5980 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices 569   7257; fax: 513   569   7475; e mail: nceadc. comment@ epa. gov.

SUPPLEMENTARY INFORMATION: This document reports on a program of research to investigate the integration of ecological risk assessment ( ERA) and economics, with an emphasis on the watershed as the scale for analysis. In 1993, the U. S. Environmental Protection Agency initiated watershed ERA ( W   ERA) in five watersheds to evaluate the feasibility and utility of this approach. In 1999, economic case studies were funded in conjunction with three of those W   ERAs: the Big Darby Creek watershed in central Ohio, the Clinch Valley ( Clinch and Powell River watersheds) in southwestern Virginia and northeastern Tennessee, and the central Platte River floodplain in Nebraska. The ecological settings, and the analytical approaches used, differed among the three locations, but each study introduced economists to the ERA process and required the interpretation of ecological risks in economic terms. A workshop was held in Cincinnati, Ohio, in 2001 to review progress on those studies, to discuss environmental problems involving other watershed settings, and to discuss the ideal characteristics of a generalized approach for conducting studies of this type. Based on the workshop results, a conceptual approach for the integration of ERA and economic analysis in watersheds was developed. The objectives of this document ( by chapter) are: to set forth the rationale, limitations, and contributions of the document ( Chapter 1); to create a context for understanding by a diverse, technical audience ( Chapter 2); to present a conceptual approach for integrating ERA and economics in the context of watershed management ( Chapter 3); to present and critically evaluate the methods and findings of the three watershed case studies ( Chapters 4   6); and to identify research needed to improve the integration of ERA and economic analysis in watersheds ( Chapter 7). This report is unique in its focus on the problem of ERA economic integration and the watershed management context and in its presentation of case studies. The conceptual approach is used as a basis of discussion of each case study to illustrate how its particular methodological advances and insights could be used to fullest advantage, both in the watershed studied and in future integration efforts. Dated: January 28, 2004. Peter W. Preuss, Director, National Center for Environmental Assessment. [ FR Doc. 04   2714 Filed 2   6   04; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2004   0072]; FRL   7344   2]

Certain New Chemicals; Receipt and Status Information AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: Section 5 of the Toxic Substances Control Act ( TSCA) requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSC, EPA is required to publish a notice of receipt of a premanufacture notice ( PMN) or an application for a test marketing exemption ( TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from December 26, 2003 to January 16, 2004, consists of the PMNs and TME's both pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. DATES: Comments identified by the docket ID number OPPT   2004   0072 and the specific PMN number or TME number, must be received on or before March 10, 2004. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics ( 7408M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2004   0072. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets.

VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1 5981 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number and specific PMN number or TME number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket/, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPPT   2004   0072. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to oppt. ncic@ epa. gov, Attention: Docket ID Number OPPT   2004   0072 and PMN Number or TME Number. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your email address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Document Control Office ( 7407M), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office ( DCO) in EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2004   0072 and PMN Number or TME Number. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 564   8930.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1 5982 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action and the specific PMN number you are commenting on in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Why is EPA Taking this Action?

Section 5 of TSCA requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSCA, EPA is required to publish a notice of receipt of a PMN or an application for a TME and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from December 26, 2003 to January 16, 2004, consists of the PMNs and TMEs both pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs and TME This status report identifies the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. If you are interested in information that is not included in the following tables, you may contact EPA as described in Unit II. to access additional non CBI information that may be available. In Table I of this unit, EPA provides the following information ( to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: the EPA case number assigned to the PMN; the date the PMN was received by EPA; the projected end date for EPA's review of the PMN; the submitting manufacturer; the potential uses identified by the manufacturer in the PMN; and the chemical identity.

