United States

ENVIRONMENTAL PROTECTION AGENCY

Washington, DC 20460

AGENCY USE ONLY

OMB Control No.: 2060-0226

Expires: 4/30/00

SNAP INFORMATION NOTICE

For Significant New Alternatives

Date of Receipt:

Date 90 Day Review Begins:

Date Review Completed:

CBI Status:

When completed send this form to:

MELISSA FIFFER

SNAP DOCUMENT CONTROL OFFICER

OFFICE OF AIR AND RADIATION, 6205 J

U.S. EPA

1200 PENNSYLVANIA AVE, NW

WASHINGTON, DC 20460

Enter the total number of pages in your SNAP information Notice:      24

Document Control Number

INTRODUCTION

GENERAL INSTRUCTIONS

This form may be used to submit information under the Significant New Alternatives Policy (SNAP) program for the review of alternatives to class I and class II ozone-depleting substances (ODS) under section 612 of the Clean Air Act.  Submitters are required to provide this information on new substitutes to assist the Agency in assessing the acceptability of chemicals or processes that are considered alternatives for ODSs.  A separate notice must be filed for each alternative you are submitting.

All submissions must be provided in three complete copies.  If information is to be claimed as confidential, all confidential information must be excised from one of the copies, which will be placed in the public docket; the other two copies must include the confidential material.  If no claims of confidentiality are made for the submission, all copies must be identical.

The attached “Guidance Manual for the SNAP Information Notice” is designed to assist applicants in completing this form.  The manual provides instructions on submitting a SNAP notice, asserting confidentiality claims, completing the notice form, sector-specific data requirements, and submitting test data and supplemental information.

To facilitate Agency review of alternatives, this form must be filled out as completely as possible.  Please provide all information requested to the extent that it is known or reasonably ascertainable.  Make reasonable estimates if actual data is unavailable.

TYPE OF NOTICE (Check only one box)

Select the appropriate box identifying the type of notice submitted:

Manufacturer Submission:  New alternative, Substance, or Formulation___________________________________________

Petition: New alternative, Substance, or Formulation__________________________________________________________

Petition: Revision of the Existing SNAP list_________________________________________________________________

Petition: Request to Grandfather Use of An Unacceptable Substitute_____________________________________________

Part 1 - GENERAL INFORMATION

You must provide the identity of the alternative chemical of processes and the identity and percentages of all components in a blend and/or process, even if you claim the identity as confidential.  You may authorize another person to submit the identity for you, but your submission will not be complete and review cannot begin until EPA receives this information.

Part II - ALTERNATIVE-SPECIFIC INFORMATION

Please indicate the sector(s) for which you are submitting information on the substitute by checking the appropriate boxes:



Foam Blowing    			     	

Solvent Cleaning 	     	  	     	

Fire Extinguishing

and Explosion Prevention 		    	

Sterilization       	 		     	

Aerosols 				     	

Adhesives, Coatings, and Inks 	      	

Tobacco Expansion

Pesticides	 		                

You may need additional copies of Part II if there are several manufacturing, processing, or use operations that you will describe in this notice.  Please reproduce these sections as needed.

If you substitute is also subject to review under FIFRA, provide the FIFRA Registration Number:

 _____________________________

Part III - RELEASE AND EXPOSURE DATA

Please reproduce additional copies of Part III as necessary.

Part IV - LIST OF ATTACHMENTS

Please attach additional sheets if you do not have enough space on the form to fully answer a question.  Label each continuation sheet with the corresponding section heading and the question.  In part IV, list these attachments and any test data, other data, or any optional information that you include in this notice.

TEST DATA AND OTHER DATA

You are required to submit all test data in your possession or control and to provide a description of all other data known to you if these data are related to the health and environmental effects of the manufacture, processing, distribution in commerce, use, or disposal of the alternative.  Standard literature citations may be submitted if they do not appear in the open scientific literature.  Complete test data (in English), not summaries of data, must be submitted if they do not appear in the open literature.  The following are test data and other data that might be submitted (see the Guidance Manual for a more complete list of data to be submitted.)  Please indicate test data to be included in your submission notice by checking the appropriate boxes:

 Yes    No

Flammability Data			 Yes    No

Environmental Effects

Data 				 Yes    No

Environmental Fate

Data				 Yes    No

Risk Assessments			 Yes    No

Test Data Not in the Possession/

Control of the Submitter		 Yes    No

Other Data 			 Yes    No

LIST OF TEST DATA IS SHOWN IN PART IV - LIST OF

ATTACHMENTS

Anyone submitting information must assert a claim of confidentiality at the time of submission for any data which are to be treated as Confidential Business Information (CBI).  Substantiation of this claim must also be provided at this time.  All information claimed as CBI will be treated in a manner consistent with 40 CFR Part 2, Subpart B.  Failure to assert a claim of confidentiality at the time of submission may result in disclosure of information by the Agency without further notice.

To assert a claim on this form, circle or bracket the information you claim as confidential and mark the confidential box at the bottom of the page.  Then provide substantiation of this claim on an attachment to the notice.  If any information is claimed as confidential, you must provide a “sanitized” version of this notice, including attachments, to EPA with our submission.  For additional information on claiming information as confidential, please see the Instructions Manual.

Information submitted as CBI may be accessed by companies designated as Authorized Representatives of the United States Environmental Protection Agency (EPA) under an EPA contract for the purpose of assisting EPA in the development and implementation of national regulations for the protection of stratospheric ozone, including the development of the SNAP program.  These Authorized Representatives may have access to any information received by the Stratospheric Protection Division within EPA Office of the Atmospheric Programs for use in reviewing the need for possible control of any substance, practice, process or activity that may reasonably be anticipated to affect stratospheric ozone.  Access to such information is necessary to ensure that these companies can complete the work required by the contract.

Authorized Representatives of the Administrator are subject to the provisions of 42 U.S.C. 7414(c) respecting confidential business information as implemented by 40 CFR 2.301(h).

Part I - GENERAL INFORMATION

Section A - SUBMITTER IDENTIFICATION

1. (a) Person Submitting Notice (in U.S.)

________________________________________________________________________ ______________________________

Name of Authorized Official         JOHN EDWARD POOLE                                                           Title   MANAGING DIRECTOR

________________________________________________________________________ ______________________________

Company/Organization                 REFRIGERANT SOLUTIONS LIMITED

________________________________________________________________________ ______________________________

Mailing Address    8 MURIESTON ROAD, HALE, ALTRINCHAM                                                  Telephone & Fax Numbers

                             CHESHIRE WA 15 9ST, ENGLAND, UNITED KINGDOM                                 00 44<PHONE_NUMBER> FAX 9875

(b) Agent (if applicable)

________________________________________________________________________ ______________________________

Name of Authorized Official                                                                                Title

________________________________________________________________________ ______________________________

Company/Organization

________________________________________________________________________ ______________________________

Mailing Address                                                                                Telephone & Fax Numbers

(c) Joint Submitter (if applicable)

________________________________________________________________________ ______________________________

Name of Authorized Official                                                                                Title

________________________________________________________________________ ______________________________

Company/Organization

________________________________________________________________________ ______________________________

Mailing Address                                                                                Telephone & Fax Numbers

2. Technical Contact (in U.S.   MR RON STEVENSON

________________________________________________________________________ ______________________________

Name of Authorized Official        Title

________________________________________________________________________ ______________________________

Company/Organization

________________________________________________________________________ ______________________________

Mailing Address

3. If you have had a prior communication with EPA concerning this notice, note the date and type of communication (letter, phone, etc.) and the EPA staff person’s name:

DAVID GOODWIN



Mark (X) this box if this page contains CBI ________  

Part I - GENERAL INFORMATION (continued)

Section B - ALTERNATIVE IDENTIFICATION

1. Commercial/Trade name (s) of alternative:  RS-50

RS-50 IS A LOW GLOBAL WARMING REPLACEMENT FOR 404A AND R507 AND A NON OZONE DEPLETING REPLACMENT FOR R22. RS-502 IS SUITABLE FOR USE IN EXISTING EQUIPMENT AND USE BY ORIGINAL EQUIPMENT MANUFACTUERS.

