Rules and Regulations. Final rule

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BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine Oral Paste AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine oral paste, administered to horses as a systemic antibacterial. DATES: This rule is effective May 31, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: *melanie.berson@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 131-918 for use of TRIBRISSEN (trimethoprim and sulfadiazine) 400 Paste, administered orally to horses as a systemic antibacterial. The supplement provides for revised food safety labeling. The supplemental NADA is approved as of April 25, 2006, and the regulations are amended in 21 CFR 520.2611 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Revise § 520.2611 to read as follows: § 520.2611 Trimethoprim and sulfadiazine paste.

(a)*Specifications* . Each gram

(g)of paste contains 67 milligrams

(mg)trimethoprim and 333 mg sulfadiazine.

(b)*Sponsors* . See sponsors in § 510.600(c) of this chapter:

(1)No. 000856 for product administered as in paragraph (c)(1)(i) of this section.

(2)No. 000061 for product administered as in paragraph (c)(1)(ii) of this section.

(c)*Conditions of use in horses* —(1) *Amount* . Administer orally as a single daily dose for 5 to 7 days:

(i)5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day.

(ii)3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.

(2)*Indications for use* . For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory infections, acute urogenital infections, and wound infections and abscesses.

(3)*Limitations* . Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: May 18, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6-8303 Filed 5-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine injectable suspension, administered to horses as a systemic antibacterial. DATES: This rule is effective May 31, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: *melanie.berson@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 106-965 for use of TRIBRISSEN (trimethoprim and sulfadiazine) 48% Injection administered to horses as a systemic antibacterial. The supplement provides for revised food safety labeling. The supplemental NADA is approved as of April 26, 2006, and the regulations are amended in § 522.2610 (21 CFR 522.2610) to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary. In addition, FDA has found that a 1997 change of sponsorship for NADA 106-965 (62 FR 61625, November 19, 1997) is not reflected in the Code of Federal Regulations. Accordingly, § 522.2610 is being revised to reflect the correct sponsor drug labeler code. This action is being taken to improve the accuracy of the regulations. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Revise § 522.2610 to read as follows: § 522.2610 Trimethoprim and sulfadiazine.

(a)*Specifications* . Each milliliter

(mL)contains:

(1)40 milligrams

(mg)trimethoprim suspended in a solution containing 200 mg sulfadiazine; or

(2)80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).

(b)*Sponsors* . See Nos. 000061 and 000856 in § 510.600(c) of this chapter.

(c)*Special considerations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d)*Conditions of use* —(1) Dogs—(i) *Amount* . 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.

(ii)*Indications for use* . For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.

(2)* Horses* —(i) *Amount.* 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.

(ii)*Indications for use* . For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.

(iii)*Limitations* . Not for use in horses intended for human consumption. Dated: May 18, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6-8309 Filed 5-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD13-06-009] RIN 1625-AA00 Safety Zones: Fireworks Displays in the Captain of the Port Portland Zone AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is amending its current regulations establishing additional safety zones on the waters of the Suislaw, Willamette, Columbia, Coos, and Chehalis Rivers, located in the Area of Responsibility

(AOR)of the Captain of the Port, Portland, Oregon, during annual fireworks displays. The Captain of the Port, Portland, Oregon, is taking this action to safeguard watercraft and their occupants from safety hazards associated with these displays. Entry into these safety zones is prohibited unless authorized by the Captain of the Port. DATES: This rule is effective June 30, 2006. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket [CGD13-06-009] and are available for inspection or copying at U.S. Coast Guard Sector Portland 6767 N. Basin Ave, Portland, OR 97217 between 7 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Petty Officer Charity Keuter, c/o Captain of the Port, Portland 6767 N. Basin Avenue, Portland, Oregon 97217,

(503)240-9301. SUPPLEMENTARY INFORMATION: Regulatory Information On March 28, 2006, we published a notice of proposed rule making

