19532 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices F. International Tolerances There are no Codex maximum residue levels established for cyprodinil. [ FR Doc. 03   9750 Filed 4   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0019; FRL   7304   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 TSCA, 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 February 11, 2003 to March 28, 2003, consists of the PMNs and the 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. DATES: Comments identified by the docket ID number OPPT   2003   0019 and the specific PMN number or TME number, must be received on or before May 21, 2003. 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   2003   0019. 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. 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.

VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 RECEIVED OPPT NCIC 2003 APR 21 7: 08AM OPPT 2003 0019 0001 19533 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices 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   2003   0019. 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   2003   0019 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 Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2003   0019 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. 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 February 11, 2003 to March 28, 2003, consists of the PMNs and the 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 TMEs This status report identifies the PMNs and TMEs 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.

VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 19534 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices 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. 112 PREMANUFACTURE NOTICES RECEIVED FROM: 02/ 11/ 03 TO 03/ 28/ 03 Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0335 02/ 11/ 03 05/ 12/ 03 Solutia ( S) Resin for industrial ultraviolet coatings ( G) Acrylate and urethane modified polyether P   03   0340 02/ 13/ 03 05/ 14/ 03 Crompton Corporation ( G) Catalyst ( G) Transition metal complex P   03   0341 02/ 13/ 03 05/ 14/ 03 CBI ( G) Base resin for ultraviolet light and electron beam cuarable formulations ( G) Functional alcohol, polymer with ipdi, 2 hydroxyethyl acrylateblocked P   03   0342 02/ 13/ 03 05/ 14/ 03 CBI ( G) Base resin for ultraviolet light and electron beam curable formulations ( G) Functional alcohol, polymer with tdi, 2 hydroxymethyl acrylateblocked P   03   0343 02/ 13/ 03 05/ 14/ 03 CBI ( G) Open, non dispersive use ( G) Acrylic polymer P   03   0344 02/ 13/ 03 05/ 14/ 03 CBI ( G) Open, non dispersive use ( G) Acrylic polymer P   03   0345 02/ 13/ 03 05/ 14/ 03 CBI ( G) Petroleum prouct additive ( G) C4 by products fraction P   03   0346 02/ 13/ 03 05/ 14/ 03 CBI ( G) Petroleum prouct additive ( G) C44 by products fraction P   03   0347 02/ 13/ 03 05/ 14/ 03 CBI ( G) Petroleum product additive ( G) C44 by products fraction P   03   0348 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0349 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0350 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0351 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0352 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0353 02/ 14/ 03 05/ 15/ 03 CBI ( G) Additive for polymer formulations ( G) Condensation polymer of anhydride and polyol P   03   0354 02/ 13/ 03 05/ 14/ 03 CBI ( G) Open non dispersive ( G) Phenylaldol P   03   0355 02/ 14/ 03 05/ 15/ 03 CBI ( G) Lubricant additive ( G) Fatty acid triester P   03   0356 02/ 21/ 03 05/ 22/ 03 Dow Agro Sciences ( G) Process intermediate ( G) Halogenated substituted mercaptophenyl alkyl ether P   03   0357 02/ 19/ 03 05/ 20/ 03 CBI ( G) Polymer catalyst ( contained use) ( G) Transition metal complex P   03   0358 02/ 19/ 03 05/ 20/ 03 Aceto Corporation ( S) Photopolymerisation initiator for for free radical ultraviolet radiation uring sytems; photopolymerisation sensitizer for cationic ultraviolet radiation curing systems ( S) 1 Chloro 4 propoxy thioxanthone P   03   0359 02/ 21/ 03 05/ 22/ 03 UCB Chemicals Corporation ( S) Resin for industrial ultraviolet coatings ( G) Modified epoxy acrylate P   03   0360 02/ 21/ 03 05/ 22/ 03 CBI ( S) Clear coating for wood ( diy); industrial wood coating ( G) Polyester polyurethane dispersion P   03   0361 02/ 21/ 03 05/ 22/ 03 International Specialty Products ( S) Component of coatings for digital printing paper ( S) 2 propenoic acid, 2 methyl, 2 hydroxyethyl ester, polymer with n[ 3 ( dimethylamino) propyl] 2 methyl 2 propenamide and 1 ethenylhexahydro 2h azepin 2 one, 2,2  azobis[ 2 methylbutanenitrile] initiated P   03   0362 02/ 21/ 03 05/ 22/ 03 Cytec Industries  Toxicology and Product Regulatory Compliance Department ( G) Sulfide mineral processing reagent ( G) Thionocarbamate derivative or modified thionocarbamate P   03   0363 02/ 21/ 03 05/ 22/ 03 Dow Agro Sciences ( G) Process intermediate ( G) Substituted aminotriazolopyrimidine P   03   0364 02/ 21/ 03 05/ 22/ 03 Dow Agro Sciences ( G) Process intermediate ( G) Halogenated substituted mercaptophenol P   03   0365 02/ 21/ 03 05/ 22/ 03 Dow Agro Sciences ( G) Process intermediate ( G) Halogenated substituted benzenesulfonyl chloride P   03   0366 02/ 21/ 03 05/ 22/ 03 BASF Corporation ( S) Gasoline additive ( G) Alkoxylated aliphatic alcohol P   03   0367 02/ 21/ 03 05/ 22/ 03 CBI ( G) Oxidation catalyst ( G) Amino ketal P   03   0368 02/ 25/ 03 05/ 26/ 03 CBI ( S) Paper colorant ( G) Copper phthalocyanine complex VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 19535 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices I. 112 PREMANUFACTURE NOTICES RECEIVED FROM: 02/ 11/ 03 TO 03/ 28/ 03   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0369 02/ 24/ 03 05/ 25/ 03 WSP Chemicals