RS-50 WAS ASSIGNED A DESIGNATED ASHRAE NUMBER OF R-442A WITH A SAFTEY CLASSIFICATION OF A1 BY ASHRAE STANDARD 34 COMMITTEE ON 28 June 2011

2. (a) Name of chemical(s) (preferably IUPAC nomenclature and/or process name.  For blends, provide the percent composition of each constituents.

  (b) Chemical Abstracts Service (CAS) registry number and molecular formula.

    (c) For alternative processes and technologies describe the technology an d and provide a diagram of the system.  Also provide the information on any chemical constituents.

    (d) If you hold a patent on the substitute, provide the patent name and number and include a copy of the patent as an attachment.  If you have submitted a patent application but have not been granted one yet, indicate the date submitted and the expected time frame for a response.

3. Generic chemical name (if chemical name of substitute is declared Confidential Business Information).

RS-50

4. Specific End-Use

   (a) Describe each end-use that may be reasonably anticipated for the alternative.  Be sure to provide a broad description (e.g. terpene-based semi-aqueous solvent cleaner for electronic parts, or HFC substitute refrigerant for centrifugal chillers).

RS-50 IS A LOW GLOBAL WARMING REPLACEMENT FOR R404A AND R507 AND A NON OZONE DEPLETING REPLACEMENT FOR R22 IN THE FOLLOWING APPLICATIONS:

SUPERMARKET REFRIGERATION

INDUSTRIAL PROCESS REFRIGERATION SYSTEMS

ICE SKATING RINKS

COLD STORAGE WAREHOUSES

REFRIGERATED TRANSPORT

RETAIL FOOD REFRIGERATION

COMMERCIAL ICE MACHINES

THE SIZE OF THE RS-50 CHARGE CAN VARY SUBSTANTIALLY ACCORDING TO THE END USE FROM APPROXIMATELY 1 KG TO OVER 1000 KGS.

 (b) Identify the ODS and the quantity of substitute (if applicable) needed to replace it for each end use in pounds (replacement ratio).

RS-50 CAN BE USED IN RETROFIT OF EXISTING EQUIPMENT AND ALSO IN NEW EQUIPMENT. THE REPLACEMENT RATIO FOR EACH END USE IS 0.9:I, NAMELY 0.9 LB OF RS-52 TO 1 LB OF R404A OR R22.

2

 							Mark (X) this box if this page contains CBI __________

Part I - GENERAL INFORMATION (continued)

Section B - ALTERNATIVE IDENTIFICATION (Continued)

5. (a) Identify each impurity that may reasonably be anticipated to be present in the chemical alternative as manufactured for commercial purposes.  If there are unidentified impurities, enter “unidentified.”

    (b) Provide the CAS Registry Number if available.

    (c) Estimate the maximum weight percentage of each impurity.  If there are unidentified impurities, estimate their total weight    percentages.

6. Byproducts:

Describe any byproducts or degradation products resulting from the manufacturer, processing, use or disposal of the chemical alternative or chemicals used in the new alternative.  If there are unidentified byproducts/ degradation products enter “unidentified.”

    (b)    Provide the CAS Registry Number if available.

    (c)    Indicate where the byproduct/degradation product is formed (e.g. during manufacturing, during use, etc.) and the amount or                rate at which it is formed.

NO BYPRODUCTS OR DEGRADATION PRODUCTS RESULT FROM THE FORMULATION OF RS-50 BY THE BLENDING OF THE FIVE COMMERCIALLY AVAILABLE HIGH PURITY STARTING MATERIALS.

(B) & (C)  HF (HYDROGEN FLUORIDE) GAS, CAS NO 7664-39-3, WILL BE THE MAIN DEGRADATION PRODUCT RESULTING FROM THE DISPOSAL BY INCINERATION OF RS-50.

NB: RS-50 CAN BE RECOVERED, RECYCLED AND RECLAIMED PROVIDED THE REFRIGERANT HAS NOT BEEN MIXED WITH OTHER REFRIGERANTS.



Part II - ALTERNATIVE-SPECIFIC INFORMATION

Section A – PHYSICAL AND CHEMICAL PROPERTIES

1.  Molecular weight      81.7 g/mol

2.  Physical state at 20 C  GAS AT  1 ATMOSPHERE

3.  Melting point             N/A

4.  Boiling point at 1 atm. Pressure              -46.5C (1)

5.  Specific gravity         1.21*                                        g/ml

6.  Odor threshhold   N/A                              mg/m3

7.  Solubility using solvent                     @ temperature                           C              N/A                                           g/L

8.  Solubility in water @ temperature LOW SOLUBILITY                                                                                C

9.  Partition coefficients  N/A

Log Kow                             Log K

10.  Vapor pressure @ 20 C   192 (1)   psi

11.  Critical temperature                                 82.4C

12.  Critical pressure                                   690 psi

13.  Are spectra attached?  N/A

14.  Disassociation constant         N/A

15.  Particle size distribution  N/A

16.  Volatilization from soil            N/A

17.  Volatilization from water  N/A

Viscosity @ 20 C LIQUID 0.141  CENTIPOISE

                             VAPOUR 0.0126 (2)

                             Cp

19.    HYPERLINK mailto:pH@concentration  pH@concentration   N/A

Thermal conductivity  LIQUID:  W/Mk*

                                         VAPOUR: W/mk(2)

21.  Adsorption coefficient    N/A

22.  Flammability limits (LFL, UFL)          NONE % vol

23.  Flash point   NONE

24.  Heat of combustion   N/A

25.  Maximum pressure rise  N/A

26.  Maximum rate of pressure rise  N/A

Other (specify)

(1) CAPACITY

(2) COEFFICIENTS OF PERFORMANCE

(3) PRESSURE/TEMPERATURE TABLE

(4) THERMODYNAMIC TABLES

(5 )PRESSURE/ENTHALPY DIAGRAM

SEE PART IV - LIST OF ATTACHMENTS

NB: (1) BUBBLE POINT

       (2) 1 ATMOSPHERE

Provide any information on flammability concerns.  For example, if any abatement techniques are being used to minimize the risks associated with flammable substances or mixtures, detail those techniques below.  If a substitute is flammable, an assessment of overall risk in each end-use may be required.  (See Guidance Manual for sector-specific data requirements for flammable substances).

RS-50 IS NON FLAMMABLE AT WORST CASE FORMULATION AND WORST CASE FRACTIONATION AS PER ASHRAE STANDARD 34 ASTM 681-98  FLAMMABILITY TEST

FLAMMABILITY TEST DATA & WORST CASE FRACTIONATION TEST DATA DURING LEAKAGE ARE DETAILED IN ATTACHED REPORT BY SAFET CONSULTING ENGINEERS INC. SEE PART IV – LIST OF ATTACHMENTS

Mark (X) this box if this page contains CBI __________

Part II - ALTERNATIVE-SPECIFIC INFORMATION (Continued)

Section B - ATMOSPHERIC INFORMATION

1.  Ozone-depletion potential (ODP):

     (a) Provide the 100 year ODP of the alternative relative to CFC-11, if known.  If the substitute is a blend, provide the ODPs of individual constituents.

(b) Provide source of ODP or any additional data on the ODP of the alternative (e.g. atmospheric lifetime, chlorine or bromine loading potentials).  Reference the source of this information and attach any supporting documentation.

2.  Global Warming Characteristics:

    (a) Provide the alternative’s global warming potential (GWP) relative to carbon dioxide over 100-, 500-, and 1000- year time horizons, if known.  If the substitute is a blend, provide the GWPs of the individual constituents.

    (b) If known, provide the alternative’s expected impact on energy efficiency relative to the substance it is replacing (e.g. +/- X%) and results of  any testing or modeling done (both theoretical and actual testing).

    (c) Provide source of GWP or any additional data on the GWP of the alternative, including the atmospheric lifetime, infrared absorption spectrum, and infrared absorption capacity.  If the alternative (e.g. CO2 captured from a stream of waste gas as a by-product of fermentation).