(NPRM)entitled Safety Zone: Fireworks Displays in the Captain of the Port Portland Zone in the **Federal Register** (71 FR 15365). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose The Coast Guard is establishing additional permanent safety zones to allow for safe annual fireworks displays. The Coast Guard is also revising 33 CFR 165.1315 paragraph (a)(8) because the current event is no longer an event which occurs with any regularity. All events occur within the Captain of the Port, Portland, OR, Area of Responsibility (AOR). These events may result in a number of vessels congregating near fireworks launching barges and sites. The safety zones are needed to protect watercraft and their occupants from safety hazards associated with fireworks displays. These safety zones will be enforced by representatives of the Captain of the Port, Portland, Oregon. The Captain of the Port may be assisted by other Federal and local agencies. This rule, for safety concerns, will control vessels, personnel and individual movements in a regulated area surrounding the fireworks event indicated in section 2 of this Final Rule. Entry into these zones is prohibited unless authorized by the Captain of the Port, Portland or his designated representative. Discussion of Comments and Changes The Coast Guard received no comments and thus has made no changes from the proposed rule. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed this rule under that Order. This rule is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated areas established by the regulation will encompass small portions of the Columbia, Willamette, Coos, Chehalis and Siuslaw Rivers in the Portland AOR on different dates, all in the evening when vessel traffic is low. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. These safety zones will not have significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only sixty minutes during the evenings when vessel traffic is low. Traffic will be allowed to pass through the zone with the permission of the Captain of the Port or his designated representatives on scene, if safe to do so. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance; please contact Petty Officer Keuter by phone at

(503)240-9301 or by e-mail at *Charity.S.Keuter@uscg.mil.* The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by State, local, or tribal government, in the aggregate, or the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian tribal governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.* , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and “Categorical Exclusion Determination” are required for this rule and are available for review in the public docket for this rulemaking. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6 and 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. In § 165.1315 revise the heading and paragraph (a)(8) and add paragraphs (a)(9)-(14) to read as follows: § 165.1315 Safety Zones: Fireworks displays in the Captain of the Port Portland Zone.

(a)* * *

(8)Florence Chamber 4th of July Fireworks Display, Florence, OR

(i)*Location.* All water of the Siuslaw River enclosed by the following points: 43°58′05″ N, 124°05′54″ W following the shoreline to 43°58′20″ N 124°04′46″ W then south to 43°58′07″ N 124°04′40″ W following the shoreline to 43°57′48″ N 124°05′54″ W then back to the point of origin.

(ii)*Enforcement Period.* This section is enforced annually on July fourth from 9 p.m. to 11 p.m. (PDT).

(9)Oaks Park July 4th Celebration, Portland, OR

(i)*Location.* All water of the Willamette River enclosed by the following points: 45°28′26″ N 122°39′43″ W following the shoreline to 45°28′10″ N 122°39′54″ W then west to 45°28′41″ N 122°40′06″ W following the shoreline to 45°28′31″ N 122°40′01″ W then back to the point of origin.

(ii)*Enforcement Period.* This section is enforced annually on July fourth from 9 p.m. to 11 p.m. (PDT).

(10)Rainier Days Fireworks Celebration, Rainier, OR

(i)*Location.* All water of the Columbia River enclosed by the following points: 46°06′04″ N, 122°56′35″ W following the shoreline to 46°05′53″ N 122°55′58″ W then south to 46°05′24″ N 122°55′58″ W following the shoreline to 46°05′38″ N 122°56′35″ W then back to the point of origin.

(ii)*Enforcement Period.* This section is enforced annually on the second Saturday of July each year from 9 p.m. to 11 p.m. (PDT). Except that when the first Saturday falls on July 1, this section will be enforced on the third Saturday of July.

(11)Ilwaco July 4th Committee Fireworks, Ilwaco, WA

(i)*Location.* All water of the Columbia River extending out to a 700′ radius from the launch site at 46°18′17″ N 124°01′55″ W.

(ii)*Enforcement Period.* This section is enforced annually on the first Saturday of July from 9 p.m. to 11 p.m. (PDT).