And Technology, LLC ( S) Oilfield down hole cement fluid loss additive ( S) 1 propanesulfonic acid, 2 methyl 2[( 1 Oxo 2 propenyl) amino], monosodium salt, polymer with N, N dimethyl 2 propenamide and 2 propenamide P   03   0370 02/ 24/ 03 05/ 25/ 03 CBI ( G) PH Control agent in textile applications ( G) Polyol ester P   03   0371 02/ 26/ 03 05/ 27/ 03 CBI ( G) Dyestuff for ink ( G) Substituted naphthalenedisulfonic acid azo dye, metal salt P   03   0372 02/ 27/ 03 05/ 28/ 03 Crompton Corporation ( G) Site limited raw material ( G) Alkyl hydroperoxide P   03   0373 02/ 24/ 03 05/ 25/ 03 CBI ( G) Component of a coating ( G) Poluyurea isocyanate prepolymer P   03   0374 02/ 24/ 03 05/ 25/ 03 CBI ( G) Component of a coating ( G) Polyurea isocyanate prepolymer P   03   0375 02/ 13/ 03 05/ 14/ 03 CBI ( G) Lubricant additive ( G) Substituted imidoalkylcarboxylic acid P   03   0376 02/ 13/ 03 05/ 14/ 03 CBI ( G) Lubricant additive ( G) Substituted imidoalkylcarboxylic acid P   03   0377 02/ 13/ 03 05/ 14/ 03 CBI ( G) Lubricant additive ( G) Substituted imidoalkylcarboxylic acid P   03   0378 02/ 14/ 03 05/ 15/ 03 CBI ( S) Polyurethane adhesive ( G) Polurethane P   03   0379 02/ 27/ 03 05/ 28/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0380 02/ 27/ 03 05/ 28/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0381 02/ 27/ 03 05/ 28/ 03 Johnson polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0382 02/ 27/ 03 05/ 28/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0383 02/ 27/ 03 05/ 28/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0384 02/ 27/ 03 05/ 28/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0385 03/ 04/ 03 06/ 02/ 03 Eastman Kodak Company ( G) Chemical intermediate, destructive use ( G) Cyano substituted phenyl sulfonamide P   03   0386 03/ 04/ 03 06/ 02/ 03 CBI ( G) Siloxane resin crosslinker additive ( G) Organofunctional polysiloxane P   03   0387 03/ 04/ 03 06/ 02/ 03 CBI ( G) Automotive coating ( G) Phthalic polyester P   03   0388 03/ 04/ 03 06/ 02/ 03 CBI ( G) Paint and coating additive ( G) Fatty acid amides P   03   0389 03/ 04/ 03 06/ 02/ 03 BASF Corporation ( G) Internal mold release ( G) Sorbitan ester with polyisobutenyl carbonic acids and fatty acid esters P   03   0390 03/ 04/ 03 06/ 02/ 03 CBI ( S) Spray applied automotive coatings ( G) Amine salt of polyurethane resin P   03   0391 03/ 04/ 03 06/ 02/ 03 CBI ( S) Spray applied automotive coatings ( G) Amine salt of polyurethane resin P   03   0392 03/ 06/ 03 06/ 04/ 03 CBI ( S) Luminiscent pigment for security printing inks ( G) Anthranilic acid derivative P   03   0393 03/ 06/ 03 06/ 04/ 03 UCB Chemicals Corporation ( S) Hardener for water thinnable paints ( G) Aliphatic polyamine P   03   0394 03/ 07/ 03 06/ 05/ 03 CBI ( S) Polymer stabilizer ( S) 1,3,2 dioxaphosphorinane, 2[ 2,4 bis( 1,1 dimethylethyl) phenoxy] 5 butyl 5 ethyl P   03   0395 03/ 07/ 03 06/ 05/ 03 BASF Corporation ( S) Ultraviolet absorber in thermoplastics ( G) Steric hindered amine, oligomer P   03   0396 03/ 07/ 03 06/ 05/ 03 CBI ( G) Dyestuff for ink ( G) Metal complexes of substituted benensulfulfonic acid derivatives P   03   0397 03/ 10/ 03 06/ 08/ 03 CBI ( G) Open, non dispersive ( intermediate) ( G) Sulfonyl chloride P   03   0398 03/ 10/ 03 06/ 08/ 03 CBI ( G) Material used in fabricating electronic articles; destructive use ( G) Modified hydrocarbylpolysilicate P   03   0399 03/ 10/ 03 06/ 08/ 03 CBI ( G) Open, non dispersive ( intermediate) ( G) Dimethoxy pyrimidine P   03   0400 03/ 10/ 03 06/ 08/ 03 CBI ( G) Raw material used in the manufacture of products sold for semiconductor applications ( G) Substituted anthracene ester P   03   0401 03/ 10/ 03 06/ 08/ 03 Syntroleum Corporation ( S) Synthetic diesel fuel ( S) Fuels, diesel, C8   28 alkane branched and linear P   03   0402 03/ 10/ 03 06/ 08/ 03 Syntroleum Corporation ( S) Synthetic diesel fuel ( S) Naphtha, gasoline range, C4   9 alkane branched and linear P   03   0403 03/ 10/ 03 06/ 08/ 03 Syntroleum Corporation ( S) Fischer tropsch naphtha ( S) Fuels, jet aircraft, C7   C18 alkane branched and linear P   03   0404 03/ 10/ 03 06/ 08/ 03 Syntroleum Corporation ( S) Fischer tropsch naphtha ( S) Alkanes, C5   20 branched and linear P   03   0405 03/ 11/ 03 06/ 09/ 03 CBI ( S) Polyurethane coating ( G) Aqueous polyurethane dispersion P   03   0406 03/ 11/ 03 06/ 09/ 03 CBI ( G) Dyestuff for ink ( G) Potassium sodium salt of substituted thiazolesulfonic acid P   03   0407 03/ 11/ 03 06/ 09/ 03 CBI ( S) Polyurethane intermediate ( G) Urethane diol P   03   0408 03/ 11/ 03 06/ 09/ 03 CBI ( G) Destructive use ( G) Substituted fulvene VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 19536 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices I. 112 PREMANUFACTURE NOTICES RECEIVED FROM: 02/ 11/ 03 TO 03/ 28/ 03   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0409 03/ 12/ 03 06/ 10/ 03 Color Resources International Co. ( S) Dye for paper cellulosic fiber application used by paper mills only as sold by Crompton and Knowles ( sensient) in U. S. A. ( G) Trisodium salt azo direct dye P   03   0410 03/ 14/ 03 06/ 12/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0411 03/ 14/ 03 06/ 12/ 03 Johnson Polymer ( G) Polymeric coating vehicle ( G) Styrene acrylic copolymer P   03   0412 03/ 14/ 03 06/ 12/ 03 CBI ( G) Photoresist additive ( G) Halogenated acrylic copolymer P   03   0413 03/ 14/ 03 06/ 12/ 03 CBI ( G) Photoresist additive ( G) Halogenated acrylic copolymer P   03   0414 03/ 14/ 03 06/ 12/ 03 CBI ( G) Photoresist additive ( G) Halogenated acrylic copolymer P   03   0415 03/ 14/ 03 06/ 12/ 03 CBI ( G) Photoresist additive ( G) Halogenated acrylic copolymer P   03   0416 03/ 18/ 03 06/ 16/ 03 Bedoukian Research, Inc. ( S) Chemical intermediate ( G) Dimethyl oxo carboxylic acid P   03   0417 03/ 18/ 03 