Executive Order 12866

This final rule is exempted from the Office of Management and Budget (OMB) review for purposes of Executive Order 12866 and, therefore, has not been reviewed by OMB.

This final rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. A notice of final rule entitled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034) exempted the Rural Utilities Service loans and loan guarantees from coverage under this order.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. The Rural Utilities Service has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all State and local laws and regulations that are in conflict with this final rule will be preempted. No retroactive effect will be given to this final rule and in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)) administrative appeal procedures, if any, must be exhausted before an action against the Department or its agencies may be initiated.

This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this final rule does not have sufficient federalism implications to require preparation of a Federalism Assessment.

The Rural Utilities Service has been determined that the Regulatory Flexibility Act is not applicable to this rule since USDA Rural Utilities Service is not required by 5 U.S.C. 551et seq.or any other provision of the law to publish a notice of proposed rulemaking with request to the subject matter of this rule.

This information collection and recordkeeping requirements contained in this final rule are cleared under OMB control number 0572-0076 pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

The program described by this final rule is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.850, Rural Electrification Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800.

This final rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. See the final rule related notice titled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034), advising that the Rural Utilities Service loans and loan guarantees are excluded from the scope of Executive Order 12372.

This final rule contains no Federal Mandates (under the regulatory provision of title II of the Unfunded Mandates Reform Act of 1995 [2 U.S.C. Chapter 25]) for State, local, and tribal governments or the private sector. Thus, this final rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.

The Rural Utilities Service has determined that this final rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321et seq.). Therefore, this action does not require an environmental impact statement or assessment.

A proposed rule entitled “Standards and Specifications for Timber Products Acceptable for Use by Rural Development Utilities Programs'Electric and Telecommunications Borrowers” was published in theFederal Registeron September 29, 2008 at 73 FR 56513, and the public was invited to submit comments on or before November 28, 2008. Comments were received and are addressed in the Summary of Comment section of this rule.

The Rural Utilities Service maintains bulletins that contain construction standards and specifications for materials and equipment. These standards and specifications apply to systems constructed by electric and telecommunications borrowers in accordance with the loan contract, and contain standard construction units, materials, and equipment units used on electric and telecommunications borrowers' systems. Bulletins 1728F-700, “Specification for Wood Poles, Stubs and Anchor Logs”; 1728H-701, “Specification for Wood Crossarms (Solid and Laminated), Transmission Timbers and Pole Keys”; and 1728H-702, “Specification for Quality Control and Inspection of Timber Products”, establish standards for the manufacture and inspection of wood utility poles, crossarms and poles keys. The summary of the major changes to these three bulletins are as follows:

1. All references cited in these bulletins are updated to the latest edition.

2. The definition “pole broker” was added to the list of definitions to include as many organizations as possible to provide borrowers a source from which they might purchase wood products.

3. Allow borrowers six months to notify treating plants about poles not meeting the required preservative retention.

4. In accordance with RUS policy on insurance requirements for contractors working for borrowers, the specification was revised to require manufacturers and inspection agencies to maintain certain limits of liability and errors and omission insurance.

5. All poles are required to be sterilized during the conditioning or treating cycle. This sterilization should further reduce the number of poles with pre-treatment decay.

6. Required to brand independent inspection agency's identification on the face of the pole.

7. RUS revised the qualifications for inspectors and quality control personnel and will return to the qualifications from the 1987 edition of the specifications.

8. Provisions are added to further clarify that wood products, producers and inspection agencies maintain the greatest degree of separation and eliminate any appearance of conflict of interest.

The Agency received comments and recommendations in response to the proposed rule from the following organizations: North American Wood Pole Council (NAWPC), McFarland Cascade, Cox Industrial Group, Wood Quality Control (WQC), Cox Industrial Group, Lee Inspection and Consulting Services, A.W. Williams Inspection Co. (AWW), Texas Electric Cooperatives (TEC), Timber Products Inspection and Dis-Tran Wood Products. No comments from any other sources were received. These comments and recommendations and the Agency's responses are summarized as follows:

Comment:Lee Inspection, NAWPC, TEC, and AWW questioned the need for liability insurance and errors and emission insurance and the amount of coverage.

Agency Response:RUS has required outside contractors doing work for borrowers to have high levels of liability insurance for many years. The insurance requirement was added to stay in line with present agency practices. The proposed insurance was reviewed and the errors and omission insurance requirement was eliminated for pole and crossarm producers. Since inspection agencies are performing a service, their liability and errors and omissions insurance requirement remains.

Comment:NAWPC and Timber Products Inspection questioned the need to treat kiln dried poles within 30 days after drying.

Agency Response:Paragraph 4.2.1 of Bulletin 1728F-700 dated September 1993 requires that “kiln dried poles shall be treated within 1 month from the time they are removed from the kiln.” This has been an RUS requirement for nearly twenty years and RUS believes that this requirement is needed.

Comment:NAWPC and Timber Products Inspection questioned why there is an inconsistency in paragraph 8.1 of Bulletin 1728F-700 concerning sterilization of Douglas fir poles.

Agency Response:The sterilization time for Douglas-fir is revised to be in line with other species.

Comment:McFarland, NAWPC and Timber Products Inspection suggested the inclusion of the modified full cell process to help control overtreatment.

Agency Response:The modified full cell process was added as suggested.

Comment:Timber Products Inspection pointed out that the maximum temperature for treatment in Western Red Cedar in the table in paragraph 8.2 of Bulletin 1728F-700 is not in agreement with American Wood Protection Association Standards.

Agency Response:Bulletin 1728F-700 was revised to meet the AWPA standard.

Comment:NMWPC, Timber Products Inspection and TEC mentioned that the wording in paragraph 9.6.2 of Bulletin 1728F-700 be revised from “supplemental groundline type preservative” to “a preservative approved for use in ground line contact by the AWPA.”

Agency Response:Wording was revised to use “a preservative approved for use by AWPA.”

Comment:Lee Inspection, NMWPC, Timber Products Inspection and AWW felt to certify inspectors and quality control personnel on the use of XRF equipment was unreasonable.

Agency Response:RUS agrees that this requirement may be difficult to achieve because there is no organization set up to perform this service. This provision was eliminated.

Comment:McFarland and TEC raised questions about the addition of the inspection agency's designation on the face brand and the use of tags.

Agency Response:This requirement does not add an extra line to the face brand. It replaces the Quality Assurance mark currently required on the second line of the brand. Treaters will be given 6 months from the publication date of this notice to revise their face brands. For treaters using metal tags, if the existing tag cannot be altered to show the independent inspection agency designation a separate tag showing this information shall be added. Metal tag users have three months to start revising their current tags or ordering an additional tags to show the agency information.

Comment:Lee Inspection disagrees with the RUS's proposal to not allow one independent inspection agency to subcontract their contracted inspection to another party.

Agency Response:When an Electric Borrower designates an inspection agency to act as their agent and inspect pole on their behalf the RUS believes they actually want that company to do the work. RUS believes that this requirement is reasonable.

Comment:Lee Inspection disagrees with the RUS's stand on not allowing independent inspection agencies to offer product warranties on inspected material.

Agency Response:RUS wants, as a secured lender, to eliminate any appearance of a conflict of interest between independent inspectors andtreaters. A product warranty put out by an inspection agency for a pole or crossarm produced by another company is unacceptable. RUS is not changing this provision.

Comment:Lee Inspection and AWW are concerned with the wording “Failure of a selected third-party inspection agency to properly perform their required overview responsibilities may subject said agency to subsequent liability claims for unsatisfactory or inadequate product performance.”

Agency Response:This specific language will be from the final rule, however, the potential liability incurred by the inspection agency for any improper performance will be left up to the borrower.

Comment:Lee Inspection and AWW felt the frequency of the precision check by independent inspectors for the x-ray fluorescence instrument at treating plant weekly was too onerous.

Agency Response:In some cases this requirement could be too burdensome. In response, the frequency was changed to monthly for analysis of preservative and treated wood at the inspector's agency laboratory.

Comment:Cox Industrial Group and Dis-Tran wanted to require borrowers to store crossarms under cover to be eligible for the one year warranty.

Agency Response:The conformance period of one year from date of delivery should not be affected if arms are stored indoors, outdoors or installed on poles. As a result, RUS will not change the proposal.

Comment:Timber Products Inspection noted that the radial drilling depths were left off Table 10 in Bulletin 1728F-700.

Agency Response:This information was added back into the bulletin.

Comment:McFarland Cascade questioned the limiting of butt treated poles to arid regions.

Agency Response:Since butt treated poles have shown to have good durability in areas other than arid regions the final rule is revised to limit their use to low to moderate decay zones.

Comment:McFarland Cascade and Timber Products questioned allowing through boring for poles were raised.

Agency Response:In response to this, a section on allowing through boring was added.

Comment:WQC suggested that the Insured Warranty program be removed since it has not been used in many years.

Agency Response:This plan for supplying poles has continued to be included to keep several options open for suppliers. There have been a few instances where suppliers have tried to start using this program again.

Comment:WQC suggested that RUS limit the percentage of defects of a “lot” of poles from 15% to 5%, which is the AWPA limit, before the entire lot is rejected.

Agency Response:In response, RUS will revise their reject percentage to stay in line with AWPA Standards.

For reasons set forth in the preamble, chapter XVII of title 7 of the Code of Federal Regulations is amended as follows:

The Federal Credit Union Act (Act) authorizes the NCUA Board to define “low-income members” so that credit unions with a membership predominantly consisting of low-income members can benefit from certain statutory relief and receive assistance from the Community Development Revolving Loan Fund. 12 U.S.C. 1752(5), 1757a(b)(2)(A), 1757a(c)(2)(B), 1772c-1. Currently, NCUA uses geo-coding software during the examination processes to designate low-income credit unions, as follows:

Credit unions also currently have the option to submit actual member data for purposes of qualifying for the low-income designation. NCUA's regulation at section 701.34(a)(3) provides that:

In December 2010, the NCUA Board proposed to amend NCUA's low-income rule to permit FCUs that would like the option to submit their own data for purposes of qualifying for the low-income designation to use a statistically valid, random sample of member incomes drawn from loan files or a member survey as the basis for the analysis. 75 FR 80364 (Dec. 22, 2010). The NCUA Board recognized FCUs may find it difficult to meet the requirement of collecting actual income data to establish the low-income status of at least 50% plus one of their members. An FCU conducting a survey of members asking its members to disclose their incomes can also be problematic. It can be difficult for the FCU to achieve a sufficient survey response rate and also members can be reluctant to disclose their income in a survey. Credit unions can also have difficulties obtaining sufficient member-income information from their loan applications because many credit unions have not made loans to over 50% of their members.

The proposed rule added language permitting FCUs to rely on a data sample as long as it meets certain criteria, and requiring the FCUs to submit a narrative describing sampling technique and evidence supporting its validity. The proposed rule required the random sample be representative of the FCU membership, sufficient in both number and scope on which to base conclusions, and have a minimal confidence level of 95% and a confidence interval of 5%.1 The NCUA Board recognized the 95% confidence level and 5% confidence interval is a widely accepted and used threshold for statistical significance in research and policy analysis.

NCUA received eight comments on the proposed rule, published in theFederal Registeron December 22, 2010. One commenter was a credit union, five were credit union leagues and trade associations, one was a bank trade association, and one was an individual. Most commenters strongly supported the goal of the proposed rule and agreed with the basic structure and framework NCUA proposed. The comments generally dealt with the specifics of the sampling approach and the NCUA review.

Three commenters expressed the need for additional language either in the text of the proposal or as a policy, letter or appendix to rule, which would address specifics of what is required of a credit union to qualify under the new approach. In response, NCUA stresses the rule will permit flexibility and will enable NCUA to work with potential candidates. NCUA may in the future consider issuing a letter to credit unions or other additional guidance on some of the specific elements of the rule if warranted.

Three commenters expressed concerns over the confidence level/interval specified in the proposal (95%/5%). Commenters differed in their approach: Two credit union trade associations recommended lowering the confidence level or interval (e.g.,to 95%/10%) in order to decrease the required sample size and burden. The bank trade association advocated increasing them (e.g.99%/5% or 95%/1%) to avoid incorrect low-income credit union designations. In response, NCUA's position is that a 95%/5% benchmark provides a good balance. NCUA will consider a more flexible approach in the future if warranted.

The bank trade association recommended expanding the sampling population from members with loans to all members to increase the representativeness of the results. NCUA's position is that the rule already adequately addresses this concern. While allowing FCUs to sample only their members with loans, the proposed rule preamble extensively discusses the need to establish representativeness of the results, which can be achieved by a relatively simple comparison of incomes of all members to incomes of borrowers using the NCUA geo-coding software.

Three commenters recommended changing the “look back” period for loans, currently proposed at 5 years. As with the issue of the confidence measures above, commenters differed in their approach. Two credit union groups recommended increasing the look back to 10 years, while the bank trade association recommended shortening the period to no more than 2 years. The NCUA Board finds that the 5-year look back period provides a good balance. The Board emphasizes that the NCUA will consider a more flexible approach in the future if warranted.

The bank trade association advocated incorporating into the rule a method by which non-sensitive parts of FCU submissions can be made available to public. In response, NCUA's position is that the public is already permitted to request release of information under the Freedom of Information Act (FOIA) and will be able to obtain information as permitted through that process.

Two credit union groups recommend incorporating a timeframe for NCUA review. NCUA will review the applications for the low-income applications in a timely manner, but the final rule does not incorporate a timeframe into the regulation.

A credit union league suggested that NCUA allow FCUs to use geo-coding software alternative to the NCUA's tool to reduce the amount of required supporting documentation and to encourage leagues or their service corps to develop alternative tools.

NCUA believes that the use of any geo-coding software will produce similar results and the use of alternative software will increase the need for documentation and review relative to using the NCUA software.

One individual opposed the rule and recommended using actual incomes of the entire membership to make the determinations. NCUA previously addressed difficulties with the commenter's approach in the preamble to the proposed rule.

The NCUA Board has adopted a final rule very similar to the proposed rule, but includes new wording about not combining a survey and loan file review. As stated in the proposed rule, NCUA will evaluate the sample income data and the supporting narrative to verify it is a statistically valid, random sample. NCUA emphasizes that a sample has to be drawn entirely from loan files or entirely from the survey; no combination will be allowed, as there is no statistically valid methodology for combining a member survey and a loan file sampling approach.

NCUA will expect the narrative and supporting materials to address the following:

• Representativeness of Members. If a credit union is relying on income datadrawn from its loan files, a credit union's submission needs evidence that members with loans are representative of the broader membership. If members with loans are not representative of the broader membership, the sampling methodology may not be appropriate. If a credit union is relying on income data from a survey, a credit union must provide evidence regarding the representativeness of its responses and adequacy of response rate.

• Income Definition and Timing: If relying on income data from a survey, the survey needs to be clear regarding its definition of income to ensure accurate responses from members and permit the credit union to use appropriate sources for comparison. If relying on income data from loan files, NCUA will expect the analysis to:

○ Clearly differentiate household versus individual income and income versus earnings in the loan files and use appropriate sources for comparison.

○ Address the age of the income data found in loan files by excluding loan files over five years old.