Mark (X) this box if this page contains CBI __________

Part II - ALTERNATIVE-SPECIFIC INFORMATION (continued)

Section C - OTHER STATUTES AND STANDARDS

1.  Describe whether an d how the alternative is regulated under other environmental regulatory statutes, for example other titles under the Clean Air Act (CAA), the Clean Water Act (CWA), the Safe Drinking Water Act (SDWA), the Resource Conservation and Recovery Act (RCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the Emergency Planning and Community Right-to-Know Act (EPCRA, also known as SARA Title III), and state and local laws.  List any concentration-based or other numerical standards to which the alternative is subject under the above standards and regulations.

REGULATION OF THIS HFC  SUBSTITUTE BLEND UNDER OTHER ENVIRONMENTAL REGULATORY STATUTES WILL BE COMPARABLE TO THOSE THAT APPLY TO OTHER HFC REFRIGERANTS, NAMELY:

U.S. CLEAN AIR ACT AMENDMENTS 1990

AND FOR APPLICATION AS A REPLACEMENT IN EXISTING EQUIPMENT, THE PROVISIONS OF:

U.S. CLEAN AIR ACT AMENDMENTS 1990 SECTION 608

APPLY TO THE REMOVAL, RECOVERY AND RECYCLING OF THE EXISTING HCFC AND/OR CFC CHARGE BEING REPLACED.

ANY U.S. REGULATIONS IMPLEMENTING THE KYOTO PROTOCOL ON CLIMATE CHANGE, RELATED TO EMISSIONS OF HFCs WILL APPLY TO THIS BLEND.

2.  Describe whether and how the alternative is regulated under health and safety related statutory authorities, such as those implemented by the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), the Department of Transportation (DOT), and state and local laws.  List any concentration-based or other numerical standards to which the alternative is subject under the above statutes and regulations.  Also list any other standard-setting organizations such as the National Fire Prevention Association (NFPA) or the American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE), by which the substitute is evaluated.

OTHER REGULATORY REQUIREMENTS  FOR HANDLING AND TRANSPORTATION APPLY AS FOR LIQUEFIED REFRIGERANT GASES UNDER PRESSURE.

OSHA EXPOSURE LIMITS AND EUROPEAN OCCUPATIONAL EXPOSURE LIMITES FOR THE COMPONENTS OF THE

RS-50 BLEND HAVE BEEN USED TO DETERMINE THE EXPOSURE LIMIT FOR THE BLEND.

MATERIAL SAFETY DATA SHEET ATTACHED.



Part II - ALTERNATIVE-SPECIFIC INFORMATION (continued)

Section D - COST AND AVAILABILITY OF THE ALTERNATIVE

1.  Estimate the cost per pound for the substitute chemical.  For alternative processes and technologies, describe installation costs associated with the alternative.

APPROXIMATE FORMULATION COST OF RS-50 IS US$7 PER LB.

IN NEW EQUIPMENT, THE BLEND CAN BE USED TO REPLACE R404A, R507 AND R22 IN NEW EQUIPOMENT. IN THE CASE OF R22 NO RE-NGINEERING OF THE EQUIPMENT IS NECESSARY. IN THE CASE OF R404A AND R507, THE EXPANSION DEVICE WILL NEED TO BE REDUCED TO REFLECT THE LOWER MASS FLOW RATE, WHICH IS SIMILAR TO R22.

EXISTING EQUIPMENT “DROP-IN”, CONVERSION INSTALLATION COSTS ARE MADE UP OF THE SERVICING COSTS, INVOLVING RECOVERY OF EXISTING R22 AND/OR R404A/R507 CHARGE AND RECHARGE WITH RS-50 AND CONSEQUENT SYSTEM OPTIMISATION. TOTAL COST IS THEREFORE COST OF REFRIGERANT CHARGE AND LABOUR ONLY.

2. Provide information on production of the substitute. Include estimates on:

(a) Year substitute will be available if not currently produced.

(b) Total pounds production per year (current figure).

(c) Years to maximum market penetration.

I(d) Estimated percentage of market at market saturation.

3.  Describe any new equipment an d use profiles.  If retrofitting of existing equipment is required, detail changes in technologies needed to use the alternative and address any materials compatibility issues.  Provide information on each end-use and capital costs associated with the substitute or alternative process.  Include cost of equipment and/or any new materials, equipment lifetime, changes in labor and energy costs.

RS-50 IS A LOW GLOBAL WARMING REPLACEMENT FOR R404A AND R507 AND A NON OZONE DEPLETING REPALCEMENT FOR R22. RS-50 IS SUITABLE FOR USE IN NEW AND EXISTING EQUIPMENT

RS-52 CAN BE USED WITH NEW EQUIPMENT DESIGNED FOR R404A & R507 OR AS A RETROFIT DROP-IN REPLACEMENT IN EXISTING R22 & R502 EQUIPMENT.

RS-50 DOES NOT REQUIRE THE REDESIGN OF EQUIPMENT. IN THE CASE OF R404A AND R507, THE EXPANSION DEVICE WILL NEED TO BE REDUCED DUE TO THE LOWER MASS FLOW RATE, WHICH IS SIMILAR TO R22

NO SIGNIFICANT CAPITAL COSTS ARE INVOLVED WHEN USING RS-50 AS A REPLACEMENT IN EITHER NEW OR EXISTING EQUIPMENT.

RS-50 IS COMPATIBLE WITH ALL MATERIALS COMMONLY USED IN SYSTEMS DESIGNED AND CHARGED WITH R22, R404A AND R507.

INFORMATION ON REFRIGERATION PERFORMANCE AND CAPACITY IS ATTACHED IN PART IV - LIST OF ATTACHMENTS. IT IS EXPECTED THAT RS-50 WILL SHOW A HIGHER ENERGY EFFICIENCY THAN R404A AND R507 WHILE HAVING A SIMIILAR CAPACITY.

_

Part III - RELEASE AND EXPOSURE DATA

Section A - TOXICITY AND HAZARD INFORMATION

For chemical alternatives and for chemicals used with alternative processes, summarize below (and attached supporting information) the acute and chronic toxicity of the substitute and of its constituent chemicals on any organism (e.g. human and/or other mammals, fish, wildlife, and plants), if available.  Include any data on impurities and degradation products if known.  Also include information on any “Allowable Exposure Limits” (AELs) that have been set for the substitute.  In addition, please attach a copy or facsimile of any hazard warning statement, label, material safety data sheet, or other information which will be provided to any person who is reasonably likely to be exposed.  (See Guidance Manual for sector-specific data requirements).

RECOVERY

RS-50 CAN BE RECOVERED FROM REFRIGERATION EQUIPMENT USING APPROVED REFRIGERATION RECOVERY PROCEDURES AND EQUIPMENT. REFRIGERANT SOLUTIONS LIMITED WILL PROVIDE A FULL RECLAMATION SERVICE THROUGH ITS DISTRIBUTOR/S.

RECLAMATION

RS-50 CAN AND SHOULD BE RECLAIMED BY THE FOLLOWING:

RECLAMATION THROUGH PROPRIETARY RECLAMATION EQUIPMENT (EG REFRIGERANT SERVICES INC).

THE BLEND CAN BE CLEANED AND DRIED THROUGH THIS TYPE OF EQUIPMENT ON A FULL BATCH PROCESSING TRANSFER BASIS. THIS ENSURES THAT THE FULL BATCH COMPONENTS ARE COLLECTED TOGETHER. THE BLEND IS THEN ANALYSED FOR COMPOSITION AND ANY DIVERGENCE FROM THE SALES SPECIFICATION WILL BE CORRECTED BY THE ADDITION OF THE APPROPRIIATE COMPONENT. THE RECOVERED WASTE MATERIAL (IE OI, WATER, PARTICULATES) WILL BE DISPOSED OF ACCORDING TO THE WASTE REGULATIONS APPLYING.

RECLAMATION BY DISTILLATION

THE BLEND CAN BE RECLAIMED BY POT TO POT BATCH DISTILLATION. THIS ENSURES THAT THE TOTAL COMPONENTS ARE RECOVERED FROM THE PROCESS AND THE DISTILLED BATCH CAN BE ANALYSED FOR CONFORMANCE TO THE COMPOSITION SPECIFICATION. ANY DIVERGENCE WILL BE CORRECTED TO BRING THE BLEND BACK TO SPECIFICATION.

