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Code · REGISTER · 2007-09-07 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

12,869 words·~58 min read·/register/2007/09/07/07-4405

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Etodolac 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 new animal drug application
(NADA)filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of etodolac injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis. DATES: This rule is effective September 7, 2007. 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: Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501 filed NADA 141-274 that provides for veterinary prescription use of ETOGESIC (etodolac) Injectable in dogs for the control of pain and inflammation associated with osteoarthritis. The application is approved as of August 16, 2007, and part 522 (21 CFR part 522) is amended by adding § 522.870 to reflect the approval. 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. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. FDA has determined under 21 CFR 25.33(d)(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. Add § 522.870 to read as follows: § 522.870 Etodolac.
(a)*Specifications* . Each milliliter contains 100 milligrams
(mg)etodolac.
(b)*Sponsor* . See No. 000856 in § 510.600 of this chapter.
(c)*Conditions of use in dogs* —(1) *Amount* . Administer 4.5 to 6.8 mg/pound (10 to 15 mg/kilogram) body weight as a single, dorsoscapular subcutaneous injection. If needed, the daily dose of etodolac tablets as in § 520.870 of this chapter may be given 24 hours after the injection.
(2)*Indications for use* . For the control of pain and inflammation associated with osteoarthritis.
(3)*Limitations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: August 28, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-17645 Filed 9-6-07; 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; Dexmedetomidine 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 Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic in cats. DATES: This rule is effective September 7, 2007. 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: Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed a supplement to NADA 141-267 for DEXDOMITOR (dexmedetomidine hydrochloride). The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic in cats. The supplemental application is approved as of August 15, 2007, and the regulations in 21 CFR 522.558 are amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and effectiveness data and information submitted to support approval of these applications 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(d)(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. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. 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. In § 522.558, revise paragraph
(c)to read as follows: § 522.558 Dexmedetomidine.
(c)*Conditions of use* —(1) *Dogs* —(i) *Indications for use and amount* .
(A)For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (μg) per square meter (/m 2 ) of body surface area by intravenous injection or 500 μg/m 2 of body surface area by intramuscular injection.
(B)For use as a preanesthetic to general anesthesia, administer 125 μg/m 2 of body surface area or 375 μg/m 2 of body surface area by intramuscular injection.
(ii)*Limitations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)*Cats* —(i) *Amount* . 40 μg/killogram by intramuscular injection.
(ii)*Indications for use* . For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
(iii)*Limitations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: August 28, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-17696 Filed 9-6-07; 8:45 am] BILLING CODE 4160-01-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA-HQ-OAR-2002-0071; FRL-8448-9] RIN 2060-A009 Update of Continuous Instrumental Test Methods: Technical Amendments AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action on “Update of Continuous Instrumental Test Methods: Technical Amendments” to correct errors in a recent final rule that amended five instrumental test methods and was published on May 15, 2006. As published, the amendments contained inadvertent errors and provisions that need to be clarified. We are correcting errors and clarifying portions of the amendments to reflect the intent of the rule and to make them more understandable by affected parties. DATES: This rule is effective on November 6, 2007 without further notice, unless EPA receives adverse comment by October 9, 2007. If EPA receives adverse 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-HQ-OAR-2002-0071, by one of the following methods: • *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. • *E-mail: a-and-r-docket@epa.gov. * • *Fax:*
(202)566-9744. • *Mail:* Update of Continuous Instrumental Test Methods, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total of two copies. • *Hand Delivery:* EPA Docket Center, 1301 Constitution Avenue, NW., EPA Headquarters Library, Room 3334, EPA West Building, Washington, DC 20460. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2002-0071. 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 *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 Update of Continuous Instrumental Test Methods, EPA/DC, EPA West Building, EPA Headquarters Library, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Update of Continuous Instrumental Test Methods is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: Mr. Foston Curtis, Air Quality and Analysis Division, Office of Air Quality Planning and Standards (D143-02), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number
(919)541-1063; fax number
(919)541-0516; e-mail address *curtis.foston@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. Why Is EPA Using a Direct Final Rule? II. Does This Action Apply to Me? III. Where Can I Obtain a Copy of This Action? IV. Judicial Review V. Background VI. This Action A. Method 3A—40 CFR Part 60, Appendix A-1 B. Method 6C—40 CFR Part 60, Appendix A-4 C. Method 7E—40 CFR Part 60, Appendix A-4 D. Method 20—40 CFR Part 60, Appendix A-7 VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Why Is EPA Using a Direct Final Rule? EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. The technical amendments we are making simply add clarity and correct errors in the prior rule. However, in the “Proposed Rules” section of today's **Federal Register** , we are publishing a separate document that will serve as the proposed rule to these technical amendments if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the **Federal Register** informing the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule. II. Does This Action Apply to Me? This rule applies to sources that are subject to the New Source Performance Standards, Clean Air Markets requirements, and other regulations that require the use of Method 3A of Appendix A-1, Methods 6C and 7E of Appendix A-4, and Method 20 of Appendix A-7 to 40 CFR part 60. Regulated Entities. Categories and entities potentially affected include the following: Examples of regulated entities SIC codes NAICS codes Fossil Fuel Steam Generators 3569 332410 Industrial, Commercial, Institutional Steam Generating Units 3569 332410 Electric Generating 3569 332410 Stationary Gas Turbines 3511 333611 Petroleum Refineries 2911 324110 Municipal Waste Combustors 4953 562213 Kraft Pulp Mills 2621 322110 Sulfuric Acid Plants 2819 325188 III. Where Can I Obtain a Copy of This Action? In addition to being available in the docket, an electronic copy of this direct final rule will also be available on the Worldwide Web
(WWW)through the Technology Transfer Network (TTN). Following the Administrator's signature, a copy of the final amendments will be placed on the TTN's policy and guidance page for newly proposed or promulgated rules at *http://www.epa.gov/ttn/oarpg.* The TTN provides information and technology exchange in various areas of air pollution control. IV. Judicial Review Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of this direct final rule is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by November 6, 2007. Under section 307(d)(7)(B) of the CAA, only an objection to this direct final rule that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by this action may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements. V. Background Methods 3A, 6C, 7E, 10, and 20 measure oxygen, carbon dioxide, sulfur dioxide, nitrogen oxides, and carbon monoxide emissions from stationary sources. They are prescribed for use in determining compliance with a number of Federal, State, and Local regulations. The EPA published amendments to simplify, harmonize, and update these test methods on May 15, 2006 (71 FR 28081). These amendments became effective August 14, 2006. As published, the amendments contained inadvertent errors and provisions that need to be clarified. We are correcting errors and clarifying portions of the amendments to reflect the intent of the rule and to make them more understandable by affected parties. VI. This Action EPA is taking the following actions: A. Method 3A—40 CFR Part 60, Appendix A-1 1. We are clearly stating that precleaned or scrubbed air may be used for the high-level calibration gas provided no interfering gases are present. 