I. 63 PREMANUFACTURE NOTICES RECEIVED FROM: 12/ 26/ 03 TO 01/ 16/ 04 Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   04   0204 12/ 29/ 03 03/ 27/ 04 CBI ( G) Resin for spray applied coatings ( G) Olefin based block copolymer P   04   0205 12/ 29/ 03 03/ 27/ 04 CBI ( S) Component in an industrial coating ( S) 1,4 cyclohexanedicarboxylic acid, polymer with 1,6 hexanediol, nonanedioic acid 1,3,5 tris( 2 hydroxyethyl 1,3,5 triazine 2,4,6( 1h, 3h, 5h) trione P   04   0206 12/ 29/ 03 03/ 27/ 04 Gharda chemicals ltd. ( G) Virgin polymer or with various colorants and glass fibers/ carbon fibers ( fillers/ processing aids for applications ( G) Polyether ether sulfone sulfone P   04   0207 12/ 29/ 03 03/ 27/ 04 CBI ( G) Contained use in energy production ( G) Phosphonate salt P   04   0208 12/ 29/ 03 03/ 27/ 04 CBI ( G) Contained use in energy production ( G) Phosphonate salt P   04   0209 12/ 29/ 03 03/ 27/ 04 CBI ( G) Contained use in energy production ( G) Phosphonate salt P   04   0210 12/ 29/ 03 03/ 27/ 04 CBI ( G) Contained use in energy production ( G) Phosphonate salt P   04   0211 12/ 29/ 03 03/ 27/ 04 CBI ( G) Contained use in energy production ( G) Phosphonate salt P   04   0212 12/ 29/ 03 03/ 27/ 04 CBI ( G) Open, non dispersive uses ( G) Disproportionated rosin esters P   04   0213 12/ 29/ 03 03/ 27/ 04 CBI ( G) Surfactant ( G) Perfluoro alkylethyl acrylate copolymer P   04   0214 12/ 29/ 03 03/ 27/ 04 CBI ( G) Surfactant ( G) Perfluoro alkylethyl acrylate copolymer P   04   0215 12/ 29/ 03 03/ 27/ 04 CBI ( G) Surfactant ( G) Perfluoro alkylethyl acrylate copolymer P   04   0216 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Decanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0217 12/ 31/ 03 03/ 29/ 04 Bp Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Dodecanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0218 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Isooctadecanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0219 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Fatty acids, soya, compounds with 2 amino 2 methyl 1 propanol P   04   0220 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Fatty acids, coco, compounds with 2 amino 2 methyl 1 propanol VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1 5983 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices I. 63 PREMANUFACTURE NOTICES RECEIVED FROM: 12/ 26/ 03 TO 01/ 16/ 04   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   04   0221 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Decanedioic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 2) P   04   0222 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Nitric acid, reaction products with cyclododecanol and cyclododecanone, by products from, high boiling fraction, compounds with 2 amino 2 methyl 1 propanol ( 1: 2) P   04   0223 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Dodecanedioic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 2) P   04   0224 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Nonanedioic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 2) P   04   0225 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Undecanedioic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 2) P   04   0226 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Propanoic acid, 2 hydroxy, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0227 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) 1 propanol, 2 amino 2 methyl, benzoate ( salt) P   04   0228 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Boric acid ( h3b03), compound with 2 amino 2 methyl 1 propanol P   04   0229 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Heptanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0230 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Octanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0231 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Nonanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0232 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Hexanoic acid, 2 ethyl, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0233 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Isononanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0234 12/ 31/ 03 03/ 29/ 04 BP Amoco Chemical Company ( S) Ferrous metal corrosion inhibitor in metalworking fluid ( S) Neodecanoic acid, compound with 2 amino 2 methyl 1 propanol ( 1: 1) P   04   0236 01/ 06/ 04 04/ 04/ 04 H. B. Fuller ( S) Polymer for fiberglassing binder ( G) Polyacrylic resin P   04   0237 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, alkoxylated amine carboxylate salt P   04   0238 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, alkoxylated amine carboxylate salt P   04   0239 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, alkoxylated amine carboxylate salt P   04   0240 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, Alkoxylated amine carboxylate salt P   04   0241 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, Alkoxylated amine carboxylate salt P   04   0242 01/ 06/ 04 04/ 04/ 04 Houghton International Inc. ( S) Lubricant additive ( G) Alkanolamine carboxylate salt, Alkoxylated amine carboxylate salt P   04   0243 01/ 06/ 04 04/ 04/ 04 Werk AM Co., LTD ( G) Developer Chemical ( G) Hydroxy arylsulphone P   04   0244 12/ 31/ 03 03/ 29/ 04 Great Lakes Chemical ( S) Chemical intermediate ( S) Ethane, 2 bromo 1,1 difluoro P   04   0245 01/ 07/ 04 04/ 05/ 04 CBI ( G) Polymeric admixture for cements ( G) Polycarboxylate polymer with alkenyloxyalkylol modified poly( oxyalkylenediyl), potassium sodium salt P   04   0246 01/ 07/ 04 04/ 05/ 04 CBI ( G) Polymeric admixture for cements ( G) Polycarboxylate polymer with alkenyloxyalkylol modified poly( oxyalkylenediyl), potassium sodium salt P   04   0247 01/ 07/ 04 04/ 05/ 04 CBI ( S) Fertilizer for turf and crops ( S) Oils, sargassum thunbergii P   04   0248 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0249 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0250 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1 5984 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices I. 63 PREMANUFACTURE NOTICES RECEIVED FROM: 12/ 26/ 03 TO 01/ 16/ 04   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   04   0251 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0252 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0253 01/ 07/ 04 04/ 05/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0254 01/ 08/ 04 04/ 06/ 04 CBI ( G) Coating additive ( G) Mixed metal complex P   04   0255 01/ 12/ 04 04/ 10/ 04 CBI ( S) Coil coatings ( G) Polymer of aliphatic/ aromtic polycarboxylic acids and aliphatic polyols P   04   0256 01/ 12/ 04 04/ 10/ 04 CBI ( S) Adhesives; coatings ( G) Polybutadiene prepolymer P   04   0257 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0258 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0259 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0260 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0261 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0262 01/ 12/ 04 04/ 10/ 04 Ashland Inc., Environmental Health and Safety ( G) Adhesive, coating, ink ( G) Multifunctional acrylate oligomer resin P   04   0263 01/ 13/ 04 04/ 11/ 04 CBI ( S) Coil coating ( G) Polymer of cycloaliphatic polycarboxylic acid and aliphatic polyol P   04   0264 01/ 13/ 04 04/ 11/ 04 CBI ( G) Lubricating agent ( lubricant) ( G) Thiophenol mix P   04   0265 01/ 13/ 04 04/ 11/ 04 CIBA Specialty Chemicals Corporation, Textile Effects ( S) A component in oil, water, and soil repellent finish of fabrics of all fibers ( G) Substituted alkyl diol polymer with substituted alkyloxime and substituted cycloalkane and unsaturated alcohols P   04   0266 01/ 14/ 04 04/ 12/ 04 AOC L. L. C. ( S) Polymer component for laminating of fiberglass reinforced plastic parts ( S) 1,3 isobenzofurandione, polymer with 1,2 ethanediol, 2,5 furandione, 2,2' oxybis[ ethanol] and 1,2 propanediol, 3a, 4,5,6,7,7ahexahydro 4,7 methano 1h inden 5( or 6) yl ester P   04   0267 01/ 15/ 04 04/ 13/ 04 CBI ( S) Laminating adhesive ( G) Aromatic polyether polyester polyurethane In Table II of this unit, EPA provides the following information ( to the extent that such information is not claimed as CBI) on the TMEs received:

II. 2 TEST MARKETING EXEMPTION NOTICES RECEIVED FROM: 12/ 26/ 03 TO 01/ 16/ 04 Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical T   04   0001 12/ 30/ 03 02/ 12/ 04 CBI ( G) Polyurethane's market ( G) Soy polyol VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1 5985 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices II. 2 TEST MARKETING EXEMPTION NOTICES RECEIVED FROM: 12/ 26/ 03 TO 01/ 16/ 04   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical T   04   0002 01/ 12/ 04 02/ 25/ 04 IIford Imaging USA ( S) Dye formulated in water based ink for use in inkjet printer cartridges. ( S) 1h pyrazole 3 carboxlic acid, 4 [[ 5[[ 4,6 bis[( 3 sulfopropyl) thio] 1,3,5 triazin 2 yl] amino] 2 sulfophenyl] azo] 1( 2,5 dichloro 4 sulfophenyl) 4,5 dihydro 5 oxo, pentasodium salt In Table III of this unit, EPA provides the following information ( to the extent that such information is not claimed as CBI) on the Notices of Commencement to manufacture received:

III. 17 NOTICES OF COMMENCEMENT FROM: 12/ 26/ 03 TO 01/ 16/ 04 Case No. Received Date Commencement Notice End Date Chemical P   01   0247 01/ 07/ 04 11/ 18/ 03 ( G) Reaction product of aliphatic amines with fatty acids, phthalic anhydride and epoxide oligomers P   02   0983 12/ 29/ 03 12/ 01/ 03 ( G) Substituted alkyl heteromonocycle P   02   1041 12/ 29/ 03 12/ 21/ 03 ( G) Isocyanate functional polyester polyether urethane polymer P   03   0104 01/ 13/ 04 12/ 08/ 03 ( G) Tristyryl phenol alkoxylate salt P   03   0108 01/ 06/ 04 12/ 12/ 03 ( G) Substituted cyan acetic acid pentyl ester P   03   0357 01/ 07/ 04 12/ 08/ 03 ( G) Transition metal complex P   03   0587 01/ 05/ 04 11/ 17/ 03 ( S) Propanoic acid, 2 hydroxy,( 2r) P   03   0598 01/ 15/ 04 12/ 29/ 03 ( G) Sulfurized vegetable oil P   03   0599 01/ 15/ 04 12/ 29/ 03 ( G) Sulfurized vegetable oil P   03   0618 01/ 12/ 04 12/ 10/ 03 ( G) Silsesquioxane P   03   0653 01/ 12/ 04 12/ 09/ 03 ( G) Polycarboxylate polymer with alkenylsubstituted carbomonocycle, modified with poly( oxyalkylenediyl) and polymer of heteromonocycle and alkylheteromonocycle monoalkyl ether, sodium salt P   03   0770 01/ 13/ 04 12/ 30/ 03 ( G) Hydrophobically modified hydroethylcellulose P   03   0787 01/ 12/ 04 12/ 09/ 03 ( S) 13 docosenoic acid, potassium salt, ( 13z) P   03   0788 12/ 29/ 03 12/ 01/ 03 ( S) Docosanoic acid, potassium salt P   03   0833 01/ 07/ 04 12/ 15/ 03 ( G) Di substituted stilbenedisulfonic acid salt P   03   0834 01/ 07/ 04 12/ 12/ 03 ( G) Derivative of a disubstituted phenylenediamine P   99   0920 12/ 29/ 03 12/ 11/ 03 ( S) Poly( oxy 1,2 ethanediyl), alpha( 9z) 9 octadecenyl omega hydroxy, phosphate ammonium salt List of Subjects Environmental protection, Chemicals, Premanufacturer notices.

Dated: January 29, 2004. Anthony Cheatham, Acting Director, Information Management Division, Office of Pollution Prevention and Toxics. [ FR Doc. 04   2709 Filed 2   6   04; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7619   7]

Clean Water Act Section 303( d): Availability of 4 Total Maximum Daily Loads ( TMDL)

AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notice of availability. SUMMARY: This notice announces the availability for comment of the administrative record files for 4 TMDLs and the calculations for these TMDLs prepared by EPA Region 6 for waters listed in the Barataria river basin, under section 303( d) of the Clean Water Act ( CWA). These TMDLs were completed in response to a court order in the lawsuit styled Sierra Club, et al. v. Clifford, et al., No. 96   0527, ( E. D. La.). DATES: Comments must be submitted in writing to EPA on or before March 10, 2004. ADDRESSES: Comments on the 4 TMDLs should be sent to Ellen Caldwell, Environmental Protection Specialist, Water Quality Protection Division, U. S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, TX 75202   2733 or e mail: caldwell. ellen@ epa. gov. For further information, contact Ellen Caldwell at ( 214) 665   7513. The administrative record files for the 4 TMDLs are available for public inspection at this address as well. Documents from the administrative record files may be viewed at http:// www. epa. gov/ region6/ water/ tmdl. htm, or obtained by calling or writing Ms. Caldwell at the above address. Please contact Ms. Caldwell to schedule an inspection.

FOR FURTHER INFORMATION CONTACT: Ellen Caldwell at ( 214) 665   7513.

SUPPLEMENTARY INFORMATION: In 1996, two Louisiana environmental groups, the Sierra Club and Louisiana Environmental Action Network ( plaintiffs), filed a lawsuit in Federal Court against the EPA, styled Sierra Club, et al. v. Clifford, et al., No. 96   0527, ( E. D. La.). Among other claims, plaintiffs alleged that EPA failed to establish Louisiana TMDLs in a timely manner.

EPA Seeks Comment on 4 TMDLs By this notice EPA is seeking comment on the following 4 TMDLs for VerDate jul< 14> 2003 14: 27 Feb 06, 2004 Jkt 203001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09FEN1. SGM 09FEN1


[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 320-322]
[FR Doc No: 2019-28408]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3535]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Special Protocol Assessment; Guidance for Industry

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 the information collection in
the April 2018 guidance for industry entitled ``Special Protocol
Assessment'' (Revision 1).

DATES: Submit either electronic or written comments on the collection
of information by March 3, 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 March 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 3, 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.
2016-N-3535 for ``Special Protocol Assessment; Guidance for Industry.''
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: Domini Bean, 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.

Special Protocol Assessment

OMB Control Number 0910-0470--Extension

    This information collection approval request is for the 2018 FDA
guidance for industry, ``Special Protocol Assessment'' (Revision 1) (83
FR 16367, April 16, 2018), that describes Agency procedures to evaluate
issues related to the adequacy (e.g., design, conduct, analysis) of
certain proposed studies. A copy of the guidance is available from our
website at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. The guidance describes procedures for sponsors to request
special protocol assessment and for FDA to act on such requests. The
guidance provides information on how FDA interprets and applies
provisions of the Food and Drug Administration Modernization Act of
1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA)
goals for special protocol assessment associated with the development
and review of PDUFA products. The guidance describes the following two
collections of information: (1) The submission of a notice of intent to
request special protocol assessment of a carcinogenicity protocol; and
(2) the submission of a request for special protocol assessment.