06/ 16/ 03 CBI ( S) Pvc to pvc bonding ( G) Polyester isocyanate polymer P   03   0418 03/ 18/ 03 06/ 16/ 03 CBI ( S) Pvc to pvc bonding ( G) Polyester isocyanate polymer P   03   0419 03/ 19/ 03 06/ 17/ 03 CBI ( G) Textile colorant ( G) Substituted cuprate [ triazin hydroxy alpha o][[( hydroxy Alpha O) sulphenyl] azo alpha n1] methoxyphenyl] azo alpha n1] naphthalenedisulfonato, sodium salt P   03   0420 03/ 19/ 03 06/ 17/ 03 Algroup Lonza  Lonza Inc. ( S) Polymer additive/ adjuvant for:  polymer extrusion;  polymer film formation; anistatic agent for:  polymer films ( G) N, N alkenebis N fatty acid amide P   03   0421 03/ 19/ 03 06/ 17/ 03 OM Group, Inc. ( S) Polyurethane rubber catalyst; pvc heat stabilizer ( S) 9 octadecenoic acid ( 9z), bismuth 3+) salt P   03   0422 03/ 19/ 03 06/ 17/ 03 CBI ( S) Resin for spray applied coatings ( G) Olefin based block copolymer P   03   0423 03/ 17/ 03 06/ 15/ 03 PPG Industries, Inc. ( G) Component of coating with open use ( G) Modified polyol P   03   0424 03/ 19/ 03 06/ 17/ 03 CBI ( G) Cross linking agent for thermosetting resin ( G) Amines adduct of epoxy resin P   03   0425 03/ 21/ 03 06/ 19/ 03 Crompton Corporation ( G) Catalyst ( G) Transition metal complex P   03   0426 03/ 21/ 03 06/ 19/ 03 CBI ( S) Coatings applications ( S) Fatty acids, C6   12, polymers with hexahydro 1,3 isobenzofurandione and trimethylolpropane P   03   0427 03/ 21/ 03 06/ 19/ 03 CBI ( G) Unsaturated polyester resin ( G) Dicyclopentadiene polymer with phtalic anhydride, maleic anhydride, ethylene glycol, diethylene glycol, monopropylene glycol P   03   0428 03/ 21/ 03 06/ 19/ 03 The Dow Chemical Company ( G) Rigid polyurethane foam for spray construction application rigid polyurethane foam for building panel production ( G) mannich based polyether polyol P   03   0429 03/ 21/ 03 06/ 19/ 03 CBI ( G) Unsaturated polyester resin ( G) Epoxy acrylate urethane modified polymer with maliec anhydrid P   03   0430 03/ 21/ 03 06/ 19/ 03 CBI ( G) Coating component ( G) Polymer of methylene diphenyl diisocyanate, polyether polyol and a polyester polyol P   03   0431 03/ 19/ 03 06/ 17/ 03 CBI ( G) Rubber elastomer for tires, wheels, rolls and other specialty urethane applications ( G) PPD/ Polyester prepolymer P   03   0432 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0433 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0434 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0435 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0436 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0437 03/ 25/ 03 06/ 23/ 03 CBI ( S) Binder/ tackifier for inks ( G) Hydrocarbon resin P   03   0438 03/ 19/ 03 06/ 17/ 03 CBI ( G) Additive, open, non dispersive use ( G) Polyether modified polyurethane urea P   03   0439 03/ 19/ 03 06/ 17/ 03 CBI ( G) Additive, open, non dispersive use ( G) Polyether modified polyurethane urea P   03   0440 03/ 26/ 03 06/ 24/ 03 CBI ( G) Open, non dispersive ( resin) ( G) Urethane acrylate resin P   03   0441 03/ 26/ 03 06/ 24/ 03 Shell Chemical Company ( G) Components of brake fluid formulation ( S) Oxirane, methyl, polymer with oxirane, monoethyl ether P   03   0442 03/ 26/ 03 06/ 24/ 03 CBI ( S) Coating material, non dispersive use ( G) Polysiloxazane P   03   0443 03/ 26/ 03 06/ 24/ 03 CBI ( G) ADhesive component ( G) Polymeric mdi prepolymer P   03   0444 03/ 26/ 03 06/ 24/ 03 CBI ( G) Adhesive component ( G) Polymeric mdi prepolymer VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 19537 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices I. 112 PREMANUFACTURE NOTICES RECEIVED FROM: 02/ 11/ 03 TO 03/ 28/ 03   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0445 03/ 28/ 03 06/ 26/ 03 CBI ( G) Destructive end use ( G) 2,5 Furandione, polymer with ( substituted) propene and octadecene ( substituted) ester P   03   0446 03/ 28/ 03 06/ 26/ 03 CBI ( G) Thermoset polymer component, open nondispersive use ( G) Acrylate, acrylonitrile, butadiene rubber extended tetra epoxy resin P   03   0447 03/ 28/ 03 06/ 26/ 03 CBI ( G) Theromoset polymer component, open nondispersive use ( G) Acrylate, acrylonitrile, butadiene rubber extended epoxy resin P   03   0448 03/ 28/ 03 06/ 23/ 03 CBI ( G) Theromoset polymer component, open nondispersive use ( G) Acrylate, acrylonitrile, butadiene rubber extended epoxy resin P   03   0449 03/ 28/ 03 06/ 23/ 03 CBI ( G) Thermoset polymer component, open nondispersive use ( G) Acrylate, acrylonitrile, butadiene rubber extended epoxy resin P   03   0450 03/ 28/ 03 06/ 23/ 03 CBI ( G) Thermostat polymer component, open nondispersive use ( G) Acrylate, acrylonitrile, butadiene rubber extended epoxy resin 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. 1 TEST MARKETING EXEMPTION NOTICES RECEIVED FROM: 02/ 11/ 03 TO 03/ 28/ 03 Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical T   03   01 03/ 17/ 03 06/ 15/ 03 PPG Industries Inc. ( G) Component of coating with open use ( G) Modified polyol 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. 