(12)Milwaukie Centennial Fireworks Display, Milwaukie, OR

(i)*Location.* All water of the Willamette River enclosed by the following points: 45°26′41″ N, 122°38′46″ W following the shoreline to 45°26′17″ N 122°38′36″ W then west to 45°26′17″ N 122°38′55″ W following the shoreline to 45°26′36″ N 122°38′50″ W then back to the point of origin.

(ii)*Enforcement Period.* This section is enforced annually on the third Saturday of July each year from 9 p.m. to 11 p.m. (PDT). Except that when the first Saturday falls on July 1, this section will be enforced on the fourth Saturday of July.

(13)Splash Aberdeen Waterfront Festival, Aberdeen, WA

(i)*Location.* All water of the Chehalis River extending out to 500 feet of the following points: 46°58′40″ N, 123°47′45″ W.

(ii)*Enforcement Period.* This section is enforced annually on July fourth from 9 p.m. to 11 p.m. (PDT).

(14)City of Coos Bay July 4th Celebration, Coos Bay, OR

(i)*Location.* All water of the Coos River extending out to 1200 feet of the following points: 43°22′12″ N, 124°12′39″ W.

(ii)*Enforcement Period.* This section is enforced annually on July fourth from 9 p.m. to 11 p.m. (PDT). Dated: May 9, 2006. Patrick G. Gerrity, Captain, U.S. Coast Guard, Captain of the Port, Portland, OR. [FR Doc. E6-8218 Filed 5-30-06; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [R06-OAR-2005-NM-0003; FRL-8175-6] Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Albuquerque/Bernalillo County AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: The EPA is approving two separate State Implementation Plan

(SIP)revisions submitted by the Governor of New Mexico. The first submittal, dated September 7, 2004, adopts local Ambient Air Quality Standards

(AAQS)and incorporates by reference the Federal National Air Quality Standards (NAAQS) for the Albuquerque/Bernalillo County, New Mexico area. The second submittal, dated July 28, 2005, revises the Variance Procedure for the Albuquerque/Bernalillo County, New Mexico area. We are approving these two separate revisions in accordance with the requirements of the Clean Air Act (the Act), section 110. DATES: This direct final rule is effective on July 31, 2006 without further notice, unless EPA receives relevant adverse comment by June 30, 2006. If EPA receives such comment, EPA will publish a timely withdrawal in the **Federal Register** informing the public that this rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-OAR-2005-NM-0003, by one of the following methods: Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. U.S. EPA Region 6 “Contact Us” web site: *http://epa.gov/region6/r6coment.htm* Please click on “6PD” (Multimedia) and select “Air” before submitting comments. E-mail: Mr. Thomas Diggs at *diggs.thomas@epa.gov* . Please also cc the person listed in the FOR FURTHER INFORMATION CONTACT section below. Fax: Mr. Thomas Diggs, Chief, Air Planning Section (6PD-L), at fax number 214-665-7263. Mail: Mr. Thomas Diggs, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Hand or Courier Delivery: Mr. Thomas Diggs, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only between the hours of 8 a.m. and 4 p.m. weekdays except for legal holidays. Special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R06-OAR-2005-NM-0003. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *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 *www.regulations.gov* or e-mail. The *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 e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail 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. *Docket:* All documents in the docket are listed in the *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 *www.regulations.gov* or in hard copy at the Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made available by appointment for public inspection in the Region 6 FOIA Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the person listed in the FOR FURTHER INFORMATION CONTACT paragraph below to make an appointment. If possible, please make the appointment at least two working days in advance of your visit. There will be a 15 cent per page fee for making photocopies of documents. On the day of the visit, please check in at the EPA Region 6 reception area at 1445 Ross Avenue, Suite 700, Dallas, Texas. The State submittal is also available for public inspection at the State Air Agency listed below during official business hours by appointment: The City of Albuquerque, Environmental Health Department, One Civic Plaza, Albuquerque, NM 87102. FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar of the Air Planning Section (6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733 at