I. Notification for a Carcinogenicity Protocol

    As described in the guidance, a sponsor interested in an FDA
assessment of a carcinogenicity protocol should notify the appropriate
division in FDA's Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER) of an intent to
request special protocol assessment at least 30 days prior to
submitting the request. With such notification, the sponsor should
submit relevant background information so that FDA may review reference
material related to carcinogenicity protocol design before receiving
the carcinogenicity protocol.

II. Request for Special Protocol Assessment

    The guidance asks that a request for special protocol assessment be
submitted as an amendment to the investigational new drug application
(IND) for the underlying product and that it be submitted to FDA in
triplicate with Form FDA 1571 (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf) attached. The guidance also
suggests that the sponsor submit the cover letter to a request for
special protocol assessment via fax to the appropriate division in CDER
or CBER. FDA regulations (21 CFR 312.23(d)) state that information
provided to us as part of an IND is to be submitted in triplicate and
with the appropriate cover form, Form FDA 1571. An IND is submitted to
FDA under existing regulations in part 312 (21 CFR part 312), which
specifies the information that manufacturers must submit so that FDA
may properly evaluate the safety and effectiveness of investigational
drugs and biological products. The information collection requirements
resulting from the preparation and submission of an IND under part 312
have been estimated by FDA, and the reporting and recordkeeping burden
has been approved by OMB under OMB control number 0910-0014.
    FDA suggests that the cover letter to the request for special
protocol assessment be submitted via fax to the appropriate division in
CDER or CBER to enable FDA staff to prepare for the arrival of the
protocol for assessment. FDA recommends that a request for special
protocol assessment be submitted as an amendment to an IND for two
reasons: (1) To ensure that each request is kept in the administrative
file with the entire IND and (2) to ensure that pertinent information
about the request is entered into the appropriate tracking databases.
Use of the information in FDA's tracking databases enables the
appropriate Agency official to monitor progress on the evaluation of
the protocol and to ensure that appropriate steps will be taken in a
timely manner.
    The guidance recommends that the following information should be
submitted to the appropriate Center with each request for special
protocol assessment so that the Center may quickly and efficiently
respond to the request:
     Questions to FDA concerning specific issues regarding the
protocol.
     All data, assumptions, and information needed to permit an
adequate evaluation of the protocol, including: (1) The role of the
study in the overall development of the drug; (2) information
supporting the proposed trial, including power calculations, the choice
of study endpoints, and other critical design features; (3) regulatory
outcomes that could be supported by the results of the study; (4) final
labeling that could be supported by the results of the study; and (5)
for a stability

protocol, product characterization and relevant manufacturing data.
    Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biologic product that FDA regulates under the Federal
Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act (42 U.S.C. 262) requesting special protocol assessment.
    Burden Estimate: Table 1 provides an estimate of the annual
reporting burden for notifications for a carcinogenicity protocol and
requests for a special protocol assessment.
    Notification for a Carcinogenicity Protocol: Based on the number of
notifications for carcinogenicity protocols and the number of
carcinogenicity protocols currently submitted to CDER and CBER, CDER
estimates that it will receive approximately 188 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 105 sponsors. CBER estimates that
it will receive approximately one notification of an intent to request
special protocol assessment of a carcinogenicity protocol per year from
approximately one sponsor. The hours per response, which is the
estimated number of hours that a sponsor would spend preparing the
notification and background information to be submitted in accordance
with the guidance, is estimated to be approximately 8 hours.
    Requests for Special Protocol Assessment: Based on the number of
requests for special protocol assessment currently submitted to CDER
and CBER, CDER estimates that it will receive approximately 108
requests for special protocol assessment per year from approximately
105 sponsors. CBER estimates that it will receive approximately eight
requests from approximately eight sponsors. The hours per response is
the estimated number of hours that a respondent would spend preparing
the information to be submitted with a request for special protocol
assessment, including the time it takes to gather and copy questions to
be posed to the Agency regarding the protocol and data, assumptions,
and information needed to permit an adequate evaluation of the
protocol. Based on our experience with these submissions, we estimate
approximately 15 hours on average would be needed per response.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity             106            1.78             189               8           1,510
 Protocols......................
Requests for Special Protocol                113            1.66             116              15           1,740
 Assessment Reports.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             305  ..............           3,250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection reflects an adjustment in burden by 608
hours. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.