61 NOTICES OF COMMENCEMENT FROM: 02/ 11/ 03 TO 03/ 28/ 03 Case No. Received Date Commencement/ Import Date Chemical P   00   0042 03/ 04/ 03 05/ 18/ 01 ( G) N alkyl 4 alkylaminonaphthalimide P   00   0043 03/ 04/ 03 05/ 18/ 01 ( G) N alkyl 4 alkylaminonaphthalimide P   00   0044 03/ 04/ 03 05/ 18/ 01 ( G) N alkyl 4 alkylaminonaphthalimide P   00   1078 02/ 21/ 03 01/ 31/ 03 ( G) Potassium sulfonate P   01   0298 03/ 07/ 03 02/ 07/ 03 ( G) Substituted propane P   01   0392 02/ 25/ 03 01/ 24/ 03 ( G) Polyacrylate polymer P   01   0394 03/ 04/ 03 02/ 10/ 03 ( G) Polyacrylate polymer P   01   0659 02/ 13/ 03 01/ 30/ 03 ( G) Substituted alkyl ester acid P   01   0732 02/ 11/ 03 01/ 16/ 03 ( G) Phosphate methacrylate P   01   0764 02/ 26/ 03 02/ 06/ 03 ( S) Magnesium potassium titanium oxide P   01   0802 02/ 27/ 03 02/ 18/ 03 ( G) Pyrimidinetrione derivative P   02   0114 02/ 21/ 03 02/ 07/ 03 ( G) Polymer of alkyl substituted propenoic acid and propenamide with alkyl acrylate P   02   0217 03/ 04/ 03 02/ 21/ 03 ( G) Fatty acid modified polyester P   02   0408 03/ 13/ 03 02/ 28/ 03 ( G) Acetamide, substituted alkylamino phenyl azo substituted isoindole P   02   0409 03/ 13/ 03 02/ 28/ 03 ( G) Acetamide, substituted methoxyalkylamino phenyl azo substituted isoindole P   02   0413 03/ 13/ 03 02/ 28/ 03 ( G) Substituted alkylamino phenyl azo substituted isoindole P   02   0457 02/ 21/ 03 02/ 03/ 03 ( G) Oxyalkylpropanoic acid, polymer with dimethylcarbonate, 1,2 ethanediamine, 1,6 hexanediol and 1,1  methylenebis[ 4 isocyanatocyclohexane] P   02   0461 02/ 26/ 03 12/ 16/ 02 ( S) Hexanoic acid, 2 ethyl, compound with guanidine ( 1: 1) P   02   0544 02/ 21/ 03 10/ 10/ 02 ( S) Oxirane, methyl, polymer with alpha hydro omega hydroxypoly[ oxy( methyl 1,2 ethanediyl)], 5 isocyanato 1( isocyanatomethyl) 1,3,3 trimethylcyclohexane and oxirane P   02   0550 03/ 19/ 03 01/ 29/ 03 ( G) Imidazolium salt P   02   0622 03/ 18/ 03 03/ 04/ 03 ( G) Branched alkenoate P   02   0629 02/ 26/ 03 02/ 05/ 03 ( G) Substituted amino acid P   02   0678 03/ 13/ 03 02/ 24/ 03 ( G) Urethane diol P   02   0705 03/ 11/ 03 02/ 27/ 03 ( S) Sulfuric acid, diethyl ester, compound with nu[ 3( dimethylamino) propyl] 2 methyl 2 propenamide polymer with 1 ethenyl 2 pyrrolidinone, sulfate P   02   0741 02/ 11/ 03 01/ 21/ 03 ( S) Piperazine, polymer with 1,6 dichlorohexane VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1 19538 Federal Register / Vol. 68, No. 76 / Monday, April 21, 2003 / Notices III. 61 NOTICES OF COMMENCEMENT FROM: 02/ 11/ 03 TO 03/ 28/ 03   Continued Case No. Received Date Commencement/ Import Date Chemical P   02   0826 02/ 21/ 03 12/ 16/ 02 ( S) Octadecanoic acid, compound with guanidine ( 1: 1) P   02   0831 03/ 28/ 03 02/ 25/ 03 ( G) Crosslinked alkyl silicone P   02   0889 03/ 26/ 03 03/ 13/ 03 ( S) Formaldehyde, polymer with 6 phenyl 1,3,5 triazine 2,4 diamine, isobutylated P   02   0895 03/ 03/ 03 02/ 20/ 03 ( G) Amine salt of carboxylated epoxy ester polymer, with fatty acids and alkyloxylated alkyl ester P   02   0896 02/ 19/ 03 01/ 30/ 03 ( G) Polyester polyol P   02   0904 02/ 21/ 03 02/ 06/ 03 ( G) Substituted alkenone P   02   0909 03/ 27/ 03 02/ 28/ 03 ( G) Aromatic polyester polyol P   02   0910 03/ 27/ 03 02/ 27/ 03 ( G) Aromatic polyester polyol P   02   0931 03/ 05/ 03 02/ 17/ 03 ( G) Sodium sulfonate P   02   0933 03/ 05/ 03 02/ 10/ 03 ( G) Calcium sulfonate P   02   0935 02/ 21/ 03 01/ 03/ 03 ( G) Polyglycolether polycarboxylate P   02   0974 03/ 13/ 03 03/ 06/ 03 ( S) 3 octen 1 ol, propanoate, ( 3z) P   02   0997 02/ 11/ 03 01/ 24/ 03 ( G) Alkaline epoxide amine adduct P   02   1006 03/ 19/ 03 03/ 03/ 03 ( G) Polyurethane crosslinker P   02   1026 02/ 11/ 03 01/ 09/ 03 ( G) Modified alkyd resin P   02   1027 03/ 13/ 03 02/ 26/ 03 ( G) Silylated polyester P   02   1037 03/ 05/ 03 02/ 12/ 03 ( G) Polyamine acrylate P   02   1052 03/ 21/ 03 03/ 10/ 03 ( G) Substituted acrylate polymer P   02   1076 02/ 27/ 03 02/ 05/ 03 ( G) Corn byproduct P   02   1077 02/ 27/ 03 02/ 01/ 03 ( G) Corn byproduct P   02   1079 03/ 28/ 03 03/ 24/ 03 ( G) Modified mannich base polyamine P   02   1088 03/ 05/ 03 02/ 19/ 03 ( G) Alkylphenol mannich P   03   0003 03/ 04/ 03 02/ 20/ 03 ( S) Soybean oil, reaction products with hydrogenated soybean oil and triethanolamine di et sulfate quaternized P   03   0038 03/ 26/ 03 03/ 05/ 03 ( G) Copper( 11) Complex of sulfonated azo dye P   03   0040 03/ 25/ 03 03/ 12/ 03 ( G) Polyamidoamine resin grafted with aziridine P   03   0048 03/ 05/ 03 02/ 07/ 03 ( G) Modified styrenated acrylated methacrylate polymer P   03   0058 02/ 27/ 03 02/ 19/ 03 ( G) Aromatic polycarbodiimide P   03   0068 03/ 13/ 03 02/ 16/ 03 ( G) Polyester polyurethane dispersion P   03   0087 03/ 05/ 03 02/ 24/ 03 ( G) Amines, polyethylenepoly, reaction products with 5 ( or 6) carboxy 4 hexyl 2 cyclohexene 1 octanoic acid, pentaethylenehexamine and substituted ethyleneamines P   03   0095 03/ 12/ 03 03/ 07/ 03 ( G) Alkyl methacrylate copolymer P   03   0097 03/ 12/ 03 03/ 07/ 03 ( G) Alkyl methacrylate copolymer P   03   0106 03/ 18/ 03 02/ 19/ 03 ( G) Fluoropolyether derivative fluoronated payurethane resin P   03   0107 03/ 14/ 03 03/ 06/ 03 ( S) 2 propenoic acid, 2 methyl, polymer with butyl 2 propenoate and ethenylbenzene, sodium salt P   03   0118 03/ 27/ 03 03/ 09/ 03 ( G) Epoxy modified alkyd resin P   03   0128 03/ 11/ 03 02/ 24/ 03 ( G) Semiconducting light emitting polyfluorene copolymer P   03   0142 03/ 26/ 03 03/ 18/ 03 ( G) Metallocene fluoride complex P   03   0145 03/ 19/ 03 03/ 05/ 03 ( G) Polyurethane P   94   2209 03/ 11/ 03 02/ 25/ 03 ( G) Fatty acid, ammonium salt P   96   1626 02/ 11/ 03 01/ 10/ 03 ( S) Mix of: 3 hexene, 1( 1 methoxypropoxy)( e), 3 hexene, 1( 1 methoxypropoxy),( z) P   97   1039 03/ 10/ 03 02/ 10/ 03 ( G) Modified perfluorinated copolymer P   98   0899 02/ 21/ 03 01/ 28/ 03 ( S) Fatty acids, C18 unsaturated, dimers, polymers with adipic acid, ethylenediamine piperazine and polypropylene glycol diamine P   99   0301 02/ 28/ 03 02/ 13/ 03 ( G) Organotin compound P   99   0646 02/ 11/ 03 01/ 28/ 03 ( G) Pentaerythritol, mixed esters with fatty acids, C8   9, branched P   99   1353 03/ 11/ 03 02/ 25/ 03 ( G) Racemic substituted dimethyl zironocene P   99   1358 02/ 21/ 03 02/ 07/ 03 ( G) Lithium salt of substituted indene P   99   1359 02/ 25/ 03 02/ 10/ 03 ( G) Substituted bis indenylsilane P   99   1360 03/ 03/ 03 02/ 17/ 03 ( G) Lithium salt of substituted bis indenylsilane P   99   1361 03/ 03/ 03 02/ 19/ 03 ( G) Substituted zirconocene dichloride, rac and meso isomer mixture List of Subjects Environmental protection, Chemicals, Premanufacturer notices.