2. An incorrect reference in Section 8.1 to Section 8.2 of Method 3 for sampling to determine gas molecular weight is corrected to reference Section 8.2.1 of Method 3. B. Method 6C—40 CFR Part 60, Appendix A-4 In Section 6.2, a reference to Section 6.2.8.1 for dual-range analyzers is expanded to include Section 6.2.8.2 which also applies. C. Method 7E—40 CFR Part 60, Appendix A-4 1. Under the descriptions for calibration gases in Section 3.3, the quality of zero gas allowed for instrument calibration is clarified. The current requirement is that all calibration gases be of EPA traceability protocol quality. However, the traceability protocol does not have a specification for zero gas. Therefore, we are adopting the specification for “zero air material” in 40 CFR 72.2 for zero gas in place of the traceability protocol. 2. In Section 3.4, we recommend the instrument calibration span be chosen such that emission concentrations are between 20 to 100 percent of the calibration span, “to the extent practicable.” We are adding a note, as an example, that meeting this 20 to 100 percent criterion may not be practicable when emissions are low relative to the emission limit and the purpose of the test is to show compliance with the emission limit. 3. Section 3.9 is clarified to note that drift is the difference between the pre- and post-run system bias checks instead of the difference between the measurement system readings for the pre- and post-run bias checks. 4. Section 3.12 is corrected to remove erroneous citations to 40 CFR 53.55 and 53.56 which have nothing to do with the manufacturer's stability test (MST). 5. Section 3.16 is corrected to note that system bias is calculated from the difference between the system calibration response and the manufacturer certified gas concentration and not from the difference between the system calibration response and the direct calibration responses. 6. In Section 6.2.2, we are specifically stating that the particulate media must be included in the system bias test only when using out-of-stack filters. 7. In Section 6.2.6, the description of the calibration gas manifold is clarified to note that blocking the sample flow is not necessary when in direct calibration mode, as suggested in the current method, but the calibration gas manifold may simply supply an excess of calibration gas through the system. 8. The method implies that all analyzers with calibration spans of 20 ppmv or less are required to perform the MST. In Section 6.2.8.2, we are clarifying the MST requirement to note that it is only required for those analyzers that are *routinely* calibrated with a calibration span of 20 ppmv or less. 9. The new converter efficiency check that was added in Section 16.2.2 requires the nitrogen dioxide (NO <sup>2</sup> ) test gas be of EPA traceability protocol quality. Subsequent discussions with the National Institute of Standards and Technology
(NIST)concerning the quality of the NIST NO <sup>2</sup> standard revealed that this standard contains small but consistent amounts of nitric acid (HNO <sup>3</sup> ). Some converters may not be able to completely convert this HNO <sup>3</sup> to nitric oxide
(NO)for analysis. There are also concerns about the cost and stability of certified NO <sup>2</sup> gas over time. We are therefore dropping the new requirement that the converter efficiency gas be of EPA traceability protocol quality and reverting to the previous requirement that the gas be of a manufacturer-certified concentration. In addition, for this converter check procedure, the gas is required to be in the 40 to 60 ppmv range while the two alternative procedures require gas in the mid- to high-calibration range. We are dropping the 40 to 60 ppmv requirement in favor of recommending the concentration be in the mid- to high-calibration range in order to keep the three procedures consistent. Subsequent references to the 40 to 60 ppmv requirement have been deleted from the method. 10. In Section 7.2, we are clearly stating that the appropriate test gases listed in Table 7E-3, * or others not listed that can potentially interfere * , as noted elsewhere, must be used for the test. We are also making it clear that the gases used should be manufacturer-certified but are not required to be prepared by the EPA traceability protocol. 11. In Section 8.1.2, we are explicitly stating that the required stratification test is to be performed at each test site except for small stacks that are less than 4 inches in diameter. 12. In Section 8.2.1, we are making it clear that testers must obtain a certificate from the gas manufacturer documenting the quality of the calibration gas. 13. In Section 8.2.4, we are clearly stating that the converter efficiency test may be performed either before or after a test or after a series of tests. 14. In Section 8.2.7, paragraph
(1)is reworded to add clarity to the interference test, and paragraph
(2)is corrected to note that the interference test is valid for the life of the instrument unless major components are replaced *with different model parts.* 15. In the sample traversing procedure in Section 8.4, we delete redundant language in paragraphs
(1)and (2). 16. In paragraph
(1)of Section 8.5, we clarify the handling of failed post-run bias checks by removing unnecessary wording. 17. In Section 10.0, we clearly state that analyzers which measure NO and NO <sup>2</sup> without using a converter must be calibrated with both NO and NO <sup>2</sup> . The current wording is not clear to some users. 18. In Section 12.1, we are revising certain definitions to reflect the corrections being made to the calculations. 19. In Section 12.4, we correct the system calibration error equation by adding a term for the dilution factor. 20. In Section 12.6, we add a missing equation for calculating sample concentration when a zero gas is used as the low-level calibration gas. 21. In Section 12.9 we replace the erroneous equation added in the updates rule with the one traditionally used by the method. 22. In Section 12.11, we correct the equation for calculating the spike recovery. 23. In Section 13.5, we are adding the 2 percent limit for the alternative converter efficiency test. 24. In Section 16.2.2, we are deleting the procedures in paragraphs
(2)and
(3)because they are not needed for the test and are confusing. 25. In Section 16.3, the erroneous references to 40 CFR 53.55 and 53.56 are removed; only 53.53 is followed for the MST. A note is added to clarify that alternative procedures or documentation of instrument stability are acceptable. 26. In Table 7E-3, the title is edited to note that the table contains *example* interference gases and concentrations. We are removing a table footnote instructing dilution extractive systems to use the hot wet concentrations because it may not be applicable in all cases. In its place, a footnote is added to remind the tester to use the highest gas concentration expected at test sites for the interference test. 27. In Table 7E-5, we correct the typographical error listing the NO <sup>X</sup> concentration at “.80% of calibration span” to read “80% of calibration span.” We have removed the note to evaluate each model by the MST at least quarterly or once per 50 production units because it is not necessary. D. Method 20—40 CFR Part 60, Appendix A-7 1. In Section 8.4, we are adding a minimum sample run time of 21 minutes. VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order. B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* These amendments do not add information collection requirements beyond those currently required under the applicable regulation. The amendments being made to the test methods do not add information collection requirements but make needed corrections to existing testing methodology. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control number for EPA's regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as:
(1)A small business whose parent company has fewer than 100 or 1,000 employees, or fewer than 4 billion kilowatt-hr per year of electricity usage, depending on the size definition for the affected North American Industry Classification System code;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today's direct final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This direct final rule will not impose any requirements on small entities because it does not impose any additional regulatory requirements. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed, under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. EPA has determined that this direct final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year, nor does this rule significantly or uniquely impact small governments, because it contains no requirements that apply to such governments or impose obligations upon them. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. E. Executive Order 13132: Federalism Executive Order 13132 entitled “Federalism” (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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.” This direct final rule does not have federalism implications. It will 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. The amendments in this direct final rule will benefit State and Local governments by clarifying and correcting provisions they currently implement. No added responsibilities or increase in implementation efforts or costs for State and Local governments are being added in today's action. Thus, Executive Order 13132 does not apply to this rule. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175 entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This direct final rule does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, 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 in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that:
(1)Is determined to be “economically significant” as defined under Executive Order 12866, and
(2)concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d)(15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order