    Dated: December 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28408 Filed 1-2-20; 8:45 am]
 BILLING CODE 4164-01-P


~~~~~~~~

UNITED STATES ENVIRONMENTAL PROTECTIONAqPPT p4:: JC REGION 111 1650 Arch Street ~~~~

Philadelphia, Pennsylvania 19103 2029 057 3 i hip!   13: 263 Mr. Richard Brewster, Program Manager Lead Program Prevention Division DC Environmental Health Administration 825 North Capitol St., NE 5th Floor Washington, DC 20062 Dear Mr. Brewster,

I received a letter from the District, dated June 1, 1999, that pertains to the District s application for State Lead Program Authorization but appears to be missing most of its attachments. The Table of Contents were included, as were Appendices B and M, but that is all that was attached to the letter. Also, the last page of the letter appears to be missing. Our version ends with a response to Item 11 but includes no signature. Wouldyou please have these sent immediately?

Based upon reviewing the material that we did receive, listed below are some questions and comments.

1E. Enforcement Rmources  Please indicate, on page 12, the Division in which each individual works. DC responded that five individuals are located in the Lead Poisoning Prevention Division but did not show where the other two individuals are located, nor which ones work in LPPD.

Is the only document now to be included in Appendix E to be the organizationalchart? The Organization Order dated 11/ 6/ 98is not included in the District s response.

5. Third Paw Exam  Please describe the alternate procedures that we underway for certification based on prior training.

Part of running an authorized State Lead Program includes administering a third party exam. When the District self certified last August, thisimplied that the District was running a full program, which includes administering a third party exam for inspectors, supervisors, and risk assessors. Whether issuance of the exam is included as a specific grant deliverable is not pertinent.

Why have no requests been received for taking the exam? Please provide a list of individuals that are certified in the District for conduct of lead based paint activities.

CustomerService Hotline: 1 800 438 2474 1 If no individuals have taken the third party exam in the District, who is supervising abatements and performing inspections and risk assessments in the District? What compliance monitoring activities are underway in the District to ensure that these LBP activities are not underway without adequate certification?

6. CertiJicatiunofIndividuals  The March 15 letter fbm the District was not fully responsive. Please see EPA s letter to the District, dated May 20, 1999. ( A copy is enclosed with this letter.)

Please call me when you receive this letter to discuss how the District intends to respond. We also should begin to discuss prospects and procedures for Interim Authorization to the District as a means of addressing EPA s enforcement related concerns.

Thank you.

cc. G. Amisial S. Arnold P. Cestone M. Coe A. Dickens D. Gal10 J. Sofield enclosure ( 1) Sincerely,

/. 9 Gerallyn Valls U Region 111Lead Program Coordinator


[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5538-5540]
[FR Doc No: 2019-02893]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85133; File No. SR-BOX-2019-03]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee
Schedule on the BOX Options Market LLC (``BOX'') Facility To Modify Its
Strategy QOO Order Fee Cap and Rebate

February 14, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 1, 2019, BOX Exchange LLC (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the Act,\3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. 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\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule to
amend the Fee Schedule [sic] on the BOX Options Market LLC (``BOX'')
options facility. The text of the proposed rule change is available
from the principal office of the Exchange, at the Commission's Public
Reference Room

and also on the Exchange's internet website at http://boxexchange.com.

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 Exchange 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 Exchange 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule for trading on BOX
to amend Section II.D (Strategy QOO Order Fee Cap and Rebate).
Currently, the Exchange caps fees and offers rebates on all reversal,
conversion, jelly roll, and box spread strategies on the BOX Trading
Floor. The Exchange is now proposing to cap fees and offer a Floor
Broker rebate for short stock interest strategy transactions.
    A short stock interest strategy is a transaction done to achieve a
short stock interest arbitrage involving the purchase, sale, and
exercise of in-the-money options of the same class. The Exchange
proposes to include this definition in a footnote in the BOX Fee
Schedule along with the other definitions of the strategies in Section
II.D.
    The Exchange proposes to offer a strategy cap for short stock
interest strategies. Today, Floor Participant transactions are capped
at $1,000 for all reversal, conversion, jelly roll, and box spread
strategies executed on the same trading day.\5\ The Exchange proposes
to include short stock interest strategies in the daily Strategy QOO
Order Fee Cap and Rebate. As such, Floor Participant transactions will
also be capped at $1,000 for all short stock interest strategies
executed on the same trading day. Further, the Exchange proposes to
include short stock interest strategies in the Floor Broker Strategy
QOO Rebate. As proposed, on each trading day, Floor Brokers are
eligible to receive a $500 rebate for presenting certain Strategy QOO
Orders on the Trading Floor. The rebate will be applied once the $1,000
fee cap for all short stock interest, reversal, conversion, jelly roll,
and box spread strategies is met.
---------------------------------------------------------------------------

    \5\ Reversal, conversion, jelly roll and box spread transactions
are not included in the monthly fee cap for Broker Dealers.
---------------------------------------------------------------------------

    The Exchange notes that the fee cap discussed herein exists at
another options exchange in the industry.\6\
---------------------------------------------------------------------------

    \6\ See Cboe Exchange Inc. (``Cboe'') Fee Schedule Footnote 13.
At Cboe, market-maker, Clearing Trading Permit Holder, JBO
participant, broker-dealer and non-Trading Permit Holder market-
maker transaction fees are capped at $1,000 for all short stock
interest strategies. Unlike Cboe, BOX does not have a monthly fee
cap because the Exchange previously removed it for being unnecessary
due to the fact that if Participants are capped at $1,000 per day,
they would never reach the previous $25,000 monthly fee cap. See SR-
BOX-2018-11.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5)of the Act,\7\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that including short stock interest
strategies in Section II.D of the BOX Fee Schedule is reasonable, as
another exchange offers fee caps for short stock interest strategies,
namely Cboe.\8\ Moreover, the Exchange believes the proposed fees are
reasonable in comparison because BOX's fee cap for short stock interest
strategies is identical to Cboe's fee cap. Further, the Exchange
believes that including short stock interest strategies in the Strategy
QOO Order rebate is appropriate as Floor Brokers are eligible to
receive a $500 rebate for presenting all other strategies to the BOX
Trading Floor.
---------------------------------------------------------------------------

    \8\ See supra note 6.
---------------------------------------------------------------------------

    The Exchange believes that the proposed fee cap for short stock
interest strategies is equitable and not unfairly discriminatory
because it provides incentives for all Participants to submit these
types of strategy orders to the BOX Trading Floor, which brings
increased liquidity and order flow to the floor for the benefit of all
market participants. Further, the Exchange believes that including