Dated: April 14, 2003. Sandra R. Wilkins, Acting Director, Information Management Division, Office of Pollution Prevention and Toxics. [ FR Doc. 03   9749 Filed 4   18   03; 8: 45 am]

BILLING CODE 6560   50   S FARM CREDIT ADMINISTRATION RIN 3052   AC13 Loan Policies and Operations; Loan Syndication Transactions AGENCY: Farm Credit Administration.

ACTION: Notice; extension of comment period. SUMMARY: The Farm Credit Administration ( FCA, we, or us) is extending the comment period on our notice concerning loan syndication transactions by Farm Credit System ( System) institutions so all interested parties have more time to respond to our questions.

DATES: Please send your comments to the FCA by June 20, 2003.

VerDate Jan< 31> 2003 15: 26 Apr 18, 2003 Jkt 200001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21APN1. SGM 21APN1


[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49743-49744]
[FR Doc No: 2019-20494]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3679]

Interacting With the Food and Drug Administration on Complex
Innovative Clinical Trial Designs for Drugs and Biological Products;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Interacting with the FDA on Complex Innovative Clinical Trial Designs
for Drugs and Biological Products.'' The draft guidance document
provides recommendations to sponsors and applicants on interacting with
the FDA on complex innovative clinical trial design (CID) proposals for
drugs or biological products. In accordance with the mandate under the
21st Century Cures Act (Cures Act), the draft guidance discusses the
use of novel trial designs in the development and regulatory review of
drugs and biological products, how sponsors may obtain feedback on
technical issues related to modeling and simulation, and the types of
quantitative and qualitative information that should be submitted for
review.

DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3679 for ``Interacting with the FDA on Complex Innovative
Clinical Trial Designs for Drugs and Biological Products; Draft
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development (OCOD), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002 or the Office of Communications, Division of Drug
Information, Center for Drug Evaluation and Research (CDER), Food and
Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist the office in processing your requests. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, CBER, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Scott Goldie, CDER, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Interacting with the FDA on Complex Innovative Clinical
Trial Designs for Drugs and Biological Products.'' The draft guidance
document provides recommendations to sponsors and applicants on
interacting with the FDA on CID proposals for drugs or biological
products. FDA is issuing this guidance to satisfy, in part, a mandate
under section 3021 of the Cures Act. In accordance with the Cures Act
mandate, the draft guidance discusses the use of novel trial designs in
the development and regulatory review of drugs and biological products,
how sponsors may obtain feedback on technical issues related to
modeling and simulation, and the types of quantitative and qualitative
information that should be submitted for review.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Interacting
with the FDA on Complex Innovative Clinical Trial Designs for Drugs and
Biological Products.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520); the
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001; the collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014; and the
collections of information in the guidance for industry entitled
``Special Protocol Assessment,'' have been approved under 0910-0470.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.

    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20494 Filed 9-20-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Proposed Rules]
[Pages 71550-71554]
[FR Doc No: 2013-28652]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2011-0833; FRL-9903-25-Region-8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Colorado Second Ten-Year PM10 Maintenance Plan for
Telluride

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve State Implementation Plan (SIP)
revisions submitted by the State of Colorado. On March 31, 2010, the
Governor of Colorado's designee submitted to EPA a revised maintenance
plan for the Telluride area for the 24-hour National Ambient Air
Quality Standards (NAAQS) for particulate matter with an aerodynamic
diameter less than or equal to 10 microns (PM10), which was
adopted on November 19, 2009. As required by Clean Air Act (CAA)
section 175A(b), this revised maintenance plan addresses maintenance of
the PM10 standard for a second 10-year period beyond the
area's original redesignation to attainment for the PM10
NAAQS. In addition, EPA is proposing to approve the revised maintenance
plan's 2021 transportation conformity motor vehicle emissions budget
for PM10. Also, we are proposing to exclude from use in
determining that Telluride continues to attain the PM10
NAAQS exceedances of the PM10 NAAQS that were recorded at
the Telluride PM10 monitor on April 5, 2010 and April 16,
2013, because they meet the criteria for exceptional events caused by
high wind natural events. This action is being taken under sections 110
and 175A of the CAA.

DATES: Written comments must be received on or before December 30,
2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2011-0833, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Carl Daly, Director, Air Program, U.S. Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
     Hand Delivery: Carl Daly, Director, Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are only
accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding
Federal holidays. Special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2011-0833. EPA's policy is that all comments received 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 information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA, without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. 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. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to Section I. General Information of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129. EPA requests that if at
all possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8:00 a.m.
to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Crystal Ostigaard, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop
Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The initials APCD mean or refer to the Colorado Air Pollution
Control Division.
    (iii) The initials AQCC mean or refer to the Colorado Air Quality
Control Commission.
    (iv) The initials AQS mean or refer to the EPA Air Quality System
database.
    (v) The words Colorado and State mean or refer to the State of
Colorado.
    (vi) The initials CDOT mean or refer to the Colorado Department of
Transportation.
    (vii) The initials CDPHE mean or refer to the Colorado Department
of Public Health and Environment.
    (viii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.

    (ix) The initials MVEB mean or refer to motor vehicle emissions
budget.
    (x) The initials NAAQS mean or refer to National Ambient Air
Quality Standard.
    (xi) The initials PM10 mean or refer to particulate
matter with an aerodynamic diameter of less than or equal to 10
micrometers (coarse particulate matter).
    (xii) The initials RTP mean or refer to the Regional Transportation
Plan.
    (xiii) The initials SIP mean or refer to State Implementation Plan.
    (xiv) The initials TIP mean or refer to the Transportation
Improvement Program.
    (xv) The initials TSD mean or refer to technical support document.

