Vanpool Programs	Create programs and incentives designed to
increase the number of vanpools in the region.	Yes	-	Yes	-	Yes	Yes	No	No
creditable emission reduction

M 	33	Free Parking for Carpools/Vanpools	Provide free reserved parking
spaces for all carpools or vanpools.	Yes	No	Yes	No	Yes	-	No	No
creditable emission reductions

M 	34	Employer Metro Shuttle Bus Services	Provide incentives for
businesses to provide employee shuttle service to the nearest rail or
transit stop.	Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	35	Improvements to Bicycle and Pedestrian Access	Provide incentives
to developments that speed improvements to bicycle/pedestrian access.
This includes improvements to sidewalks, curb ramps, crosswalks,
lighting, etc.	-	No	Yes	-	Yes	No	No	No creditable emission reduction

M 	36	Bicycle Racks	Install bicycle racks at various locations
throughout the region.	Yes	No	Yes	-	Yes	No	No	No creditable emission
reductions

M 	37	Bike Lockers at Transit Stations, Park & Ride Lots, Other
Locations	Expand existing bike lockers at Transit stations, install
bicycle storage spaces in parking lots.	Yes	No	Yes	-	Yes	No	No	No
creditable emission reduction

M 	38	Bike Racks on Transit Buses	Provide external bike racks on MARC
and other local transit buses.	Yes	No	Yes	-	Yes	No	No	No creditable
emission reduction

M 	39	Bike to Work Day	Conduct a one-day bike to work event. Provide
outreach activities, education on the bike-to-work option, and
assistance in trying bike-to-work.	Yes	No	Yes	-	Yes	No	No	No creditable
emission reduction

M 	40	Bike/Pedestrian Paths	Fund construction of additional
bicycle/pedestrian paths in the region.	No	No	Yes	-	Yes	No	No	No
creditable emission reduction

M 	41	Employers Provide Free Bicycles for Midday Use	Require employers
to provide one bicycle per 50 employees for mid-day business or personal
use.	Yes	No	Yes	-	Yes	No	No	No creditable emission reduction

M 	42	Car Sharing Program	Fund incentives for new car sharing customers
(i.e., Flexcar or Zipcar services).	Yes	No	Yes	-	Yes	No	No	No creditable
emission reduction

M 	43	Vehicle Share Programs:  Transit Stations	Develop a transit
station car/low emission vehicle share program.	Yes	No	Yes	-	Yes	No	No
No creditable emission reduction

M 	44	Vehicle Share Programs:  Neighborhoods	Implement a neighborhood
electric vehicle share program.	Yes	No	Yes	-	Yes	No	No	No creditable
emission reduction

M 	45	Clean Commute/Try Transit Week	Promotes use of alternative
transportation, including transit, by daily commuters for one week per
year.	Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	46	Student & staff based college & university rideshare programs
Create rideshare program focused on students and staff at regional
universities.	Yes	No	Yes	-	Yes	No	No	No creditable emission reduction

M 	47	Establish Restricted Zones in Downtown Areas and Transit Centers
Restrict private vehicle use in certain areas during business hours,
encouraging pedestrian, bicycle, and transit use.	No	Yes	Yes	-	No	Yes	No
Will not provide reductions by May 2008

M 	48	4 Day Work Week/Flexible Work Schedules	Encourage employers to
adopt a shorter work week, with employees working 4 10-hour days.	Yes	No
Yes	-	Yes	-	No	No creditable emission reductions

M 	50	Expand MARC Train Service	Expand MARC train service to include
additional departures.	No	No	-	-	Yes	-	No	Will not provide reductions by
May 2008

M 	51	Support Rail to BWI Airport	Provide funding to expand rail
services to BWI airport.	No	No	Yes	-	Yes	-	No	Will not provide
reductions by May 2008

M 	52	Increase Commuter Rail Frequency	Increase frequency of MARC
service to every 15 minutes.	No	No	-	-	Yes	-	No	Will not provide
reductions by May 2008

M 	53	Provide Additional Transit Service to Core	Increase funding for
transit services to expand core service.	No	No	-	-	Yes	-	No	Will not
provide reductions by May 2008

M 	54	Provide Additional Transit Service Access	Increase funding for
enhancing access to transit services.	Yes	No	Yes	-	Yes	No	No	No
creditable emission reductions

M 	56	Express Buses From Outyling Areas	Implement direct bus service
from outlying Park & Ride lots and far suburbs to major work centers.
Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	57	Express Reverse Commuter Buses	Implement reverse commute express
buses from Baltimore to major outlying work centers.	Yes	No	Yes	-	Yes	-
No	No creditable emission reductions

M 	60	Shorter Distance from Buildings to Bus Stops	For existing
buildings, re-route traffic to allow buses to come closer to the
building. For new buildings, alter setback requirements to allow closer
bus access.	No	No	-	-	Yes	-	No	No creditable emission reductions