○ Address issues related to income verification, for example, addressing general credit union practices related to income verification and percentage of loans in the selected sample with unverified income. For surveys, address credit union verification, if any, of self-reported income information from members.

• Based on membership size and conservative statistical sampling practices and requirements, establish minimum sample size of members with income data from loan files or valid survey responses.

• Describe the method used for sampling loan files or conducting a survey, including any external validation or oversight.

• For income data from loan files, submit the well-documented data set used in the analysis and, for surveys, a copy of the survey, data summary, and narrative, as necessary to describe the conduct of the survey.

NCUA staff will review an FCU's submission, may contact the FCU to resolve any questions about its submission or to request additional information, and will inform the FCU whether it qualifies as expeditiously as possible. The final rule does not establish a time frame for a NCUA staff's review and determination because the Board believes a submission under the final rule is likely to present issues unique to the submitting FCU. The Board believes FCUs and the NCUA will benefit from having the flexibility to evaluate a credit union's submission and potentially resolve questions without regulatory time constraints. FCUs that are considering making a submission will find it helpful to contact NCUA staff to discuss their approach in providing sample income data before undertaking a review of loan files or conducting a survey.

Lastly, the final rule has possible implications for federally insured, state-chartered credit unions (FISCUs) under NCUA's regulations at section 741.204(b). Under this section, a FISCU must obtain a low-income designation to accept certain nonmember accounts, if these can be accepted under state law. Additionally, pursuant to section 705.3, in order to participate in the Community Revolving Loan Program, a low-income determination must be made pursuant to section 701.34. The appropriate state regulator makes the low-income designation, with the concurrence of NCUA, on the same basis as provided in section 701.34(a) for FCUs. 12 CFR 741.204(b).

The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact any regulation may have on a substantial number of small entities. 5 U.S.C. 603(a). For purposes of this analysis, NCUA considers credit unions having under $10 million in assets small entities. Interpretive Ruling and Policy Statement 03-2, 68 FR 31949 (May 29, 2003). As of December 31, 2010, out of approximately 4,589 FCUs, 1,868 had less than $10 million in assets.

This rule directly affects all low-income FCUs, of which currently there are approximately 945. NCUA estimates approximately 533 low-income FCUs are small entities, but that only about two in a year will avail themselves of the option of providing actual data or sample data to meet the low-income criteria and receive the designation. Therefore, NCUA has determined this rule will not have an impact on a substantial number of small entities.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, Public Law 104-121, provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by Section 551 of the Administrative Procedures Act. 5 U.S.C. 551. The Office of Information and Regulatory Affairs (OIRA) is reviewing this final rule and we have recommended to OIRA that it is not a major rule for purposes of SBREFA.

The low-income rule contains a “collection of information” within the meaning of section 3502(3) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3502(3), to the extent the rule permits FCUs that do not qualify under NCUA's geo-coding software the option of applying on the basis of actual membership income data and, as set out in this amendment to the rule, the additional option of submitting a random and statistically valid sample of membership income data to meet the rule's requirement that a majority of its members are low-income as defined in the rule.

The final rule will permit FCUs, which do not qualify for a low-income designation using the geo-coding software the NCUA has developed for that purpose, to submit an analysis of a statistically valid sample of their member income data as evidence the FCUs qualify. NCUA does not believe many FCUs are likely to apply for the designation on the basis of their member income data, perhaps two applications per year.

If relying on income data drawn from loan files, NCUA estimates an FCU that maintains its loan files electronically can use statistical computer programs that are freely available and its own staff. In that case, staff time is estimated at about 40 hours. If an FCU uses the services of a contractor or other outside party, such as a computer programmer, it is estimated those services would cost approximately $100 per hour, for a cost of approximately $4,000. If an FCU conducts a survey, various free computer programs are available on the internet. The costs of conducting a survey may vary significantly depending on the size of the membership. If an FCU uses the services of a contractor or other outside party to assist it in developing and conducting a survey, the costs are estimated at approximately $4,000 to $5,000.

In summary, NCUA estimates the total information collection burden represented by this proposal involving: 2 respondents, 80 annual burden hours, and an annual cost burden of approximately $10,000. NCUA has submitted these numbers to OMB and is awaiting review.

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles,NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The final rule would not have substantial direct effect on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined this final rule does not constitute a policy that has federalism implications for purposes of the executive order.

NCUA has determined that this final rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).

NCUA's goal is to promulgate clear and understandable regulations that impose minimal regulatory burden. We request your comments on whether the final amendment is understandable and minimally intrusive if implemented as proposed.

For the reasons stated above, NCUA amends 12 CFR part 701 as follows:

The NCUA published a final rule in theFederal Registeron May 26, 2011, at 76 FR 30510, containing a comprehensive framework outlining permissible and impermissible payments that FICUs can make in the nature of golden parachutes and indemnification for IAPs. The final rule requires a technical correction to conform the language concerning one permissible exception involving golden parachute restrictions to the intent of the rule, as described in the preamble to the May 26, 2011 rulemaking.

The intent of the final rule is that post-employment payments having reasonable business purposes should not be prohibited. Accordingly, the rule excludes from the definition of “golden parachute payment” certain qualified retirement plans such as those permitted under § 401 of the Internal Revenue Code (IRC). As discussed in the preamble to the final rule, in response to comments the Board intended to provide similar treatment to retirement plans that are permissible under § 457 of the IRC, which are frequently used by credit unions and other tax exempt organizations.

Plans qualifying as eligible deferred compensation plans under § 457(b) of the IRC exhibit characteristics that are similar to the more common § 401(k) deferred compensation plans that many employers make available to their employees. For example, the amount of income that may be deferred under such a plan is equivalent to that which may be deferred under § 401, which for 2011 is $16,500. As with § 401 plans, moreover, manipulation of the timing and amount of the payout are also closely circumscribed by law. For example, these plans may not typically provide for an in-service distribution prior to retirement. Accordingly, the Board intended for § 457(b) plans to be treated like § 401 plans and excluded from the definition of golden parachute payment.

Although the preamble to the final rule makes reference to plans under subsections (b) and (f) of § 457, it does not provide any substantive discussion concerning the differences between them. In fact, however, plans that are permissible under the latter subsection are significantly broader and are accorded much greater flexibility in terms of structure, vesting, etc. The intent of the rule has always been that § 457(f) plans must also meet the “bona fide” criteria outlined in § 750.1(c) to qualify as exceptions to the otherwise applicable golden parachute restrictions. Because of the limits inherent in § 457(b) and the constraints governing plans offered under that subsection, the Board intended to specify that only § 457(b) plans are excluded by definition from the term golden parachute payment.

This interim final rule amends § 750.1(e) to clarify that plans offered by FICUs under § 457(b) of the IRC are excluded from the definition of golden parachute payment. Plans offered under § 457(f), however, must meet the “bona fide” criteria outlined in § 750.1(c) to qualify as exceptions to the golden parachute payment definition.

NCUA is issuing this rulemaking as an interim final rule effective as of June 27, 2011, which is the date the new part 750 will take effect. 76 FR 30510 (May 26, 2011). The Administrative Procedure Act (APA), 5 U.S.C. 553, generally requires that before a rulemaking can be finalized it must first be published as a notice of proposed rulemaking with the opportunity for public comment, unless the agency for good cause finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. In this regard, NCUA believes good cause exists for issuing this clarifying amendment as an interim final rule, in order to coordinate with the effective date of the new part 750 as well as eliminate as soon as possible any confusion resulting from preamble language that is inconsistent with, or makes ambiguous, the associated regulatory text. To that extent, NCUA believes issuing this rulemaking as an interim final rule is in the public interest. NCUA does not anticipate comments on this change and so is allowing only a 30-day comment period.

The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact any proposed regulation may have on a substantial number of small entities (those under $10 million in assets). This interim final rule provides clarification regarding the applicability of one of the exceptions to otherwise applicable regulatory restrictions. Accordingly, it will not have a significant economic impact on a substantial number of small credit unions, and therefore, no regulatory flexibility analysis is required.

NCUA has determined that this rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).

The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) (SBREFA) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by Section 551 of the APA. 5 U.S.C. 551. NCUA does not believe this final rule is a “major rule” within the meaning of the relevant sections of SBREFA. NCUA has submitted the rule to the Office of Management and Budget for its determination in that regard.

The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden. 44 U.S.C. 3507(d); 5 CFR part 1320. For purposes of the PRA, a paperwork burden may take the form of either a reporting or a recordkeeping requirement, both referred to as information collections. These technical corrections do not impose any new paperwork burden.

For the reasons stated in the preamble, the National Credit Union Administration amends 12 CFR part 750 as set forth below:

Airworthiness Directive 2011-09-51, Amendment 39-16697 (76 FR 27872, May 13, 2011), currently requires an inspection and functional test of the valves and drain holes in the fuselage and requires sending a report of the results to Piaggio. If the valves and drain holes are found to not drain properly and where no additional drain holes have been drilled, then there is a requirement to drill additional drain holes.

As published, the AD number specified in the preamble section of the first page is incorrect.

No other part of the preamble or regulatory information has been changed; therefore, only the changed portion of the final rule is being published in theFederal Register.

The effective date of AD 2011-09-51 remains May 31, 2011.

In theFederal Registerof May 13, 2011, AD 2011-09-51, Amendment 39-16697, on page 27872, in the 3rd column, on line 3 of the agency identification number section of the preamble of AD 2011-09-51, the AD number is incorrectly referenced as AD 2011-10-16. This correction changes that AD number to AD 2011-09-51.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2011-0050, dated March 21, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Title 49 of the United States Code (U.S.C.), section 40103(a)(1), provides that the “United States Government has exclusive sovereignty of airspace of the United States.” Paragraph (b) of this section directs the FAA to “develop plans and policy for the use of the navigable airspace and assign by regulation or order the use of the airspace necessary to ensure the safety of aircraft and the efficient use of the airspace.”

In recognition of the threat tall structures can pose to aviation safety, 49 U.S.C. 44718 directed the FAA to promulgate regulations requiring notice of proposed structures or alterations of existing structures when the notice will promote safety in air commerce and the efficient use and preservation of the navigable airspace and of airport traffic capacity at public-use airports.See14 CFR part 77. The agency was further directed to study such structures and determine the extent of any adverse impacts on the safe and efficient use of the airspace, facilities or equipment.

Consistent with the above statutory and regulatory framework, the FAA has adopted policy to establish the standards for which the FAA identifies “obstructions” and “hazards” in the navigable airspace in furtherance of itsresponsibilities to manage the navigable airspace safely and efficiently.See14 CFR part 77 and FAA Order 7400.2, Procedures for Handling Airspace Matters.

Part 77 specifies when notice must be filed with the FAA for the construction of a structure or alteration of (an existing) structure. In filing this notice, the proponent provides the required information and submits its marking and lighting plan for that proposal, if appropriate. Sponsors are encouraged to review the guidance in Advisory Circular No. 70/7460-1, Obstruction Marking and Lighting in devising the marking and lighting plan for the proposed structure. In conducting the aeronautical study, the FAA considers the proposed structure, including the marking and lighting plan, and determines the impact on air navigation. If the FAA issues a Determination of No Hazard to Air Navigation, the determination may be conditioned on the structure being marked and lighted in accordance with the determination. Unless notice is required under a separate paragraph of § 77.9, the FAA does not study structures under 200 feet AGL at its site.

The FAA has been approached by operators, associations representing agricultural operators, and state governments concerning the visibility of METs in remote and rural areas that also have low-level flight operations. METs are used by wind energy companies to determine feasible sites for wind turbines. Some of these towers are less than 200 feet AGL, usually at 198 feet or less. The structures are portable, erected in a matter of hours, installed with guyed wires and constructed from a galvanized material often making them difficult to see in certain atmospheric conditions. The METs that fall under the 200 foot AGL threshold, specified in § 77.9, are not subject to the notice requirements and do not trigger any aeronautical study by the FAA.

On January 5, 2011, the FAA published a document seeking comments on proposed guidance for the voluntary marking of METs less than 200 feet AGL (76 FR 1326). The FAA agrees that marking these structures would enhance the conspicuity of these METs, particularly for low-level agricultural operations.

The document set forth three recommendations for comment. First, the FAA recommended that the METs be painted in accordance with the criteria contained in Chapter 3, paragraphs 30-33 of AC No. 70/7460-1. In particular, paragraph 33 discusses the paint pattern used to mark structures based on size and shape. Section (d) of that paragraph specifically refers to communication towers and catenary support structures, poles, smokestacks and skeletal framework of storage tanks and similar structures. The METs addressed in this document are similar to the structures identified in this paragraph. Therefore, the FAA proposed the guidance recommended for these structures, which is alternating bands of aviation orange and white.

Secondly, the FAA recommended spherical and/or flag markers be used in addition to the above paint pattern when additional conspicuity is necessary for aviation safety. Paragraph 34 provides recommended guidance for the use of spherical and flag markers.

Lastly, the FAA proposed high visibility sleeves and/or flags on the outer guy wires of these METs. While AC No. 70/7460-1 does not contain this type of marking, the FAA specifically sought comments as whether this type of marking would be feasible and appropriate.

The comment period closed on February 4, 2011 and the FAA received approximately 460 comments from individuals, aviation associations, industry users, aviation businesses, emergency medical services, state governments and state departments of transportation. Many comments received were in response to the January 10, 2011 fatal accident involving a Rockwell International S-2R aircraft that collided with a MET during an aerial application in Oakley, California. Most commenters supported a goal of improving the safety of certain aviation operations in the vicinity of METs that are less than 200 feet in height. Some commenters supported various forms of marking the METs not proposed in the document, and others supported marking and lighting METs. Only 3 commenters opposed the proposed guidance.

The comments covered the following general areas of the proposal: marking and lighting METS, the advantages and disadvantages of affixing sleeves and spherical marker balls, establishing a database of METs, and making the guidance for marking mandatory.

The American Wind Energy Association (AWEA) and California Wind Energy Association favored enhancing pilot safety. AWEA supported painting the METs as proposed, but commented that painting the top1/3of the tower would be sufficient. The National Agricultural Aviation Association (NAAA) commented that the marking provisions should apply to any tower over 50 feet AGL. NAAA further contends that paint must be applied to the entire vertical length of the tower in order to be effective. Transport Canada, which recently issued an Advisory Circular1 for marking of METs, recommend painting the entire support mast.

The FAA agrees that painting the entire structure will provide the best visibility for pilots. As aerial applicators fly close to the vegetation and well below 200 feet AGL, the MET should be visible against the terrain as well as the sky. Therefore, the most effective painting scheme would entail painting the entire structure with alternating bands of aviation orange and white paint, as described in AC No. 70/7460-1, paragraphs 30-33. These provisions also recommend that the paint should be replaced when faded or otherwise deteriorated.

The FAA received varying comments on the usage and length of sleeves on METs. Several commenters, including AWEA and Iberdrola, stated that there is a practical limit as to how much weight the guy wires can sustain and a limited percentage of wires can bear the additional weight of sheathing. AWEA also stated that sleeves could add significant stress, particularly in icing situations, and undermine the structural integrity of the tower and lead to failure.