DISPOSAL

WHEN THE RS-50 BLEND MATERIAL IS NO LONGER REQUIRED, OR IS CONTAMINATED WITH OTHER GASES THAN THE FOUR COMPONENTS, RENDERING IT UNSUITABLE FOR RECLAMATION BY EITHER OF THE ABOVE METHODS, THE MATERIAL WILL BE DESTROYED. DESTRUCTION WILL BE CARRIED OUT IN INCINERATORS, APPROVED AND REGISTERED BY THE AUTHORITIES FOR THE DESTRUCTION OF FLUOROCARBON COMPOUNDS IN LIGUEFIED FORM.

REFRIGERANT SOLUTIONS LIMITED WILL TAKE ALL STEPS NECESSARY TO ENSURE THAT ANY RECLAMATION OR DESTRUCTION IS CARRIED OUT IN ACCORDANCE WITH THE ABOVE AND IIN CONFORMANCE WITH APPROPRIATE STATE AND FEDERAL LAWS.

Section B - ENVIRONMENTAL RELEASE AND DISPOSAL AT MANUFACTURE

For each manufacturing site:

     (a) Identify all site locations (i.e. name and address) for each chemical manufacturing process.

     (b) Identify all site locations for manufacturing of products using substitutes (e.g. refrigerators containing the substitutes).

     (c) Identify the points of release and/or exposure during the manufacture of: (i) the substitute and/or (ii) products containing the substitutes.

     (d) Provide information on the magnitude of release if available, along with the media to which the substitute is released (e.g. indoor air, outdoor air, water, land).

REFRIGERANT SOLUTIONS LIMITED

8 MURIESTON RAOD

HALE

ALTRINCHAM

CHESHIRE WA15 9ST

ENGLAND

UNITED KINGDOM

RESOURCE SEPARATIONS

Rt 16

BOX 308QA

LONGVIEW

TEXAS 7X 75603

USA

REFRIGERANT SERVICES INC

15 WILLIAMS AVENUE

DARTMOUTH

HALIFAX

NOVA SCOTIA B33 1X3

CANADA

NO SITE LOCATIONS AT PRESENT FOR MANUFACTURE OF PRODUCTS USING RS-50. THIS NEW REFRIGERANT WILL BE USED AT MANY SERVICE SITES.

NO RELEASE OF CONSTITUENTS DURING FORMULATION AND PACKAGING OF RS-24 EXCEPT AT

DISCONNECTION OF TRANSFER HOSE. THIS IS MINIMISED TO NEGLIGIBLE LEVELS BY RECOVERY & CAPTURE OF THE REFRIGERANT IN THE DEAD SPACE OF THE CONNECTION.

GOOD WORKING PRACTICE AND STATUTORY CONTROLS ON EMISSIONS SHOULD ENSURE EMISSIONS ARE

NEGLIGIBLE. ANY ACCIDIENTIAL RELEASE WOULD BE TO AIR.

Mark (X) this box if this page contains CBI __________

Part III - RELEASE AND EXPOSURE DATA

Section C- OCCUPATIONAL EXPOSURE AT MANUFACTURE

For each manufacturing site (manufacturing of substitutes and/or products containing substitutes):

     (a) Describe the activities in which workers may be exposed to chemicals.

     (b) Describe any protective equipment and engineering controls used to protect workers (e.g. goggles, gloves, chemical hoods).

     (c) Indicate the physical form of chemicals at the time of handling/exposure (e.g. solid, liquid, gas).

     (d) Estimate average and maximum numbers of workers involved in each activity.

     (e) Estimate average and maximum duration of activity for any worker, in terms of (1) hour/day and (2) days/year.

     (f) Enter the contact pathway (e.g. ingestion, inhalation, dermal).

     (g) Estimate the average and high-end exposure concentrations (separated by a /), being sure to provide units of measure.

THE FORMUATION AND PACKAGING FACILITIES FOR THE PRODUCTION OF RS-50 ARE DESIGNED AND CONSTRUCTED TO ENSURE NEGLIGIBLE EMISSIONS. THE FACILITIES COMPLY WITH UK REQUIREMENTS FOR EMISSIONS AND SAFETY AND CONSEQUENTLY WORKERS ARE NOT EXPOSED TO EITHER RS-50 OR ITS CONSTITUENTS.

PERSONAL PROTECTIVE EQUIPMENT ACCORDING TO THE RS-50 PRODUCT SAFETY DATA SHEET IS WORN DURING MANUFACTURE OF RS-52, IE EYE PROTECTION AND IMPERVIOUS GLOVES. ALL EQUIPMENT IS EARTHED.

ALL THE COMPONENTS OF RS-50 ARE LIQUEFIED GASES UNDER PRESSURE

THE AVERAGE NUMBER OF WORKERS EMPLOYED IN THE MANUFACTURE OF RS-50 IS TWO. THE MAXIMUM NUMBER OF WORKERS IS FOUR.

THE WORKERS OPERATE A ROTATION SYSTEM WORKING A MAXIMUM 8 HOUSRS/DAY AND APPROXIMATELY 100 DAYS/YEAR.

THE CONTACT PATHWAY WOULD BE INHALATION SHOULD ANY RELEASE OCCUR.

UNDER NORMAL CONDITIONS OF FORMULATION AND PACKAGING, THE ESTIMATED EXPOSURE CONCENTRATION IS NEGLIGIBLE. THE RECOMMENDED OCCUPATIONAL LEVEL (TWA) FOR RS-50 IS 1000 PPM AS QUOTED IN THE PRODUCT SAFETY DATA SHEET.

Section D - ENVIRONMENTAL RELEASE AND DISPOSAL IN END-USE

For each end-use of a substitute:

Provide the estimated amount (in kg/day) of each chemical released directly to the environment (e.g. as a hazardous waste or

Waste water effluent) at a site using the substitute (e.g. in products containing the substitute and processes using the substitute).

     (b)   Identify the media (indoor air, outdoor air, land, water) to which the chemical will be released from that release point.

     (c)    Describe the control technology used to limit release; estimate the amount released to the environment with the control

             technology in place to limit release.  If the substitute is to be disposed of, indicate the method and location of disposal.

     (d)    Are releases covered under RCRA?  If so, identify the RCRA hazardous waste codes.

     (e)    Identify the appropriate number of sites expected to use the substitute.

     (f)     Provide information on recycling of the substitute.  Describe any associated costs and equipment.

RS-50 IS A REPLACEMENT FOR R22, R404A AND R507 FOR USE IN LEAK-FREE REFRIGERATION AND AIR CONDITIONING SYSTEMS. RS-50 CAN BE RECOVERED AND RECYCLED. RESTRICTIONS ON VENTING TO ATMOSPHERE SHOULD BE OBSERVED, AND RELEASES DURING CHARGING AND MAINTENANCE WILL BE MINIMAL.

ANY ACCIDENTIAL RELEASE WILL BE EITHER INDOOR AIR OR OUTDOOR AIR DEPENDING ON THE LOCATION OF THE EQUIPMENT AND POSITION OF THE LEAK.

GOOD HOUSEKEEPING AND FREQUENT INSPECTION WILL LIMIT RELEASES. REFRIGERANT SOLUTIONS LIMITED IN THE UK, RESOURCE SEPARATIONS IN THE USA AND REFRIGERANT SERVICES INC IN CANADA WILL TAKE BACK RECOVERED RS-50 FOR RECYCLING AND RECLAMATION. IF RS-50 IS MIXED WITH OTHER REFRIGERANTS THEN THE MIXTURE CAN BE DESTROYED BY HIGH TEMPERATURE INCINERATION IN AN APPROVED FACILITY CAPABLE OF ABSORBING AND NEUTRALISING THE BY-PRODUCTS.

RS-50 IS NOT A HAZARDOUS WASTE.

FEW MANUFACTURING SITES ARE EXPECTED TO USE RS-50. HOWEVER, MANY REFRIGERATION  SERVICE SITES ARE EXPECTED TO USE RS-50.

RS-50 CAN BE RECOVERED, RECYCLED AND RECLAIMED USING STANDARD REFRIGERATION EQUIPMENT IN A SIMILAR MANNER AND AT A SIMILAR COST TO A SINGLE FLUID REFRIGERANT.