M 	61	New MARC Coaches	Purchase additional coaches for MARC to
accommodate increased ridership.	No	No	Yes	-	Yes	-	No	Will not provide
reductions by May 2008

M 	62	Additional Transit Stores	Establish additional stationary transit
stores in the region.	Yes	No	Yes	-	Yes	No	No	No creditable emission
reductions

M 	64	Traffic Signal Optimization	Regularly optimize traffic signals to
reduce idling and low-speed emissions.	Yes	Yes	Yes	-	Yes	-	No	No
creditable emission reductions

M 	65	Transit Prioritization -- Queue Jumps	Provide queue jumps for
buses at over-capacity signalized intersections throughout the region.
Queue jumps allow buses to use a shoulder or other designated lane to
bypass intersection queues and move forward towards the stop line.	Yes
No	Yes	-	Yes	No	No	No creditable emission reductions

M 	66	Manage Roadway Usage: Traffic Incident Management	Regional Travel
Information System/Driver Assistance.  Enhance real time traffic
information to allow drivers to make better decisions about when and
where to travel.  	-	No	-	-	Yes	-	No	No creditable emission reductions

M 	67	Replace Traffic Signals with Lesser Controls	Install roundabouts
in place of signals at low volume intersections.	No	Yes	Yes	-	Yes	-	No
Will not provide reductions by May 2008

M 	68	Signals to Flashing Yellow 12am-5am	From midnight until 5am, set
intersection signals to flashing yellow in predominant direction and
flashing red in minor direction for all low volume intersections where
safety permits.	Yes	Yes	Yes	-	Yes	-	No	No creditable emission reductions

M 	69	Extend Ramp Metering	Install signals to control flow of vehicles
at selected freeway ramp entrances to maintain level of service.	Yes	Yes
Yes	-	-	No	No	No creditable emission reductions

M 	71	Manage Roadway Usage:  Dedicated Bus Lanes	Dedicate roadway lanes
for use by buses.	No	Yes	Yes	-	No	-	No	Potential adverse impacts

M 	72	Value Pricing (HOT lanes)	Implement value pricing strategies on
busy freeways during rush hour.	No	Yes	Yes	-	-	-	No	Will not provide
reductions by May 2008

M 	73	Green Curb Initiative	Restricted Access/ “Green Curb”.
Differential fees and access permits applied during periods of high
congestion.  Target delivery/loading zones and carpool/vanpool pickup
areas.	No	Yes	Yes	-	-	No	No	Will not provide reductions by May 2008

M 	74	Congestion Pricing on Low Occupancy Vehicles	Impose a fee on
vehicles containing two or fewer persons that use designated roadways,
tunnels, and bridges during the peak AM periods.	No	Yes	Yes	-	-	-	No
Will not provide reductions by May 2008

M 	75	Establish Clean Air Fund	Sell Clean Air License Plates to fund air
quality programs (similar to “Save the Bay” tags).	No	Yes	Yes	Yes
Yes	-	No	Will not provide reductions by May 2008

M 	76	Electronic Tolling	Expand interoperability of electronic tolling
systems.	Yes	Yes	Yes	-	Yes	-	No	No creditable emission reductions

M 	77	Annual Gasoline Vehicle Pollution Fee	Levy an annual fee on
petroleum-powered vehicles based on mileage driven and emission rates
(odometer tax).	No	Yes	-	-	-	-	No	Will not provide reductions by May
2008

M 	78	VMT-Based Car Tax	Charge VMT fee for all vehicles registered or
garaged in the region.	No	Yes	-	-	-	-	No	Will not provide reductions by
May 2008

M 	79	Graduated Car Tax: Additional Vehicles	Charge higher car tax on
each additional vehicle registered by a household.	No	Yes	Yes	-	-	-	No
Will not provide reductions by May 2008

M 	80	Graduated Car Tax: Miles Per Gallon	Charge graduated car taxes
based on a vehicle's EPA miles per gallon rating.	No	-	-	-	-	-	No	Will
not provide reductions by May 2008

M 	81	Graduated Car Tax: Petroleum-Based Vehicles only	Implement
region-wide car tax for petroleum-fueled vehicles.	No	Yes	Yes	-	-	-	No
Will not provide reductions by May 2008

M 	82	Graduated Vehicle Registration Fee Based on Number of Vehicles
Assess graduated vehicle registration fee/car tax on every privately
owned vehicle in the region. Households with multiple vehicles pay
higher tax on each additional vehicle.	No	Yes	-	-	-	-	No	Will not
provide reductions by May 2008

M 	83	Pay-as-you-drive auto insurance ($/gal)	Offer auto insurance rates
linked to number of gallons of fuel consumed by vehicle.	No	Yes	-	-	-	-
No	Will not provide reductions by May 2008

M 	84	Mobile Source Mitigation Fees:  Vehicle Garage	Collect a fee from
each homeowner with a vehicle garage.	No	Yes	-	-	-	-	No	Will not provide
reductions by May 2008