short stock interest strategies in the Strategy QOO Order rebate is
equitable and not unfairly discriminatory as the rebate is available to
all Floor Brokers who submit such orders to the BOX Trading Floor.

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 because the proposed change
applies uniformly to all Participants that incur transaction fees for
short stock interest strategies. Further, another options exchange
today offer caps on short stock interest strategies; therefore, the
Exchange believes that the proposal is consistent with robust
competition and does not provide any unnecessary burden on competition.
Further, because Floor Participants pay Floor Brokers to execute trades
on the Exchange floor, the Exchange believes that offering fee caps on
short stock interest strategies to Participants executing floor
transactions and not electronic executions does not create an
unnecessary burden on competition because the fee cap defrays brokerage
costs associated with executing short stock interest strategy
transactions, similar to other strategies today.
    The Exchange operates in a highly competitive market in which
market participants can easily and readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or rebates to be inadequate. Accordingly, the fee cap and
Floor Broker rebate for short stock interest strategies proposed by the
Exchange, as described in the proposal, are influenced by these robust
market forces and therefore must remain competitive with fee caps at
other venues and therefore must continue to be reasonable and equitably
allocated to those Participants that opt to direct orders to the
Exchange rather than competing venues.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \9\ and Rule 19b-4(f)(2)
thereunder,\10\ because it establishes or changes a due, or fee.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may

temporarily suspend the rule change if it appears to the Commission
that the action is necessary or appropriate in the public interest, for
the protection of investors, or would otherwise further the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or 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-BOX-2019-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2019-03. 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 website (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 website 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 such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BOX-2019-03, and should be submitted on
or before March 14, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02893 Filed 2-20-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Page 85656]
[FR Doc No: 2020-28728]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3541-EM; Docket ID FEMA-2020-0001]

Arkansas; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of Arkansas (FEMA-3541-EM), dated August 27, 2020, and
related determinations.

DATES: This amendment was issued September 11, 2020.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective August 28, 2020.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-28728 Filed 12-28-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Rules and Regulations]
[Pages 12243-12244]
[FR Doc No: 2013-04001]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0094; FRL-9783-3]

Interim Final Determination To Stay and Defer Sanctions, Placer
County Air Pollution Control District and Feather River Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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SUMMARY: EPA is making an interim final determination to stay the
imposition of offset sanctions and to defer the imposition of highway
sanctions based on a proposed approval of a revision to the Placer
County Air Pollution Control District (PCAPCD) and Feather River Air
Quality Management District (FRAQMD) portion of the California State
Implementation Plan (SIP) published elsewhere in this Federal Register.
The SIP revision concerns two permitting rules submitted by the PCAPCD
and FRAQMD, respectively: Rule 502, New Source Review, and Rule 10.1,
New Source Review.

DATES: This interim final determination is effective on February 22,
2013. However, comments will be accepted until March 25, 2013.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0094, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or email. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send email directly to EPA, your email address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment.
    Docket: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

I. Background

    On July 27, 2011 (76 FR 44809), we published a limited approval and
limited disapproval of PCAPCD Rule 502 and FRAQMD Rule 10.1 as adopted
locally on October 28, 2010 and October 5, 2009, respectively. We based
our limited disapproval action on certain deficiencies in the submitted
rule. This disapproval action started a sanctions clock for imposition
of offset sanctions 18 months after August 27, 2011 and highway
sanctions 6 months later, pursuant to section 179 of the Clean Air Act
(CAA) and our regulations at 40 CFR 52.31. Under 40 CFR 52.31(d)(1),
offset sanctions apply eighteen months after the effective date of a
disapproval and highway sanctions apply six months after the offset
sanctions, unless we determine that the deficiencies forming the basis
of the disapproval have been corrected.
    On October 31, 2011 and February 7, 2012, PCAPCD and FRAQMD adopted
amended versions of Rules 502 and 10.1, respectively, which were
intended to correct the deficiencies identified in our July 27, 2011
limited disapproval action. On November 18, 2011 and September 21,
2012, the State submitted these amended rules to EPA. In the Proposed
Rules section of today's Federal Register, we are proposing a limited
approval/limited disapproval of these rules because we believe it
corrects the deficiencies identified in our July 27, 2011 disapproval
action, but other revisions have created new deficiencies. Based on
today's proposed action, we are taking this final rulemaking action,
effective on publication, to stay the imposition of the offset
sanctions and to defer the imposition of the highway sanctions

that were triggered by our July 27, 2011 limited disapproval.
    EPA is providing the public with an opportunity to comment on this
stay/deferral of sanctions. If comments are submitted that change our
assessment described in this final determination and our proposed
limited approval and limited disapproval of PCAPCD Rule 502 and FRAQMD
Rule 10.1, respectively, we intend to take subsequent final action to
reimpose sanctions pursuant to 40 CFR 52.31(d). If no comments are
submitted that change our assessment, then all sanctions and sanction
clocks will be permanently terminated on the effective date of a final
rule approval.

II. EPA Action

    We are making an interim final determination to stay the imposition
of the offset sanctions and to defer the imposition of the highway
sanctions associated with PCAPCD Rule 502 and FRAQMD Rule 10.1 (as
adopted 2010 and 2009 respectively) based on our concurrent proposal to
approve the State's SIP revision as correcting the deficiencies that
initiated sanctions.
    Because EPA has preliminarily determined that the State has
corrected the deficiencies identified in EPA's limited disapproval
action, relief from sanctions should be provided as quickly as
possible. Therefore, EPA is invoking the good cause exception under the
Administrative Procedure Act (APA) in not providing an opportunity for
comment before this action takes effect (5 U.S.C. 553(b)(3)). However,
by this action EPA is providing the public with a chance to comment on
EPA's determination after the effective date, and EPA will consider any
comments received in determining whether to reverse such action.
    EPA believes that notice-and-comment rulemaking before the
effective date of this action is impracticable and contrary to the
public interest. EPA has reviewed the State's submittal and, through
its proposed action, is indicating that it is more likely than not that
the State has corrected the deficiencies that started the sanctions
clocks. Therefore, it is not in the public interest to initially impose