Mark (X) this box if this page contains CBI __________

Part III - RELEASE AND EXPOSURE DATA (continued)

Section E - OCCUPATIONAL EXPOSURE AT END-USE

For all end-use scenarios of the substitute (end-uses utilizing the substitute in products and/or processes):

Describe the activities in which workers may be exposed to chemicals.

Describe any protective equipment or engineering controls used to protect workers (e.g. goggles, gloves, chemical hoods).

Indicate the physical form of chemicals at the time of handling/exposure (e.g. solid, liquid, gas).

Estimate average and maximum numbers of workers involved in each activity.

Estimate average and maximum duration of activity for any worker, in terms of (1) hours/day and (2) days/year

Enter the contact pathway (e.g. ingestion, inhalation, dermal).

Estimate the average and high-end exposure concentrations (separated by a /), being sure to provide units.

RS-50 IS A REFRIGERANT TO REPLACE R22, R404 AND R507 AND WILL BE HANDLED AND USED IN THE SAME MANNER AS OTHER REFRIGERANTS. GOOD HOUSEKEEPING, SAFE PRACTICES AND OBSERVATION OF REGULATIONS ON VENTING TO ATMOSPHERE WILL AVOID END-USERS BEING EXPOSED TO RS-50 AND ITS CONSTITUENTS.

INFORMATION ON PERSONAL PROTECTIVE EQUIPMENT HANDLING AND THE RECOMMENDED EXPOSURE LEVEL (TWA) OF 1000 PPM IS GIVEN IN THE PRODUCT SAFETY DATA SHEET. HOWEVER, LOCAL CONCENTRATIONS DURING CHARGING AND SERVICING OF EQUIPMENT WILL BE CONSIDERABLY BELOW THE TWA.

RS-50 IS HANDLED AS A LIQUEFIED GAS UNDER PRESSURE.

SITE SERVICE WORK INVOLVING RS-50 IS NORMALLY UNDERTAKEN BY INDIVIDUAL REFRIGERATION AND AIR CONDITIONING ENGINEERS.

THE DURATION FOR HANDLING RS-50 BY WORKERS INVOLVED IN EQUIPMENT MANUFACTURE OR SERVICE WORK IS LIMITED TO THE RELATIVELY SHORT TIME OF CHARGING THE NEW REFRIGERANT.

THE CONTACT PATHWAY WOULD BE INHALATION SHOULD ANY RELEASE OCCUR.

UNDER NORMAL CONDITIONS OF END-USE, THE EXPECTED EXPOSURE CONCENTRATION IS NEGLIGIBLE.

Section F - CONSUMER EXPOSURE

For each end-use of a substitute:

     (a) Identify the potentially exposed population (e.g. indoor residents).

     (b) Identify the exposure medium (e.g. air).

     (c) Enter the contact pathway (e.g. ingestion, inhalation, dermal).

     (d) Enter the exposure point of concentration.  Provide (1) average and (2) high-end estimates.

RS-50 IS A REPLACEMENT REFRIGERANT FOR USE IN LEAK-FREE REFRIGERATION AND AIR CONDITIONING SYSTEMS. HENCE, EXPOSURE TO THE GENERAL CONSUMER IS EXTREMELY REMOTE. SHOULD EMISSIONS OCCUR, THEY WOULD MOST LIKELY BE THE RESULT OF EQUIPMENT LEAKAGE, PARTICULARLY AT THE HIGH PRESSURE SIDE OF THE EQUIPMENT. AS LEAKS TEND TO DEVELOP GRADUALLY AND THE HIGH PRESSURE SIDE OF LARGER EQUIPMENT IS USUALLY REMOTE FROM GENERAL CONSUMERS AND THE PUBLIC AND LOCATED IN WELL VENTILATED AREAS, THE LIKELY POPULATION TO BE EXPOSED IS EXTREMELY SMALL.

THE EXPOSURE MEDIUM WOULD BE AIR.

THE CONTACT PATHWAY WOULD BE INHALATION SHOULD EXPOSURE OCCUR.

THE CONCENTRATION AT THE EXPOSURE POINT IS EXPECTED TO BE EXTREMELY LOW AND VERY INFREQUENT, IF AT ALL.



Part III - RELEASE AND EXPOSURE DATA (continued)

Section G - GENERAL POPULATION EXPOSURE (optional)

For manufacturing of substitutes and products containing substitutes:

     (a) Identify and number potential exposure points.

     (b) For each exposure point described in (a), identify the potentially exposed population (e.g. residents at the fenceline).

     (c) Identify the contact pathway (e.g. ingestion, inhalation, dermal).

     (d) Identify the exposure medium (e.g. air, water).

     (e) Enter the exposure point concentration (mg/m3).  Provide (1) average and (2) high-end estimates.

THE GUIDANCE DOCUMENT STATES: “ YOU DO NOT NEED TO PROVIDE THE INFORMATION REQUESTED IN THIS SECTION UNLESS YOU CHOOSE TO DO SO.”

(a)&(b) IT IS NOT ANTICIPATED THAT THE GENERAL PUBLIC WOULD COME INTO DIRECT CONTACT WITH PARTS CONTAINING RS-50. EMISSIONS FROM EQUIPMENT LEAKAGE, OR EVEN FAILURE, WOULD BE CONFINED TO THE RELATIVELY SMALL AREA AROUND THE EQUIPMENT. HENCE, EXPOSURE TO THE GENERAL PUBLIC WOULD BE EXPECTED TO BE NEGLIGIBLE AND VIRTUALLY ZERO.

THE CONTACT PATHWAY WOULD BE INHALATION SHOULD EXPOSURE OCCUR.

THE EXPOSURE MEDIUM WOULD BE AIR.

THE CONCENTRATION AT THE EXPOSURE POINT IS EXPECTED TO BE VIRTUALLY ZERO.

Mark (X) this box if this page contains CBI __________

Part IV - LIST OF ATTACHMENTS

List below any attachments that complete the responses to the questions on this form or that provide additional information that may assist EPA’s review of the alternative under Section 612 of the Clean Air Act.  Also, provide citation for information already submitted to EPA as part of past regulatory and information activities, as well as for other information that could not be included with this submission.  If you have attached continuation pages, describe the Part, Section and question number being continued.  Attach additional pages if necessary.

Attachment Name

Question #

Number of Pages

CBI

Â

Ã

咊

 hN

hN

 hN

 hN

 hN

 hN

 hN

 hN

 hN

hN

 hN

 hN

 hN

 hN

 hN

 hN

葞Ũ

葞Ũ

਀&䘋

葞ɉ

                  APPENDIX 2

PTII SECTION A Q27

4

RS-50- THERMODYNAMIC TABLES                                    APPENDIX 3	 PTII SECTION A

 Q27

21

RS-50 PRESSURE ENTHALPY DIAGRAM                          APPENDIX 4

	 PTII SECTION A

 Q27

1

IPCC 2007 GLOBAL WARMING POTENTIALS                 APPENDIX 7

PTII SECTION B Q2

1

RS-50 RETROFIT PROCEDURE FOR R404A & R507      APPENDIX 8	PTII SECTION D Q3

3

RS-50 RETROFIT PROCEDURE FOR R22                       APPENDIX 9	PTII SECTION D Q3

2

RS-50 CAPACITY                                                                APPENDIX 10	PTII SECTION A

 Q27

1

RS-50 COEFFICIENT OF PERFORMANCE                      APPENDIX 11	PTII SECTION A

 Q27

1

RS-50 PHYSICAL PROPERTIES                                       APPENDIX 13

	PTII SECTION D Q3

1

RS-50 PRODUCT SAFETY DATA SHEET                        APPENDIX 14	PTIII SECTION A

8

HFC134a MATERIAL SAFETY DATA SHEET                  APPENDIX 15

PTIII SECTION A

9

HFC125 MATERIAL SAFETY DATA SHEET                    APPENDIX 16

PTIII SECTION A

7

R227ea MATERIAL SAFETY DATA SHEET                    APPENDIX 17

PTIII SECTION A

5

R32 MATERIAL SAFETY DATA SHEET                          APPENDIX 18

PTIII SECTION A

7

R152a MATERIAL SAFETY DATA SHEET                      APPENDIX 19

PTIII SECTION A

9

PRODUCT STEWARDHSIP                                             APPENDIX 20

PTIII SECTION A

1

PAFT HFC125 TOXICITY SUMMARY                              APPENDIX 21

PTIII SECTION A

1

PAFT HFC134a TOXICITY SUMMARY                          APPENDXI 22

PTIII SECTION A

2

PAFT HFC32 TOXICITY SUMMARY                              APPENDIX 23

PTIII SECTION A

1

PAFT HFC227ea TOXICITY SUMMARY                       APPENDIX 24

PTIII SECTION A

2

	Mark (X) this box if this page contains CBI __________

Part V – CERTIFICATION

I certify to the best of my knowledge and belief that:

1.  All information provided in this notice is complete and truthful as of the date of the submission.

2.  I am submitting with this notice all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me.

3.  If this is a submission of a new alternative, the company name in Part I, Question 1a of this notice:

     (a) intends to manufacture, formulate, import, market, or use a new alternative to a Class I or Class II ozone-depleting substance which is identified in Part I, Section B, Question 2.