M 	85	Mobile Source Mitigation Fees:  Ozone Season VMT Surcharge	Require
a surcharge to be paid by drivers during the summer season based on the
number of driving miles.	No	Yes	-	-	-	-	No	Will not provide reductions
by May 2008

M 	86	Area Pricing:  Entry Fees	Collect fees from drivers to enter a
pre-defined area.	No	Yes	Yes	-	-	-	No	Will not provide reductions by May
2008

M 	87	Gas Tax Increase	Implement a fuel tax on on-road gasoline.	No	Yes
Yes	-	No	-	No	Will not provide reductions by May 2008

M 	88	Diesel Tax Increase	Implement a fuel tax on on-road diesel.	No	Yes
Yes	-	No	-	No	Will not provide reductions by May 2008

M 	89	Commuter Parking Tax:  Employees	Implement daily tax on employees
using commuter parking spaces.	No	No	Yes	No	No	-	No	Will not provide
reductions by May 2008

M 	90	Commuter Parking Tax: Employers with No Discounted Commuter
Parking Spaces	Implement daily tax on employers providing free or
discounted commuter parking spaces.	No	No	Yes	No	No	-	No	Will not
provide reductions by May 2008

M 	91	Commuter Parking Tax: Employers with No Transit Benefits	Implement
daily tax on employers who do not provide transit benefits to employees.
No	Yes	Yes	No	No	-	No	Potential adverse impacts

M 	93	Parking Impact Fee:  All Parking	Levy annual impact fee on every
parking space in nonattainment area.	No	No	Yes	-	No	-	No	Will not
provide reductions by May 2008

M 	94	Parking Impact Fee:  Commuter Parking	Levy an annual fee on every
commuter parking space in the Washington nonattainment area.	No	No	Yes
No	No	-	No	Will not provide reductions by May 2008

M 	95	Tax Parking Spaces Above Code Minimum	Discourage developers from
providing parking in excess of code minimum by imposing a graduated tax
on excess spaces.	No	No	Yes	No	No	-	No	Will not provide reductions by
May 2008

M 	96	Episodic Parking Fee Increases	Increase fees for parking garages
and meter during episodes.	No	No	Yes	No	No	-	No	Will not provide
reductions by May 2008

M 	98	Commuter Choice - State & Local Government Employees	Provide the
region's local, state and municipal employees with transit benefits.	Yes
No	Yes	-	Yes	-	No	No creditable emission reductions

M 	101	Flat Fare For All Transit Trips	Single price all public transit
services with free transfers all day, 7 days per week.	-	No	-	-	Yes	-	No
Will not provide reductions by May 2008

M 	102	Subsidize Transit Usage	Expand Commuter Choice Maryland to all
public sector employees	Yes	No	Yes	-	Yes	-	No	Will not advance
attainment date

M 	103	Free Bus Service Off-Peak	Institute free off-peak bus service
from 10-2 on weekdays and all day on weekends.	-	No	Yes	-	Yes	-	No	Will
not provide reductions by May 2008

M 	106	Employer Parking Cash-Out: Voluntary	Implement voluntary program
encouraging employers to provide the value of subsidized parking to
employees who use alternative commute strategies.	Yes	No	Yes	-	No	-	No
No creditable emission reductions

M 	107	Free Transit Passes to Students	Free transit passes for high
school and college students, subsidized by schools or through student
registration fee.	-	No	Yes	-	Yes	-	No	Will not provide reductions by May
2008

M 	108	Half Price Fares on Feeder Bus Service	All bus services to
transit stations reduce fares by half.	-	No	Yes	-	Yes	-	No	Will not
provide reductions by May 2008

M 	109	MTA College Pass Program	Expand Baltimore college bus fare
program.  Program allows students to receive reduced fares near 19
participating schools in the region.	Yes	No	Yes	-	Yes	-	No	Will not
advance attainment date

M 	110	Discount Multi-Trip Bus Fares	Introduce discount programs
reducing cost of multiple bus rides through purchase of pass books (e.g.
10-trip tickets).	Yes	No	Yes	-	Yes	-	No	Will not advance attainment date

M 	111	Vanpool Insurance	Establish a special risk pool to underwrite the
cost of vanpool insurance.	Yes	No	Yes	-	Yes	-	No	No creditable emission
reduction

M 	112	Commuter Choice Tax Credit	Employers subsidize employees' monthly
transit or vanpool costs and receive a tax credit for incurred expenses.
Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	113	Rebate for Purchase of Hybrid Vehicles	Issue rebate for purchase
and registration of hybrid vehicles.	Yes	No	Yes	-	Yes	-	No	No creditable
emission reduction

M 	114	Real-Time Bus Schedule Information	Expand trials of real-time bus
schedule information to local transit providers.	Yes	No	Yes	-	Yes	No	No
No creditable emission reductions

M 	115	Automatic Bus Locator System	System would provide bus location
information to transit dispatchers. This would decrease wait time and
improve on-time arrival/departure.	Yes	No	Yes	-	Yes	-	No	No creditable
emission reductions