Commenters indicated that the length of the sleeve should be determined on a case-by-case basis, and result in a sheath that is sufficient to rise above tall crops or other land cover but still remain visible to pilots. The Helicopter Association International recommended at least 16 feet of high visibility sleeves on guy wires at the anchor point to extend above any surrounding crop. Other commenters recommended sheathing in a range of 6-10 feet.

The FAA received similar comments from Iberdrola, AWEA, NAAA and other agricultural associations on the use of spherical marker balls. These commenters stated that marker balls can attract significant icing, which increase loads on the tower and can lead to tower failure, as well as interfere with instrumentation and affect accuracy of MET readings. Various agricultural associations and others supported the use of spherical marker balls painted aviation orange. EcoEnergy uses 4 high visibility cable balls on the outer guy wires. Iowa Agricultural Aviation Association recommended 8 totalmarker balls. Iberdrola uses 4 marker balls installed just above ground-based sheathing to enhance visibility of the furthest extent of guy wires and a second set of 4 marker balls installed approximately 45 meters AGL to enhance visibility of the painted tower segment that delineates the tallest extent of the tower. Iberdola strongly discouraged consideration of additional maker balls (more than 8) on METs as structural integrity limits are encroached upon with further loading.

Additionally, a few comments supported the use of marker flags in conjunction with spherical marker balls. The commenters also noted that flags may be useful as a visual aid, but are subject to rapid deterioration from weather conditions such as wind, snow, and ice.

The FAA concludes that sleeves and spherical marker balls will enhance the conspicuity of METs particularly for low flying agricultural and other aviation operations. The FAA recommends one high visibility sleeve on each guy wire anchor point that will reach a height well above the crop or vegetation canopy, and another sleeve installed on each of the outer guy wires. The FAA recognizes that certain weather conditions may affect the placement and use of high visibility sleeves on guy wires, and that the length should be determined on a case-by-case basis.

Spherical markers may have different placement standards, depending on the company that manufactures them. Varying placement standards and other factors such as weather play a role in the placement of spherical markers and flexibility is needed when determining their position on the METs. As a general recommendation, that FAA recommends a total of 8 high visibility spherical marker (or cable) balls of aviation orange color attached to the guy wires; four marker balls should be attached to guy wires at the top of the tower no further than 15 feet from the top wire connection to the tower, and 4 marker balls at or below the mid point of the structure on the outer guy wires. As stated previously, the FAA recognizes that the varying factors identified above may result in the placement or number of marker balls used and should be addressed on a case-by-case basis. The use of sleeves should not impact the placement of spherical marker balls.

Existing guidance in AC 70/7460, paragraph 34(b) states that flags are used to mark certain structures or objects when it is technically impractical to use spherical markers or painting. The FAA recommends spherical markers and paint, however, the FAA did not receive sufficient data on the use of flags on the guy wires that support METs to provide recommendations on their use for these towers.

NAAA, HAI, and others submitted various recommendations for lighting METs. The comments recommended varied uses of red lights and white strobe lights. Some commenters also stated that a recommendation for lights would require a Notice to Airmen (NOTAM) to be issued when the lights were not operational.2

Lighting studies indicate that red lights are difficult to see during the day, and that the most acceptable lighting configuration would be the use of a high intensity white strobe. The FAA acknowledges that the addition of lights may make METs more visible to agricultural and other low flying operations. The FAA concludes, however, that it would not be practical to recommend lights for the METs addressed in this document. The remoteness of many MET locations does not allow for pre-existing power sources, and strobe lights require more power than red lights. While solar lights may be a possible option, the FAA has not studied solar lighting and therefore, cannot provide recommendations for flight visibility.

Additionally, when the FAA conducts an aeronautical study, it reviews many factors in determining whether lighting is necessary. These factors include height, location, proximity to an airport, flight activity in the area, and complexity of terrain. Without a similar evaluation process, the FAA cannot recommend lighting for METs. It is important to note that the FAA does not recommending lighting in every aeronautical study.

The State of Minnesota commented that it is important to collect and share information METs siting in a timely manner, and that recommendations to mark and light METs should not hinder any growth aspirations of the wind industry. NAAA proposed that the FAA establish a database that catalogues all tower locations, similar to the initiative by the State of Wyoming.

It is not feasible for the FAA to maintain a national database for structures that are less than 200 feet AGL and otherwise not subject to the notice requirement in part 77. The FAA does not object to a state or local jurisdiction maintaining or providing a source of information that would inform pilots as to the location or planned location of these towers or for some other zoning, planning or public welfare purpose.

Many commenters responded that marking and lighting of METs should be mandatory. The FAA also received comments from the Experimental Aircraft Association, the National Association of State Aviation Officials, and others recommending changes to part 77 so that the FAA may study different structures at heights constructed less than 200 feet. NAAA also commented that upon adoption of revised standards, any towers erected before the adoption date shall be marked within six months after the effective date.

The purpose of this proposal was to address a limited population of METs that are not studied under part 77, but are difficult to see by certain low level aircraft operations. The guidance is recommended to landowners and developers siting these towers in remote, rural agricultural areas. The guidance recommended here is not necessary for METs that are erected in urban areas and far removed from areas where rural agricultural spraying operations are conducted. Landowners and developers must exercise discretion in determining if the METs will be erected in this type area where these operations are conducted and whether the marking and painting would enhance the visibility of these structures to low-level flight operations.

The FAA received comments pertaining to environmental impact issues and vegetation management. The Marin Audubon Society supporting the inclusion of guidance for measures to reduce the risk of collision for aircraft and birds. Other commenters claimed that steady red lights attract and confuse birds and that sleeves and skeletal framework of METs should be designed to make them visible for birds.

Three commenters opposed the proposal. One commenter was concerned that the proposal would be expanded to include amateur radio antenna supports. Another commenter was concerned with light pollution and applicability regardless of terrain and other factors. The remaining commenter inaccurately referred to this notice of policy as a notice of proposed rulemaking to amend the regulations in part 77. This commenter also argued that some developers may follow the guidance and others may not, which may introduce potential for pilots to presume that all METs will be marked and could result in failure to identify and avoid unmarked towers. The commenter contends that developers that choose to voluntarily mark andlight their METs would incur additional costs and time delays and this affects their ability to compete with others in the market. As stated previously, the FAA is not amending the regulations to require notice for structures less than 200 feet AGL in non-airport environments. The FAA is providing this information to enhance the visibility of structures that otherwise may be difficult to see due to the terrain and the nature of specific operations conducted around these METs. While this guidance is not mandatory, the FAA anticipates that in the interest of aviation safety, developers and landowners will consider this guidance for METs erected in the environments described in this document.

The FAA recommends voluntary marking of METs less than 200 feet AGL in accordance with marking guidance contained in this document and Advisory Circular 70-7460-l, Obstruction Marking and Lighting. The FAA notes that historically this guidance has not been applied to the voluntary marking of METs less than 200 feet AGL. However, the FAA recognizes the need to address safety impacts to low-level flight operations due to the construction of METs in remote and rural areas, especially as agricultural spraying season approaches. Due to the growing concerns expressed by operators, associations representing agricultural operators, and state and local governments throughout the agricultural industry, the FAA believes that voluntary marking of METs less than 200 AGL in remote and rural areas enhance the visibility of these structures to low level agricultural operations in the vicinity of these towers.

The FAA recommends that landowners and developers use guidance contained in Advisory Circular 70/7460-1, Obstruction marking and Lighting for the voluntary marking of METs less than 200 feet AGL. METs should be painted in accordance to criteria contained in Chapter 3, paragraphs 30-33 of AC No. 70/7460-1, specifically, with alternate bands of aviation orange and white paint. In addition, paragraph 34 states that all markings should be replaced when faded or otherwise deteriorated. The FAA recommends that high visibility sleeves be installed on the outer guy wires of METs as described in this document. The FAA intends, at a future date, to amend the advisory circular to include guidance on sleeves. Additionally, the FAA recommends high visibility spherical marker (or cable) balls of aviation orange color are attached to the guy wires. Spherical markers should be installed and displayed in accordance to guidance contained in this document and additional standards contained in Chapter 3, paragraph 34 of AC No. 70/70460-1. The FAA, however, recognizes various weather conditions and manufacturing placement standards may affect the placement and use of high visibility sleeves and/or spherical markers. Thus, flexibility is needed when determining sleeve length and marker placement on METs.

In July 1996, the United States and thirty-three other countries gave final approval to the establishment of a new multilateral export control arrangement called the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual Use Goods and Technologies (Wassenaar Arrangement or WA). The Wassenaar Arrangement contributes to regional and international security and stability by promoting transparency and greater responsibility in transfers of conventional arms and dual use goods and technologies, thus preventing destabilizing accumulations of such items. Participating states committed to exchange information on exports of dual use goods and technologies to non-participating states for the purposes of enhancing transparency and assisting in developing a common understanding of the risks associated with the transfers of these items. For more information on the Wassenaar Arrangement go tohttp://www.wassenaar.org/.

Many computers are exported and reexported using License Exception Adjusted Peak Performance (APP). The primary eligibility criteria considered for this license exception are destination country and the processing speed. In the past, the processing speed was measured using a formula that would result in the Composite Theoretical Performance (CTP) of a computer. Presently, the speed of computers is calculated using a formula that results in the Adjusted Peak Performance(APP). The countries eligible for export or reexport under License Exception APP are divided into two groups or “Tiers”, (Tier 1 and Tier 3). Countries listed in Tier 1 are ally countries or countries that do not pose a national security, nuclear or missile threat to the United States. Tier 3 Countries are all other countries with the exception of the terrorist supporting countries listed in Country Group E:1 of Supplement No. 1 to part 740.

The National Defense Authorization Act (NDAA) Congressional Notification Requirement, Subsections 1211(d) and (e) of the National Defense Authorization Act (NDAA) for FY 1998 (Pub. L. 105-85, November 18, 1997, 111 Stat. 1932), provides that a new composite theoretical performance level for purposes of licensing exports of digital computers to Tier 3 countries may not take effect until sixty days after the President submits a report to Congress setting forth the new level and the justification for the new level. The President sent a report to Congress on February 7, 2011 that identifies and provides justification for a new 1.5 Weighted TeraFLOPS (WT) control level using the Adjusted Peak Performance (APP) formula.

This rule revises Export Control Classification Number (ECCN) 4A003 on the Commerce Control List (CCL) to implement the changes to the Wassenaar List of Dual Use Goods and Technologies agreed to at the December 2009 WA Plenary meeting. These changes are described in more detail below.

ECCN 4A003 is amended by:

The WA members agreed at the 2009 Plenary to raise the “License Exception Adjusted Peak Performance” (APP) parameter in ECCNs 4D001 (0.25 WT), and 4E001 (0.25 WT), because of the advancement of computer technology. In License Exception APP, with regard to deemed exports of “development” and “production” technology controlled by ECCN 4E001 and source code controlled by ECCN 4D001, BIS is raising the eligibility parameter (APP) from 0.5 WT to 1.5 WT for foreign nationals of Computer Tier 1 countries (with the exception of the countries listed in Section 740.7(c)(3)(i) that have unlimited APP for “development” and “production” technology and source code) and from 0.1 WT to 0.5 WT for foreign nationals of Computer Tier 3 countries, because of the advancement of high performance computer technology.

This rule removes Albania and Croatia from Computer Tier 3 and places these countries in Computer Tier 1 in Section 740.7 License Exception APP. The requirements in the 1998 National Defense Authorization Act (NDAA) provides that the removal of a country from Tier 3 may take effect 120 days after Congress receives a report justifying such a removal. The President sent a report to Congress on February 7, 2011, therefore the 120 days have passed. Albania and Croatia have made significant progress in conforming to international nonproliferation norms and export control standards. Croatia is a member of the Australia Group, the Nuclear Suppliers Group, and the Wassenaar Arrangement. Albania has declared its adherence to the international export control regimes and is working on becoming a member of the regimes. Albania and Croatia are parties to the Nuclear Non-Proliferation Treaty, the Chemical Weapons Convention, and the Biological Weapons Convention. In addition, Albania and Croatia adhere to the Hague Code of Conduct and are now North Atlantic Treaty Organization (NATO) allies. This revision will result in fewer license applications, because Albania and Croatia will now be eligible for License Exception APP. In addition, the EAR will no longer require NDAA-based recordkeeping and post shipment verification reporting of exports of high performance computers to Albania and Croatia (see Section 743.2 of the EAR).

Foreign-made computers with an APP of 0.75 WT located in a foreign country are not eligible for the application of thede minimisrules when they contain U.S.-origin controlled semiconductors (other than memory circuits) classified under ECCN 3A001 and are destined to a country in Computer Tier 3 of Section 740.7 of the EAR. This rule increases the APP parameter from 0.75 WT to 1.5 WT in harmonization with the revision made to ECCN 4A003.

This section outlines special post-shipment reporting requirements for the export of certain computers to destinations in Computer Tier 3 of License Exception APP (Section 740.7 of the EAR). The reporting requirement applies to high performance computer exports to destinations in Computer Tier 3, as well as exports of commodities used to enhance computers previously exported or reexported to Computer Tier 3 destinations, where the APP is greater than 0.75 WT. This rule increases that APP level from 0.75 WT to 1.5 WT in accordance with the WA agreement to increase the APP level in ECCN 4A003.

Since August 21, 2001, the Export Administration Act of 1979, as amended, has been in lapse. However, the President has continued the EAR in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701-1707) through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 12, 2010, 75 FR 50681 (August 16, 2010).

1. This final rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule involves two collections of information subject to the PRA. One of the collections has been approved by OMB under control number 0694-0088, “Multi Purpose Application,” and carries a burden hour estimate of 43.8 minutes for a manual or electronic submission. The other of the collections has been approved by OMB under control number 0694-0137, “'Licensing Exceptions and Exclusions,” and carries a burden hour estimate of 21 minutes for a manual or electronic submission. Send comments regarding these burden estimates or any other aspect of these collections of information, includingsuggestions for reducing the burden, to OMB Desk Officer, New Executive Office Building, Washington, DC 20503; and to Jasmeet Seehra, OMB Desk Officer, by e-mail atJasmeet_K._Seehra@omb.eop.govor by fax to (202) 395-7285; and to the Office of Administration, Bureau of Industry and Security, Department of Commerce, 14th and Pennsylvania Avenue, NW., Room 6622, Washington, DC 20230.

3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Immediate implementation of these amendments fulfills the United States' international obligation to the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual Use Goods and Technologies. The Wassenaar Arrangement contributes to international security and regional stability by promoting greater responsibility in transfers of conventional arms and dual use goods and technologies, thus preventing destabilizing accumulations of such items. The Wassenaar Arrangement consists of 44 member countries that act on a consensus basis and the changes set forth in this rule implement agreements reached at the December 2009 plenary session of the WA. Because the United States is a significant exporter of the items in this rule, implementation of this provision is necessary for the WA to achieve its purpose. Delaying implementation will create a disruption in the movement of affected items globally because of disharmony between export control measures implemented by WA members, resulting in tension between member countries. Export controls work best when all countries implement the same export controls in a timely manner. If this rulemaking was delayed to allow for notice and comment, it would prevent the United States from fulfilling its commitment to the WA in a timely manner and would injure the credibility of the United States in this and other multilateral regimes.

Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601et seq.) are not applicable. Therefore, this regulation is issued in final form. Although there is no formal comment period, public comments on this regulation are welcome on a continuing basis. Comments should be submitted to Sharron Cook, Office of Exporter Services, Bureau of Industry and Security, Department of Commerce, 14th and Pennsylvania Ave., NW., Room 2099, Washington, DC 20230.

Accordingly, Parts 734, 740, 743 and 774 of the Export Administration Regulations (15 CFR Parts 730 through 774) are amended as follows:

In theFederal Registerof June 7, 2006 (71 FR 32827), FDA published an Interim Final Rule that established an exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in specified circumstances. The IFR amended 21 CFR 50.23, to add paragraph (e). The rule was issued under the authority set forth in section 520(g)(3)(D) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)(3)(D)). FDA gave interested parties 60 days to comment on the IFR. FDA is publishing this final rule that incorporates one change in response to comments that the rule did not protect against misuse of the exception. This change is described in section II of this document.

This regulation is being issued under the statutory authority provided in section 520(g)(3)(D) of the FD&C Act, which outlines the criteria under which an exemption from informed consent may be permissible. Under section 520(g)(3)(D) of the FD&C Act, informed consent is required unless the investigator determines the following in writing: (1) There exists a life threatening situation involving the human subject of such testing which necessitates the use of such device; (2) it is not feasible to obtain informed consent from the subject; and (3) there is not sufficient time to obtain such consent from the subject's legally authorized representative. Further, a licensed physician uninvolved in the testing must agree with this three-part determination in advance of using the device unless use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence.

The preamble to the IFR described the provisions of this rule in detail (71 FR 32827). In issuing this final rule, FDA is making one change to the IFR, in response to comments that the rule did not protect against misuse of this limited exception from informed consent requirements. In response to those concerns, FDA is adding a requirement that investigators also send the required documentation to FDA, not just to the reviewing IRB. This new requirement provides an additional level of oversight to help ensure that the limited exception criteria are met.

The Agency received comments on the IFR from nine different entities. Comments were received from four individual consumers, two from consumer groups, and one each from a health professional, a health professional group, and a local government. A summary of the comments received, grouped by subject matter follows.

(Comment 1) Three comments expressed support for the IFR, noting that the rule is needed and greatly improves the ability of public health laboratories to respond to a public health emergency. In contrast, six comments expressed general concern that the rule presents too much risk to the consumer. Some comments raised issues that are beyond the scope of this rulemaking. For example, one of these comments suggested that informed consent documents have a line addressing in vitro diagnostic testing; another encouraged the production of templates to easily provide the detailed information required to be included in the reports.

(Response) FDA agrees with the comments recognizing that the rule will enable better response in public health emergencies. FDA also shares thegeneral concerns related to ensuring human subject protections. To that end, the Agency has ensured that the rule confers several layers of human subject protection, including IRB review, review and evaluation of the determinations made by the investigator by an independent physician, and disclosure of the investigational status of device to the subject's health care provider. FDA believes the rule balances the need to ensure human subjects are protected with the need to act quickly during a public health emergency and avoid potentially dangerous delays in using investigational devices to identify chemical, biological, radiological, or nuclear agents in human specimens.

(Comment 2) Two comments noted that the IFR has no provisions to prevent abuse.

(Response) FDA disagrees that the rule has no provisions to prevent abuse. The rule requires that the investigator and an independent physician each make specific determinations and that an IRB review these determinations. The determinations that the investigator and independent physician must make require careful consideration related to the use of the device and are intended to prevent abuse. However, FDA does agree that the IFR could have included an additional measure to prevent abuse of the exception; specifically, the IFR could have required that an investigator's documentation be submitted to the Agency, not just to the reviewing IRB. Although FDA relies on IRBs to adequately monitor the procedures set forth by the rule, the Agency recognizes that the IFR did not provide a mechanism for FDA to track the use of this exception from the general requirements for informed consent. Therefore, FDA is adding a requirement that the investigator submit to FDA the documentation required in 21 CFR 50.23(e)(1) or (e)(2) within 5 working days after the use of the device, in addition to submitting this information to the IRB within the same timeframe.

(Comment 3) One comment expressed concern that the only oversight over the determinations made by the investigator and the independent physician on behalf of the subject is that of the IRB and it will take 5 days. The comment claimed that consumers do not have confidence in IRB oversight and recommended the development of an open and clear process for choosing qualified individuals to be granted the extraordinary emergency power to waive informed consent, with opportunity for public comment.

(Response) The Agency agrees that the decision to enter subjects in clinical trials without informed consent is not a trivial matter and should be made by qualified individuals. The FD&C Act allows for carefully considered exceptions to the general requirements for informed consent in emergency circumstances. The requirements described in this rule follow section 520(g)(3)(D) of the FD&C Act. This rule is to be used during emergencies and, among other requirements, only when there are no cleared or approved available alternative methods of diagnosis to identify the chemical, biological, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life of the subject.

In general, the rule assures that the determinations designed to safeguard the subject are made by two different and independent persons, i.e., the investigator and the independent physician, and that the use is then reviewed by the IRB. In the final rule, FDA is adding another level of oversight by requiring that investigators submit to FDA the same documentation they are required to submit to the IRB. FDA notes that this rule is intended for use in situations where public health laboratories must employ investigational in vitro diagnostic devices to diagnose patients when there are no approved or cleared diagnostic devices available that provide an equal or greater likelihood of saving patients' lives.

(Comment 4) Some comments contended that the rule will allow the use of experimental tests, which have an unknown rate of inaccurate test results.

(Response) FDA agrees that investigational in vitro diagnostic devices do not yet have established performance characteristics and, therefore, their accuracy is unknown until data collected during the investigation demonstrates the device's performance. FDA believes that when an investigational in vitro diagnostic device is needed to identify a chemical, biological, radiological, or nuclear agent and no cleared or approved alternative method of diagnosis is available that provides an equal or greater likelihood of saving the life of the subject, the benefits of the investigational in vitro diagnostic device outweigh the risks. The rule creates an exception to the general requirement for informed consent under these circumstances.

(Comment 5) One comment stated that if the patient is awake there is no justification for not obtaining informed consent.

(Response) The rule contemplates the scenario when the person directing the specimen collection does not know, at the time the specimen is collected, that an investigational device may need to be used in the future, usually by reference laboratories far from where the specimen was collected. Because of the geographic and temporal separation between specimen collection and testing for a life-threatening agent, to obtain informed consent would require a number of steps and introduce unacceptable delays, independent of whether the patient is physically able to provide informed consent.

(Comment 6) One comment stated that the notification obligations of the investigator described in the IFR are too complex, stating it should be sufficient to have a certification by the laboratory director declaring that the investigational test was performed in accordance with the rule and to send to the subject a copy of the notice sent to the IRB. The comment also noted that the concurrence of an independent physician adds no value.

(Response) The Agency believes that the notification obligations of the investigator described in this rule, which are similar to the obligations described in other exceptions from the general requirements of informed consent under 21 CFR 50.23, are needed because they are intended to provide added human subject protections and to prevent abuses. Moreover, concurrence of an independent physician is mandated by section 520(g)(3)(D) of the FD&C Act.

(Comment 7) One comment requested the inclusion of explicit language in the rule directing the investigator to notify or report positive results to public health authorities when appropriate or required by State or Federal law.

(Response) FDA agrees that it is important to report the detection of biologic, chemical, nuclear, or radiological agents to public health authorities and encourages this practice. FDA expects this reporting to occur when appropriate or when required under Federal or State law.

(Comment 8) One comment asked whether the term “investigator” can be interpreted to mean the single entity that deploys the investigational device, in which case it would be possible to use a centralized IRB and have the deploying entity be responsible for the reporting requirements.

(Response) For purposes of this regulation, the Agency interprets the term “investigator” to mean the individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed or used in the diagnosis or treatment of a subject. In the event of an investigation conducted by a team of individuals, we use the term “investigator” to mean the responsible leader of that team. (See 21 CFR 50.3(d)). For purposes of this rule, we anticipate that the investigator will generally be the director of the clinical laboratory using the investigational device. This interpretation does not preclude local IRBs from deferring their review to a centralized IRB, provided that the IRB meets the requirements of 21 CFR part 56.

(Comment 9) One comment requested that FDA consider extending the number of days allowed for submitting the written certification for the exception. (Under the rule the investigator has 5 working days after the use of the investigational device to submit the investigator's determinations and those of the independent physician to the IRB.)

(Response) FDA disagrees with this comment. The requirement that the investigator's determinations and those of the independent physician be submitted to the IRB within 5 working days, which is similar to the obligations described in other exceptions from the general requirements of informed consent under 21 CFR 50.23, are intended to assure prompt action by the IRB, as needed.

(Comment 10) Two comments contended that the term “other public health emergency” is vague and should be removed or should be revised to specify in exact terms what constitutes a public health emergency worthy of this extraordinary exception from informed consent.

(Response) For purposes of this rule, the term “other public health emergency” means serious domestic emergencies that have the potential to significantly impact public health such as those caused by deadly weather disasters or by widespread infectious disease such as pandemic influenza.

(Comment 11) One comment requested that the following preamble statement, “subjects or their legally authorized representatives will not be entitled to withdraw previously collected data from the research database * * *” (71 FR 32827 at 32830), be eliminated because it sets a dangerous precedent by allowing government research to take priority over personal privacy.

(Response) FDA does not agree to eliminate the referenced statement. While a subject may withdraw from a study, FDA reiterates that the withdrawal does not extend to the data already obtained during the time the subject was enrolled. FDA's longstanding position has been that all data collected up to the point of withdrawal is to be maintained in the database and included in subsequent analyses, as appropriate, in order for the study to be scientifically valid.1 If a subject withdraws from a study, removal of already collected data would undermine the scientific, and therefore the ethical, integrity of the research.

As described in the IFR, some of the activities described in this rule may also constitute non-exempt human subjects research within the meaning of 45 CFR part 46, according to the Office for Human Research Protection (OHRP) in the Department of Health and Human Services (HHS). In particular, the use of the investigational in vitro diagnostic device on individually identifiable human specimens as described in this rule would not be human subjects research under 45 CFR part 46, while the analysis of the individually identifiable data obtained from the use of the investigational device to determine the safety and effectiveness of the device would be considered human subject research under 45 CFR part 46. If the analysis of individually identifiable data involves non-exempt human subjects research that is conducted or supported by HHS, the institution conducting the analysis must obtain an OHRP-approved assurance. In addition, this means that this research activity, if not exempt, i.e., the analysis of the individually identifiable data, must be reviewed prospectively by an IRB and must be conducted with the informed consent of the subjects unless waived. OHRP expects that IRBs will often find that informed consent may be waived under 45 CFR 46.116(d) for the analysis of the individually identifiable data obtained through the use of the investigational device. OHRP issued guidance regarding this issue simultaneously with the publication of the IFR, on June 7, 2006. This guidance can be found athttp://www.hhs.gov/ohrp/policy/invitrodev.html.Those interested in seeking additional information concerning the application of the regulations at 45 CFR part 46 should contact OHRP. We note that research conducted or supported by another Department or Agency may be subject to other laws and regulations. Sponsors should check to see if they are complying with all applicable requirements.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this action provides an exception from an otherwise applicable requirement for investigators, FDA believes that it does not impose a significant burden. The Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forthin Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State or authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain federal requirements applicable to devices. 21 U.S.C. 360k; seeMedtronicv.Lohr,518 U.S. 470 (1996);Riegelv.Medtronic,128 S. Ct. 999 (2008). This final rule creates requirements for specific medical devices under 21 U.S.C. 360k.Papikev.Tambrands, Inc.,107 F.3d 737, 740-42 (9th Cir. 1997).

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title:Medical Devices; Exception From General Requirements for Informed Consent.

Description:The final rule amends FDA's informed consent regulation to provide an exception from the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or uncleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. For the exception to apply, it is necessary for the investigator and an independent licensed physician to make the determination and certify in writing certain facts concerning the need for use of the investigational in vitro diagnostic device without informed consent (21 CFR 50.23(e)(1)). When reporting the test results to the subject's health care provider and, possibly, to the appropriate public health authorities, the investigator must disclose the investigational status of the in vitro diagnostic device (21 CFR 50.23(e)(4)). If use of the device is necessary to preserve the life of the subject and there is not sufficient time to obtain the determination of the independent licensed physician in advance of using the investigational device, 21 CFR 50.23(e)(2) provides that the determination must be made within 5 working days of use of the device. In either case, the certifications are submitted to the IRB within 5 working days after the use of the device (21 CFR 50.23(e)(3)).

The information collection requirements in 21 CFR 50.23(e)(1), (e)(2), and (e)(4) in the IFR have been approved under OMB control number 0910-0586. The information collection requirement in 21 CFR 50.23(e)(3) (submitting the certifications to the IRB) was considered part of the burden for 21 CFR 50.23(e)(1) and (e)(2).

This final rule makes one change to the regulatory requirements established by the IFR. This change requires the investigator to submit the documentation required in 21 CFR 50.23(e)(1) and (e)(2) to FDA, in addition to the reviewing IRB. The documentation the investigator must submit to FDA is identical to the documentation the investigator must submit to the IRB.

Description of Respondents:Clinical laboratory directors, physicians who are investigators.

FDA estimates the burden of the collection of information as follows:

From its knowledge of in vitro diagnostic device investigations, FDA estimates that there are approximately 150 laboratory directors or physicians who could perform this type of testing and, as investigators, are required to comply with information collection and recordkeeping. FDA estimates that there are approximately 450 naturally occurring cases of this type each year. Based on its knowledge of similar types of submissions, FDA estimates that it will take about .25 hour or 15 minutes to prepare each written documentation to be submitted to FDA as required by 21 CFR 50.23(e)(3). The estimated 112.5 total hours was calculated by multiplying the estimated total annual response by the hours per response.

In compliance with the Paperwork Reduction Act of 1995, the collection of information in this final rule has been submitted to OMB for review. The new information has been submitted as a revision to the previously approved collection OMB control number 0910-0586.

This final rule also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995. The collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130; and the collections of information in 21 CFR 50.23(e)(1), (e)(2), and (e)(4) have been approved under OMB control number 0910-0586.

The Agency has determined under 21 CFR 25.30(h) 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.