     (b) seeks an acceptability determination on a new alternative(s) to a Class I or Class II ozone-depleting substance, which is identified in Part I, Section B, Question 2.

4.  The accuracy of the statements made in this notice reflects my best prediction of the anticipated facts regarding the alternative described herein.  Any knowing and willful misinterpretation is subject to criminal penalty pursuant to section 113(c) of the Clean Air Act and 18 U.S.C.§1001.

Signature and Title of Authorized Official (Original Signature Required):

                                                                                Date:

Signature of Agent (Where Applicable):                                                                                Date

For persons filing a SNAP Information Notice, the reporting burden is estimated to average 150 hours per year.  For persons filing a TSCA/SNAP Addendum, the reporting burden is estimated to average 46 hours her year.  Burden means that total time, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instruction; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.  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.

Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the U.S.Environmental Protection Agency, Attn: Director, Collection Strategies Division, Office of Information Collection, 1200 Pennsylvania Avenue, NW, Mail Code 2822T, Washington, DC 20460.  Please include the EPA Docket ID Number OAR-2004-0077 and OMB Control Number 2060-0226 in nay correspondence. Do not send the completed form to this address.

Form 1265-93 (Revised 1/05)

Previous editions are obsolete

 PAGE  1

Managing Director


[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31994-31996]
[FR Doc No: 2013-12533]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69614; File No. SR-EDGX-2013-17]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing of Proposed Rule Change Relating to the EDGX Exchange, Inc.'s
Routing Broker Dealer, as Described in EDGX Rule 2.12(b)

May 21, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on May 16, 2013, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to make permanent the existing pilot program
that permits the Exchange's inbound router, as described in Rule
2.12(b), to receive inbound routes of equities orders through Direct
Edge ECN LLC d/b/a DE Route (``DE Route''), the Exchange's routing
broker dealer, from EDGA Exchange, Inc. (``EDGA''). All of the changes
described herein are applicable to EDGX Members. The text of the
proposed rule change is available on the Exchange's Internet Web site
at www.directedge.com, at the Exchange's principal office, and at the
Public Reference Room of the Commission.

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

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

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

1. Purpose
    Currently, DE Route is the approved outbound order routing facility
of EDGA.\4\ The Exchange has been authorized to receive inbound routes
of equities orders by DE Route from EDGA. The Exchange's authority to
receive inbound routes of equities orders by DE Route from EDGA is
currently subject to a pilot period of twelve months, ending June 30,
2013.\5\ The Exchange hereby seeks permanent approval to permit the
Exchange to accept inbound orders that DE Route routes in its capacity
as a facility of EDGA. This is reflected in the proposed amendment to
EDGX Rule 2.12(b).
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 61698 (March 12,
2010), 75 FR 13151 (March 18, 2010).
    \5\ See Securities Exchange Act Release No. 66644 (March 22,
2012), 77 FR 18877 (March 28, 2012) (SR-EDGX-2012-09).
---------------------------------------------------------------------------

    Under the pilot, the Exchange is committed to the following
obligations and conditions:
     The Exchange shall: (a) Enter into a plan pursuant to Rule
17d-2 under the Exchange Act with a non-affiliated self-regulatory
organization (``SRO'') to relieve the Exchange of regulatory
responsibilities for DE Route with respect to rules that are common
rules between the Exchange and the SRO, and (b) enter into a regulatory
services contract (``Regulatory Contract'') with a non-affiliated SRO
to perform regulatory responsibilities for DE Route for unique Exchange
rules.
     The regulatory services contract shall require the
Exchange to provide the non-affiliated SRO with information, in an
easily accessible manner, regarding all exception reports, alerts,
complaints, trading errors, cancellations, investigations, and
enforcement matters (collectively ``Exceptions'') in which DE Route is
identified as a participant that has potentially violated Exchange or
SEC Rules, and shall require that the non-affiliated SRO provide a
report, at least quarterly, to the Exchange quantifying all Exceptions
in which DE Route is identified as a participant that has potentially
violated Exchange or SEC rules.
     The Exchange, on behalf of Direct Edge Holdings LLC, shall
establish and maintain procedures and internal controls reasonably
designed to ensure that DE Route does not develop or implement changes
to its system on the basis of non-public information obtained as a
result of its affiliation with the Exchange until such information is
available generally to similarly situated Members \6\ in connection
with the provision of inbound order routing to the Exchange.
---------------------------------------------------------------------------

    \6\ As defined in EDGX Rule 1.5(n).
---------------------------------------------------------------------------

    The Exchange has complied with the above-listed conditions during
the pilot. In meeting them, the Exchange has set up mechanisms that
protect the independence of the Exchange's regulatory responsibility
with respect to DE Route, as well as demonstrate that DE Route cannot
use any information that it may have because of its affiliation with
the Exchange to its advantage. Since the Exchange has met all the
above-listed obligations and conditions, it now seeks permanent
approval of the Exchange and DE Route's inbound routing relationship.
Upon approval of the proposed rule change, the Exchange will continue
to comply with the obligations and conditions as set forth in proposed
EDGX Rule 2.12.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\7\ Specifically, the
proposal is consistent with Section 6(b)(5) of the Act,\8\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the proposed rule change will allow the Exchange to
continue receiving inbound routes of equities orders from DE Route
acting in its capacity as a facility of EDGA, in a manner consistent
with prior approvals and established protections. The Exchange believes
that meeting the commitments established during the pilot program
demonstrates that the Exchange has mechanisms that protect the
independence of the Exchange's regulatory responsibility with respect
to DE Route, as well as demonstrates that DE Route cannot use any
information that it may have because of its affiliation with the
Exchange to its advantage.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change does
not impose any burden on intermarket or intramarket competition as it
would allow the Exchange to have a permanent inbound router consistent
with its competitors.\9\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 65453 (September 30,
2011), 76 FR 62122 (October 6, 2011) (SR-NYSE-2011-45); Securities
Exchange Act Release No. 64090 (March 17, 2011), 76 FR 16462 (March
23, 2011) (SR-BX-2011-007); Securities Exchange Act Release No.
66807 (April 13, 2012), 77 FR 23300 (April 18, 2012) (SR-BYX-2012-
006); Securities Exchange Act Release No. 66808 (April 13, 2012), 77
FR 23294 (April 18, 2012) (SR-BATS-2012-013).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from its Members or other interested parties.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(A) By order approve or disapprove such proposed rule change, or (B)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGX-2013-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGX-2013-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2013-17 and should be
submitted on or before June 18, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-12533 Filed 5-24-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Notices]
[Page 40819]
[DOCID:fr14jy10-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD10-14-000]

Reliability Standards Development and NERC and Regional Entity
Enforcement; Notice Soliciting Comments