sanctions or to keep applied sanctions in place when the State has most
likely done all it can to correct the deficiencies that triggered the
sanctions clocks. Moreover, it would be impracticable to go through
notice-and-comment rulemaking on a finding that the State has corrected
the deficiencies prior to the rulemaking approving the State's
submittal. Therefore, EPA believes that it is necessary to use the
interim final rulemaking process to stay and defer sanctions while EPA
completes its rulemaking process on the approvability of the State's
submittal. Moreover, with respect to the effective date of this action,
EPA is invoking the good cause exception to the 30-day notice
requirement of the APA because the purpose of this notice is to relieve
a restriction (5 U.S.C. 553(d)(1)).

III. Statutory and Executive Order Reviews

    This action stays and defers Federal sanctions and imposes no
additional requirements.
    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.
    This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action.
    The administrator certifies that this action will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
    This rule does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule does not have tribal implications because it will 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).
    This action does not have Federalism implications because it does
not 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 in Executive Order 13132 (64 FR 43255, August 10, 1999).
    This rule 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.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply to
this rule because it imposes no standards.
    This rule 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 to Congress and the Comptroller
General. However, section 808 provides that any rule for which the
issuing agency for good cause finds that notice and public procedure
thereon are impracticable, unnecessary, or contrary to the public
interest, shall take effect at such time as the agency promulgating the
rule determines. 5 U.S.C. 808(2). EPA has made such a good cause
finding, including the reasons therefore, and established an effective
date of February 22, 2013. 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 rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 23, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purpose of judicial review nor does
it extend the time within which petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental regulations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

    Dated: February 12, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013-04001 Filed 2-21-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40110-40112]
[FR Doc No: 2018-17253]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83788; File No. SR-MIAX-2018-18]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

August 7, 2018.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4

thereunder,\2\ notice is hereby given that on July 31, 2018, Miami
International Securities Exchange LLC (``MIAX Options'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings, at MIAX's principal
office, and at the Commission's Public Reference Room.

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 Exchange 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 Exchange 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule to adopt a stock
handling fee for stock-option orders (including stock-option eQuotes)
executed against other stock-option orders in the complex order book,
which the Exchange must route to an outside venue.
    The Exchange recently amended Exchange Rule 518, Complex Orders, to
update its rule text regarding stock-option orders, in connection with
the upcoming launch of such orders on the Exchange.\3\ Complex orders
began trading on the Exchange on October 24, 2016.\4\ In its rule
filing to establish the trading of complex orders, the Exchange adopted
rules for handling stock-option orders.\5\ The Exchange also indicated
that it would determine when stock-option orders would be made
available for trading in the System \6\ and would communicate such
determination to Members \7\ via Regulatory Circular.\8\ The Exchange
made certain changes to its rule text, in connection with the upcoming
launch of such orders on the Exchange, which is scheduled for Q3 2018.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 83726 (July 27,
2018) (SR-MIAX-2018-16) Notice of Filing and Immediate Effectiveness
of a Proposed Rule Change to Amend Exchange Rule 518, Complex
Orders.
    \4\ See MIAX Regulatory Circular 2016-43, October 20, 2016.
    \5\ See Securities Exchange Act Release No. 79072 (October 7,
2014), 81 FR 71131 (October 14, 2016) (SR-MIAX-2016-26).
    \6\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \7\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \8\ See supra note 3.
---------------------------------------------------------------------------

    The Exchange proposes to adopt a stock handling fee applicable to
stock-option orders (including stock-option eQuotes) executed against
other stock-option orders in the complex order book, which the Exchange
must route to an outside venue. Specifically, the Exchange proposes to
adopt a stock handling fee of $0.0010 per share for the stock leg of
stock-option orders executed against other stock-option orders in the
complex order book, which are routed to an outside venue. This stock
handling fee to be assessed by the Exchange will cover all fees charged
by the outside venue that prints the trade, and it is also intended to
compensate the Exchange for matching these stock-option orders against
other stock-option orders on the complex order book. A maximum of $50
per order, per day, will be assessed under this fee. The cap is
intended to give market participants assurance that they will not pay
more than the capped amount for the execution of the stock leg of their
stock-option orders. The Exchange believes that by limiting this fee to
a maximum of $50 per order, per day, the Exchange addresses the
possibility that a GTC order could be executed over multiple days. For
example, if such an order was partially-executed on a Monday, and then
the remainder was fully-executed on a Tuesday, the total maximum fee
charged to the market participant would be $100 ($50 per day). In
addition to the Exchange's fee, the Exchange will also pass through to
the Member any fees assessed by the routing broker-dealer utilized by
the Exchange with respect to the execution of the stock leg of any such
order (with such fees to be passed through at cost). For example, the
Exchange anticipates that the routing broker-dealer will bill the
Exchange for Section 31 fees and FINRA Trading Activity Fees with
respect to the execution of the stock leg of any such order. The
Exchange will pass such fees through to the Member, at cost (that is,
without any additional mark-up).
    Separately, the Exchange also notes that it currently charges fees
to Members who subscribe to an Exchange-provided data feed that
contains real-time clearing trade updates, which includes trades in its
complex order book. Specifically, through the Exchange's Clearing Trade
Drop (``CTD'') port, it provides updates, including the Member's
clearing trade messages, on a low latency, real-time basis.\9\ With
respect to stock-option orders, the Exchange notes that while such CTD
port will now include information relating to the execution of both the
option leg(s) and the stock leg(s) of a stock-option order, the
Exchange will not charge an additional CTD fee for the stock leg(s) of
a stock-option order.
---------------------------------------------------------------------------

    \9\ See Fee Schedule 5)d)iii).
---------------------------------------------------------------------------

    The proposed rule change is scheduled to become operative on August
1, 2018.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \10\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \11\ in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among Exchange Members and
issuers and other persons using its facilities The Exchange also