Table of Contents

I. General Information
II. Background
III. What was the State's process?
IV. EPA's Evaluation of the Revised Telluride PM10
Maintenance Plan
V. Proposed Action
VI. Statutory and Executive Orders Review

I. General Information

    1. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    The Telluride area was designated nonattainment for PM10
and classified as moderate by operation of law upon enactment of the
CAA Amendments of 1990. See 56 FR 56694, 56705, 56736 (November 6,
1991). EPA partially/conditionally approved Colorado's nonattainment
area SIP for the Telluride PM10 nonattainment area on
September 19, 1994 (59 FR 47807) and fully approved the SIP on October
4, 1996 (61 FR 51784). On May 10, 2000, the Governor of Colorado
submitted a request to EPA to redesignate the Telluride moderate
PM10 nonattainment area to attainment for the 1987 24-hour
PM10 NAAQS. Along with this request, the State submitted a
maintenance plan, which demonstrated that the area was expected to
remain in attainment of the 24-hour PM10 NAAQS through 2012.
EPA approved the Telluride maintenance plan and redesignation to
attainment on June 15, 2001 (66 FR 32556).
    Eight years after an area is redesignated to attainment, CAA
section 175A(b) requires the state to submit a subsequent maintenance
plan to EPA, covering a second 10-year period.\1\ This second 10-year
maintenance plan must demonstrate continued maintenance of the
applicable NAAQS during this second 10-year period. To fulfill this
requirement of the Act, the Governor of Colorado's designee submitted
the second 10-year update of the PM10 maintenance plan to
EPA on March 31, 2010 (hereafter; ``revised Telluride PM10
Maintenance Plan'').
---------------------------------------------------------------------------

    \1\ In this case, the initial maintenance period described in
CAA section 175A(a) was required to extend for at least 10 years
after the redesignation to attainment, which was effective on August
14, 2001. See 66 FR 32556. So the first maintenance plan was
required to show maintenance at least through 2011. CAA section
175A(b) requires that the second 10-year maintenance plan maintain
the NAAQS for ``10 years after the expiration of the 10-year period
referred to in [section 175A(a)].'' Thus, for the Telluride area,
the second 10-year period ends in 2021.
---------------------------------------------------------------------------

    As described in 40 CFR 50.6, the level of the national primary and
secondary 24-hour ambient air quality standards for PM10 is
150 micrograms per cubic meter ([mu]g/m\3\). An area attains the 24-
hour PM10 standard when the expected number of days per
calendar year with a 24-hour concentration in excess of the standard
(referred to herein as ``exceedance''), as determined in accordance
with 40 CFR part 50, appendix K, is equal to or less than one, averaged
over a three-year period.\2\ See 40 CFR 50.6 and 40 CFR part 50,
appendix K.
---------------------------------------------------------------------------

    \2\ An exceedance is defined as a daily value that is above the
level of the 24-hour standard, 150 [micro]g/m\3\, after rounding to
the nearest 10 [micro]g/m\3\ (i.e., values ending in five or greater
are to be rounded up). Thus, a recorded value of 154 [micro]g/m\3\
would not be an exceedance since it would be rounded to 150
[micro]g/m\3\; whereas, a recorded value of 155 [micro]g/m\3\ would
be an exceedance since it would be rounded to 160 [micro]g/m\3\. See
40 CFR part 50, appendix K, section 1.0.
---------------------------------------------------------------------------

    Table 1 below shows the maximum monitored 24-hour PM10
values for the Telluride PM10 maintenance area for 2004
through 2012, excluding one value that the State flagged as being
caused by an exceptional event. The table reflects that the values for
the Telluride area were well below the 24-hour PM10 NAAQS
standard of 150 [mu]g/m\3\. However, on April 5, 2010, the area
experienced an exceedance measured at 354 [mu]g/m\3\. The State flagged
this value as a high wind exceptional event in EPA's Air Quality System
(AQS), which is EPA's repository for ambient air quality data.
    40 CFR 50.1(j) defines an exceptional event as an event which
affects air quality, is not reasonably controllable or preventable, is
an event caused by human activity that is unlikely to recur at a
particular location or a natural event, and is determined by the
Administrator in accordance with 40 CFR 50.14 to be an exceptional
event. Exceptional events do not include stagnation of air masses or
meteorological inversions, meteorological events involving high
temperatures or lack of precipitation, or air pollution relating to
source noncompliance. 40 CFR 5.14(b) states that EPA shall exclude data
from use in determinations of exceedances and NAAQS violations where a
state demonstrates to EPA's satisfaction that an exceptional event
caused a specific air pollution concentration in excess of one or more
NAAQS at a particular air quality monitoring location and otherwise
satisfies the requirements of section 50.14.
    The State submitted an exceptional event package on June 28, 2013
requesting EPA's concurrence on the flag for the April 5, 2010
exceedance. EPA completed its review of the exceptional events package
for Telluride's 2010 exceedance and concurred on the flag on August 21,

2013 because the State successfully demonstrated that the exceedance on
April 5, 2010 was caused by a natural high wind exceptional event due
to blowing desert dust from upwind natural desert areas of Arizona,
Utah, and southwest Colorado into the Telluride area.\3\ Thus, we are
proposing to exclude from use in determining that Telluride continues
to attain the 24- hour PM10 NAAQS the exceedance of the 24-
hour PM10 NAAQS that was recorded at the Telluride
PM10 monitor on April 5, 2010. See 40 CFR 50.14(b) and
(c)(2)(ii). With the exclusion of this data point, the highest value in
2010 is 133 [mu]g/m\3\, which is well below the 24-hour PM10
NAAQS standard.
---------------------------------------------------------------------------

    \3\ Copies of the State's June 28, 2013 exceptional events
package and our concurrence documents are included in the docket for
this action.
---------------------------------------------------------------------------

    Additionally, EPA reviewed 2013 data from AQS (this data has not
yet been quality assured by Colorado) and found a high wind exceptional
event of 265 [mu]g/m\3\ at the Telluride monitor on April 16, 2013. The
State submitted the exceptional events package for this exceedance on
October 3, 2013, and EPA concurred on the package on November 1, 2013,
because the State successfully demonstrated that the exceedance on
April 16, 2013 was caused by a natural high wind exceptional event
blowing desert dust from upwind natural desert areas of Arizona, Utah,
and southwest Colorado into the Telluride area.\4\ Thus, we are
proposing to exclude from use in determining that Telluride continues
to attain the 24-hour PM10 NAAQS the exceedance of the 24-
hour PM10 NAAQS that was recorded at the Telluride
PM10 monitor on April 16, 2013.
---------------------------------------------------------------------------

    \4\ Copies of the State's October 3, 2013 exceptional events
package and our concurrence documents are included in the docket for
this action.

             Table 1--Telluride PM10 Maximum 24-Hour Values
 [Based on Data from 333 West Colorado Avenue, AQS Identification Number
                              08-113-0004]
------------------------------------------------------------------------
                                                               Maximum
                                                                Value
                            Year                               ([mu]g/
                                                                m\3\)
------------------------------------------------------------------------
2004.......................................................           72
2005.......................................................           70
2006.......................................................           69
2007.......................................................           77
2008.......................................................           82
2009.......................................................          130
2010.......................................................          133
2011.......................................................           68
2012.......................................................           80
------------------------------------------------------------------------

    Table 2 below shows the estimated number of exceedances for the
Telluride PM10 maintenance area for the three-year periods
of 2004 through 2006, 2005 through 2007, 2006 through 2008, 2007
through 2009, 2008 through 2010, 2009 through 2011, and 2010 through
2012. To attain the standard, the three-year average number of expected
exceedances (values greater than 150 [mu]g/m\3\) must be less than or
equal to one. The table reflects continuous attainment of the 24-hour
PM10 NAAQS.