(EO)12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this direct final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This direct final rule does not relax the control measures on sources regulated by the rule and therefore will not cause emissions increases from these sources. K. Congressional Review Act 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. 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). This rule will be effective November 6, 2007. List of Subjects in 40 CFR Part 60 Environmental protection, Administrative practice and procedures, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: July 26, 2007. Stephen L. Johnson, Administrator. For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows: PART 60—STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES 1. The authority citation for part 60 continues to read as follows: Authority: 23 U.S.C. 101; 42 U.S.C. 7401-7671q. Appendix A-2—[Amended] 2. Amend Method 3A as follows: a. Add a sentence after the second sentence of Section 7.1. b. Revise the second sentence in Section 8.1. Method 3A—Determination of Oxygen and Carbon Dioxide Concentrations in Emissions From Stationary Sources (Instrumental Analyzer Procedure) 7.1 Calibration Gas. * * * Precleaned or scrubbed air may be used for the O <sup>2</sup> high-calibration gas provided it does not contain other gases that interfere with the O <sup>2</sup> measurement. 8.1 Sampling Site and Sampling Points. * * * In that case, you may use single-point integrated sampling as described in Section 8.2.1 of Method 3. Appendix A-4—[Amended] 3. Amend Method 6C by revising the last sentence in Section 6.2 to read as follows: Method 6C—Determination of Sulfur Dioxide Emissions From Stationary Sources (Instrumental Analyzer Procedure) 6.2 * * * The low-range and dual-range analyzer provisions in Sections 6.2.8.1 and 6.2.8.2 of Method 7E apply. 4. Amend Method 7E as follows: a. Revise Sections 3.3, 3.4, and 3.9. b. Revise the third sentence in Section 3.12. c. Revise the first sentence in Section 3.16. d. Revise Section 6.2.2. e. Revise the second sentence in Section 6.2.6. f. Revise Section 6.2.8.2. g. Add a sentence after the second sentence in Section 7.1. h. Revise Section 7.1.4. i. Revise Section 7.2. j. Add two sentences to the beginning of Section 8.1.2. k. Revise the second sentence in Section 8.2.1. l. Revise the first sentence in Section 8.2.4. m. Revise Section 8.2.4.1. n. Revise the first and second sentences in paragraph
(1)and the second sentence in paragraph
(2)of Section 8.2.7. o. Revise paragraphs
(1)and
(2)in Section 8.4. p. Revise the introductory paragraph and paragraph
(1)of Section 8.5. q. In Section 9.0, the table entitled “Summary Table of QA/QC” is amended by revising the entry for “M” “System Performance” “NO <sup>2</sup> -NO conversion efficiency” “≥90% of certified test gas concentration” “before each test.” r. Revise the last sentence in paragraph
(1)of Section 10.0. s. Add a definitions for “C <sup>native</sup> ,” “C <sup>OA</sup> ,” and “DF” in alphabetical order to Section 12.1. t. Remove the definition for “NO <sup>final</sup> ” in Section 12.1. u. Revise the definition of “SB <sup>f</sup> ” in Section 12.1. v. Revise Equation 7E-3 in Section 12.4. w. Revise Sections 12.6 and 12.9. x. Revise Equation 7E-12 in Section 12.11. y. Revise Section 13.5. z. Revise the third sentence in paragraph
(1)of Section 16.2.2. aa. Remove and reserve paragraph
(2)and remove paragraph
(3)of Section 16.2.2. bb. Revise Section 16.3. cc. Revise Table 7E-3. dd. Revise Table 7E-5. Method 7E—Determination of Nitrogen Oxides Emissions From Stationary Sources (Instrumental Analyzer Procedure) 3.3 *Calibration Gas* means the gas mixture containing NO <sup>X</sup> at a known concentration and produced and certified in accordance with “EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards,” September 1997, as amended August 25, 1999, EPA-600/R-97/121 or more recent updates. The tests for analyzer calibration error, drift, and system bias require the use of calibration gas prepared according to this protocol. If a zero gas is used for the low-level gas, it must meet the requirements under the definition for “zero air material” in 40 CFR 72.2 in place of being prepared by the traceability protocol. 3.4 *Calibration Span* means the upper limit of the analyzer's calibration that is set by the choice of high-level calibration gas. No valid run average concentration may exceed the calibration span. To the extent practicable, the measured emissions should be between 20 to 100 percent of the selected calibration span. This may not be practicable in some cases of low-concentration measurements or testing for compliance with an emission limit when emissions are substantially less than the limit. In such cases, calibration spans that are practicable to achieving the data quality objectives without being excessively high should be chosen. 3.9 *Drift* means the difference between the pre- and post-run system bias (or system calibration error) checks at a specific calibration gas concentration level (i.e. low-, mid- or high-). 3.12 * * * An MST subjects the analyzer to a range of line voltages and temperatures that reflect potential field conditions to demonstrate its stability following procedures similar to those provided in 40 CFR 53.23. Ambient-level analyzers are exempt from the MST requirements of Section 16.3. * * * 3.16 *System Bias* means the difference between a calibration gas measured in system calibration mode and the manufacturer certified concentration of the gas expressed as a percentage of the calibration span. 6.2.2 Particulate Filter. An in-stack or out-of-stack filter. The filter must be made of material that is non-reactive to the gas being sampled. The filter media for out-of-stack filters must be included in the system bias test. The particulate filter requirement may be waived in applications where no significant particulate matter is expected (e.g., for emission testing of a combustion turbine firing natural gas). 6.2.6 Calibration Gas Manifold. * * * In system calibration mode, the system should be able to flood the sampling probe and vent excess gas. * * * 6.2.8.2 Low Concentration Analyzer. When an analyzer is routinely calibrated with a calibration span of 20 ppmv or less, the manufacturer's stability test
(MST)is required. See Table 7E-5 for test parameters. 7.1 Calibration Gas. * * * If a zero gas is used for the low-level gas, it must meet the requirements under the definition for “zero air material” in 40 CFR 72.2. * * * 7.1.4 Converter Efficiency Gas. What reagents do I need for the converter efficiency test? The converter efficiency gas is a manufacturer-certified gas with a recommended concentration in the mid- to high-calibration gas range. Lower concentrations may be more appropriate where source emissions are low. For the test described in Section 8.2.4.1, NO <sup>2</sup> is required. For the alternative converter efficiency tests in Section 16.2, NO is required. 7.2 Interference Check. What reagents do I need for the interference check? Use the appropriate test gases listed in Table 7E-3 or others not listed that can potentially interfere (as indicated by the test facility type, instrument manufacturer, etc.) to conduct the interference check. These gases should be manufacturer certified but do not have to be prepared by the EPA traceability protocol. 8.1.2 Determination of Stratification. Perform a stratification test at each test site to determine the appropriate number of sample traverse points. A stratification test is not required for small stacks that are less than 4 inches in diameter. * * * 8.2.1 Calibration Gas Verification. * * * Obtain a certificate from the gas manufacturer documenting the quality of gas. * * * 8.2.4 NO <sup>2</sup> to NO Conversion Efficiency. Before or after each field test, you must conduct an NO <sup>2</sup> to NO conversion efficiency test if your system converts NO <sup>2</sup> to NO before analyzing for NO <sup>X</sup> . You may risk testing multiple facilities before performing this test provided you pass this test at the conclusion of the final facility test. A failed final conversion efficiency test in this case will invalidate all tests performed subsequent to the test in which the converter efficiency test was passed. * * * 8.2.4.1 Introduce NO <sup>2</sup> converter efficiency gas to the analyzer in direct calibration mode and record the NO <sup>X</sup> concentration displayed by the analyzer. Calculate the converter efficiency using Equation 7E-7 in Section 12.7. The specification for converter efficiency in Section 13.5 must be met. The user is cautioned that state-of-the-art NO <sup>2</sup> calibration gases may have limited shelf lives, and this could affect the ability to pass the 90 percent conversion efficiency requirement. 8.2.7 Interference Check. * * *
(1)You may introduce the appropriate interference test gases (that are potentially encountered during a test, see examples in Table 7E-3) into the analyzer separately or as mixtures. Test the analyzer with the interference gas alone at the highest concentration expected at a test source and again with the interference gas and NO <sup>X</sup> at a representative NO <sup>X</sup> test concentration. * * *
(2)* * * This interference test is valid for the life of the instrument unless major analytical components (e.g., the detector) are replaced with different model parts. If major components are replaced with different model parts, the interference gas check must be repeated before returning the analyzer to service. 8.4 Sample Collection.