believes the proposal furthers the objectives of Section 6(b)(5) of the
Act \12\ in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest and is not designed to
permit unfair discrimination between customer, issuers, brokers and
dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed stock handling fee for
stock-option orders (including stock-option eQuotes) is consistent with
Section 6(b)(4) of the Act in that it is reasonable, equitable and not
unfairly discriminatory. The Exchange believes the proposed stock
handling fee for

stock-option orders is reasonable and equitable as the proposed fee
will cover the costs of developing and maintaining the systems that
allow for the matching and processing of the stock legs of stock-option
orders executed in the complex order book, as well as all fees charged
by the outside venue that prints the trade. The Exchange also believes
it is reasonable and equitable to pass through to the Member any fees
assessed by the routing broker-dealer utilized by the Exchange with
respect to the execution of the stock leg of any such order (with such
fees to be passed through at cost). The Exchange notes that another
exchange has a comparable fee for the handling of the stock leg of
stock-option orders. Specifically, Nasdaq ISE (``ISE'') charges a stock
handling fee of $0.0010 per share which is capped at $50 per order.\13\
The Exchange also believes that its proposal is consistent with Section
6(b)(5) of the Act \14\ because it will be uniformly applied to all
Members that execute stock-option orders in the complex order book on
the Exchange.
---------------------------------------------------------------------------

    \13\ See ISE Schedule of Fees, Section II; see also Securities
Exchange Act Release No. 74117 (January 22, 2015), 80 FR 4600
(January 28, 2015) (SR-ISE-2015-03).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 fee is similar to
and within the range of fees charged by the Exchange's competitor.\15\
The Exchange notes that it operates in a highly competitive market in
which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive. In such an
environment, the Exchange must continually adjust its fees to remain
competitive with other exchanges and to attract order flow to the
Exchange. For the reasons stated above, the Exchange believes that the
proposed rule change reflects this competitive environment.
---------------------------------------------------------------------------

    \15\ See supra note 13.
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\16\ and Rule 19b-4(f)(2)\17\ thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-MIAX-2018-18 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2018-18. 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 website (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 website 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 also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MIAX-2018-18 and should be submitted on
or before September 4, 2018.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-17253 Filed 8-10-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38789-38790]
[FR Doc No: 2021-15575]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Federal Transit Administration

Notice of Limitation on Claims Against Proposed Public
Transportation Project

AGENCY: Federal Railroad Administration (FRA), Federal Transit
Administration (FTA), U.S. Department of Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice announces final environmental actions taken by FRA
and FTA regarding the Hudson Tunnel Project (Project). The purpose of
this notice is to announce publicly the environmental decisions on the
subject project and to activate the limitation on any claims that may
challenge these final environmental actions.

DATES: A claim seeking judicial review of actions announced herein for
the listed public transportation project will be barred unless the
claim is filed on or before December 20, 2021.

FOR FURTHER INFORMATION CONTACT:
    For FRA: Kathryn Johnson, Attorney-Advisor, Office of Chief
Counsel, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or
Amishi Castelli, Northeast Corridor Program Manager, Office of Railroad
Policy and Development, telephone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For FTA: John A. Sautter, Region 2 Counsel, Office of Chief
Counsel, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or
Donald Burns, Region 2 Supervisory Transportation Program Specialist,
telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or Saadat Khan,
Environmental Protection Specialist, Office of Environmental Programs,
telephone:

(202) 366-9647, email<EMAIL_ADDRESS>FTA Region 2 is located at
1 Bowling Green, Room 428, New York, NY 10004. FTA and FRA Headquarters
are located at 1200 New Jersey Avenue SE, Washington, DC 20590. Office
hours for both Regional and Headquarters Offices are from 9:00 a.m. to
5:00 p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: Notice is hereby given that FRA and FTA have
taken final agency action by issuing certain approvals for the public
transportation project listed below. In accordance with 40 CFR 1506.3
and 23 U.S.C. 139, FRA and FTA issued a final environmental impact
statement (FEIS) and record of decision (ROD) on May 28, 2021. All
actions on the project, as well as the laws under which such actions
were taken, are described in the documentation issued in connection
with the project to comply with the National Environmental Policy Act
(NEPA) as well as in documents in the FTA environmental project file.
Interested parties may find more information on the Project website
(http://www.hudsontunnelproject.com/) or FRA's website for the Project
(https://railroads.dot.gov/environmental-reviews/hudson-tunnel-project/environmental-impact-statement).
    A summary of the Project that is the subject of this notice
follows:
    Project name and location: Hudson Tunnel Project, Hudson River
passenger rail crossing, Hudson County, New Jersey and New York County,
New York.
    Project Sponsor: Port Authority of New York and New Jersey, New
York, New York.
    Project description: The Project involves construction of a two-
track tunnel under the Hudson River (the Hudson River Tunnel) and
railroad infrastructure in New Jersey and New York connecting the new
rail tunnel to the existing Northeast Corridor (NEC), and
rehabilitation of the existing North River Tunnel. The new Hudson River
Tunnel will have two new tracks extending from the NEC in Secaucus, New
Jersey, beneath the Palisades (North Bergen and Union City, New Jersey)
and the Hoboken/Weehawken, New Jersey waterfront area, and beneath the
Hudson River to connect to the existing tracks in Penn Station New York
(PSNY). The new Hudson River Tunnel will be parallel to, and south of,
the existing NEC between Secaucus, New Jersey and PSNY. This alignment
will extend for a distance of approximately 4.5 miles. New ventilation
shafts and associated fan plants will be located above the tunnel in
New Jersey and New York for regular and emergency ventilation and
emergency access and egress. The western terminus of the new tunnel and
related tracks and infrastructure will be at Allied Interlocking, east
of County Road in Secaucus, New Jersey and the eastern terminus will be
at approximately Ninth Avenue in Manhattan, New York.
    This notice applies to all decisions on the Project as of the
issuance date of this notice and all laws under which such actions were
taken, including, but not limited to, NEPA [42 U.S.C. 4321-4375],
Section 4(f) requirements [23 U.S.C. 138, 49 U.S.C. 303], Section 106
of the National Historic Preservation Act [54 U.S.C. 306108],
Endangered Species Act [16 U.S.C. 1531], Clean Water Act [33 U.S.C.
1251], Clean Air Act [42 U.S.C. 7401-7671q], the Rivers and Harbors Act
of 1899 (33 U.S.C. 403), and the Coastal Zone Management Act of 1972
(16 U.S.C. 1451).
    Authority: 23 U.S.C. 139(l)(1).

Jamie P. Rennert,
Director, Office of Infrastructure Investment, Federal Railroad
Administration.
Mark A. Ferroni,
Deputy Associate Administrator for Planning and Environment, Federal
Transit Administration.
[FR Doc. 2021-15575 Filed 7-21-21; 8:45 am]
BILLING CODE 4910-57-P