M 	118	Expand Remote Sensing Program	Expand the Adoption of a Remote
Sensing Program to Maryland.	No	Yes	Yes	-	Yes	-	No	Will not provide
reductions by May 2008

M 	119	Control Heavy Duty Diesel Engines	Heavy-duty engine Engine
Control Module (ECM) recalibration (chip reflash).	Yes	No	Yes	-	Yes	-	No
No creditable emission reduction

M 	120	Zero I/M waivers and exemptions	Eliminate all waivers and
exemptions in the I/M program.	No	Yes	Yes	-	-	-	No	Will not provide
reductions by May 2008

M 	121	Motorcycle I/M Program	End the motorcycle smog check exemption.
No	Yes	Yes	-	Yes	-	No	Will not provide reductions by May 2008

M 	122	Diesel I/M Program	Perform community-based inspections of trucks
and buses.	Yes	No	Yes	No	Yes	-	No	No creditable emission reduction

M 	123	Expand I/M Requirements to Upwind Counties	Expand Inspection and
Maintenance Requirements.	No	Yes	Yes	-	Yes	Yes	No	Will not provide
reductions by May 2008

M 	124	Mandatory Diesel Retrofit Program:  Public Fleets	Require
retrofit of on-road diesel vehicles in public fleets.	No	Yes	Yes	-	Yes
Yes	No	Will not provide reductions by May 2008

M 	125	Mandatory Diesel Retrofit Program:  Private Fleets	Require
retrofit of on-road diesel vehicles in private fleets.	No	Yes	Yes	-	Yes
Yes	No	Will not provide reductions by May 2008

M 	126	On-road Heavy-Duty Diesel Smoke Testing and I/M Program	Implement
a smoke testing and/or Inspection/Maintenance Program for on-road
heavy-duty diesel engines.	No	Yes	Yes	-	Yes	No	No	Will not provide
reductions by May 2008

M 	128	Biodiesel Fuel	Expand use of biodiesel fuel for on-road vehicles.
Yes	No	Yes	-	Yes	-	No	No creditable emission reduction

M 	129	High Cetane Fuel	Require high-Cetane diesel fuel for on-road
vehicles.	No	Yes	Yes	No	Yes	-	No	Will not provide reductions by May 2008

M 	130	Low-NOx Diesel Fuel	Require regional use of low-NOx fuel
additives for on-road diesel vehicles	No	No	-	No	Yes	-	No	Will not
provide reductions by May 2008

M 	131	Low-NOx On-Road Diesel Fuel in Ozone Season	Require use of
low-NOx additive in on-road diesel fuel during ozone season.	No	No	-	No
Yes	-	No	Will not provide reductions by May 2008

M 	132	Low-NOx On-Road Diesel Fuel in Ozone Season	Require use of
low-NOx additive by state or local diesel vehicles during ozone season.
No	No	-	No	Yes	-	No	Will not provide reductions by May 2008

M 	133	Fuel Additives to Reduce Emissions	Use emulsified diesel fuel in
diesel-burning heavy duty vehicles.	Yes	No	-	No	Yes	-	No	Not enforceable

M 	134	CARB Diesel Fuel	Implement CARB diesel fuel standards.	No	Yes	Yes
No	Yes	-	No	Will not provide reductions by May 2008

M 	135	Enhanced Enforcement: Bus and Truck Idling	Step-up enforcement of
existing regulations to prevent extended bus and truck idling.	Yes	No
Yes	-	Yes	No	No	No creditable emission reduction

M 	136	Enhanced Enforcement: On-road Idling	Increase enforcement of
regional idling restrictions for on-road vehicles.	Yes	No	Yes	-	Yes	No
No	No creditable emission reduction

M 	137	Enhanced Enforcement of Mobile Source Regulations	Increase
smoking vehicle enforcement.	Yes	No	Yes	-	Yes	No	No	No creditable
emission reduction

M 	138	Enhanced Enforcement:  Speed Limits	Increase speed limit
enforcement so that more vehicles are traveling at or below the posted
limit.	Yes	No	Yes	-	Yes	No	No	No creditable emission reduction

M 	139	Control Vehicle Idling	No Idling Rule – Restriction.  Limits
idling to 5 minutes for all non-commercial, consumer operated vehicles
within the Washington NAA.  Establish exemptions where required.	No	Yes
Yes	-	Yes	No	No	Will not provide reductions by May 2008

M 	140	Permit Right Turn on Red	Reduce vehicle idling time by permitting
right turn on red, where safety allows.	Yes	Yes	Yes	-	Yes	No	No	No
creditable emission reductions

M 	141	Control Vehicle Speeds:  Automated Enforcement	Automate speed
enforcement and lower the speed limit to 55 mph for heavy duty vehicles.
No	Yes	Yes	-	Yes	-	No	Will not provide reductions by May 2008