(1)Position the probe at the first sampling point. Purge the system for at least two times the response time before recording any data. Then, traverse all required sampling points, sampling at each point for an equal length of time and maintaining the appropriate sample flow rate or dilution ratio (as applicable). You must record at least one valid data point per minute during the test run.
(2)Each time the probe is removed from the stack and replaced, you must recondition the sampling system for at least two times the system response time prior to your next recording. If the average of any run exceeds the calibration span value, that run is invalid. 8.5 Post-Run System Bias Check and Drift Assessment. How do I confirm that each sample I collect is valid? After each run, repeat the system bias check or 2-point system calibration error check (for dilution systems) to validate the run. Do not make adjustments to the measurement system (other than to maintain the target sampling rate or dilution ratio) between the end of the run and the completion of the post-run system bias or system calibration error check. Note that for all post-run system bias or 2-point system calibration error checks, you may inject the low-level gas first and the upscale gas last, or vice-versa. You may risk sampling for multiple runs before performing the post-run bias or system calibration error check provided you pass this test at the conclusion of the group of runs. A failed final test in this case will invalidate all runs subsequent to the last passed test.
(1)If you do not pass the post-run system bias (or system calibration error) check, then the run is invalid. You must diagnose and fix the problem and pass another calibration error test (Section 8.2.3) and system bias (or 2-point system calibration error) check (Section 8.2.5) before repeating the run. Record the system bias (or system calibration error) results on a form similar to Table 7E-2. 9.0 Quality Control Summary Table of QA/QC Status Process or element QA/QC specification Acceptance criteria Checking frequency * * * * * * * M System Performance NO <sup>2</sup> -NO conversion efficiency ≥90% of certified test gas concentration Before or after each test. * * * * * * * 10.0 Calibration and Standardization * * *
(1)* * * Analyzers that measure NO and NO <sup>2</sup> separately without using a converter must be calibrated with both NO and NO <sup>2</sup> . 12.1 Nomenclature. * * * C <sup>native</sup> = NO <sup>X</sup> concentration in the stack gas as calculated in Section 12.6, ppmv. * * * C <sup>OA</sup> = Actual concentration of the low-level calibration gas, ppmv. * * * DF = Dilution system dilution factor or spike gas dilution factor, dimensionless. * * * SB <sup>final</sup> = Post-run system bias, percent of calibration span. 12.4 System Calibration Error. * * * ER07SE07.000 12.6 Effluent Gas Concentration. For each test run, calculate C <sup>avg</sup> , the arithmetic average of all valid NO <sup>X</sup> concentration values (e.g., 1-minute averages). Then adjust the value of C <sup>avg</sup> for bias using Equation 7E-5a if you use a non-zero gas as your low-level calibration gas, or Equation 7E-5b if you use a zero gas as your low-level calibration gas. ER07SE07.001 ER07SE07.002 12.9 Alternative NO <sup>2</sup> Converter Efficiency. If the alternative procedure of Section 16.2.2 is used, determine the NO <sup>X</sup> concentration decrease from NO <sup>XPeak</sup> after the minimum 30-minute test interval using Equation 7E-9. This decrease from NO <sup>XPeak</sup> must meet the requirement in Section 13.5 for the converter to be acceptable. ER07SE07.003 12.11 Calculated Spike Gas Concentration and Spike Recovery for the Example Alternative Dynamic Spiking Procedure in Section 16.1.3. * * * ER07SE07.004 13.5 NO <sup>2</sup> to NO Conversion Efficiency Test (as applicable). The NO <sup>2</sup> to NO conversion efficiency, calculated according to Equation 7E-7, must be greater than or equal to 90 percent. The alternative conversion efficiency check, described in Section 16.2.2 and calculated according to Equation 7E-9, must not result in a decrease from NO <sup>XPeak</sup> by more than 2.0 percent. 16.2.2 Tedlar Bag Procedure. * * * Fill the remainder of the bag with mid- to high-level NO in nitrogen (or other appropriate concentration) calibration gas. 16.3 Manufacturer's Stability Test. A manufacturer's stability test is required for all analyzers that routinely measure emissions below 20 ppmv and is optional but recommended for other analyzers. This test evaluates each analyzer model by subjecting it to the tests listed in Table 7E-5 following procedures similar to those in 40 CFR 53.23 for thermal stability and insensitivity to supply voltage variations. If the analyzer will be used under temperature conditions that are outside the test conditions in Table B-4 of Part 53.23, alternative test temperatures that better reflect the analyzer field environment should be used. Alternative procedures or documentation that establish the analyzer's stability over the appropriate line voltages and temperatures are acceptable. Table 7E-3.—Example Interference Check Gas Concentrations Potential interferent gas 1 Concentrations 2 Sample conditioning type Hot wet Dried CO <sup>2</sup> 5 and 15% 5 and 15%. H <sup>2</sup> O 25% 1%. NO 15 ppmv 15 ppmv. NO <sup>2</sup> 15 ppmv 15 ppmv. N <sup>2</sup> O 10 ppmv 10 ppmv. CO 50 ppmv 50 ppmv. NH <sup>3</sup> 10 ppmv 10 ppmv. CH <sup>4</sup> 50 ppmv 50 ppmv. SO <sup>2</sup> 20 ppmv 20 ppmv. H <sup>2</sup> 50 ppmv 50 ppmv. HCl 10 ppmv 10 ppmv. 1 Any applicable gas may be eliminated or tested at a reduced level if the manufacturer has provided reliable means for limiting or scrubbing that gas to a specified level. 2 As Practicable, gas concentrations should be the highest expected at test sites. Table 7E-5.—Manufacturer Stability Test Test description Acceptance criteria (note 1) Thermal Stability Temperature range when drift does not exceed 3.0% of analyzer range over a 12-hour run when measured with NO <sup>X</sup> present @ 80% of calibration span. Fault Conditions Identify conditions which, when they occur, result in performance which is not in compliance with the Manufacturer's Stability Test criteria. These are to be indicated visually or electrically to alert the operator of the problem. Insensitivity to Supply Voltage Variations ±10.0% (or manufacturers alternative) variation from nominal voltage must produce a drift of ≤ 2.0% of calibration span for either zero or concentration ≥ 80% NO <sup>X</sup> present. Analyzer Calibration Error For a low-, medium-, and high-calibration gas, the difference between the manufacturer certified value and the analyzer response in direct calibration mode, no more than 2.0% of calibration span. Note 1: If the instrument is to be used as a Low Range analyzer, all tests must be performed at a calibration span of 20 ppm or less. Appendix A-7—[Amended] 5. Amend Method 20 by adding a sentence to the end of Section 8.4 to read as follows: Method 20—Determination of Oxygen and Carbon Dioxide Concentrations in Emissions From Stationary Sources (Instrumental Analyzer Procedure) 8.4 Sample Collection. * * * A test run must have a duration of at least 21 minutes. [FR Doc. E7-17415 Filed 9-6-07; 8:45 am] BILLING CODE 6560-50-P GENERAL SERVICES ADMINISTRATION 41 CFR Part 300-80 [FTR Amendment 2007-04; FTR Case 2007-303; Docket 2007-0002, Sequence 3] RIN 3090-AI36 Federal Travel Regulation; FTR Case 2007-303, Relocation Expenses Test Programs AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Final rule. SUMMARY: The Travel and Transportation Reform Act of 1998 (Pub. L. 105-264, October 19, 1998), authorized Federal agencies to conduct travel and relocation expenses test programs when determined by the Administrator of General Services to be in the interest of the Government. The provisions of the Act were implemented by a Federal Travel Regulation