(214)665-6691, or *shar.alan@epa.gov* . SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Evaluation of New Mexico's Submittal A. 20.11.8 NMAC, Ambient Air Quality Standards B. 20.11.7 NMAC, Variance Procedure III. Final Action IV. Statutory and Executive Order Reviews Throughout this document “we,” “us,” and “our” refer to EPA. I. Background A revision to the New Mexico SIP concerning Title 20, Chapter 11, Part 8 of the New Mexico Administrative Code (20.11.8 NMAC) was submitted to us by the Governor of New Mexico on September 7, 2004. This SIP revision establishes and adopts local AAQS for the Albuquerque/Bernalillo County, New Mexico area. These AAQS are similar to the New Mexico AAQS adopted by the New Mexico Environment Department (NMED). It also incorporates by reference the Federal NAAQS at 40 CFR part 50, as amended through July 18, 1997. The EPA approved the NMED-adopted state AAQS and incorporated Federal NAAQS in Title 20, Chapter 2, Air Quality, Part 3 Ambient Air Quality Standards on 09/26/97 (62 FR 50518) at § 52.1620(c)(66) and became effective 11/25/1997 for the State of New Mexico excluding the Albuquerque/Bernalillo County area. See our Technical Support Document

(TSD)prepared in conjunction with this SIP revision for more information concerning our evaluation of this part. Initially, EPA approved the New Mexico Regulation 24 Variance Procedure for the Albuquerque/Bernalillo County area on April 10, 1980. See April 10, 1980 (45 FR 24460) at § 52.1620(c)(11) to (c)(15). The Albuquerque/Bernalillo Board adopted and replaced its Variance Procedure rules on October 1, 2002 as Title 20, Chapter 11, Part 7 (20.11.7 NMAC) and adopted changes on August 1, 2004. A revision to the New Mexico SIP 20.11.7 NMAC concerning Variance Procedure for the Albuquerque/Bernalillo County area was submitted to us by the Governor of New Mexico on July 28, 2005. This SIP revision makes the Variance Procedure more stringent than the original SIP-approved rule. Among other things, it precludes issuance of variances from enumerated Federal emissions limitations and programs, and clarifies that approval or granting of a variance does not mean automatic approval by the EPA, for the Albuquerque/Bernalillo County area. II. Evaluation of New Mexico's Submittal A. 20.11.8 NMAC, Ambient Air Quality Standards A revision to the New Mexico SIP concerning 20.11.8 NMAC was submitted to us by the Governor of New Mexico on September 7, 2004. This SIP revision establishes and adopts local AAQS for the Albuquerque/Bernalillo County. It also incorporates by reference the federal NAAQS as amended through July 18, 1997. The current Federally-approved SIP, for the Albuquerque/Bernalillo County area, does not contain the local or National AAQS for this area. As stated in section I of this document, the local standards we are approving today are similar to those that EPA has already approved for the remaining parts of the New Mexico State. See September 26, 1997 (62 FR 50518). The local AAQS are for hydrogen sulfide, total reduced sulfur, a 24-hour average for nitrogen dioxide, a 24-hour average, 7-day average, 30-day average, and annual geometric mean for particulate matter, and limitations more stringent than the Federal NAAQS for the 8-hour and 1-hour average for carbon monoxide, and the 24-hour average and annual arithmetic mean for sulfur dioxide. Approval of these local standards will lead to improved air quality. We are approving the incorporation of the Federal NAAQS because it will make the Albuquerque/Bernalillo County SIP consistent with the latest Federally-promulgated NAAQS. This SIP revision will provide for consistency between the NMED-adopted SIP and the Albuquerque/Bernalillo County SIP. Thus, by approving the SIP revision, all sources within the County that are emitting, or wish to emit, any of the locally regulated pollutants and precursors are required to comply with the same AAQS as all sources anywhere within the geographical boundaries of the State. This SIP revision will enhance the County's air quality. This SIP revision will add more stringent requirements to the current Federally-approved SIP and ensure that the SIP contains the most up-to-date Federal NAAQS. For these reasons, we are approving, as a part of the SIP, the local AAQS for the Albuquerque/Bernalillo County, New Mexico area under sections 110 and 116, and approving the incorporation of the Federal NAAQS under section 110 of the Act. B. 20.11.7 NMAC, Variance Procedure A revision to the New Mexico SIP concerning 20.11.7 NMAC was submitted to us by the Governor of New Mexico on July 28, 2005. This SIP revision includes a rule that replaces and revises the previous Variance Procedure rule and imposes additional restrictions on the Variance Procedures for the Albuquerque/Bernalillo County area. As stated in section I of this document, EPA initially approved the New Mexico Regulation 24 Variance Procedure for the Albuquerque/Bernalillo County area on April 10, 1980 (45 FR 24460). The Variance Procedure rule, adopted in 2002 and revised in 2004, adds more extensive public participation requirements, including several forms of public notification, newspaper publications, public comment periods, and adds a requirement for an evidentiary hearing versus a public comment hearing. The granting of a variance still cannot either result in a condition injurious to health or safety, or cause or contribute to an air contaminant level in excess of any primary NAAQS. The petitioner, however, now has the burden of proof in the evidentiary hearing to show the need for a variance and now must prove by a preponderance of evidence the facts relied upon to justify the requested relief. Another significant improvement is that there no longer is an automatic stay of enforcement pending the Board's decision. Sections 20.11.7.2 (Scope) and 20.11.7.6 (Objective) add the requirement to this SIP revision that variance from a limitation, order, or permit condition does not apply to enumerated Federally promulgated emissions standards and programs; *e.g.* , the requirements to obtain a minor preconstruction permit, a nonattainment preconstruction permit, a Prevention of Significant Deterioration preconstruction permit, or an operating permit and the requirements to meet the Federal acid rain program, the Federal New Source Performance Standards, and the Federal National Emission Standards for Hazardous Air Pollutants. Furthermore, section 20.11.7.2 (Scope) specifies that approval or granting of a variance to a source does not mean automatic approval by EPA. Our TSD prepared in conjunction with this SIP revision contains detailed information concerning our evaluation of this part. This SIP revision greatly improves the current Federally-approved SIP rule, adds many more safeguards to protect the existing air quality, *e.g.* , no automatic stay of enforcement, no variance from Federal programs, more stringent public participation, and evidentiary hearings. We find that approving 20.11.7 NMAC into the SIP meets section 110(l) of the Act. For this reason, we are approving, as a part of the SIP, the Variance Procedure 20.11.7 NMAC, as adopted in 2002 and revised in 2004, for the Albuquerque/Bernalillo County, New Mexico area. III. Final Action The EPA is approving the revisions to the New Mexico's Albuquerque/Bernalillo County SIP because the revisions are consistent with the Act and EPA regulatory requirements. The EPA is publishing this rule without prior proposal because the EPA views this as a non-controversial submittal and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective July 31, 2006 without further notice, unless EPA receives relevant adverse comment by June 30, 2006. If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on July 31, 2006, and no further action will be taken on the proposed rule. IV. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule 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.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it 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 also 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 also 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 action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 31, 2006. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a 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 relations, Reporting and recordkeeping requirements. Dated: May 19, 2006. Richard E. Greene, Regional Administrator, Region 6. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart GG—New Mexico 2. Section 52.1620, paragraph (c), the second table entitled “EPA Approved Albuquerque/Bernalillo County, NM Regulations,” is amended by revising the entry for Part 7 and adding an entry for Part 8 to read as follows: § 52.1620 Identification of plan.

(c)* * * EPA-Approved Albuquerque/Bernalillo County, NM Regulations State citation Title/subject State approval/effective date EPA approval date Explanation Albuquerque/Bernalillo County, Air Quality Control Regulations * * * * * * * New Mexico Administrative Code

(NMAC)Title 20—Environment Protection, Chapter 11-Albuquerque/Bernalillo County Air Quality Control Board * * * * * * * Part 7 (20.11.7 NMAC) Variance Procedure 09/07/04 05/31/06 [Insert FR page where document begins] Part 8 (20.11.8 NMAC) Ambient Air Quality Standards 09/07/04 05/31/06 [Insert FR page where document begins] * * * * * * * [FR Doc. 06-4921 Filed 5-30-06; 8:45 am]

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