              Table 2--Telluride PM10 Estimated Exceedances
 [Based on Data from 333 West Colorado Avenue, AQS Identification Number
                              08-113-0004]
------------------------------------------------------------------------
                                                              3-Year
                                                            estimated
                  Design value period                       number of
                                                           exceedances
------------------------------------------------------------------------
2004--2006.............................................                0
2005--2007.............................................                0
2006--2008.............................................                0
2007--2009.............................................                0
2008--2010.............................................                0
2009--2011.............................................                0
2010--2012.............................................                0
------------------------------------------------------------------------

III. What was the State's process?

    Section 110(a)(2) of the CAA requires that a state provide
reasonable notice and public hearing before adopting a SIP revision and
submitting it to EPA.
    The Colorado Air Quality Control Commission (AQCC) held a public
hearing for the revised Telluride PM10 Maintenance Plan on
November 19, 2009. The AQCC approved and adopted the revised Telluride
PM10 Maintenance Plan during the hearing. The Governor's
designee submitted the revised plan to EPA on March 31, 2010.
    We have evaluated the revised maintenance plan and have determined
that the State met the requirements for reasonable public notice and
public hearing under section 110(a)(2) of the CAA. On September 30,
2010, by operation of law under CAA section 110(k)(1)(B), the revised
maintenance plan was deemed to have met the minimum ``completeness''
criteria found in 40 CFR part 51, appendix V.

IV. EPA's Evaluation of the Revised Telluride PM10
Maintenance Plan

    The following are the key elements of a Maintenance Plan for
PM10: Emission Inventory, Maintenance Demonstration,
Monitoring Network/Verification of Continued Attainment, Contingency
Plan, and Transportation Conformity Requirements including the Motor
Vehicle Emission Budget for PM10. Below, we describe our
evaluation of these elements as they pertain to the revised Telluride
PM10 Maintenance Plan.

A. Emission Inventory

    The revised Telluride PM10 Maintenance Plan includes
three inventories of daily PM10 emissions for the Telluride
area, for years 2007, 2015, and 2021. The Air Pollution Control
Division (APCD) developed these emission inventories using EPA-approved
emissions modeling methods and updated transportation and demographics
data. Each emission inventory is a list, by source category, of the air
contaminants directly emitted into the Telluride PM10
maintenance area. A more detailed description of the 2007, 2015 and
2021 inventories and information on model assumptions and parameters
for each source category are contained in the State's PM10
Maintenance Plan Technical Support Document (TSD). Included in both
inventories are agriculture, highway vehicle exhaust, railroads, road
dust, commercial cooking, construction, fuel combustion, non-road
sources, structure fires, and woodburning. We find that Colorado has
prepared adequate emission inventories for the area.

B. Maintenance Demonstration

    The revised Telluride PM10 Maintenance Plan uses
emission roll-forward modeling to demonstrate maintenance of the 24-
hour PM10 NAAQS through 2021. Using the 2007 and 2021
emissions inventories, the State first determined the projected growth
in PM10 emissions from the 2007 base year to the 2021
maintenance year. The State estimated that emissions would increase
from 1,285 pounds per day in 2007 to 1,989 pounds per day in 2021. This
represents an increase of 54.8 percent.
    The State then applied this percentage increase to the design day
concentration of 82 [mu]g/m\3\, which was the highest 24-hour maximum
PM10 value recorded in the Telluride area from 2006-2008.
This resulted in an estimated maximum 24-hour PM10
concentration in 2021 of 126.9 [mu]g/m\3\. This is well below the 24-
hour PM10 NAAQS of 150 [mu]g/m\3\.

C. Monitoring Network/Verification of Continued Attainment

    In the revised Telluride PM10 Maintenance Plan, the
State commits to continue to operate an air quality monitoring network
in accordance with 40 CFR part 58 to verify continued attainment of the
24-hour PM10 NAAQS. This includes the continued operation of
a PM10 monitor in the Telluride area, which the State will
rely on to track PM10 emissions in the maintenance

area. The State also commits to conduct an annual review of the air
quality surveillance system in accordance with 40 CFR 58.20(d) to
determine whether the system continues to meet the monitoring
objectives presented in Appendix D of 40 CFR part 58. Additionally, the
State commits to track and document PM10 mobile source
parameters and new and modified stationary source permits. If these and
the resulting emissions change significantly over time, the APCD will
perform appropriate studies to determine: (1) whether additional and/or
re-sited monitors are necessary; and (2) whether mobile and stationary
source emissions projections are on target.
    Based on the above, we are proposing approval of these commitments
as satisfying the relevant requirements.

D. Contingency Plan

    Section 175A(d) of the CAA requires that a maintenance plan include
contingency provisions to promptly correct any violation of the NAAQS
that occurs after redesignation of an area. To meet this requirement
the State has identified appropriate contingency measures along with a
schedule for the development and implementation of such measures.
    As stated in the revised Telluride PM10 Maintenance
Plan, the contingency measures will be triggered by a violation of the
24-hour PM10 NAAQS. However, the maintenance plan notes that
an exceedance of the 24-hour PM10 NAAQS may initiate a
voluntary, local process by the Town of Telluride, the Town of Mountain
Village, San Miguel County and the APCD to identify and evaluate
potential contingency measures.
    The Town of Telluride, the Town of Mountain Village and San Miguel
County in coordination with the APCD, AQCC, and the Colorado Department
of Transportation (CDOT) will initiate a process to begin evaluating
potential contingency measures no more than 60 days after notification
from APCD that a violation of the 24-hour PM10 NAAQS has
occurred. The AQCC will then hold a public hearing to consider the
contingency measures recommended by the Town of Telluride, the Town of
Mountain Village, San Miguel County, APCD and CDOT along with any other
contingency measures the AQCC determines may be appropriate to
effectively address the violation. The State commits to adopt and
implement any necessary contingency measures within one year after a
violation occurs.
    The State identifies the following as potential contingency
measures in the revised Telluride PM10 maintenance plan: (1)
Increased street sweeping requirements; (2) expanded, mandatory use of
alternative de-icers; (3) more stringent street sand specifications;
(4) road paving requirements; (5) woodburning restrictions; (6) re-
establishing new source review permitting requirements for stationary
sources; and (7) other emission control measures appropriate for the
area based on consideration of cost effectiveness, PM10
emission reduction potential, economic and social considerations, or
other factors.
    We find that the contingency measures provided in the revised
Telluride PM10 Maintenance Plan are sufficient and meet the
requirements of section 175A(d) of the CAA.