(FTR)amendment, and published in the **Federal Register** at 64 FR 28880, May 27, 1999. They permit agencies to test new and innovative methods of reimbursing travel and relocation expenses without seeking a waiver of current rules or authorizing legislation. However, the test authority for the travel and relocation programs expired in October 2005. Pub. L. 109-325, October 11, 2006, amends 5 U.S.C. 5739 by extending the authority for the General Services Administration
(GSA)to approve relocation expenses test programs for an additional four years. In addition, the law removes the 24-month period in which an agency had to complete an approved relocation expense test program. The amendments provided by Pub. L. No. 109-325 are effective as though enacted as part of the Travel and Transportation Reform Act of 1998. This final rule incorporates Pub. L. 109-325 by removing the required period of time to complete a relocation test program and extends the authority to conduct relocation tests for an additional four years. The authority to conduct a travel test expense program was not renewed; accordingly, this final rule also deletes those provisions. The FTR and any corresponding documents may be accessed at GSA's website at *http://www.gsa.gov/ftr* . DATES: *Effective Date* : September 7, 2007. FOR FURTHER INFORMATION CONTACT: For clarification of content, contact Jim Harte, Program Analyst, Travel and Transportation Management Policy Division (MTT), telephone
(202)501-0483, email *james.harte@gsa.gov* . For information pertaining to status or publication schedules, contact the Regulatory Secretariat (VIR), Room 4035, GS Building, Washington, DC 20405,
(202)501-4755. Please cite FTR Amendment 2007-04; FTR case 2007-303. SUPPLEMENTARY INFORMATION: A. Background On October 19, 1998, the President signed into law the Travel and Transportation Reform Act of 1998 (the Act) (Pub. L. 105-264). In applicable part, the Act authorized travel and relocation expenses test programs designed to enhance cost savings or other efficiencies that may accrue to the Government. The provisions of the Act were implemented by Federal Travel Regulation
(FTR)Amendment Number 83, dated May 7, 1999, and published in the **Federal Register** on May 27, 1999 (64 FR 28880). The provisions of the Act terminated October 2005. Public Law (Pub. L.) 109-325, October 11, 2006, extends the provisions relating to relocation test programs for an additional four years. This final rule implements the provisions of Pub. L. 109-325 by authorizing the continuance of the relocation expense test programs. This final rule also requires agencies having an approved test program to submit annual reports on the progress of the test to the General Services Administration, Office of Governmentwide Policy, Office of Travel, Transportation and Asset Management. Failure to submit a report may cause termination of the test program approval. In addition, this final rule removes the provisions of the FTR relating to travel test programs as there is no longer any statutory authority for conducting such tests. B. Executive Order 12866 This regulation is excepted from the definition of “regulation” or “rule” under Section 3(d)(3) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993, and therefore was not subject to review under Section 6(b) of that executive order. C. Regulatory Flexibility Act This final rule is not required to be published in the **Federal Register** for notice and comment as per the exemption specified in 5 U.S.C. 553(a)(2); therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, *et seq.* , does not apply. D. Paperwork Reduction Act The Paperwork Reduction Act does not apply because the final rule does not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public which require the approval of the Office of Management and Budget under 44 U.S.C. 3501 *et seq.* E. Small Business Regulatory Reform Act This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel. List of Subjects in 41 CFR Part 300-80 Government employees, Travel and transportation expenses. Dated: June 5, 2007. Lurita Doan, Administrator of General Services. For the reasons set forth in the preamble, 41 CFR part 300-80 is amended as follows: PART 300-80—RELOCATION EXPENSES TEST PROGRAMS 1. The authority for 41 CFR part 300-80 is revised to read as follows: Authority: 5 U.S.C. 5707, 5738, and 5739. 2. The part heading for 41 CFR part 300-80 is revised to read as set forth above. § 300-80.1 [Amended] 3. Amend § 300-80.1 by removing the words “travel and” in both the section heading and text. § 300-80.2 [Amended] 4. Amend § 300-80.2 by removing the word “such” in both the section heading and text. § 300-80.3 [Amended] 5. Amend § 300-80.3, paragraph
(b)by removing “(travel and/or relocation)”. § 300-80.4 [Amended] 6. Amend § 300-80.4 by removing the words “10 travel expense test programs and”. § 300-80.5 [Amended] 7. Amend § 300-80.5 by removing the words “travel or” in the section heading. § 300-80.6 [Removed] 8. Remove § 300-80.6. § 300-80.7 [Redesignated as § 300-80.6] 9. Redesignate § 300-80.7 as § 300-80.6. 10. Revise newly redesignated § 300-80.6 to read as follows: § 300-80.6 What limits are there to test programs? None. When authorized by the Administrator of General Services, the agency may pay any necessary relocation expenses in lieu of payments authorized or required under Chapter 302 of this title. § 300-80.8 [Redesignated as § 300-80.7] 11. Redesignate § 300-80.8 as § 300-80.7. 12. Revise newly redesignated § 300-80.7 to read as follows: § 300-80.7 What is the maximum duration of test programs? The duration of a test program is 24 months from the date of authorization unless terminated prior to that date by the Administrator of General Services due to changes in law or regulation. Extensions of the 24 month period may be granted by the Administrator of General Services for up to an additional 24 months, but not beyond October 2009, the expiration of the test authority. A request to extend the test program shall be submitted to the Administrator of General Services not later than 45 days prior to the expiration of the original test period. § 300-80.9 [Redesignated as § 300-80.8] 13. Redesignate § 300-80.9 as § 300-80.8. 14. Amend newly redesignated § 300-80.8 by revising paragraph
(b)to read as follows: § 300-80.8 What reports are required for a test program?