July 7, 2010.
    Take notice that on July 6, 2010, the Federal Energy Regulatory
Commission held a Commissioner-led technical conference to explore
issues pertaining to the development of mandatory Reliability Standards
for the Bulk-Power System by the North American Electric Reliability
Corporation. As previously noticed,\1\ and as stated at the technical
conference, any person interested may submit written comments regarding
the issues discussed at the conference. Comments should be filed with
the Commission in this docket, AD10-14-000, no later than July 26,
2010.
---------------------------------------------------------------------------

    \1\ Supplemental Notice of Technical Conference, 75 FR 36,385
(June 18, 2010).
---------------------------------------------------------------------------

    Anyone with questions pertaining to the technical conference or
this notice should contact either Karin Larson at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Christopher Young at<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17101 Filed 7-13-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Page 36389]
[FR Doc No: 2017-16457]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC17-142-000.
    Applicants: Exelon Generation Company, LLC, Exelon FitzPatrick,
LLC.
    Description: Joint Application for Authorization Under Section 203
of the FPA of Exelon Generation Company, LLC, et. al.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5234.
    Comments Due: 5 p.m. ET 8/18/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-131-000.
    Applicants: Cap Ridge Wind I, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cap Ridge Wind I, LLC.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5243.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-132-000.
    Applicants: Cap Ridge Wind II, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cap Ridge Wind II, LLC.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5245.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-133-000.
    Applicants: Cap Ridge Wind III, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cap Ridge Wind III, LLC.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5246.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-134-000.
    Applicants: Cap Ridge Wind IV, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cap Ridge Wind IV, LLC.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5248.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-135-000.
    Applicants: Cap Ridge Interconnection, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cap Ridge Interconnection, LLC.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5249.
    Comments Due: 5 p.m. ET 8/18/17.

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

    Docket Numbers: ER10-2794-023; ER14-2672-008; ER12-1825-021.
    Applicants: EDF Trading North America, LLC, EDF Energy Services,
LLC, EDF Industrial Power Services (CA), LLC.
    Description: Notice of Non-Material Change in Status of EDF Trading
North America, LLC, et al.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5233.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2179-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2017-07-28 Remove Conceptual
Statewide Plan Amendment to be effective 9/27/2017.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5211.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2180-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Attachment AE Revisions
Regarding Staggered Start Resources to be effective 10/1/2017.
    Filed Date: 7/28/17.
    Accession Number: 20170728-5222.
    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2181-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Q2 2017 Quarterly Filing of
City and County of San Francisco's WDT SA (SA 275) to be effective 6/
30/2017.
    Filed Date: 7/31/17.
    Accession Number: 20170731-5000.
    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2182-000.
    Applicants: Coyote Canyon Energy LLC.
    Description: Tariff Cancellation: Coyote Canyon Energy MBR Tariff
Cancellation to be effective 9/30/2017.
    Filed Date: 7/31/17.
    Accession Number: 20170731-5020.
    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2183-000.
    Applicants: Duke Energy Progress, LLC
    Description: Tariff Cancellation: Cancellation of CCCP IA (OATT SA
206) to be effective 8/1/2017.
    Filed Date: 7/31/17.
    Accession Number: 20170731-5035.
    Comments Due: 5 p.m. ET 8/21/17.

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

    Dated: July 31, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-16457 Filed 8-3-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Rules and Regulations]
[Pages 41342-41343]
[FR Doc No: 2017-18422]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-2017-NJ1; FRL-9967-14-Region 2]

Approval and Promulgation of Implementation Plans; New Jersey;
Revised Format for Materials Being Incorporated by Reference;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction.

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

SUMMARY: The Environmental Protection Agency (EPA) is correcting a
final rule; administrative change, that was published in the Federal
Register on July 3, 2017. In that document, EPA approved the revised
format for materials submitted by New Jersey that have been
incorporated by reference into its State Implementation Plan (SIP). An
error in the docket number was identified and is being corrected in
this action.

DATES: This rule is effective on August 31, 2017.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-2017-NJ1. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through www.regulations.gov, or please contact
the person identified in the For Further Information Contact section
for additional availability information.

FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: EPA approved a final rule; administrative
change published on July 3, 2017 (82 FR 30758). In that document, EPA
approved the revised format for materials submitted by New Jersey that
have been incorporated by reference into its SIP. The regulations and
other materials affected by this format change have all been previously
submitted by New Jersey and approved by EPA as SIP revisions. In that
approval, EPA erroneously added the incorrect docket number. In this
notice, the docket

number is revised to reflect the correct docket number.

Correction

    In the final rule published in the Federal Register on July 3, 2017
(82 FR 30758), the following correction is made:
    1. On page 30758, first column, ``EPA-R02-OAR-2016-0060'' is
corrected to read ``EPA-R02-2017-NJ1''.

    Dated: August 18, 2017.
Catherine R. McCabe,
Acting Regional Administrator, Region 2.
[FR Doc. 2017-18422 Filed 8-30-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Notices]
[Pages 28493-28496]
[FR Doc No: 2017-12641]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3615]

Administering the Hatch-Waxman Amendments: Ensuring a Balance
Between Innovation and Access; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following meeting: ``The Hatch-Waxman Amendments:
Ensuring a Balance Between Innovation and Access.'' This public meeting
is intended to provide the public an opportunity to submit comments
concerning administration of the Hatch-Waxman Amendments to the Federal
Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended
balance between encouraging innovation in drug development and
accelerating the availability to the public of lower cost alternatives
to innovator drugs is maintained.

DATES: The meeting will be held on July 18, 2017, from 9 a.m. to 5 p.m.
The deadline for submitting comments regarding this meeting is
September 18, 2017.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2017. 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-2017-N-3615 for ``Administering the Hatch-Waxman Amendments:
Ensuring a Balance Between Innovation and Access; Public Meeting;
Request for Comments.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to 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: Philip Bonforte, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-
6980, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    With the Drug Price Competition and Patent Term Restoration Act of
1984 (Pub. L. 98-417) (Hatch-Waxman Amendments), Congress intended to
strike a balance between encouraging innovation in drug development and
accelerating the availability to the public of lower cost alternatives
to innovator drugs. See H.R. Rep. No. 98-857 (Part I), 98th Cong, 2d
Sess. At 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647-48; see
also, e.g., Teva Pharmaceutical Industries Ltd. v. Crawford, 410 F.3d
51, 54 (D.C. Cir. 2005). To provide incentives intended to encourage
the development of innovative new drugs and new uses of approved drugs,
the Hatch-Waxman Amendments provided sponsors of innovator drugs with
exclusivity and protections based on patent listings that protect
certain aspects of innovator drugs from generic competition for certain
periods of time. To ensure the availability of generic drugs, the
Hatch-Waxman Amendments created an abbreviated new drug application
(ANDA) process that allows sponsors of generic drugs to rely on the
Agency's finding of safety and effectiveness for innovator drugs in
seeking approval of their generic products after patent or marketing
exclusivity protections held by the innovator expire or are otherwise
removed.
    FDA's generic drug program has dramatically expanded access to
quality, affordable generic medicines. According to the IMS Institute
for Healthcare Informatics, generic drugs saved the U.S healthcare
system $1.68 trillion from 2005-2014.\1\
---------------------------------------------------------------------------

    \1\ IMS Health Institute for Healthcare Informatics (April
2015), available at http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports.
---------------------------------------------------------------------------

    Over the past several years, the Agency has undertaken major
initiatives to expand access to quality, affordable generic medicines.
For example, pursuant to the Generic Drug User Fee Amendments of 2012
(GDUFA I), FDA modernized the ANDA review program, and adopted metric
goals to promote timely and predictable ANDA review. As a result, in
Fiscal Year 2016, combined ANDA approvals and tentative approvals
reached record highs. Pursuant to the proposed GDUFA II,\2\ FDA would
further enhance the ANDA review program by clarifying regulatory
expectations early in product development, helping applicants develop
more complete submissions, and giving applicants more opportunities to
address deficiencies within a review cycle, all with the goal of
reducing the number of review cycles necessary to obtain ANDA approval.
---------------------------------------------------------------------------

    \2\ GDUFA Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018-2022 (October 2016), available at
https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf.
---------------------------------------------------------------------------