M 	142	Control Vehicle Speeds:  Lower Limits	Speed Limit Restriction:
Regional speed limit of 55 mph on all roads which previously had posted
speeds of greater than 55 mph.	No	Yes	Yes	-	Yes	Yes	No	Will not provide
reductions by May 2008

M 	143	Clean Air Partners: Air Quality Action Days	Take a variety of
actions on Air Quality Action Days to reduce emissions and improve air
quality (free transit, telework, carpool).	Yes	No	Yes	-	Yes	-	No	No
creditable emission reductions

M 	144	Government Actions (air quality action day similar to snow day)
Implement a liberal leave policy for local, state and federal employees
on Air Quality Action Days, permitting employees to work from home or
take unscheduled leave.	Yes	No	Yes	-	Yes	-	No	No creditable emission
reductions

M 	145	Clean Air Partners: Public Outreach and Education	Implement
Strategic Communication Campaigns to Increase Public Awareness (reduce
vehicle use).	Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	146	Local Government Education Campaign	Implement Strategic
Communication Campaigns to Increase Local Government Air Quality
Improvement Efforts (reduce vehicle use).	Yes	No	Yes	-	Yes	-	No	No
creditable emission reductions

M 	147	Mass Marketing Campaign	Marketing effort involving
business-to-business advertising campaign in print media and on world
wide web. 	Yes	No	Yes	-	Yes	-	No	No creditable emission reductions

M 	148	"Cash for Clunkers" On-Road Vehicles	Fund voluntary program
paying car owners to turn in old vehicles for scrappage.  Target
pre-1980 vehicles with minimal/no emissions control.	Yes	No	Yes	No	Yes	-
No	Not economically feasible

M 	149	"Cash for Clunkers" Early Bus Engine Replacement	Replaces
high-polluting diesel engines in MTA buses with new diesel engines.	Yes
No	Yes	No	Yes	-	No	Not economically feasible

M 	150	"Cash for Clunkers" Taxicab Replacement - Conventional Vehicles
Replace taxicabs with new "conventional" LDGVs.	Yes	No	Yes	No	Yes	-	No
Not economically feasible

M 	151	"Cash for Clunkers"  Gas Caps Program	Provide free replacement
gas caps to light- and medium-duty vehicle owners.	Yes	No	Yes	-	Yes	-	No
No creditable emission reduction

M 	152	Control Delivery Truck Emissions	Establish voluntary emission
reduction program with delivery fleets.	Yes	No	Yes	-	Yes	-	No	No
creditable emission reduction

M 	153	Rush Hour Shift	Shift transit rush hours to start 30 min earlier
and end 30 min later.	Yes	No	-	-	Yes	-	No	No creditable emission
reduction

M 	154	Mandatory Employee Commute Reduction	Mandatory employer trip
reduction to reduce employee vehicle trips.	No	No	Yes	No	No	-	No
Potential adverse impacts

M 	155	Manage Roadway Usage:  No Drive Days	Odd/Even License Plate no
Drive Days.  Prohibit drivers from traveling during certain periods,
based on vehicle tags or other easily identifiable criteria. Can be a
permanent or episodic control.	No	Yes	-	-	No	Yes	No	Will not provide
reductions by May 2008

M 	156	Transportation Funding Initiatives	Require that Congestion
Mitigation Air Quality (CMAQ) funds be used only for projects that
improve air quality.	No	No	Yes	No	Yes	-	No	Will not provide reductions
by May 2008

M 	157	Restrict Parking at Schools	Restrict high school students from
driving to and parking at high schools when bus service is available.
Yes	No	Yes	No	No	No	No	No creditable emission reduction

M 	158	Restrict Construction of New Parking 	Restrict construction of
new parking at employment centers based on distance from transit and
urban core.	No	Yes	Yes	-	No	-	No	No creditable emission reduction

M 	159	Employer Parking Cash-Out: Mandatory	Implement program requiring
employers to provide the value of subsidized parking to employees who
use alternative commute strategies.	No	Yes	Yes	-	No	-	No	No creditable
emission reductions

M 	160	Remove Trash Trucks From Area Streets	Reduce use of trash trucks
through transport of trash by barge.	-	No	-	-	Yes	-	No	No creditable
emission reductions

M 	161	Increase Intermodal Transport	Increase use of intermodal options
for transporting goods.	Yes	No	Yes	Yes	Yes	-	No	No creditable emission
reduction

M 	162	Fleet ILEV for light-duty gasoline vehicles	Require fleets
operating in nonattainment area to be comprised of a percentage of
Inherently Low Emission Vehicles (ILEV).	No	Yes	Yes	No	No	-	No	Will not
provide reductions by May 2008

M 	163	Control Vehicle Technology	Install systems on gasoline vehicles
to reduce emissions (e.g., Bose high-speed centrifugal separation
system).	No	-	-	-	Yes	-	No	Will not provide reductions by May 2008

M 	164	Control VOC Content of Automotive Products	Windshield Wiper Fluid
– lower VOC.  Establish evaporative standards that are lower than
those set by the EPA – 35 weight-percent VOC.	No	-	-	-	Yes	-	No	Will
not provide reductions by May 2008

M 	165	Gasoline Engine Retrofit Program	Retrofit with 3-way catalysts on
gasoline-burning heavy duty trucks that currently have 2-way catalysts
or no catalysts.	Yes	No	-	-	Yes	No	No	No creditable emission reduction

M 	166	Improve Truck Fleet Fuel Economy	Encourage adoption of
technologies that increase truck fleet fuel economy.	Yes	No	-	Yes	Yes	-
No	No creditable emission reduction


[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71958-71961]
[FR Doc No: 2019-28098]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0804]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with medical device premarket notification (510(k)).