(b)The agency authorized to conduct the test program must submit the following reports:
(1)An annual report on the progress of the test, submitted to the General Services Administration, Office of Governmentwide Policy, Office of Travel, Transportation and Asset Management (Attention MTT), Washington, DC 20405. The Administrator or designee may terminate the test program approval for failure to comply with these reporting requirements; and
(2)A final report on the results of the test program must be submitted to the General Services Administration, Office of Governmentwide Policy, Office of Travel, Transportation and Asset Management (Attention MTT), Washington, DC 20405, and to the appropriate committees of Congress within 3 months after completion of the program. § 300-80.10 [Redesignated as § 300-80.9] 15. Redesignate § 300-80.10 as § 300-80.9. § 300-80.9 [Amended] 16. Amend newly redesignated § 300-80.9 by removing “2005” and adding “2009” in its place. [FR Doc. E7-17654 Filed 9-6-07; 8:45 am] BILLING CODE 6820-14-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 90 [WT Docket No. 96-86; FCC 00-264] Public Safety 700 MHz Band AGENCY: Federal Communications Commission. ACTION: Final rule; announcement of effective date. SUMMARY: The Federal Communications Commission (Commission) announces that a certain rule adopted in its Public Safety 700 MHz Band proceeding (WT Docket No. 96-86; FCC 00-264) in 2000, to the extent it contained an information collection requirement that required approval by the Office of Management and Budget
(OMB)was approved, and became effective November 15, 2000, following approval by OMB. DATES: The effective date for the final rule published on September 5, 2000 (65 FR 53645) revising 47 CFR 90.176 is November 15, 2000. FOR FURTHER INFORMATION CONTACT: Rodney P. Conway, Wireless Telecommunications Bureau, at
(202)418-2904, or at *Judith-B.Herman@fcc.gov.* Announcement of Effective Date of a Certain Commission Rule 1. On July 21, 2000, the Commission adopted a Second Memorandum Opinion and Order ( *2nd MO&O* ) in WT Docket No. 96-86; FCC 00-264, a summary of which was published at 65 FR 53641 (September 5, 2000). In that *2nd MO&O* , the Commission stated that, upon OMB approval, it would publish in the **Federal Register** a document announcing the effective date of the change to 47 CFR 90.176. 2. On November 15, 2000, OMB approved the public information collection associated with this rule change under OMB Control No. 3060-0783. Therefore, the change to 47 CFR 90.176 became effective on November 15, 2000. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7-17454 Filed 9-6-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board 49 CFR Parts 1002, 1111, 1114, and 1115 [STB Ex Parte No. 646 (Sub-No. 1)] Simplified Standards for Rail Rate Cases AGENCY: Surface Transportation Board, DOT. ACTION: Final rulemaking. SUMMARY: On September 5, 2007, the Board served a decision that modifies its simplified rail rate guidelines, creating a simplified stand-alone cost approach for medium-size rail rate disputes and revising its three-benchmark approach for smaller rail rate disputes. The Board also places limits on the total relief available over a 5-year period under these two simplified approaches. Several rules in the Code of Federal Regulations
(CFR)have been updated to reflect the changes in the simplified rail rate dispute approaches. DATES: This action is effective October 7, 2007. FOR FURTHER INFORMATION CONTACT: Timothy J. Strafford,
(202)245-0356. [Assistance for the hearing impaired is available through the Federal Information Relay Service
(FIRS)at 1-800-877-8339.] SUPPLEMENTARY INFORMATION: On September 5, 2007, the Board served a decision that modifies its simplified rail rate guidelines, creating a simplified stand-alone approach for medium-size rail rate disputes and revising its three-benchmark approach for smaller rail rate disputes. The Board also places limits on the total relief available over a 5-year period under these two simplified approaches. Under the new rail rate guidelines, rather than the Board declaring eligibility thresholds, the shipper will be required to determine which rate relief method will be applied to its case, with the understanding that there will be limits on the amount of relief available over a 5-year period based on the approach selected. The following limits will apply: Three-benchmark, $1 million over 5 years; and Simplified stand-alone cost, $5 million over 5 years. To reflect the changes in this decision, the following sections of the CFR have been amended: 1111.1, 1111.2, 1111.4, 1111.9, 1111.10, 1114.21, 1114.22, 1114.26, 1114.30, 1114.31, and 1115.9. The Board's full decision is posted on the Board's Web site, *http://www.stb.dot.gov* . To purchase a copy of the full decision, write to, e-mail, or call: ASAP Document Solutions, 9332 Annapolis Rd., Suite 103, Lanham, MD 20706; e-mail: *asapdc@verizon.net* ; telephone:
(202)306-4004. [Assistance for the hearing impaired is available through FIRS at 1-800-877-8339.] Pursuant to 5 U.S.C. 605(b), we conclude that our action in this proceeding will not have a significant economic impact on a substantial number of small entities. This action will not significantly affect either the quality of the human environment or the conservation of energy resources. Authority: 49 U.S.C. 721, 49 U.S.C. 10701(d)(1) and (3). Decided: September 4, 2007. By the Board, Chairman Nottingham, Vice-Chairman Buttrey, and Commissioner Mulvey. Vernon A. Williams, Secretary. List of Subjects 49 CFR Part 1002 Administrative practice and procedure, Common carriers, Freedom of Information. 49 CFR Part 1111 Administrative practice and procedure, Investigations, 49 CFR Parts 1114 and 1115 Administrative practice and procedure. For the reasons set forth in the preamble, the Surface Transportation Board amends parts 1002, 1111, 1114, and 1115 of title 49, chapter X of the Code of Federal Regulations as follows: PART 1002—FEES 1. The authority citation for part 1002 continues to read as follows: Authority: 5 U.S.C. 552(a)(4)(A) and 553; 31 U.S.C. 9701; and 49 U.S.C. 721. Section 1002.1(g)(11) also issued under 5 U.S.C. 5514 and 31 U.S.C. 3717. 2. Amend § 1002.2 by revising paragraphs (f)(56)(ii) through
(v)and adding paragraph (f)(56)(vi) to read as follows: § 1002.2 Filing fees.
(f)* * *
(56)* * *
(ii)A formal complaint involving rail maximum rates filed under the Simplified-SAC methodology—10,600.