Accordingly, the interim final rule amending 21 CFR part 50 which was published at 71 FR 32827 on June 7, 2006, is adopted as a final rule with the following change:

FDA is clarifying the regulatory authority for human dura mater in the Agency's codified regulations for part 882 (21 CFR part 882). In theFederal Registerof November 24, 2004 (69 FR 68612), FDA published a final rule regarding current good tissue practice for establishments that manufacture human cell, tissue, and cellular and tissue-based products (HCT/Ps). That rule became effective on May 25, 2005. Prior to the effective date of the final rule, human dura mater was regulated as a medical device under § 882.5975. As stated in the final rule, human dura mater is now defined under 21 CFR 1271.3(d) as a HCT/P. As such, it is regulated under section 361 of the Public Health Service Act (42 U.S.C. 264) and the requirements of 21 CFR part 1271, including requirements related to registration and listing, donor eligibility determinations, and current good tissue practice. Accordingly, the device classification contained in § 882.5975 is only applicable for human dura mater recovered prior to the effective date of the final rule, May 25, 2005. The final rule omitted a corresponding annotation to § 882.5975 to clarify that the device classification is only applicable for human dura mater recovered prior to the effective date of the final rule. This document clarifies the regulatory authority for human dura mater. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

On June 24, 2008, the IRS published final and temporary regulations under section 956 (TD 9402) in theFederal Register(73 FR 35580). On the same date, the IRS published a notice of proposed rulemaking (REG-102122-08) (the proposed regulations) in theFederal Register(73 FR 35606) cross-referencing the temporary regulations. The temporary and proposed regulations provided guidance regarding the determination of basis in certain United States property (as defined in section 956(c)) acquired by a controlled foreign corporation (as defined in section 957(a)) in certain nonrecognitiontransactions that are intended to repatriate earnings and profits of the controlled foreign corporation without an income inclusion by its United States shareholders under section 951(a)(1)(B). The purpose of these regulations is to prevent a United States shareholder of a controlled foreign corporation from avoiding an income inclusion under section 951(a)(1)(B) where the controlled foreign corporation acquires United States property in an exchange to which these regulations apply and claims a basis in the United States property that is less than the amount of earnings and profits repatriated. No comments in response to the proposed regulations were received and no public hearing was requested or held. This Treasury decision adopts the proposed regulations with minor changes, described below, as final regulations and removes the corresponding temporary regulations.

Language was added to § 1.956-1(e)(6)(iii) to clarify the effect of the assumption of a liability by a controlled foreign corporation in connection with an exchange to which § 1.956-1(e)(6) applies. The final regulations also modify § 1.956-1(e)(6)(v) to address the situation in which the controlled foreign corporation exchanges specified United States property the adjusted basis in which has been determined under § 1.956-1(e)(6) for other United States property, by providing that for purposes of applying section 956 the controlled foreign corporation's adjusted basis in the other United States property is no less than its adjusted basis in the specified United States property as determined under § 1.956-1(e)(6)(iii). A cross-reference to the anti-abuse rule of § 1.956-1T(b)(4) was also added to § 1.956-1(e)(6)(vi),Example 3.

These final regulations apply to property acquired in exchanges occurring on or after June 24, 2011. For transactions that occur prior to June 24, 2011, see § 1.956-1T(e)(6) as contained in 26 CFR Part 1 revised as of April 1, 2011.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866; therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, these regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Kristine A. Crabtree, Office of Associate Chief Counsel (International). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

The temporary regulations that are the subject of this correction are under section 6038A of the Internal Revenue Code.

As published, temporary regulations (TD 9529) contain errors that may prove to be misleading and are in need of clarification.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

The temporary regulations that are the subject of this correction are under section 6038A of the Internal Revenue Code.

As published, temporary regulations (TD 9529) contain errors that may prove to be misleading and are in need of clarification.

Accordingly, the publication of the temporary regulations (TD 9529) which were the subject of FR Doc. 2011-14468 is corrected as follows:

1. On page 33998, column 3, in the preamble, under the paragraph heading “Special Analyses”, the last paragraph of the column, first and second lines, the language “It has been determined that this temporary regulation is not a significant” is corrected to read “It has been determined that these temporary regulations are not a significant”.

2. On page 33999, column 1, in the preamble, under the paragraph heading “Special Analyses”, the first paragraph of the column, third and fourth lines, the language “section 7805(f) of the Code, this regulation has been submitted to the” is corrected to read “section 7805(f) of the Code, these regulations have been submitted to the”.

3. On page 33999, column 1, in the preamble, under the paragraph heading “Drafting Information”, sixth line of the paragraph, the language “Department participated in its” is corrected to read “Department participated in their”.

This document contains amendments to 26 CFR parts 1 and 54 under section 6081 of the Internal Revenue Code (Code). On November 8, 2005, the Treasury Department and the IRS published a notice of proposed rulemaking (REG-144898-04) by cross-reference to temporary regulations (TD 9229) in theFederal Register(70 FR 67356, 70 FR 67397) relating to the simplification of procedures for obtaining automatic extensions of timeto file certain returns. On July 1, 2008, the Treasury Department and the IRS published final and temporary regulations (TD 9407) in theFederal Register(73 FR 37362) finalizing the rules simplifying the procedures for obtaining automatic extensions of time to file certain returns. A notice of proposed rulemaking (REG-115457-08) cross-referencing the temporary regulations also was published in theFederal Register(73 FR 37389) on July 1, 2008. The temporary and proposed regulations reduced the automatic six-month extension of time to file contained in the 2005 proposed regulations to five months for certain pass-through entities (most partnerships, estates, and certain trusts).

As these pass-through entities were previously allowed to obtain an automatic six-month extension of time to file certain returns, the Treasury Department and the IRS requested comments on whether, and how, a five-month extension of time to file for these pass-through entities might increase or reduce overall taxpayer burden. Approximately 70 comments were received in response to the notice of proposed rulemaking. A public hearing was held on January 13, 2009. Three speakers appeared at the public hearing and commented on the notice of proposed rulemaking.

All comments were considered and are available for public inspection athttp://www.regulations.govor upon request. After consideration of the written comments and the comments provided at the public hearing, the proposed regulations under section 6081 are adopted as revised by this Treasury decision. The public comments, public hearing, and the revisions are discussed in this preamble.

Prior to issuance of the 2005 temporary regulations, TD 9229, pass-through entities were entitled to an automatic three-month extension of time to file certain returns by filing one form, and could also request a discretionary additional three-month extension of time to file by filing a second form. TD 9229 provided temporary regulations that simplified the extension process by allowing most taxpayers, including pass-through entities, to obtain a six-month automatic extension of time to file by filing one single form. In the 2008 final and temporary regulations, TD 9407, the Treasury Department and the IRS finalized rules granting an automatic six-month extension of time to file for non pass-through entities and granting certain pass-through entities a five-month automatic extension of time to file certain returns. The five-month extension included in the 2008 final and temporary regulations for certain pass-through entities responded to comments received on the 2005 temporary regulations. Commentators expressed concern that an automatic six-month extension for pass-through entities would unduly burden individual and corporate taxpayers with ownership interests in pass-through entities because individual and corporate taxpayers might not receive information returns from pass-through entities in sufficient time to complete their income tax returns in an accurate and timely manner.

Recognizing the inherent conflict between providing sufficient time for pass-through entities to prepare returns and ensuring that the owners and beneficiaries of pass-through entities timely receive information returns needed to file their own returns, the 2008 proposed and temporary regulations specifically requested comments on whether a shorter filing extension period for pass-through entities might increase or reduce overall taxpayer burden. The IRS received approximately 70 comments, many of which are summarized in this preamble.

Several commentators suggested that the Treasury Department and the IRS should consider changing the filing and extension due dates for individual and corporate tax returns rather than shortening the extension period for pass-through entities. For example, some commentators suggested moving the individual taxpayer return due date to April 30th, or allowing individuals and corporations a seven-month extension of time to file returns. Other commentators suggested moving up the filing date for partnership, trust, and estate taxpayers to March 15th, thereby allowing these entities a full six-month extension of time to file until September 15th so that individual taxpayers with ownership interests in the entities would receive information timely.

These suggestions are not viable options for a regulation project because the due dates for filing tax returns are determined by statute.See,for example, sections 6012(a) and 6072. Further, section 6081 provides that, except in the case of taxpayers who are abroad, the maximum extension of time to file a tax return cannot exceed six months. Accordingly, without legislative action, the Treasury Department and the IRS cannot change the due date for filing tax returns or increase the maximum extension of time to file a tax return for pass-through entities, individuals, or corporations.

Although the comments with regard to shortening the automatic extension period for these pass-through entities varied as to time periods, the majority of commentators agreed that a less than six-month extension period for pass-through entities would generally reduce overall taxpayer burden by allowing taxpayers with ownership interests in pass-through entities to receive information in a more timely fashion vis-à-vis preparation of their own individual or corporate income tax returns. There was no clear consensus, however, regarding what the optimal period of extension would be for reducing taxpayer burden.

The Treasury Department and the IRS considered several extension periods for pass-through entities, including a four-month and a five-month extension period, when drafting the proposed and temporary regulations. The Treasury Department and the IRS ultimately decided upon a five-month automatic extension period for the proposed and temporary regulations. Many comments were received supporting the five-month extension period. Some commentators noted, however, that the five-month extension period would not alleviate the burden on corporate taxpayers with ownership interests in pass-through entities. These commentators expressed a concern that even a five-month extension period for these entities would, in most cases, simply align the extended due date for pass-through entities with the extended due date for corporate returns, resulting in the same delay of information to corporate owners of these entities. That delay, the commentators contend, would greatly increase the need for filing amended returns. Commentators suggested shortening the automatic extension for these entities to less than five months.

In opting for the five-month extension, the Treasury Department and the IRS recognize that some corporations with ownership interests in pass-through entities may continue to experience delayed receipt of information needed to complete their own corporate returns. The Treasury Department and the IRS, however, continue to believe that a five-month extension period reduces the overall burden on taxpayers and strikes the most reasonable balance for all affected taxpayers. The five-month extension period allows pass-through entities, including complex and tiered entities, an adequate time for preparation of therequired pass-through returns and also ensures the timely and accurate dissemination of information to a large number of taxpayers who require that information for completion of their own income tax returns.

Electing large partnerships required to file Form 1065-B, “U.S. Return of Income for Electing Large Partnerships,” for any taxable year will be allowed an automatic six-month extension of time to file the return, however, because these pass-through entities are statutorily required to furnish Schedules K-1 by March 15, regardless of any extension of time to file the return.Seesection 6031(b).

Comments varied in response to the five-month automatic filing extension period provided for trust taxpayers. Several commentators expressed support of the overall five-month extension to pass-through entities. Other commentators suggested that trusts resemble an end taxpayer more than a pass-through entity, and in that respect are more akin to individuals than to partnerships. These commentators argued that trusts did not belong in the same class of entities as partnerships and estates for purposes of automatic filing extensions.

Some commentators further expressed concern that Schedules K-1 would not be received by trusts in a sufficiently timely fashion. For example, commenters noted that trusts are often invested in partnerships, which are often invested in other partnerships in tiered structures, with each entity relying on the next for information before preparing their own statements. These commenters feared that, due to the compressed timeframe when Forms 1065, “U.S. Return of Partnership Income,” will typically be prepared, Schedules K-1 received by each succeeding entity in the chain ultimately will be received by trusts at the very last minute, resulting in inaccuracies and increased preparer burden.

Commentators also pointed out that the five-month extended deadline for trusts would coincide with the extended due date for S Corporation tax returns. Due to the fact that many trusts are invested in S Corporations, these commentators viewed this as an increased burden on trusts and their return preparers.

The Treasury Department and the IRS recognize that only allowing a five-month extension of time to file for trusts may cause a hardship, as some trusts may have less time to complete accurate income tax returns and to provide timely information to the trust's beneficiaries. Providing a longer extension of time to file, however, still presents the potential of shifting the burden to individuals who might not receive timely information. In addition, the Treasury Department and the IRS believe that the five-month automatic filing extension period has generally been successful and continues to strike the right balance in reducing overall taxpayer burden since the proposed and temporary regulations were adopted.

Therefore, after thorough consideration of all the comments, the Treasury Department and the IRS determined that the five-month extension period best reduces overall tax burden. Accordingly, these final regulations provide that trusts will continue to receive an automatic five month extension of time to file as provided in the proposed and temporary regulations.

Finally, a comment questioned whether the five-month automatic extension of time to file estate or trust income tax returns applies to individuals filing bankruptcy petitions under chapter 7 or 11 of title 11 of the United States Code. The bankruptcy estate created when a petition is filed by an individual under either chapter 7 or 11 is a separate taxable entity for title 26 purposes.See26 U.S.C. 1398. Although fiduciaries of these individual bankruptcy estates (trustees or debtors-in-possession) may be required to file Forms 1041, the bankruptcy estates are not pass-through entities as described in these regulations. Therefore, the five-month automatic extension provided by these regulations is inapplicable to bankruptcy estates of individuals under chapter 7 or 11 of title 11 of the Bankruptcy Code.

Pass-through entities eligible to file bankruptcy petitions, such as partnerships, would be affected by these regulations. A separate taxable entity is not created when a partnership files a bankruptcy case.See generally26 U.S.C. § 1399. The trustee or debtor-in-possession of the bankrupt partnership files a Form 1065, not a Form 1041. Thus, the five-month automatic extension provided in these regulations would apply, as the filing of a bankruptcy petition does not change the information reporting requirements of pass-through entities, such as a partnership.

Accordingly, after consideration of all comments and in order to best minimize overall taxpayer burden, these final regulations provide for a five-month automatic extension of time to file certain returns for partnerships, trusts, and estates other than certain bankruptcy estates.

These final regulations also adopt without modification the proposed amendments to 26 CFR part 54, which allow filers of Form 8928, “Return of Certain Excise Taxes Under Chapter 43 of the Internal Revenue Code,” to obtain an automatic six-month extension of time to file the return after the date prescribed for filing the return.

It has been determined that this Treasury Decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. Although these final regulations reference forms that are approved under the Paperwork Reduction Act (44 U.S.C. chapter 35), the regulations themselves do not impose a collection of information on small entities. Therefore, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small businesses.

The principal author of these regulations is Jason Bremer of the Office of the Associate Chief Counsel (Procedure and Administration).

Accordingly, 26 CFR parts 1 and 54 are amended as follows:

In rule FR Doc. 2011-4048, published on February 24, 2011 (76 FR 10234), on page 10245, in the third column, in line 16, 31 CFR 1010.350(d), the citation to “31 CFR 1010(hhh)” should have read “31 CFR 1010.100(hhh).” This document corrects the citation.

Because this document is correcting a minor typographical error, FinCEN finds that prior notice and comment under the Administrative Procedure Act are unnecessary.

Accordingly, 31 CFR part 1010 is corrected by making the following correcting amendment:

The Coast Guard will enforce the special localregulation for the annual Seattle Seafair Unlimited Hydroplane Race in 33 CFR 100.1301 from 8 a.m. on August 4, 2011 through 11:59 p.m. on August 7, 2011.

Under the provisions of 33 CFR 100.1301, the Coast Guard will restrict general navigation in the following area; the waters of Lake Washington bounded by the Interstate 90 (Mercer Island/Lacey V. Murrow) Bridge, the western shore of Lake Washington, and the east/west line drawn tangent to Bailey Peninsula and along the shoreline of Mercer Island.

The regulated area has been divided into two zones. The zones are separated by a line perpendicular from the I-90 Bridge to the northwest corner of the East log boom and a line extending from the southeast corner of the East log boom to the southeast corner of the hydroplane race course and then to the northerly tip of Ohlers Island in Andrews Bay. The western zone is designated Zone I, the eastern zone, Zone II. (Refer to NOAA Chart 18447).

The Coast Guard will maintain a patrol consisting of Coast Guard vessels, assisted by Auxiliary Coast Guard vessels, in Zone II. The Coast Guard patrol of this area is under the direction of the Coast Guard Patrol Commander (the “Patrol Commander”). The Patrol Commander is empowered to control the movement of vessels on the racecourse and in the adjoining waters during the periods this regulation is in effect. The Patrol Commander may be assisted by other federal, state and local law enforcement agencies.