DATES: Submit either electronic or written comments on the collection
of information by February 28, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0804 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Notification.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Premarket Notification--21 CFR Part 807, Subpart E OMB Control Number
0910-0120--Extension
    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) require a person who intends to market a
medical device to submit a 510(k) submission to FDA at least 90 days
before proposing to begin the introduction, or delivery for
introduction into interstate commerce, for commercial distribution of a
device intended for human use. Based on the information provided in the

notification, FDA must determine whether the new device is
substantially equivalent to a legally marketed device, as defined in
Sec.  807.92(a)(3) (21 CFR 807.92(a)(3)). If the device is determined
to be not substantially equivalent to a legally marketed device, it
must have an approved premarket approval application (PMA), product
development protocol, humanitarian device exemption (HDE), request for
an evaluation of automatic class III designation (De Novo request), or
be reclassified into class I or class II before being marketed (see OMB
control numbers 0910-0231, 0910-0332, 0910-0844, and 0910-0138). FDA
makes the final decision of whether a device is substantially
equivalent or not substantially equivalent.
    Section 807.81 states when a 510(k) is required. A 510(k) is
required to be submitted by a person who is: (1) Introducing a device
to the market for the first time; (2) introducing a device into
commercial distribution for the first time by a person who is required
to register; or (3) introducing or reintroducing a device that is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device. Section 807.87 lists the information
required in each 510(k).
    Form FDA 3514, a summary cover sheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, De Novo requests, HDEs, etc.
    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act
(21 U.S.C. 360d). Amended section 514 of the FD&C Act allows FDA to
recognize consensus standards developed by international and national
organizations for use in satisfying portions of device premarket review
submissions including 510(k) or other requirements. FDA has published
and updated regularly the list of recognized standards since enactment
of FDAMA and has allowed 510(k) submitters to certify conformance to
recognized standards to meet the requirements of Sec.  807.87.
    Under Sec.  807.90(a)(3), inquiries regarding a 510(k) submission
should be in writing and sent to one of the addresses in Sec.
807.90(a).
    Under Sec.  807.87(h), each 510(k) submitter must include in the
510(k) either a summary of the information in the 510(k) as required by
Sec.  807.92 (510(k) summary) or a statement certifying that the
submitter will make available upon request the information in the
510(k) with certain exceptions as per Sec.  807.93 (510(k) statement).
    Section 745A(b) of the FD&C Act, amended by section 207 of the FDA
Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), requires that
submissions for devices under section 510(k), among other submission
types, be submitted in electronic format specified by FDA. In addition,
in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment
Letter from the Secretary of Health and Human Services to Congress,\1\
FDA committed to developing ``electronic submission templates that will
serve as guided submission preparation tools for industry to improve
submission consistency and enhance efficiency in the review process.''
The Electronic Submission Template and Resource (eSTAR) is such an
electronic submission template for 510(k) submissions to facilitate the
preparation of submissions in electronic format.
---------------------------------------------------------------------------

    \1\ See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017)
(Food and Drug Administration User Fee Reauthorization), also
available at https://www.fda.gov/media/102699/download.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
     Activity and 21 CFR part/section         Form number      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses                 \2\                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart E).........        FDA 3881           3,800               1           3,800  79.25.......................         301,150
Summary cover sheet (807.87)..............        FDA 3514           1,906               1           1,906  0.5.........................             953
Status request (807.90(a)(3)).............  ..............               1               1               1  0.25........................               1
510(k) summary (807.92)...................  ..............           2,725               1           2,725  4...........................          10,900
510(k) statement (807.93).................  ..............             215               1             215  10..........................           2,150
510(k) submission (807 subpart E)--via            FDA 4062             100               1             100  40..........................           4,000
 eSTAR.
                                                           ---------------------------------------------------------------------------------------------
eSTAR setup--(one-time burden)............  ..............              80               1              80  0.08 (5 minutes)............               6
                                                                                ---------------
    Total.................................  ..............  ..............  ..............  ..............  ............................         319,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Upon review of this information collection, we have made the
following changes:
     We have updated the burden estimate consistent with new
provisions in Sec.  807.87(j) regarding ``Human Subject Protection;
Acceptance of Data from Clinical Investigations for Medical Devices''
(83 FR 7366; February 21, 2018) (approved under OMB control number
0910-0741). Section 807.87 was amended to address requirements for
510(k) submissions supported by clinical data. For clinical
investigations conducted in the United States, submitters are required
to submit a statement as described in Sec.  807.87(j)(1). For clinical
investigations conducted outside the United States, submitters are
required to submit the information as described in Sec.  807.87(j)(2).
Consistent with our estimate in OMB control number 0910-0741, this
revision increases our burden estimate for a

510(k) submission by 15 minutes per submission.
     We corrected the burden table to include a line for the
``510(k) Summary'' under Sec.  807.92. This section was inadvertently
removed from the previous version of the information collection request
(ICR).
     We are making available Form FDA 3881 ``Indications for
Use'' that respondents include as part of a medical device 510(k). The
information provided via the form is already approved under this ICR.
The form does not ask for new information and does not bear on the
underlying program or on the hour or cost burden associated with the
information collection, rather it provides a fillable, 508-compliant
format for respondents to use for the ``Indications for Use'' portion
of their 510(k) submission.
     We updated the guidance ``Refuse to Accept Policy for
510(k)s'' to explicitly recommend providing an Acceptance Checklist in
the 510(k) submission. The guidance previously provided the checklist
as an example of a tool that FDA staff use when reviewing a 510(k)
submission. While it was not explicitly recommended, respondents had
used the example and had included it with their 510(k) submission. We
believe the checklist can be a helpful tool for both reviewers and
510(k) submitters and have therefore updated the guidance to explicitly
recommend inclusion of the checklist in the 510(k) submission. Because
most submitters included the checklist on their own initiative and
because it may simplify preparation of the 510(k), we do not believe
adding the checklist to this ICR affects the overall burden for a
510(k) submission. Additionally, we have updated the checklist to
include combination products, as appropriate. The estimated number of
responses as updated with current data in this submission, reflects the
inclusion of combination products.
     We revised and reformatted Form FDA 3514, ``CDRH Premarket
Review Submission Cover Sheet,'' to improve usability and to be
inclusive of most medical device product submission types. Form FDA
3514, a summary cover sheet form, assists respondents in categorizing
510(k) information for submission to FDA. This form also assists
respondents in categorizing information for other FDA medical device
programs. The total burden for Form FDA 3514 and for the 510(k) program
is estimated in this ICR. The burden for the other medical device
programs listed on Form FDA 3514 are approved under the corresponding
product submission ICRs as follows: premarket approval applications
(OMB control number 0910-0231), investigational device exemptions (OMB
control number 0910-0078), humanitarian device exemptions (control
number 0910-0332), CLIA waivers (OMB control number 0910-0598), Q-
Submissions (OMB control number 0910-0756), De Novo requests (OMB
control number 0910-0844), Emergency Use Authorizations (OMB control
number 0910-0595), 513(g) requests (OMB control number 0910-0705); and
Appeals (OMB control number 0910-0738).
     Certain revisions to Form FDA 3514, as previously
described, eliminate the need for Form FDA 3654, ``Standards Data
Report for 510(k)s.'' Additionally, the ability for Form FDA 3514 to be
expandable for the number of standards cited will increase awareness of
actual standards in a submission and how they were used on a single
form (compared to including several Form FDA 3654 documents). In the
rare occasions where the sponsor elects to not use Form FDA 3514 for
standards, this would not have any effect on the review outcome, with
regard to standards, as the form serves as a means to identify what
standards are cited, how they are used, and where in the submission
they are located.
     We have removed Form FDA 3541, ``Status Request.'' In
practice, Form FDA 3541 is rarely used. We have adjusted the burden
estimate to reflect this removal. Under Sec.  807.90(a)(3), all
inquiries regarding a premarket notification submission should be in
writing and sent to one of the addresses listed in Sec.  807.90(a).
     We have added burden estimates for the eSTAR and eSTAR
setup (one-time burden). Under section 745A(b) of FD&C Act, amended by
section 207 of FDARA (Pub. L. 115-52), and consistent with the MDUFA IV
Commitment Letter, FDA has developed the eSTAR (eSTAR, Form FDA 4062)
for 510(k) submissions to facilitate the preparation of submissions in
electronic format. We expect to receive approximately 100 510(k)
submissions via eSTAR per year. We estimate that eSTAR submissions will
take approximately 40 hours per submission. Additionally, we've
estimated a one-time setup burden of 5 minutes for approximately 80 new
eSTAR users annually.
    The adjustments and revisions previously mentioned have resulted in
a 39,473-hour decrease in the total hour burden estimate since the last
OMB approval.

    Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28098 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Rules and Regulations]
[Pages 42263-42264]
[FR Doc No: 2016-15051]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0636; FRL-9948-24-Region 9]

Designation of Areas for Air Quality Planning Purposes;
California; San Joaquin Valley; Reclassification as Serious
Nonattainment for the 2006 PM2.5 NAAQS; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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

SUMMARY: This document corrects a paragraph designation error that
occurred in a January 20, 2016, final rule pertaining to the
Environmental Protection Agency's (EPA's) reclassification of the San
Joaquin Valley in California from Moderate to Serious for the 2006
PM2.5 National Ambient Air Quality Standards (NAAQS). The
paragraph designation in that rulemaking conflicts with a paragraph
designation in a different final rule. The EPA, therefore, is
correcting the erroneous paragraph designation.

DATES: This correcting amendment is effective on June 29, 2016.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, Air Planning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA published a final rule document on
January 20, 2016 (81 FR 2993) to reclassify the San Joaquin Valley
Moderate nonattainment area, including areas of Indian country within
it, as a Serious nonattainment area for the 2006 PM2.5
NAAQS. In the January 20, 2016 document, the EPA included amendatory
instructions that added paragraph (e) to 40 CFR 52.247. 81 FR 2993, at
3000 (column 2). However, in a separate final rule published on January
13, 2016 (81 FR 1514), the EPA also included amendatory instructions
that added paragraph (e) to 40 CFR 52.247. 81 FR 1514, at 1520 (column
2). As such, the amendments to 40 CFR 52.247 in the two final rules are
in conflict and cannot be implemented together. The January 20, 2016
final rule should have included amendatory instructions adding
paragraph (f), rather than (e). This document corrects that error.
    The EPA has determined that this action falls under the ``good
cause'' exemption in section 553(b)(B) of the Administrative Procedure
Act (APA) which, upon finding ``good cause,'' authorizes agencies to
dispense with public participation where public notice and comment
procedures are impracticable, unnecessary or contrary to the public
interest. Public notice and comment for this action are unnecessary
because the underlying rule for which this correcting amendment has
been prepared was already subject to a 30-day comment period and
because the error addressed herein does not change the regulatory
language in the rule. It only changes the paragraph designation for the
relevant regulatory language. Thus, no purpose would be served by
additional public notice and comment, and additional public notice and
comment is unnecessary.
    The EPA also finds that there is good cause under APA section
553(d)(3) for the correction in the amendatory instructions and related
paragraph designation to become effective on the date of publication.
Section 553(d)(3) of the APA allows an effective date less than 30 days
after publication ``as otherwise provided by the agency for good cause
found and published with the rule.'' 5 U.S.C. 553(d)(3). The EPA finds
that resolving the conflict in the amendatory instructions in the two
relevant final rules does not create any new regulatory requirements
such that affected parties would need time to prepare before the rule
takes effect. Rather, this rule eliminates the confusion caused by
designating two paragraphs in 40 CFR 52.247 as paragraph (e). For these
reasons, the EPA finds good cause under APA section 553(d)(3) for the
correction in the amendatory instructions associated with the January
20, 2016 final rule to become effective on the date of publication of
this final rule.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). Because the
agency has made a ``good cause'' finding that this action is not
subject to notice-and-comment requirements under the Administrative
Procedure Act or any other statute as indicated in the SUPPLEMENTARY
INFORMATION section, above, it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) or to sections 202 and 205 of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L.

104-4). In addition, this action does not significantly or uniquely
affect small governments or impose a significant intergovernmental
mandate, as described in sections 203 and 204 of UMRA. This rule also
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, as specified by Executive Order
13175 (65 FR 67249, November 9, 2000), nor will it have substantial
direct effects on the states, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government, as specified
by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also
is not subject to Executive Order 13045, ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant. In addition, this
rule does not involve technical standards, thus the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule also does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 808 allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and public procedure is impracticable,
unnecessary or contrary to the public interest. This determination must
be supported by a brief statement. 5 U.S.C. 808(2). As stated
previously, the EPA has made such a good cause finding, including the
reasons therefore, and established an effective date of June 29, 2016.
The EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. A major rule cannot take effect until
60 days after it is published in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 804(2).

Correction

    In final rule FR Doc. 2016-00739, published in the Federal Register
on January 20, 2016 (81 FR 2993), make the following correction:
    On page 3000, in the second column, remove amendatory instruction
3.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter.

    Dated: June 14, 2016.
 Alexis Strauss,
Acting Regional Administrator, Region IX.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

0
2. Section 52.247 is amended by adding paragraph (f) to read as
follows:

Sec.  52.247  Control Strategy and regulations: Fine Particle Matter.

* * * * *
    (f) By August 21, 2017, California must adopt and submit a Serious
Area plan to provide for attainment of the 2006 PM2.5 NAAQS
in the San Joaquin Valley PM2.5 nonattainment area. The
Serious Area plan must include emissions inventories, an attainment
demonstration, best available control measures, a reasonable further
progress plan, quantitative milestones, contingency measures, and such
other measures as may be necessary or appropriate to provide for
attainment of the 2006 PM2.5 NAAQS by the applicable
attainment date, in accordance with the requirements of subparts 1 and
4 of part D, title I of the Clean Air Act.

[FR Doc. 2016-15051 Filed 6-28-16; 8:45 am]
 BILLING CODE 6560-50-P