(iii)A formal complaint involving rail maximum rates filed under the Three Benchmark methodology—150.
(iv)All other formal complaints (except competitive access complaints)—17,600.
(v)Competitive access complaints—150.
(vi)A request for an order compelling a rail carrier to establish a common carrier rate—200. PART 1111—COMPLAINT AND INVESTIGATION PROCEDURES 3. The authority citation for part 1111 continues to read as follows: Authority: 49 U.S.C. 721, 10704, and 11701. 4. Amend § 1111.1 by revising paragraphs (a)(1) through (10), redesignate paragraphs
(b)through
(d)as paragraphs
(c)through
(e)respectively, and add a new paragraph
(b)to read as follows: § 1111.1 Content of formal complaints; joinder.
(a)* * *
(1)The carrier or region identifier.
(2)The type of shipment (local, received-terminated, etc.).
(3)The one-way distance of the shipment.
(4)The type of car (by URCS code).
(5)The number of cars.
(6)The car ownership (private or railroad).
(7)The commodity type (STCC code).
(8)The weight of the shipment (in tons per car).
(9)The type of movement (individual, multi-car, or unit train).
(10)A narrative addressing whether there is any feasible transportation alternative for the challenged movements.
(b)*Disclosure with simplified standards complaint.* The complainant must provide to the defendant all documents relied upon in formulating its assessment of a feasible transportation alternative and all documents relied upon to determine the inputs to the URCS Phase III program. 5. Revise § 1111.2 to read as follows: § 1111.2 Amended and supplemental complaints.
(a)*Generally.* An amended or supplemental complaint may be tendered for filing by a complainant against a defendant or defendants named in the original complaint, stating a cause of action alleged to have accrued within the statutory period immediately preceding the date of such tender, in favor of complainant and against the defendant or defendants. The time limits for responding to an amended or supplemental complaint are computed pursuant to §§ 1111.4 and 1111.5 of this part, as if the amended or supplemental complaint was an original complaint.
(b)*Simplified standards.* A complaint filed under the simplified standards may be amended once before the filing of opening evidence to opt for a different rate reasonableness methodology, among Three-Benchmark, Simplified-SAC or Full-SAC. If so amended, the procedural schedule begins again under the new methodology as set forth at §§ 1111.8 and 1111.9. However, only one mediation period per complaint shall be required. 6. Revise § 1111.4 to read as follows: § 1111.4 Answers and cross complaints.
(a)*Generally.* An answer shall be filed within the time provided in paragraph
(c)of this section. An answer should be responsive to the complaint and should fully advise the Board and the parties of the nature of the defense. In answering a complaint challenging the reasonableness of a rail rate, the defendant should indicate whether it will contend that the Board is deprived of jurisdiction to hear the complaint because the revenue-variable cost percentage generated by the traffic is less than 180 percent, or the traffic is subject to effective product or geographic competition. In response to a complaint filed under the simplified standards, the answer must include the defendant's preliminary estimate of the variable cost of each challenged movement calculated using the unadjusted figures produced by the URCS Phase III program.
(b)*Disclosure with simplified standards answer.* The defendant must provide to the complainant all documents that it relied upon to determine the inputs used in the URCS Phase III program.
(c)*Time for filing; copies; service.* An answer must be filed within 20 days after the service of the complaint or within such additional time as the Board may provide. The original and 10 copies of an answer must be filed with the Board. The defendant must serve copies of the answer upon the complainant and any other defendants.
(d)*Cross complaints.* A cross complaint alleging violations by other parties to the proceeding or seeking relief against them may be filed with the answer. An answer to a cross complaint shall be filed within 20 days after the service date of the cross complaint. The party shall serve copies of an answer to a cross complaint upon the other parties.
(e)*Failure to answer complaint.* Averments in a complaint are admitted when not denied in an answer to the complaint. 7. Revise § 1111.9 to read as follows: § 1111.9 Procedural schedule in cases using simplified standards.
(a)*Procedural schedule.* Absent a specific order by the Board, the following general procedural schedules will apply in cases using the simplified standards:
(1)In cases relying upon the Simplified-SAC methodology: Day 0—Complaint filed (including complainant's disclosure). Day 10—Mediation begins. Day 20—Defendant's answer to complaint (including defendant's initial disclosure). Day 30—Mediation ends; discovery begins. Day 140—Defendant's second disclosure. Day 150—Discovery closes. Day 220—Opening evidence. Day 280—Reply evidence. Day 310—Rebuttal evidence Day 320—Technical conference (market dominance and merits). Day 330—Final briefs.
(2)In cases relying upon the Three-Benchmark method: Day 0—Complaint filed (including complainant's disclosure). Day 10—Mediation begins. (STB production of unmasked Waybill Sample.) Day 20—Defendant's answer to complaint (including defendant's initial disclosure). Day 30—Mediation ends; discovery begins. Day 60—Discovery closes. Day 90—Complainant's opening (initial tender of comparison group and opening evidence on market dominance). Defendant's opening (initial tender of comparison group). Day 95—Technical conference on comparison group. Day 120—Parties' final tenders on comparison group. Defendant's reply on market dominance. Day 150—Parties' replies to final tenders. Complainant's rebuttal on market dominance.
(b)*Defendant's second disclosure.* In cases using the Simplified-SAC methodology, the defendant must make the following disclosures to the complainant by Day 170 of the procedural schedule.
(1)Identification of all traffic that moved over the routes replicated by the SARR in the Test Year.
(2)Information about those movements, in electronic format, aggregated by origin-destination pair and shipper, showing the origin, destination, volume, and total revenues from each movement.
(3)Total operating and equipment cost calculations for each of those movements, provided in electronic format.
(4)Revenue allocation for the on-SARR portion of each cross-over movement in the traffic group provided in electronic format.
(5)Total trackage rights payments paid or received during the Test Year associated with the route replicated by the SARR.
(6)All workpapers and documentation necessary to support the calculations.
(c)*Conferences with parties.* The Board may convene a conference of the parties with Board staff to facilitate voluntary resolution of discovery disputes and to address technical issues that may arise.
(d)*Complaint filed with a petition to revoke a class exemption.* If a complaint is filed simultaneously with a petition to revoke a class exemption, the Board will take no action on the complaint and the procedural schedule will be held in abeyance automatically until the petition to revoke is adjudicated. 8. Revise § 1111.10 to read as follows: § 1111.10 Meeting to discuss procedural matters.
(a)*Generally.* In all complaint proceedings, other than those challenging the reasonableness of a rail rate based on stand-alone cost or the simplified standards, the parties shall meet, or discuss by telephone, discovery and procedural matters within 12 days after an answer to a complaint is filed. Within 19 days after an answer to a complaint is filed, the parties, either jointly or separately, shall file a report with the Board setting forth a proposed procedural schedule to govern future activities and deadlines in the case.