Only authorized vessels may be allowed to enter Zone I during the hours this regulation is in effect. Vessels in the vicinity of Zone I shall maneuver and anchor as directed by Coast Guard Officers or Petty Officers.

During the times in which this regulation is in effect, the following rules shall apply:

(1) Swimming, wading, or otherwise entering the water in Zone I by any person is prohibited while hydroplane boats are on the racecourse. At other times in Zone I, any person entering the water from the shoreline shall remain west of the swim line, denoted by buoys, and any person entering the water from the log boom shall remain within ten (10) feet of the log boom.

(2) Any person swimming or otherwise entering the water in Zone II shall remain within ten (10) feet of a vessel.

(3) Rafting to a log boom will be limited to groups of three vessels.

(4) Up to six (6) vessels may raft together in Zone II if none of the vessels are secured to a log boom. Only vessels authorized by the Patrol Commander, other law enforcement agencies or event sponsors shall be permitted to tow other watercraft or inflatable devices.

(5) Vessels proceeding in either Zone I or Zone II during the hours this regulation is in effect shall do so only at speeds which will create minimum wake, seven (07) miles per hour or less. This maximum speed may be reduced at the discretion of the Patrol Commander.

(6) Upon completion of the daily racing activities, all vessels leaving either Zone I or Zone II shall proceed at speeds of seven (07) miles per hour or less. The maximum speed may be reduced at the discretion of the Patrol Commander.

(7) A succession of sharp, short signals by whistle or horn from vessels patrolling the areas under the direction of the Patrol Commander shall serve as signal to stop. Vessels signaled shall stop and shall comply with the orders of the patrol vessel; failure to do so may result in expulsion from the area, citation for failure to comply, or both.

The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 100.1301 and 5 U.S.C. 552(a). If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

The Borgata Hotel Casino and Spa, on behalf of New Jersey Department of Transportation, requested a temporary deviation from the current operating regulations of the Route 30/Absecon Boulevard Bridge across Beach Thorofare, NJICW mile 67.2, at Atlantic City, NJ.

The closure has been requested to ensure the safety of the heavy volumes of vehicular traffic that would be transiting over the bridge for the July 4th fireworks show at Borgata Hotel Casino and Spa. Under this temporary deviation, the bridge will remain in the closed position to vessels requiring an opening in order to facilitate the movement of vehicular traffic intending to view the Fourth of July fireworks show.

The Fourth of July fireworks show is scheduled to take place on July 4, 2011. Therefore, under this temporary deviation, the bridge will remain in the closed position to vessels requiring an opening from 9:40 p.m. through 11:15 p.m. on July 4, 2011. However, should weather preclude this event from taking place on July 4, 2011, the event will be re-scheduled to take place on July 5, 2011. In that case, the bridge will operate as normal on July 4, 2011 and the bridge will remain in the closed position to vessels requiring an openingfrom 9:40 p.m. through 11:15 p.m. on July 5, 2011. At all other times during the effective period of this temporary regulation, the bridge will operate as outlined at 33 CFR 117.733(e).

The vertical clearance of this bascule bridge is 20 feet above mean high water in the closed position to vessels and unlimited in the open position. The current operating regulations are outlined at 33 CFR 117.733(e), which require that the bridge shall open on signal but only if at least four hours of notice is given; except that from April 1 through October 31, from 7 a.m. to 11 p.m., the draw need only open on the hour. The majority of the vessels that transit this bridge during this time are recreational boats. Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies. The Atlantic Ocean is an alternate route for vessels with mast heights greater than 20 feet. The Coast Guard will inform the users of the waterway through our Local and Broadcast Notices to Mariners of the closure period so that vessels can plan their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Burlington County Bridge Commission, who owns and operates this vertical-lift type drawbridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.5 and 117.716(b) to facilitate the replacement of the lift cables.

The Burlington-Bristol Bridge on Route 413, at mile 117.8, across the Delaware River, between Burlington NJ and Bristol PA, has a vertical clearance in the closed position to vessels of 62 feet above mean high water.

Under the regular operating schedule the bridge opens on signal as required by 33 CFR 117.5 and the opening of a bridge may not be delayed more than five minutes for a highway bridge, after the signal to open is given as required by 33 CFR 117.716(b).

Under this temporary deviation, beginning 12:01 a.m. on Saturday July 9, 2011 and ending at 11:59 p.m. on Friday July 22, 2011, the Burlington-Bristol Bridge will be closed to vessels and unable to open on signal.

Vessels that can pass under the bridge without a drawbridge opening may do so at all times. A barge/crane, involved in the maintenance operation, will be located near the center of the channel, adjacent to the bridge, reducing the horizontal clearance of the waterway to approximately 200 feet. on either side of the barge/crane. Vessels able to pass under the closed span in conjunction with this horizontal clearance may do so at any time. There are no alternate routes for vessels transiting this section of the Delaware River.

There are approximately four to six vessels per week from four facilities whose vertical clearance surpasses the closed bridge position, requiring an opening of the draw span. The Coast Guard has coordinated this replacement work with the Mariners Advisory Committee for Bay & River Delaware, and will inform the other users of the waterway through our Local and Broadcast Notices to Mariners of the closure periods for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation. The bridge will not be able to open in an emergency due to the lift cables being removed.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive information regarding the dates and scope of the event in time to publish a NPRM followed by a final rule before the effective date.

The Coast Guard was notified of this event on February 24, 2011. This event is a reoccurring marine event with a proposed permanent rule currently in a public comment period under docket number USCG-2010-1001 titled, Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port New York Zone.

The sponsor was not aware of the requirements for submitting an application for a marine event 135 days in advance, resulting in a late notification to the Coast Guard. The sponsor is aware of this requirement for all future events. The sponsor is unable to reschedule this event due to other activities being held in conjunction with the fireworks display.

Due to the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to provide for the safety of event participants, spectator craft, and other vessels operating near the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register.The rule must become effective on the date specified above in order to provide for the safety of the public including spectators and vessels operating in the area near the fireworks display. Delaying the effective date of this rule until after 30 days have elapsed since publication is impractical and would expose spectators, vessels, and other property to the hazards associated with pyrotechnics used in the fireworks display.

The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define safety zones.

The Central Astoria Local Development Coalition has planned a fireworks event to celebrate Independence Day. The fireworks will commence at 9:15 p.m. on June 30, 2011 and will last approximately 25 minutes. This event poses significant potential risk to participants, spectators and the maritime public because of hazardous conditions associated with a fireworks display. This temporary safety zone is necessary to ensure the safety of participants, spectators and vessels.

This rule establishes a temporary safety zone on a portion of the waters of the East River. The temporary safety zone will encompass all waters of the East River in the vicinity of Wards Island, Queens, NY, within a 150-yard radius of a shore location, approximate position 40°46′57.83″ N, 073°55′28.58″ W (NAD 83) approximately 150 yards south of Hells Gate Bridge.

All persons and vessels shall comply with the instructions of the COTP New York or the designated on-scene representative. Entry into, transiting, or anchoring within the temporary safety zone is prohibited unless authorized by the COTP New York or the designated on-scene representative. The COTP New York or the designated representative may be reached on VFH Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, 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 it under that Order.

The Coast Guard's implementation of this temporary safety zone will be of short duration and designed to minimize the impact to vessel traffic on navigable waters. This safety zone will only be enforced for 90 minutes. Furthermore, vessels may be authorized to transit the zone with permission of the COTP New York or the designated on-scene representative.

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.

This rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor within the fireworks fall-out zone, a portion of the East River in the vicinity of Wards Island, Queens, NY. The fireworks will commence at 9:15 p.m. on June 30, 2011 and will last approximately 25 minutes.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: Vessel traffic can safely transit around the zone. Before the effective period, we will issuemaritime advisories widely available to users of the waterway. This rule will be in effect for only 90 minutes.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

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 a State, local, or tribal government, in the aggregate, or by 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.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This 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.

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.

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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a temporary safety zone on a portion of the Upper New York Bay during the launching of fireworks.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows:

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because sufficient information regarding the dates and scope of the event was not received in time to publish a NPRM followed by a final rule as the event would occur before the rulemaking process was complete. The Coast Guard was notified of this event on May 5, 2011. The sponsor was not aware of the requirements for submitting an application for a marine event 135 days in advance, resulting in a late notification to the Coast Guard. The sponsor is aware of this requirement for all future events. The sponsor is unable to reschedule this event due to other activities being held in conjunction with the fireworks display. Due to the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to provide for the safety of event participants, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register.Any delay in the effective date of this rule would expose spectators, vessels and other property to the hazards associated with pyrotechnics used in the fireworks display.

The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define safety zones.

The safety zone is being issued to establish a temporary regulated area in Boston Harbor around the fireworks launch barge during the fireworks display.

This temporary rule is necessary to ensure the safety of spectators, vessels and other property from the hazards associated with fireworks display. The COTP Boston has determined that fireworks displays in close proximity to watercraft and waterfront structures pose a significant risk to public safety and property. Such hazards include obstructions to the waterway that may cause marine casualties and the explosive danger of fireworks and debris falling into the water that may cause death or serious bodily harm. Establishing a safety zone around the location of this fireworks event will help ensure the safety of spectators, vessels and other property and help minimize the associated risks.

The Coast Guard has implemented safety zones for past events and has not received public comments or concerns regarding the impact to waterway traffic from these events.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, 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 it under that Order.

The Coast Guard determined that this rule is not a significant regulatory action for the following reasons: The safety zone will be of limited duration and is designed to avoid, to the extentpossible, fishing and recreational boating traffic routes. The fireworks will also be coordinated to ensure there is no interruption of commercial vessel transits.

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 would not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, moor or anchor in portions of Boston Harbor during a fireworks display.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will only be in effect for1/2hour and vessels will be able to transit around the safety zone. The fireworks will also be coordinated around commercial vessels traffic to avoid interruption of transits. Before the effective period, we will issue maritime advisories widely available to users of the waterway.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact MST1 David Labadie at the telephone number or e-mail address indicated under theFOR FURTHER INFORMATION CONTACTsection of this notice.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

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 a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) 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.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This 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.

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.

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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the humanenvironment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event would occur before the rulemaking process would be completed. Because of the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to provide for the safety of event participants, spectators, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Any delay in the effective date of this rule would expose mariners to the dangers posed by the pyrotechnics used in the fireworks display.

Stockton Ports Baseball Club will sponsor the Stockton Ports Baseball Club Fourth of July Fireworks Display on July 4, 2011 on the navigable waters off of Weber Point, in Stockton, California. The fireworks display is meant for entertainment purposes. This safety zone is issued to establish a temporary restricted area on the waters surrounding the fireworks launch site during loading of the pyrotechnics, and during the fireworks display. This restricted area around the launch site is necessary to protect spectators, vessels, and other property from the hazards associated with the pyrotechnics. The Coast Guard has granted the event sponsor a marine event permit for the fireworks display.

During the set up of the fireworks and until the start of the fireworks display, the temporary safety zone applies to thenavigable waters around the fireworks launch site within a radius of 100 feet. From 9:30 p.m. until 9:50 p.m., the area to which the temporary safety zone applies will increase in size to encompass the navigable waters around the fireworks launch site within a radius of 1,000 feet. The fireworks launch site will be located on land in position 37°57′15.69″ N, 121°17′39.74″ W (NAD 83).

The effect of the temporary safety zone will be to restrict navigation in the vicinity of the fireworks launch site while the fireworks are set up, and until the conclusion of the scheduled display. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the restricted area. These regulations are needed to keep spectators and vessels a safe distance away from the fireworks launch site to ensure the safety of participants, spectators, and transiting vessels.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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 it under that Order.

Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are pleasure craft engaged in recreational activities.

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.

This rule may affect owners and operators of pleasure craft engaged in recreational activities and sightseeing. This rule will not have a significant economic impact on a substantial number of small entities for several reasons: (i) vessel traffic can pass safely around the area, (ii) vessels engaged in recreational activities and sightseeing have ample space outside of the effected portion of the areas off of Stockton, CA to engage in these activities, (iii) this rule will encompass only a small portion of the waterway for a limited period of time, and (iv) the maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

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 a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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.

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.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This 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.

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.

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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does notrequire a Statement of Energy Effects under Executive Order 13211.

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.

We have analyzed this rule under Department of Homeland Security Management Directive 0023.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a temporary safety zone.

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act(APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event would occur before the rulemaking process would be completed. Because of the dangers posed by the pyrotechnics used in this fireworks display, the safety zone is necessary to provide for the safety of event participants, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Any delay in the effective date of this rule would expose mariners to the dangers posed by the pyrotechnics used in the fireworks display.

Document Systems Inc. will sponsor a fireworks display on July 4, 2011 in the waters of South Lake Tahoe. The fireworks display is meant for entertainment purposes. This safety zone is issued to establish a temporary restricted area off of Jameson Beach in South Lake Tahoe, California while the pyrotechnics are being loaded on the pyrotechnics barge, transited to the launch location and during the fireworks display. This restricted area around the launch barge is necessary to protect spectators, vessels, and other property from the hazards associated with the pyrotechnics on the fireworks barges. The Coast Guard has granted the event sponsor a marine event permit for the fireworks display.

The Coast Guard is establishing a temporary safety zone in the navigable waters of South Lake Tahoe. During the loading of the fireworks barge, while the barge is towed to the display location, and until the start of the fireworks display, the temporary safety zone applies to the navigable waters around and under the fireworks barge within a radius of 100 feet. Loading of the pyrotechnics onto the fireworks barge is scheduled to commence at 9 a.m. on July 3, 2011, and will take place at the Tahoe Keys Marina in South Lake Tahoe, California. Towing of the barge from the Marina to the display location is scheduled to take place at 9 a.m. on July 4, 2011. From 9:45 p.m. until 10 p.m. on July 4, 2011 the area to which the temporary safety zone applies will increase in size to encompass the navigable waters around and under the fireworks barge within a radius of 1,000 feet. During the fireworks display, scheduled to commence at approximately 9:45 p.m. on July 4, 2011, the fireworks barge will be located in position 38° 56′24.89″ N, 120° 02′07.37″ W (NAD 83). The fireworks display is scheduled to last approximately fifteen minutes.

The effect of the temporary safety zone will be to restrict navigation in the vicinity of the fireworks barge while the fireworks are loaded, during the transit of the fireworks barge, and until the conclusion of the scheduled display. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the restricted area. These regulations are needed to keep spectators and vessels a safe distance away from the fireworks barge to ensure the safety of participants, spectators, and transiting vessels.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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 it under that Order.

Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are pleasure craft engaged in recreational activities.

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.

This rule may affect owners and operators of pleasure craft engaged in recreational activities and sightseeing. This rule will not have a significant economic impact on a substantial number of small entities for several reasons: (i) Vessel traffic can pass safely around the area, (ii) vessels engaged in recreational activities and sightseeing have ample space outside of the effected portion of Lake Tahoe to engage in these activities, (iii) this rule will encompass only a small portion of the waterway for a limited period of time, and (iv) the maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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 havedetermined that it does not have implications for federalism.

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 a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This 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.

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.

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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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.

We have analyzed this rule under Department of Homeland Security Management Directive 0023.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under Figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule involves establishing a temporary safety zone.