    The development and approval of an innovator drug, and the
subsequent approval and marketing of a generic version, together make
up the life cycle of that drug product as contemplated by the Hatch-
Waxman Amendments.
    At the front end of the life cycle, innovation in drug products--
including improvements to approved innovator drug products--provides
life-changing and oftentimes life-saving therapeutic benefits to
patients. In enacting the Hatch-Waxman Amendments, Congress recognized
the importance of providing incentives to develop new products, and

new conditions of use for approved products. To further incentivize
innovation, Congress subsequently established additional incentives in
the form of exclusivity periods for drug products studied in pediatric
populations, rare diseases, and new antibiotic treatments. Congress
also provided a period of 180-day exclusivity for certain first generic
applications as an incentive for generic manufacturers to challenge
patents on innovator drugs that might otherwise prevent approval or
delay generic entry into the market. These exclusivities, which are
generally designed to reward sponsors with finite periods of limited or
no generic or follow-on competition, were intended to expand the
availability of safe and effective medicines for which insufficient or
no treatment previously existed or to encourage generic drug
development that might not have been profitable otherwise.
    In some cases, however, the legal framework surrounding these
exclusivities may have been applied to delay generic competition to an
extent that may not have been intended by the Hatch-Waxman Amendments,
and in ways that may not serve the public health. Relatedly, certain
elements of the approval process for both innovator and generic drugs
have been used in ways that may (depending on the circumstances)
inappropriately hinder generic competition. For example, innovators in
some cases have made late changes in patent use codes that create new
obstacles to previously acceptable labeling carve-outs. The entry of
generic products to the marketplace is also affected by factors
external to regulation under the FD&C Act--e.g., the outcome of private
party patent litigation, and commercial decisions not to market
approved innovator or generic products. In other cases, restrictions on
the distribution of innovator drug products, whether voluntarily
adopted by the innovator or imposed as a requirement of FDA regulation,
have prevented developers from accessing the product samples needed for
testing to support ANDAs or other follow-on applications.
    FDA will hold a public meeting on July 18, 2017, 9 a.m. to 5 p.m.,
to provide an opportunity for all interested stakeholders to submit
comments concerning the appropriate balance between encouraging
innovation in drug development and accelerating the availability to the
public of lower cost alternatives to innovator drugs.
    The format of the meeting involves presentations from the public
only. The Agency will not be inviting specific presenters; rather, with
this document, FDA is soliciting presentations from interested
stakeholders. FDA also invites interested persons to submit written
comments to the docket on the topics described in section II.

II. Topics for This Public Meeting

    FDA is soliciting input from the public concerning how best to
preserve the balance Congress intended to strike in the Hatch-Waxman
Amendments between encouraging innovation in drug development and
accelerating the availability to the public of lower cost alternatives
to innovator drugs. Preserving this balance is critical to the public
health, and innovators, generic drug manufacturers, and FDA (among
others) all have a role to play in maintaining it. This public meeting
is part of an effort to create a broader understanding of the interplay
between the existing legal and regulatory framework, available
incentives and marketplace practices, and consumer access to generic
drugs.
    The Agency welcomes any relevant information that stakeholders wish
to share. We are particularly interested in stakeholder input on the
following questions:
    1. How has the balance struck in the Hatch-Waxman Amendments been
affected by practices and trends related to the following:
    a. Exclusivity periods,
    b. Patents (including patent listing procedures),
    c. Innovator drug product labeling,
    d. Post-approval changes to innovator drug products, e.g.,
reformulations, and
    e. Other regulatory processes, including the citizen petition
process?
    2. The drugs described in more than half of all FDA-approved ANDAs
are never marketed, marketed only after a substantial delay after
approval, or marketed only intermittently. Such failures to market
contribute to drug shortages, and hinder consumer access to approved
products. What marketplace dynamics dis-incentivize the marketing of
approved generic products? What should FDA do, within its statutory
authority, to help more approved generics reach consumers?
    3. For approximately 10 percent of all innovator drugs, patent and
exclusivity protections have expired, but FDA has not received an ANDA.
Are there market niches where the Hatch-Waxman Amendments incentives to
develop an ANDA are insufficient? Similarly, are there niches where the
incentives are insufficient to seek new drug approval of a marketed
unapproved drug product that in turn could serve as a Reference Listed
Drug? What should FDA do, consistent with its legal authority, to
encourage submission development in any such market niches?
    4. The statutory requirement that Risk Evaluation and Mitigation
Strategies (REMS) that include elements to assure safe use (ETASU) be
implemented through a ``single shared system'' relies on brand and
generic companies agreeing on such a system before generic drugs may
come to market. In some cases, challenges in reaching such an agreement
between the parties may cause delays to generic competition. How should
FDA apply its statutory authority to waive this requirement to
implement a ``single shared system,'' or develop other administrative
tools, to avoid these delays?
    5. Restrictions on distribution, either required by innovators or
as part of a REMS ETASU, can prevent generic companies from obtaining
drug products for bioequivalence and other testing to support ANDA
submissions. FDA published a draft guidance for industry, entitled
``How to Obtain a Letter from the Food and Drug Administration Stating
That Bioequivalence Study Protocols Contain Safety Protections
Comparable to Applicable Risk and Evaluation Mitigation Studies for
Reference Listed Drugs,'' in December 2014. Despite this draft
guidance, generic companies have reported continuing difficulties
obtaining sufficient samples of drug products for testing. What
additional actions should FDA take, within its legal authority, to
promote access to these drug products for generic companies seeking to
conduct studies required to support ANDA submissions?
    6. What other elements of drug product development, regulation, and
marketing have the potential to disrupt the Hatch-Waxman Amendments'
balance between innovation and generic availability, and how should the
Agency and other stakeholders address them?
    Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone,
email address, and fax number), and written material and requests to
make oral presentations, to the contact person by July 3, 2017.
    If you need special accommodations due to a disability, please
contact Philip Bonforte (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES).

    Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12641 Filed 6-21-17; 8:45 am]
BILLING CODE 4164-01-P


Placeholder for document 148; this document is titled " Response to Section 114 Request for Information Concerning Ameribrom's Inventories of Methyl Bromide as of December 31, 2002, dated January 16, 2003" and contains Confidential Business Information.

Please contact Hodayah Finman at 202 343 9246 for more information.


[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Rules and Regulations]
[Page 38829]
[FR Doc No: 2013-15498]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0387]

Special Local Regulations; Recurring Marine Events in the Seventh
Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the special local regulation for
the St. John 4th of July Carnival Fireworks Display from 8 p.m. until
10 p.m. on July 4, 2013. This action is necessary to ensure safety of
life on navigable waters of the United States. During the enforcement
period, a regulated area will exclude the presence of all vessels not
associated with the show. All vessels not associated with the show will
be prohibited from entering, transiting through, anchoring in, or
remaining within the area unless authorized by the Captain of the Port
San Juan or a designated representative.

DATES: The regulation in 33 CFR 100.701 Table 1 as well as the general
regulations in that section will be enforced from 8 p.m. through 10
p.m. on July 4, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Mr. Efrain Lopez, Sector San Juan Prevention Department,
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation for the annual St. John 4th of July Carnival Fireworks
Display in 33 CFR 100.701, Table 1, and the general regulations in that
section on July 4, 2013, from 8 p.m. until 10 p.m. This rule creates a
regulated area that will encompass all waters within a 200 yard radius
centered on the following position: 18[deg]19'55'' N/064[deg]48'06'' W.
    Under the general provisions of 33 CFR 100.701, vessels not
associated with the show may not enter, transit through, anchor in, or
remain in the regulated area, unless they receive permission from the
COTP. Vessels may safely transit outside the regulated area, but may
not anchor, block, loiter in, or impede the official patrol vessels.
The Coast Guard may be assisted by other Federal, State, or local law
enforcement agencies in enforcing this regulation.
    This notice is issued under authority of 33 CFR 100.701 and 5
U.S.C. 552 (a). The Coast Guard will provide notice of the regulated
areas by Local Notice to Mariners, Broadcast Notice to Mariners, and
on-scene designated representatives.

    Dated: June 14, 2013.
D. W. Pearson,
Captain, U.S. Coast Guard, Captain of the Port San Juan.
[FR Doc. 2013-15498 Filed 6-27-13; 8:45 am]
BILLING CODE 9110-04-P