(b)*Stand-alone cost or simplified standards complaints.* In complaints challenging the reasonableness of a rail rate based on stand-alone cost or the simplified standards, the parties shall meet, or discuss by telephone, discovery and procedural matters within 7 days after the mediation period ends. The parties should inform the Board as soon as possible thereafter whether there are unresolved disputes that require Board intervention and, if so, the nature of such disputes. PART 1114—EVIDENCE; DISCOVERY 9. The authority citation for part 1114 continues to read as follows: Authority: 5 U.S.C. 559; 49 U.S.C. 721. 10. Amend § 1114.21 by adding paragraph (a)(3) to read as follows: § 1114.21 Applicability; general provisions.
(a)* * *
(3)In cases using the simplified standards Three-Benchmark method, the number of discovery requests that either party can submit is limited as set forth in §§ 1114.22, 1114.26, and 1114.30, absent advance authorization from the Board. 11. Amend § 1114.22 by adding paragraph
(c)to read as follows: § 1114.22 Deposition.
(c)*Limitation under simplified standards.* In a case using the Three-Benchmark methodology, each party is limited to one deposition absent advance authorization from the Board. 12. Amend § 1114.26 by adding paragraph
(d)to read as follows: § 1114.26 Written interrogatories to parties.
(d)*Limitation under simplified standards.* In a case using the Three-Benchmark methodology, each party is limited to ten interrogatories (including subparts) absent advance authorization from the Board. 13. Amend § 1114.30 by adding paragraph
(c)to read as follows: § 1114.30 Production of documents and records and entry upon land for inspection and other purposes.
(c)*Limitation under simplified standards.* In a case using the Three-Benchmark methodology, each party is limited to ten document requests (including subparts) absent advance authorization from the Board. 14. Amend § 1114.31 by revising paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) to read as follows: § 1114.31 Failure to respond to discovery.
(a)* * *
(1)*Reply to motion to compel generally.* Except in rate cases to be considered under the stand-alone cost methodology or simplified standards, the time for filing a reply to a motion to compel is governed by 49 CFR 1104.13.
(2)*Reply to motion to compel in stand-alone cost and simplified standards rate cases.* A reply to a motion to compel must be filed with the Board within 10 days thereafter in a rate case to be considered under the stand-alone cost methodology or under the simplified standards.
(3)*Conference with parties on motion to compel.* Within 5 business days after the filing of a reply to a motion to compel in a rate case to be considered under the stand-alone cost methodology or under the simplified standards, Board staff may convene a conference with the parties to discuss the dispute, attempt to narrow the issues, and gather any further information needed to render a ruling.
(4)*Ruling on motion to compel in stand-alone cost and simplified standards rate cases.* Within 5 business days after a conference with the parties convened pursuant to paragraph (a)(3) of this section, the Secretary will issue a summary ruling on the motion to compel discovery. If no conference is convened, the Secretary will issue this summary ruling within 10 days after the filing of the reply to the motion to compel. Appeals of a Secretary's ruling will proceed under 49 CFR 1115.9, and the Board will attempt to rule on such appeals within 20 days after the filing of the reply to the appeal. PART 1115—APPELLATE PROCEDURES 15. The authority citation for part 1115 continues to read as follows: Authority: 5 U.S.C. 559; 49 U.S.C. 721. 16. Amend § 1115.9 by revising paragraph
(b)to read as follows: § 1115.9 Interlocutory appeals.
(b)In stand-alone cost complaints or in cases filed under the simplified standards, any interlocutory appeal of a ruling shall be filed with the Board within three
(3)business days of the ruling. Replies to any interlocutory appeal shall be filed with the Board within three
(3)business days after the filing of any such appeal. In all other cases, interlocutory appeals shall be filed with the Board within seven
(7)calendar days of the ruling and replies to interlocutory appeals shall be filed with Board within seven
(7)calendar days after the filing of any such appeal as computed under 49 CFR 1104.7. [FR Doc. E7-17689 Filed 9-6-07; 8:45 am] BILLING CODE 4915-01-P 72 173 Friday, September 7, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 59 [Docket No. AMS-LS-07-0106; LS-07-01] RIN 0581-AC67 Livestock Mandatory Reporting; Reestablishment and Revision of the Reporting Regulation for Swine, Cattle, Lamb, and Boxed Beef AGENCY: Agricultural Marketing Service, USDA. ACTION: Extension of comment period. SUMMARY: Notice is hereby given that the comment period on the reestablishment and revision of the Livestock Mandatory Reporting
(LMR)program is extended until September 24, 2007. DATES: Comments must be submitted on or before September 24, 2007, to be assured of consideration. ADDRESSES: Interested persons are invited to submit written comments concerning this proposal. Comments can be submitted on the Internet at: *http://www.regulations.gov.* Written comments can be sent to Warren P. Preston, Chief, Livestock and Grain Market News Branch, Docket No. LS-07-01, 1400 Independence Ave., SW., Room 2619-S, Washington, DC 20250-0252, or by facsimile to
(202)690-3732. All comments should reference the docket number and the date and page number of this issue. All comments will be available for public inspection at the above location, or on the Internet at *http://www.regulations.gov* . Comments that specifically pertain to the information collection and recordkeeping requirements of this action should also be sent to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, 725 17th Street, NW., Room 725, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Warren P. Preston, Chief, Livestock and Grain Market News Branch at
(202)720-6231, fax
(202)690-3732, or e-mail *Warren.Preston@usda.gov.* SUPPLEMENTARY INFORMATION: On April 2, 2001, AMS implemented the LMR program as required by the Livestock Mandatory Reporting Act of 1999 (1999 Act). The statutory authority for the program lapsed on Sept. 30, 2005. In October 2006, Congress enacted legislation to reauthorize the 1999 Act through Sept. 30, 2010 (Reauthorization Act), and to amend the swine reporting requirements of the 1999 Act. As such, a proposed rule was published in the **Federal Register** on August 8, 2007, (72 FR 44671) to re-establish the regulatory authority for the program's continued operation and incorporate the swine reporting changes contained within the Reauthorization Act. In addition, the rule proposed changes to the LMR program that seek to enhance the program's overall effectiveness and efficiency based on AMS' experience in the administration of the program over the past six years. The comment period was originally scheduled to end on September 7, 2007. However, several industry organizations have requested additional time to provide more thorough comments. AMS believes it is beneficial to extend the comment period until September 5, 2007, in order to receive input from all interested parties. Authority: 7 U.S.C. 1621 *et seq.* Dated: September 5, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. 07-4405 Filed 9-5-07; 10:51 am]
Connectionstraces to 29
21 references not yet in our index
  • 21 CFR 522
  • 21 CFR 20
  • 5 USC 801-808
  • 40 CFR 60
  • 40 CFR 72.2
  • 40 CFR 9
  • Pub. L. 104-4
  • Pub. L. 104-113
  • 42 USC 7401-7671q
  • 41 CFR 300
  • Pub. L. 105-264
  • Pub. L. 109-325
  • 47 CFR 90
  • 47 CFR 90.176
  • 49 USC 721
  • 49 CFR 1002
  • 49 CFR 1111
  • 49 CFR 1104.13
  • 49 CFR 1115.9
  • 49 CFR 1104.7
  • 7 CFR 59
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