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event would occur before the rulemaking process would be completed. Because of the dangers posed by the pyrotechnics used in these fireworks displays, the safety zones are necessary to provide for the safety of event participants, spectators, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it would be impracticable to not have these regulations in effect during the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Any delay in the effective date of this rule would expose mariners to the dangers posed by the pyrotechnics used in the fireworks display.

The City of Richmond will sponsor the Independence Day Fireworks Celebration for the City of Richmond on July 3, 2011, on the navigable waters of Richmond Inner Harbor, off of the Lucretia Edwards Park, Richmond, California. The fireworks display is meant for entertainment purposes. This temporary safety zone establishes a temporary restricted area on the waters surrounding the fireworks launch site during the fireworks displays. This temporary safety zone around the launch site is necessary to protect spectators, vessels, and other property from the hazards associated with the pyrotechnics over the water. The Coast Guard has granted the event sponsor a marine event permit for the fireworks displays.

From 9 a.m. until 9:30 p.m. on July 3, 2011, the temporary safety zone will extend 100 feet while pyrotechnics are loaded onto the land launch site at position 37°54′34.14″ N, 122°21′16.93″ W (NAD 83). The fireworks display will occur from 9:30 p.m. until 9:50 p.m., during which the safety zone will extend 1,000 feet off of the Lucretia Edwards Park land launch site at position 37°51′40.34″ N, 122°19′19.59″ W (NAD 83). At 10 p.m. the safety zone shall terminate.

The effect of the temporary safety zone will be to restrict navigation in the vicinity of the fireworks site while the fireworks are set up, and until the conclusion of the scheduled displays. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the restricted area. These regulations are needed to keep spectators and vessels a safe distance away from the launch site to ensure the safety of participants, spectators, and transiting vessels.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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 it under that Order.

Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant. The entities most likely to be affected are pleasure craft engaged in recreational activities. In addition, the rule will only restrict access for a limited time. Finally, the Public Broadcast Notice to Mariners will notify the users of local waterway to ensure that the safety zone will result in minimum impact.

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 independentlyowned 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.

Although this rule may affect owners and operators of pleasure craft engaged in recreational activities and sightseeing, it will not have a significant economic impact on a substantial number of small entities for several reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time; (ii) vessel traffic can pass safely around the area; (iii) vessels engaged in recreational activities and sightseeing have ample space outside of the affected areas of San Francisco Bay, CA, to engage in these activities; and (iv) the maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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). 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.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

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 a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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.

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.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This 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.

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.

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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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.

We have analyzed this rule under Department of Homeland Security Management Directive 0023.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under Figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing, disestablishing, or changing Regulated Navigation Areas and security or safety zones.

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

I. General Information A. Does this action apply to me?

Public water systems are the regulated entities required to measure contaminants in drinking water samples. In addition, EPA Regions as well as States and Tribal governments with authority to administer the regulatory program for public water systems under SDWA may also measure contaminants in water samples. When EPA sets a monitoring requirement in its national primary drinking water regulations for a given contaminant, the Agency also establishes in the regulations standardized test procedures for analysis of the contaminant. This action makes alternative testing methods available for particular drinking water contaminants beyond the testing methods currently established in the regulations. EPA is providing public water systems required to test water samples with a choice of using either a test procedure already established in the existing regulations or an alternative test procedure that has been approved in this action or in prior expedited approval actions. Categories and entities that may ultimately be affected by this action include:

This table is not exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be impacted. To determine whether your facility isaffected by this action, you should carefully examine the applicability language in theCode of Federal Regulations(CFR) at 40 CFR 141.2 (definition of public water system). If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the precedingFOR FURTHER INFORMATION CONTACTsection.

Docket.EPA established a docket for this action under Docket ID No. EPA-HQ-OW-2011-0413. Publicly available docket materials are available either electronically throughhttp://www.regulations.govor in hard copy at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Copyrighted materials are available only in hard copy. The EPA Docket Center 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 Water Docket is (202) 566-2426.

In this action, EPA is approving 11 analytical methods for determining contaminant concentrations in samples collected under SDWA. Regulated parties required to sample and monitor may use either the testing methods already established in existing regulations or the alternative testing methods being approved in this action or in prior expedited approval actions. The new methods are listed in Appendix A to Subpart C of Part 141 and on EPA's drinking water methods Web site athttp://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_expedited.cfm.

This action also corrects the entry for dalapon in Appendix A to Subpart C of Part 141. In an earlier expedited methods approval action, Standard Methods 6640 B and 6640 B-01 were incorrectly listed under the same analytical methodology as EPA Method 557 for the determination of dalapon in drinking water. This action amends the dalapon entry to specify the appropriate methodology for each of these methods.

This action also revised entries in Appendix A to Subpart C of Part 141 for arsenic, barium, beryllium, cadmium, calcium, chromium, copper, lead, magnesium, nickel, selenium, silica, sodium, iron, manganese, and silver to include the footnote citation for EPA Method 200.5, Revision 4.2.

When EPA determines that an alternative analytical method is “equally effective” (i.e., as effective as a method that has already been promulgated in the regulations), SDWA allows EPA to approve the use of the alternative method through publication in theFederal Register. (See Section 1401(1) of SDWA.) EPA is using this streamlined approval authority to make 11 additional methods available for determining contaminant concentrations in samples collected under SDWA. EPA has determined that, for each contaminant or group of contaminants listed in Section III, the additional testing methods being approved in this action are as effective as one or more of the testing methods already approved in the regulations for those contaminants. Section 1401(1) of SDWA states that the newly approved methods “shall be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulation.” Accordingly, this action makes these additional (and optional) 11 analytical methods legally available for meeting EPA's monitoring requirements.

This action does not add regulatory language, but does, for informational purposes, update an appendix to the regulations at 40 CFR Part 141 that lists all methods approved under Section 1401(1) of SDWA. Accordingly, while this action is not a rule, it is updating CFR text and therefore is being published in the “Final Rules” section of theFederal Register.

EPA is approving 11 methods that are equally effective relative to methods previously promulgated in the regulations. By means of this notice, these 11 methods are added to Appendix A to Subpart C of 40 CFR Part 141.

1. Standard Methods for the Examination of Water and Wastewater (Standard Methods). EPA compared the most recent versions of four Standard Methods to earlier versions of those methods that are currently approved in 40 CFR 141 and 143. Changes between the earlier approved version and the most recent version of each method are summarized in Smith (2011). The revisions primarily involve editorial changes (i.e., corrections of errors, procedural clarifications, and reorganization of text). The revised methods are the same as the earlier approved versions with respect to the chemistry, sample handling protocols, and method performance data. The new versions are thus equally effective relative to those that are currently approved in the regulations. Therefore, EPA is approving the use of the four updated Standard Methods for the contaminants and their respective regulations listed in the following table:

Two additional Standard Methods, 6640 B, published in the 21st edition (APHA 2005), and its identical online version, 6640 B-01 (APHA 2001), were approved in a previous expedited methods approval action for determining dalapon in drinking water (75 FR 32295, June 8, 2010) (USEPA 2010). Standard Method 6640 B was developed directly from EPA Method 515.4 (USEPA 2000), and thus entails the identical sample collection/handling protocols, sample preparation and derivatization steps, chromatographic conditions, and detection. The method performance data (e.g.,detection levels, accuracy and precision) specified in Standard Method 6640 B and EPA Method 515.4 are identical. In addition to addressing dalapon, EPA Method 515.4 is also an approved method for analyzing drinking water compliance samples for 2,4-D, 2,4,5-TP (i.e., Silvex), dinoseb, pentachlorophenol, and picloram as cited at 40 CFR 141.24(e)(1). Therefore, in this action EPA is expanding approval of Standard Method 6640 B and Standard Method 6640 B-01 for determining 2,4-D, 2,4,5-TP (i.e., Silvex), dinoseb, pentachlorophenol, and picloram in drinking water. The 21st edition can be obtained from the American Public Health Association (APHA), 800 I Street, NW., Washington, DC 20001-3710. Online versions of Standard Methods are available athttp://www.standardmethods.org.

2. ASTM International. EPA compared the most recent versions of three ASTM International methods to the earlier versions of those methods that are currently approved in 40 CFR 141. Changes between the earlier approved version and the most recent version of each method are summarized in Smith (2011). The revisions primarily involve editorial changes (i.e.,updated references, definitions, terminology, and reorganization of text). The revised methods are the same as the approved versions with respect to sample collection and handling protocols, sample preparation, analytical methodology, and method performance data. In addition, the revised version of the ASTM method for the radiochemical determination of uranium (ASTM Method D3972-09) expands the QC requirements beyond those required in the previous version. EPA has thus determined that the new versions are equally effective relative to those currently in the regulations. Therefore, EPA is approving the use of the three updated ASTM methods for the contaminants and their respective regulations listed in the following table:

The ASTM methods are available from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959 orhttp://www.astm.org.

1. Hach Company TNTplusTM835/836 Nitrate Method 10206 (Hach Company 2011a). The Hach Company TNTplus 835/836 nitrate method 10206 uses spectrophotometric analysis to determine nitrate concentrations in drinking water. The method involves the following steps:

• Electrophilic substitution of the dimethylphenol reagent results in a colored nitro-dimethylphenol product, and

• Colorimetric measurement of the absorbance at 345 nm is directly proportional to the concentration of the nitrate in the sample.

The currently approved methods for nitrate are listed at 40 CFR 141.23(k)(1). An inter-laboratory study was conducted by the vendor to compare the method performance of the Hach Company TNTplus 835/836 nitrate method 10206 to the performance of three approved methods: EPA Method 353.2 (USEPA 1993a), EPA Method 300.0 (USEPA 1993b), and Standard Method 4500-NO3 −E (APHA 1998). Three laboratories analyzed a variety of matrices (e.g., low ionic strength, high ionic strength, and drinking water samples derived from both surface water and ground water sources). The samples were analyzed for nitrate by running approved methods alongside the Hach Company TNTplus 835/836 nitrate method 10206. EPA has determined that the Hach Company TNTplus 835/836 nitrate method 10206 is as effective as EPA Method 353.2, EPA Method 300.0, and Standard Method 4500-NO3 −E. The basis for this determination is discussed in the validation study report (Hach Company 2010a) which summarizes the results obtained from the inter-laboratory study. The method is also a “green” alternative to approved nitrate methods that use the toxic metal, cadmium. Therefore, EPA is approving the Hach Company TNTplus 835/836 nitrate method 10206 for determining nitrate concentrations in drinking water. The Hach Company TNTplus 835/836 nitrate method 10206 can be obtained from Hach Company, 5600 Lindbergh Drive, P.O. Box 389, Loveland, Colorado 80539, phone: (970) 669-3050.

2. Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225 (Hach Company 2011b). The Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225 uses spectrophotometric analysis to determine fluoride concentrations in drinking water. The currently approved method using SPADNS chemistry for determining fluoride concentrations, Standard Method 4500-F−D (APHA 1998), is listed at 40 CFR 141.23(k)(1). As described in the approved method,the presence of residual chlorine in water is a known interferent and the method specifies addition of sodium arsenite to quench the chlorine. The Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225 replaces sodium arsenite with a proprietary non-toxic, non-hazardous chlorine scavenger. An inter-laboratory study was conducted by the vendor to compare the method performance of the Hach Company SPADNS 2 (Arsenic-free) Fluoride method 10225 to the performance of the approved SPADNS method. Three laboratories analyzed a variety of matrices (e.g.,low ionic strength, high ionic strength, distilled and undistilled chlorinated drinking water samples derived from both surface water and ground water sources). The samples were analyzed for fluoride by running the approved method alongside the Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225. EPA has determined that the Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225 is as effective as Standard Method 4500-F−D. The basis for this determination is discussed in the validation study report (Hach Company 2010b) which summarizes the results obtained from the inter-laboratory study. Therefore, EPA is approving the Hach Company SPADNS 2 (Arsenic-free) Fluoride Method 10225 for determining fluoride concentrations in drinking water. The Hach Company SPADNS (Arsenic-free) Fluoride Method 10225 can be obtained from Hach Company, 5600 Lindbergh Drive, P.O. Box 389, Loveland, Colorado 80539, phone: (800) 227-4224.

As noted in Section II, under the terms of SDWA Section 1401(1), this streamlined method approval action is not a rule. Accordingly, the Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3). Similarly, this action is not subject to the Regulatory Flexibility Act because it is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute. In addition, because this approval action is not a rule but simply makes alternative (optional) testing methods available for monitoring under SDWA, EPA has concluded that other statutes and executive orders generally applicable to rulemaking do not apply to this approval action.

For the reasons stated in the preamble, 40 CFR Part 141 is amended as follows:

A. Why are revisions to State programs necessary?

States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur.

Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.

We conclude that Louisiana's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Louisiana final authorization to operate its hazardous waste program with the changes described in the authorization application. Louisiana has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Louisiana including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in Louisiana subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Louisiana has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

• Do inspections, and require monitoring, tests, analyses, or reports;

• Enforce RCRA requirements and suspend or revoke permits and

• Take enforcement actions after notice to and consultation with the State.

This action does not impose additional requirements on the regulated community because the regulations for which Louisiana is being authorized by today's action are already effective under State law, and are not changed by today's action.

The EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today'sFederal Registerwe are publishing a separate document that proposes to authorize the State program changes.

If the EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in theFederal Registerbefore the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. TheFederal Registerwithdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

The State of Louisiana initially received final authorization on February 7, 1985, (50 FR 3348), to implement its base Hazardous Waste Management Program. We granted authorization for changes to their program on November 28, 1989 (54 FR 48889) effective January 29, 1990; August 26, 1991 (56 FR 41958) effective August 26, 1991; November 7, 1994 (59 FR 55368) effective January 23, 1995; December 23, 1994 (59 FR 66200) effective March 8, 1995; there were technical corrections made on January 23, 1995 (60 FR 4380), effective January 23, 1995; and another technical correction was made on April 11, 1995 (60 FR 18360) effective April 11, 1995; October 17, 1995 (60 FR 53704) effective January 2, 1996; March 28, 1996 (61 FR13777) effective June 11, 1996; December 29, 1997 (62 FR 67572) effective March 16, 1998; October 23, 1998 (63 FR 56830) effective December 22, 1998; August 25, 1999 (64 FR 46302) effective October 25, 1999; September 2, 1999 (64 FR 48099) effective November 1, 1999; February 28, 2000 (65 FR 10411) effective April 28, 2000; January 2, 2001 (66 FR 23) effective March 5, 2001; December 9, 2003 (68 FR 68526) effective February 9, 2004, June 10, 2005 (70 FR 33852) effective August 9, 2005; November 13, 2006 (71 FR 66116) effective January 12, 2007, August 16, 2007 (72 FR 45905) effective October 15, 2007 and May 20, 2009 (74 FR 23645) effective July 20, 2009. On January 29, 2010, Louisiana applied for approval of its program revisions for RCRA Cluster XVIII including Checklist 209 (Universal Waste Rule: Specific Provisions for Mercury-Containing Equipment).

In this application, Louisiana is seeking approval for RCRA Checklists 209 and 216 through 218 in accordance with 40 CFR 271.21(b)(3).