E. Transportation Conformity Requirements: Motor Vehicle Emission
Budget for PM10

    Transportation conformity is required by section 176(c) of the CAA.
EPA's conformity rule at 40 CFR part 93 requires that transportation
plans, programs, and projects conform to SIPs and establishes the
criteria and procedures for determining whether or not they conform.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS. To effectuate its purpose, the
conformity rule requires a demonstration that emissions from the
Regional Transportation Plan (RTP) and the Transportation Improvement
Program (TIP) are consistent with the motor vehicle emissions budget(s)
(MVEB(s)) contained in a control strategy SIP revision or maintenance
plan (40 CFR 93.101, 93.118, and 93.124). A MVEB is defined as the
level of mobile source emissions of a pollutant relied upon in the
attainment or maintenance demonstration to attain or maintain
compliance with the NAAQS in the nonattainment or maintenance area.
Further information concerning EPA's interpretations regarding MVEBs
can be found in the preamble to EPA's November 24, 1993, transportation
conformity rule (see 58 FR 62193--62196).
    The revised Telluride PM10 Maintenance Plan contains a
single MVEB of 1,108 lbs/day of PM10 for the year 2021, the
maintenance year. Once the State submitted the revised plan with the
2021 MVEB to EPA for approval, 40 CFR 93.118 required that EPA
determine whether the MVEB was adequate.
    Our criteria for determining whether a SIP's MVEB is adequate for
conformity purposes are outlined in 40 CFR 93.118(e)(4), which was
promulgated August 15, 1997 (see 62 FR 43780). Our process for
determining adequacy is described in our July 1, 2004 Transportation
Conformity Rule Amendments (see 69 FR 40004) and in relevant
guidance.\5\ We used these resources in making our adequacy
determination described below.
---------------------------------------------------------------------------

    \5\ ``Companion Guidance for the July 1, 2004 Final
Transportation Conformity Rule, Conformity Implementation in Multi-
Jurisdictional Nonattainment and Maintenance Areas for Existing and
New Air Quality Standards'' (EPA 420-B-04-012 July, 2004).
---------------------------------------------------------------------------

    On November 22, 2010, EPA announced the availability of the revised
Telluride PM10 Maintenance Plan, and the PM10
MVEB, on EPA's transportation conformity adequacy Web site. EPA
solicited public comment on the MVEB, and the public comment period
closed on December 22, 2010. We did not receive any comments. This
information is available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/currsips.htm#telluride.
    By letter to the Colorado Department of Public Health and
Environment (CDPHE) dated March 21, 2011, EPA found that the revised
Telluride PM10 Maintenance Plan and the 2021 PM10
MVEB were adequate for transportation conformity purposes.\6\ However,
we noted in our letter that the revised Telluride PM10
Maintenance Plan did not discuss the PM10 MVEB for 2012 of
10,001 lbs/day from the original PM10 maintenance plan that
EPA approved in 2001 (see 66 FR 32556, June 15, 2001).
---------------------------------------------------------------------------

    \6\ In a Federal Register notice dated August 2, 2011, we
notified the public of our finding (see 76 FR 46288). This adequacy
determination became effective on August 17, 2011.
---------------------------------------------------------------------------

    According to 40 CFR 93.118(e)(1), the EPA-approved 2012
PM10 MVEB must continue to be used for analysis years 2012
through 2020 (as long as such years are within the timeframe of the
transportation plan), unless the State elects to submit a SIP revision
to revise the 2012 PM10 MVEB and EPA approves the SIP
revision. This is because the revised Telluride PM10
Maintenance Plan did not revise the previously-approved 2012
PM10 MVEB nor establish a new MVEB for 2012. Accordingly,
the MVEB ``. . . for the most recent prior year . . .'' (i.e., 2012)
from the original maintenance plan must continue to be used (see 40 CFR
93.118(b)(1)(ii) and (b)(2)(iv)).
    We note that there is a considerable difference between the 2021
and 2012 budgets--1,108 lbs/day versus 10,001 lbs/day. This is largely
an artifact of changes in the methods, models, and

emission factors used to estimate mobile source emissions. The 2021
MVEB is consistent with the State's 2021 emissions inventory for
vehicle exhaust and road dust, and, thus, is consistent with the
State's maintenance demonstration for 2021.
    The discrepancy between the 2012 and 2021 MVEBs is not a
significant issue for several reasons. As a practical matter, the 2021
MVEB of 1,108 lbs/day of PM10 would be controlling for any
conformity determination involving the relevant years because
conformity would have to be shown to both the 2012 MVEB and the 2021
MVEB. Also, for any maintenance plan, like the revised Telluride
PM10 Maintenance Plan, that only establishes a MVEB for the
last year of the maintenance plan, 40 CFR 93.118(b)(2)(i) requires that
the demonstration of consistency with the budget be accompanied by a
qualitative finding that there are no factors that would cause or
contribute to a new violation or exacerbate an existing violation in
the years before the last year of the maintenance plan. Therefore, when
a conformity determination is prepared which assesses conformity for
the years before 2021, the 2021 MVEB and the underlying assumptions
supporting it would have to be considered. Finally, 40 CFR 93.110
requires the use of the latest planning assumptions in conformity
determinations. Thus, the most current motor vehicle and road dust
emission factors would need to be used, and we expect the analysis
would show greatly reduced PM10 motor vehicle and road dust
emissions from those calculated in the first maintenance plan. In view
of the above, EPA is proposing to approve the 2021 PM10 MVEB
of 1,108 lbs/day.

V. Proposed Action

    We are proposing to approve the revised Telluride PM10
Maintenance Plan that was submitted to us on March 31, 2010. We are
proposing to approve the revised maintenance plan because it
demonstrates maintenance through 2021 as required by CAA section
175A(b), retains the control measures from the initial PM10
maintenance plan that EPA approved in June of 2001, and meets other CAA
requirements for a section 175A maintenance plan. We are proposing to
exclude from use in determining that Telluride continues to attain the
24-hour PM10 NAAQS exceedances of the 24-hour
PM10 NAAQS that were recorded at the Telluride
PM10 monitor on April 5, 2010 and April 16, 2013 because
they meet the criteria for exceptional events caused by high wind
natural events. We are also proposing to approve the revised
maintenance plan's 2021 transportation conformity MVEB for
PM10 of 1,108 lbs/day.

VI. Statutory and Executive Orders Review

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
This proposed action merely proposes to approve state law as meeting
Federal requirements and does not propose to impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed action does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP would not be approved to apply in Indian country
located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, PM10,
Incorporation by reference, Intergovernmental relations, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: November 18, 2013.
Howard M. Cantor,
Acting Regional Administrator, Region 8.
[FR Doc. 2013-28652 Filed 11-27-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Proposed Rules]
[Pages 20910-20911]
[FR Doc No: 2011-8860]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-0545; FRL-9295-2]

Proposed Approval of Air Quality Implementation Plans; Indiana;
Stage I Vapor Recovery Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve into the Indiana State
Implementation Plan (SIP), amendments to the stage I vapor recovery
rule and administrative changes to stage II vapor recovery rule
submitted by the Indiana Department of Environmental Management on June
11, 2010. These rule revisions made volatile organic compounds (VOC)
emission control requirements for filling at gasoline dispensing
facilities more stringent by applying them statewide, making the rule
applicable to smaller tanks and revising the requirements for newer
submerged fill pipes. These new state requirements update the SIP
consistent with new Federal requirements from January 10, 2008 area
source National Emissions Standards for Hazardous Air Pollutants for
gasoline dispensing facilities. The revisions also delete references to
compliance dates which have passed. The rules are approvable because
they are consistent with the Clean Air Act and EPA regulations, and
should result in additional emission reductions of VOCs throughout
Indiana.

DATES: Comments must be received on or before May 16, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2010-0545, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The

Regional Office official hours of business are Monday through Friday,
8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Please see the direct final rule which is located in the Final
Rules section of this Federal Register for detailed instructions on how
to submit comments.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: March 30, 2011.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2011-8860 Filed 4-13-11; 8:45 am]
BILLING CODE 6560-50-P