Since 1979 through the Environmental Affairs Act, Act 449 enabled the Office of Environmental Affairs within the Louisiana Department of Natural Resources, as well as, the Environmental Control Commission to conduct an effective program designed to regulate those who generate, transport, treat, store, dispose or recycle hazardous waste. During the 1983 Regular Session of the Louisiana Legislature, Act 97 was adopted, which amended and reenacted La. R. S. 30:1051et seq.as the Environmental Quality Act, renaming the Environmental Affairs Act (Act 1938 of 1979). This Act created Louisiana Department of Environmental Quality (LDEQ), including provisions for new offices within this new Department of Environmental Quality. Act 97 also transferred the duties and responsibilities previously delegated to the Department of Natural Resources, Office of Environmental Affairs, to the new Department. The LDEQ has lead agency jurisdictional authority for administering the Resource Recovery and Conservation Act (RCRA) Subtitle C program in Louisiana. Also, the LDEQ is designated to facilitate communication between the EPA and the State. During the 1999 Regular Session of Louisiana Legislature, Act 303 revised the La.R.S.30:2011et. seq.allowing LDEQ to reengineer the Department to perform more efficiently and to meet its strategic goals.

It is the intention of the State, through this application, to demonstrate its equivalence and consistency with the Federal statutory tests, which are outlined in the United States Environmental Protection Agency regulatory requirements under 40 CFR 271, Subpart A, for final authorization. The submittal of this application is in keeping with the spirit and intent of RCRA, which provides equivalent States the opportunity to apply for final authorization to operate all aspects of their hazardous waste management programs in lieu of the Federal government. The Louisiana Environmental Quality Act authorizes the State's program, Subtitle II of Title 30 of the Louisiana Revised Statutes. With this application Louisiana is applying for authorization for specific areas of the State regulations identified as requiring authorization and the listed Checklists are: 209, 216, 217 and 218 will allow the State to implement the equivalent RCRA Subtitle C portion of the program. Louisiana has demonstrated to EPA that its program was substantially equivalent in its management of hazardous waste to the Federal program developed pursuant to RCRA.

On January 29, 2010 Louisiana submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of written comments that oppose this action, that Louisiana's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant the State of Louisiana Final authorization for the following changes: The State of Louisiana's program revisions consist of regulations which specifically govern RCRA Cluster XVIII including Cluster XVI Checklist 209 as documented in thisFederal Register:

In this authorization of the State of Louisiana program revisions for Cluster XVIII rules, there are no provisions that are more stringent or broader in scope.

Louisiana will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Louisiana is not yet authorized.

Louisiana is not authorized to carry out its Hazardous Waste Program in Indian Country within the State. This authority remains with EPA. Therefore, this action has no effect in Indian Country.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart T for this authorization of Louisiana's program changes until a later date. In this authorization application the EPA is not codifying the rules documented in thisFederal Registernotice.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.). Because this action authorizes preexisting 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. 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.

Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.).

The Congressional Review Act, 5 U.S.C. 801et 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 document 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 in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective August 23, 2011.

This final rule amends 49 CFR Part 595, Subpart C, “Make Inoperative Exemptions, Vehicle Modifications to Accommodate People With Disabilities,” to update and expand a reference in an exemption relating to FMVSS No. 214. The notice of proposed rulemaking (NPRM) on which this final rule is based was published on September 28, 2010 (75 FR 59674) (Docket No. NHTSA-2010-0133).

The National Traffic and Motor Vehicle Safety Act (49 U.S.C. Chapter 301) (“Safety Act”) and NHTSA's regulations require vehicle manufacturers to certify that their vehicles comply with all applicable Federal motor vehicle safety standards (FMVSSs) (see49 U.S.C. 30112; 49 CFR Part 567). A vehicle manufacturer, distributor, dealer, or repair business generally may not knowingly make inoperative any part of a device or element of design installed in or on a motor vehicle in compliance with an applicable FMVSS (see49 U.S.C. 30122). NHTSA has the authority to issue regulations that exempt regulated entities from the “make inoperative” provision (49 U.S.C. 30122(c)). The agency has used that authority to promulgate 49 CFR Part 595 Subpart C, “Make Inoperative Exemptions, Vehicle Modifications to Accommodate People with Disabilities.”

49 CFR Part 595 Subpart C sets forth exemptions from the make inoperative provision to permit, under limited circumstances, vehicle modifications that take the vehicles out of compliance with certain FMVSSs when the vehicles are modified to be used by persons with disabilities after the first retail sale of the vehicle for purposes other than resale. The regulation was promulgated to facilitate the modification of motor vehicles so that persons with disabilities can drive or ride in them. The regulation involves information and disclosure requirements and limits the extent of modifications that may be made.

Under the regulation, a motor vehicle repair business that modifies a vehicle to enable a person with a disability to operate or ride as a passenger in the motor vehicle and that avails itself of the exemption provided by 49 CFR Part 595 Subpart C must register itself with NHTSA. The modifier is exempted from the make inoperative provision of the Safety Act, but only to the extent that the modifications affect the vehicle's compliance with the FMVSSs specified in 49 CFR 595.7(c) and only to the extent specified in 595.7(c). Modifications that would take the vehicle out of compliance with any other FMVSS, or with an FMVSS listed in 595.7(c) but in a manner not specified in that paragraph are not exempted by the regulation. The modifier must affix a permanent label to the vehicle identifying itself as the modifier and the vehicle as no longer complying with all FMVSS in effect at original manufacture, and must provide and retain a document listing the FMVSSs with which the vehicle no longer complies and indicating any reduction in the load carrying capacity of the vehicle of more than 100 kilograms (220 pounds).

Before today's final rule, 49 CFR Part 595 Subpart C set forth an exemption from “S5 of 49 CFR 571.214 [FMVSS No. 214] for the designated seating position modified, in any cases in which the restraint system and/or seat at that position must be changed to accommodate a person with a disability.” 49 CFR 595.7(c)(15). However, the reference to S5 of FMVSS No. 214 became outdated as a result of a 2007 amendment to Standard 214. Prior to 2007, S5 had referred to the dynamic performance requirements that vehicles must meet when subjected to amoving deformable barrier (MDB) test.1 In 2007, NHTSA upgraded FMVSS No. 214 and reorganized the standard.2 The MDB test was redesignated from S5 to S7 and was upgraded with the adoption of new technically-advanced test dummies representing a 5th percentile adult female and a 50th percentile adult male and enhanced injury criteria.

In addition, the 2007 rule added a new vehicle-to-pole test to the standard (seeS9, 49 CFR 571.214). The pole test simulates a vehicle crashing sideways into narrow fixed objects, such as utility poles and trees. The pole test requires vehicle manufacturers to assure head and improved chest protection in side crashes for a wide range of occupant sizes and over a broad range of seating positions. Manufacturers are meeting the upgraded requirements of the standard by vehicle modifications that include installing side air bags in vehicle seats and/or door panels and side roof rails. The phase-in of the upgraded MDB and pole test requirements began on September 1, 2010.

On February 12, 2009, Bruno Independent Living Aids (Bruno) submitted a petition for rulemaking to expand the specified requirements of FMVSS No. 214 referenced in § 595.7. Bruno manufactures a product line called “Turning Automotive Seating (TAS)” which replaces the seat installed by the original equipment manufacturer (OEM). Bruno believes that their product affords disabled persons a safer method of vehicle entry and exit when compared to using a platform lift or entering and exiting unassisted. However, in their petition, Bruno expressed concern that: “* * * torso side air bags are commonly installed in the outboard side of the OEM seat backrest” and would be removed when installing a TAS system. For these reasons, Bruno sought in their petition to update Part 595 to maintain a similar exemption from the MDB test (to reflect the new designation under S7), and to expand Part 595 to allow an exemption from the new S9 vehicle-to-pole test requirements.

On September 28, 2010, NHTSA published an NPRM in theFederal Register. In that document, we proposed to amend § 595.7(c)(15) to reference the upgraded MDB requirements and to expand the exemption to include the pole test requirements. In support of the NPRM, the agency expressed the belief that, due to the nature of the modifications, there exists a continuing need for exemption from the MDB requirements and that there is a need to exempt vehicles modified to accommodate disabled persons from the pole test requirements.

We recognized in the NPRM that the proposed exemption presents a trade-off of substantial side impact protection in exchange for continued mobility for people with disabilities and some enhancement in easier and possibly safer vehicle entry and exit.3 Thus, we requested comments on how the agency should proceed in order to achieve the maximum safety benefit with the narrowest exemption possible to accommodate the needs of disabled persons. However, the agency received no comments on the NPRM.

The agency remains concerned about the negative effect an exemption may have on the safety benefits afforded to disabled persons who require modifications to their vehicles. However, we are unaware at this time of any other reasonable alternatives that can appropriately balance the mobility needs of people who must have vehicle modifications to accommodate a disability with the MDB and pole test requirements of FMVSS No. 214. Thus, for the reasons provided in the NPRM, we amend § 595.7(c)(15) to add references to both S7 and S9 and to remove any reference to S5.

Since § 595.7(c)(15)'s reference to S5 is no longer valid, today's final rule updates that paragraph's reference from S5 to S7. We believe that there is a continuing need for the exemption from the MDB requirements. Since the upgraded FMVSS No. 214 incorporates enhanced MDB requirements, compliance with these requirements could continue to be affected by an alteration of the restraint system and/or the seat.

Many vehicles will depend on side impact air bag technology to meet all of the injury criteria of the standard when tested with the 5th percentile female and 50th percentile male dummies. Since many modifiers make alterations that include removing the side air bags in vehicles designed to the new requirements, the agency believes that these modifications could take the vehicles out of compliance with the MDB test.

The agency also believes that the compliance with the injury criteria for the MDB test could be affected even if vehicle seats with seat-mounted air bags are not removed but are instead changed in a less significant way to accommodate a person with a disability (e.g.,an OEM seat is mounted on a 6-way power seat base). This is because countermeasures that were designed to protect the occupant at the OEM seating position that may no longer be as protective at the position at which the seat is placed after the modification. Thus, NHTSA believes that there is a continuing need to exempt modifiers from the MDB test requirements for the purpose of accommodating persons with disabilities.

This final rule also expands § 595.7(c)(15) to include S9 of FMVSS No. 214. This change exempts modifications that affect the vehicle's compliance with the pole test requirements of FMVSS No. 214 in any case in which the restraint system and/or seat position must be changed to accommodate a person with a disability.

Removing an OEM seat that has a side air bag and replacing it with an aftermarket seat that does not would likely make inoperative the system installed in compliance with FMVSS No. 214. Making some other substantive modification of the OEM seat or restraint system to accommodate a person with a disability could also affect the measurement of the injury criteria specified in the standard. We believe that an exemption from the make inoperative provision with regard to the pole test in FMVSS No. 214 is needed to permit modification of the vehicle's seating system to accommodate a person with a disability. This is comparable to the position taken by NHTSA with regard to the make inoperative exemption for frontal air bags required by FMVSS No. 208. See 595.7(c)(14). Thus, we conclude today that the inclusion of S9 of FMVSS No. 214 in § 595.7(c)(15) is needed.

NHTSA has considered the impact of this rulemaking action under ExecutiveOrder 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed by the Office of Management and Budget under E.O. 12866, “Regulatory Planning and Review.” It is not considered to be significant under E.O. 12866 or the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979). NHTSA has determined that the effects are minor and that a regulatory evaluation is not needed to support the subject rulemaking. Today's final rule imposes no costs on the vehicle modification industry. If there is any effect, it will be a cost savings due to the exemptions.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601et seq.,as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of proposed rulemaking or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e.,small businesses, small organizations, and small governmental jurisdictions). No regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

NHTSA has considered the effects of this final rule under the Regulatory Flexibility Act. Many dealerships and repair businesses would be considered small entities, and some of these businesses modify vehicles to accommodate individuals with disabilities. I certify that this final rule does not have a significant economic impact on a substantial number of small entities. While many dealers and repair businesses are considered small entities, this exemption does not impose any new requirements, but instead provides additional flexibility. Therefore, the impacts on any small businesses affected by this rulemaking would not be substantial.

NHTSA has examined today's final rule pursuant to Executive Order 13132 (64 FR 43255; Aug. 10, 1999) and concluded that no additional consultation with States, local governments, or their representatives is mandated beyond the rulemaking process. The agency has concluded that the final rule does not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The final rule 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.” Today's final rule does not impose any additional requirements. Instead, it lessens burdens on the exempted entities.

NHTSA rules can have preemptive effect in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision:

The express preemption provision described above is subject to a savings clause under which “[c]ompliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law.” 49 U.S.C. 30103(e) Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision are generally preserved. However, the Supreme Court has recognized the possibility, in some instances, of implied preemption of State common law tort causes of action by virtue of NHTSA's rules—even if not expressly preempted.

This second way that NHTSA rules can preempt is dependent upon the existence of an actual conflict between an FMVSS and the higher standard that would effectively be imposed on motor vehicle manufacturers if someone obtained a State common law tort judgment against the manufacturer—notwithstanding the manufacturer's compliance with the NHTSA standard. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers will generally not be preempted. However, if and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. SeeGeierv.American Honda Motor Co.,529 U.S. 861 (2000).

Pursuant to Executive Order 13132, NHTSA has considered whether this rule could or should preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation.

To this end, the agency has examined the nature (e.g.,the language and structure of the regulatory text) and objectives of today's rule and finds that this rule merely increases flexibility for certain exempted entities. As such, NHTSA does not intend that this rule preempt state tort law that would effectively impose a higher standard on motor vehicle manufacturers than that established by today's rule. Establishment of a higher standard by means of State tort law would not conflict with the exemption announced here. Without any conflict, there could not be any implied preemption of a State common law tort cause of action. Further, we are unaware of any State law or action that would prohibit the actions that this final rule would permit.

When promulgating a regulation, agencies are required under Executive Order 12988 to make every reasonable effort to ensure that the regulation, as appropriate: (1) Specifies in clear language the preemptive effect; (2) specifies in clear language the effect on existing Federal law or regulation, including all provisions repealed, circumscribed, displaced, impaired, or modified; (3) provides a clear legal standard for affected conduct rather than a general standard, while promoting simplification and burden reduction; (4) specifies in clear language the retroactive effect; (5) specifies whether administrative proceedings are to be required before parties may file suit in court; (6) explicitly or implicitly defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship of regulations.

Pursuant to this Order, NHTSA notes as follows. The preemptive effect of today's final rule is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.

Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” 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, such as the Society of Automotive Engineers (SAE). The NTTAA directs us to provide Congress, through OMB, explanations when we decide not to use available and applicable voluntary consensus standards. No voluntary standards exist regarding this exemption for modification of vehicles to accommodate persons with disabilities.

The Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). This exemption will not result in expenditures by State, local or tribal governments, in the aggregate, or by the private sector in excess of $100 million annually.

NHTSA has analyzed today's final rule for the purposes of the National Environmental Policy Act. The agency has determined that implementation of today's final rule will not have any significant impact on the quality of the human environment.

Under the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. Today's final rule does not contain new reporting requirements or requests for information beyond what is already required by 49 CFR part 595 subpart C.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that isn't clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please notify the agency in writing.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In consideration of the foregoing, we amend 49 CFR part 595 as follows: