On January 9, 2006, the Attorney General directed the Deputy Attorney General and Associate Attorney General to conduct a comprehensive review of the Immigration Courts and the Board of Immigration Appeals (Board). This review was undertaken in response to concerns about the quality of decisions being issued by the immigration judges and the Board and reports of intemperate behavior on the part of some immigration judges.

On August 9, 2006, the Attorney General announced that the review was complete, and that he was directing that a series of measures be taken to improve adjudications by the immigration judges and the Board. One of these was a directive to the Director of the Executive Office of Immigration Review to increase the number of Board members from 11 to 15. This rule carries out that directive by revising the third sentence of 8 CFR 1003.1(a)(1) (leaving the remainder of paragraph (a)(1) unchanged).

The size of the Board was last set through rules promulgated in 2002 to improve case management. See 67 FR 54878-01 (Aug. 26, 2002); 8 CFR 1003.1(a), (d), (e) and (g). Those rules, among other provisions, expanded the use of affirmances without opinion and instituted single Board member review of additional cases. At that time the Department also determined that a reduction in the number of Board members was appropriate, and that the number of Board members should be set at 11. See 67 FR at 54893-94. The Department reached this conclusion based upon “the historic capacity of appellate courts and administrative appellate bodies to adjudicate the law in a cohesive manner, the ability of individuals to reach consensus on legal issues, and the requirements of the existing and projected caseload.” Id. at 54893. The Department specifically noted that reducing the size of the Board to 11 members “should increase the coherence of Board decisions and facilitate the en banc process, thereby improving the value of Board precedents.” Id . at 54894. The commentary concluded that the Attorney General would consider reevaluating the staffing requirements of the Board in the future in light of changing caseloads and legal requirements. Id . at 54893.

The streamlining changes brought much needed efficiency to the review process, enabling the Board to eliminate its backlog and provide the parties with a final decision in a more timely fashion. The Attorney General has concluded, however, that some adjustments to the Board's streamlining practices are now appropriate in order to improve the quality of the Board's review of complex or problematic cases. Accordingly, in his August 9, 2006, directive, the Attorney General has instructed the Board to encourage the increased use of one-member written opinions to address poor or intemperate immigration judge decisions, allow the limited use of three-member written opinions to provide greater legal analysis in a small class of particularly complex cases, and to publish more three-member panel decisions as precedent decisions. 1 The Attorney General recognizes that these changes will affect the workload of the Board members by resulting in more detailed one-member orders and more three-member orders. An increase in the number of Board members is therefore warranted to put the Board in the best position to implement these changes.

Moreover, the Board has seen its filings increase from 35,000 appeals and motions in FY 2002 to 42,700 in FY 2005. The Attorney General anticipates that more immigration judges will be needed to handle a further increase in caseloads at the Immigration Courts, which will in turn result in an increase in appeals. The current caseload is extremely burdensome and may become overwhelming in the future for a Board of 11 members.

At the same time, experience suggests that if the Board becomes too large, it will have considerably more difficulty fulfilling its responsibility of providing coherent direction with respect to the immigration laws. Keeping in mind the goal of maintaining cohesion and the ability to reach consensus, but recognizing the challenges the Board faces in light of its current and anticipated caseload, the Attorney General has determined that four members should be added to the Board at this time.

The rules at 8 CFR 1003.1(a)(4) allow the Director of EOIR to designate immigration judges, retired Board members, retired immigration judges, and administrative law judges employed within, or retired from, EOIR to act as temporary Board members. These provisions offer a mechanism through which the Department can provide the Board temporary assistance without changing the number of Board members. This is an appropriate means of responding to an unanticipated increase or temporary surge in the number, size, or type of cases, and other short-term circumstances that might impair the Board's ability to adjudicate cases in a manner that is both timely and fair. Temporary Board members appointed through this process do not participate in en banc Board proceedings, so these provisions also offer the Department a mechanism through which it can temporarily increase the Board's reviewing capacity without impairing its ability to review cases en banc as permanently expanding the Board beyond a certain number would be likely to do. The Board is presently being assisted by three immigration judges whom the Director has designated through this mechanism.

This rule enhances the utility of the temporary appointment authority by making an additional category of people eligible to serve as temporary Board members. It amends 8 CFR 1003.1(a)(4) to allow the Director, with the approval of the Deputy Attorney General, to designate senior EOIR attorneys with at least ten years of experience in the field of immigration law to serve for up to six months in this capacity. Because immigration judges generally are already required to handle an exceptionally large caseload, designation of immigration judges to sit on the Board as temporary Board members is not always practical. In addition to taking immigration judges away from their dockets, their designation can result in significant agency expenses, including travel and housing. By contrast, many senior EOIR attorneys with 10 years of experience are co-located with the Board, minimizing expense and disruption, and allowing them to assume their new duties immediately upon designation. This change will accordingly expand the pool of available candidates to provide a modicum of additional flexibility in making these appointments.

This change serves a similar function to a provision that at one time authorized the Chief Attorney Examiner to serve as a temporary Board member in exigent circumstances. Since the position of Chief Attorney Examiner no longer exists, that particular provision is no longer included in the current rules, but this rule similarly authorizes a senior and highly experienced EOIR attorney to serve as a temporary Board member. In order to allow greater flexibility, the rule does not specify particular titles or job descriptions. Instead, this rule simply authorizes the Director, with the approval of the Deputy Attorney General, to designate one or more senior EOIR attorneys with at least ten years of experience in the field of immigration law to serve as a temporary Board member.

This rule also amends the current rule to state explicitly that temporary Board members have the authority of a permanent Board member, with the exception that a temporary Board member may not vote in en banc proceedings.

Because this is a rule of internal agency organization, notice and comment are not required prior to its promulgation. The Department is nonetheless promulgating it as an interim rule with opportunity for post-promulgation comment in order to provide an opportunity for public comment before it issues a final rule on these matters.

Compliance with 5 U.S.C. 553 as to notice of proposed rulemaking or delayed effective date is unnecessary as this rule addresses only internal agency organization and management. Accordingly, it is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)), and the reporting requirement of 5 U.S.C. 801 does not apply.

The Regulatory Flexibility Act (RFA) mandates that an agency conduct an RFA analysis when an agency is “required by section 553 * * *, or any other law, to publish general notice of proposed rule making for any proposed rule.” 5 U.S.C. 603(a). RFA analysis is not required when a rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(b). This rule is exempt from notice and comment rulemaking. Therefore, no RFA analysis under 5 U.S.C. 603 is required for this rule.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Act of 1996, 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department does not consider this rule to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review.

This rule 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. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant preparation of a federalism summary impact statement.

This rule has been prepared in accordance with the standards in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rule does not create any information collection requirement.

You may examine the AD docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with an airworthiness directive (AD) to revise AD 2006-09-06, amendment 39-14576 (71 FR 25926, May 3, 2006). The existing AD applies to certain Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-300, 747-400, 747-400D, and 747SR series airplanes. The proposed AD was published in the Federal Register on July 13, 2006 (71 FR 39600) to require repetitive inspections to detect cracking of certain lower lobe fuselage frames, and repair if necessary, and to specify appropriate service information for certain corrective actions.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Boeing supports the proposed AD.

The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporated by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings. MARPA is concerned that the failure to incorporate essential service information could result in a court decision invalidating the AD.

MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the Federal Register needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under 14 CFR 21.303 (parts manufacturer approval (PMA)). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS.

We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register (OFR) requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the document necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information.

Additionally, we do not publish service documents in DMS. We are currently reviewing our practice of publishing proprietary service information. Once we have thoroughly examined all aspects of this issue, and have made a final determination, we will consider whether our current practice needs to be revised. However, we consider that to delay this AD action for that reason would be inappropriate, since we have determined that an unsafe condition exists and that the requirements in this AD must be accomplished to ensure continued safety. Therefore, we have not changed the AD in this regard.

We have revised the heading, “RESTATEMENT OF THE REQUIREMENTS OF AD 99-07-12, WITH ADDITIONAL INFORMATION FOR GROUP 2 AIRPLANES,” to state, “* * * WITH COMPLIANCE TIMES FOR GROUP 2 AIRPLANES.” This change provides more information about the new requirements of this AD.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 681 airplanes of the affected design in the worldwide fleet. This AD affects about 99 airplanes of U.S. registry. The new requirements of this AD add no additional economic burden. The current costs for this AD are repeated for the convenience of affected operators, as follows:

The actions in this AD take about 2 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of both the retained and new actions for U.S. operators is $15,840, or $160 per airplane, per inspection cycle.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 777 airplanes. That NPRM was published in the Federal Register on February 8, 2006 (71 FR 6402). That NPRM proposed to require repetitive inspections for corrosion or missing corrosion inhibiting compound (CIC) of the fuselage skin under the forward and aft wing-to-body fairings for certain airplanes, or the fuselage skin under the forward wing-to-body fairings only for other airplanes; and corrective action if necessary. That NPRM also proposed to provide an optional preventive modification of the wing-to-body fairing panels, which would terminate the repetitive inspections.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Continental Airlines (CAL) asks that the NPRM mandate Revision 1 of the referenced service bulletin when it becomes available, instead of the original issue. (Boeing Alert Service Bulletin 777-53A0044, dated July 28, 2005, was referenced in the NPRM as the appropriate source of service information for accomplishing the specified actions.) CAL states that it found some discrepancies in the instructions in Part 2 of the service bulletin during incorporation of the preventive modification specified in the original issue of the service bulletin. CAL adds that those discrepancies need clarification in order to meet the scope of the service bulletin and the objective of the NPRM. CAL notes that the instructions specified in Figures 11 and 15 of the original issue of the service bulletin are misleading and can cause incorrect assumptions and actions when implemented. CAL coordinated with Boeing to obtain clarification and enhancement of the instructions specified in Figures 11 and 15. CAL notes that the corrected instructions will be incorporated into Revision 1 of the service bulletin by Boeing.

We partially agree with CAL. Boeing has issued Service Bulletin 777-53A0044, Revision 1, dated June 22, 2006, which we have subsequently reviewed.

We agree to include Revision 1 of the referenced service bulletin in the AD as the appropriate source of service information for accomplishing the specified actions. Revision 1 is essentially the same as the original issue of the service bulletin; however, Revision 1 recommends that airplanes in Groups 1 and 4 that have been previously changed per the original issue of the service bulletin be inspected at the next scheduled under-fairing zonal or surveillance inspections. This is to ensure that the fastener fillet sealing at body stations 1035 and 1434 are in compliance with Figures 11, 15, and 20, as applicable, of Revision 1. The original issue of the service bulletin identified airplanes that were divided into Groups 1 and 2. Revision 1 of the service bulletin divides the airplanes into Groups 1 through 6; however, there is no increase in the number of airplanes.

We do not agree to remove reference to the original issue of the service bulletin and refer to only Revision 1, because operators who previously did the required actions in accordance with the original issue of the service bulletin would then be out of compliance as of the effective date of the new AD. We find that actions done before the effective date of this AD in accordance with the instructions in the original issue of the service bulletin will provide an acceptable level of safety until the newly required actions are done. We have changed paragraph (h) of this AD to add the following sentence: “After the effective date of this AD, only Revision 1 of the service bulletin may be used for accomplishing the preventive modification.” Although no more work is necessary on airplanes changed per the original issue of the service bulletin; it is recommended that airplanes in Groups 1 and 4 which have been previously changed per the original issue, be inspected at the next scheduled under-fairing zonal or surveillance inspections as specified above.

Boeing asks that the language for the optional terminating action specified in paragraph (h) of the NPRM be changed. Boeing reiterates that paragraph and states that it should be changed to read “Accomplishing the preventive modification in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-53A0044, dated July 28, 2005, terminates the repetitive inspections required by paragraph (f) of this AD.” Boeing states that, in the forward fairing area the preventive modification consists of modification to the forward body fairing panels, as well as addition of fastener head fillet sealing and revised CIC in specific areas above the wing body fairing panels. Boeing adds that, in the aft fairing area, the preventive modification consists of fastener head fillet sealing and revised CIC in specific areas above the wing body fairing panels. Boeing states that there is no change to the wing-to-body fairing panels in the aft fairing area, and the proposed wording could be interpreted as not providing a terminating action for the aft fairing area. Boeing notes that this is inconsistent with the referenced service bulletin, and changing the language would make the NPRM consistent with the service bulletin.

We agree with Boeing for the reasons provided. We have changed the subject language in the Summary section. We have also changed the language in paragraph (h) of this AD to read “Accomplishing the preventive modification of the fairing areas in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-53A0044, dated July 28, 2005; or Boeing Service Bulletin 777-53A0044, Revision 1, dated June 22, 2006; terminates the repetitive inspections required by paragraph (f) of this AD.”

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. These changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 385 airplanes of the affected design in the worldwide fleet. This AD affects about 140 airplanes of U.S. registry.

The inspection takes about 8 work hours per airplane for Groups 1, 3, 4, and 5 airplanes, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the inspection for U.S. operators is $520 per airplane, per inspection cycle.

The inspection takes about 4 work hours per airplane for Groups 2 and 6 airplanes, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the inspection for U.S. operators is $260 per airplane, per inspection cycle.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Discussion

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. This streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to allow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on August 18, 2006 (71 FR 47752). That NPRM proposed to require a periodic test to ensure the availability of the pitch trim system 2 and its possibility to deflect the trimmable horizontal stabilizer (THS) at high speed of trim. The MCAI states that the refined study of an in-service event has evidenced the need to perform a periodic test of pitch trim system 2. In the conditions of overriding the automatic pitch torque limiter, the clutch of the pitch trim servo-motor 1 is opened so that electric pitch trim system 1 will disconnect. The question is pending about the availability of the system 2 and its capability to take over the pitch trim function, particularly during a go-around. Failure of pitch trim system 2 to deflect the THS at maximum rate could result in loss of high-speed trim and consequent reduced controllability of the airplane.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received from one commenter.

The Modification and Replacement Parts Association (MARPA) states that airworthiness directives (ADs) are based on service information that originates from the type certificate holder or its suppliers. MARPA adds that manufacturer's service documents are privately authored instruments, generally having copyright protection against duplication and distribution. MARPA states that when a service document is incorporated by reference into a public document, such as an AD, pursuant to 5 U.S.C. 552(a) and 1 CFR part 51, it loses its private, protected status and becomes a public document. MARPA notes that if a service document is used as a mandatory element of compliance it should not simply be referenced, but should be incorporated by reference. MARPA believes that public laws, by definition, should be public, which means they cannot rely upon private writings for compliance. MARPA adds that the legal interpretation of a document is a question of law, not of fact; therefore, unless the service document is incorporated by reference it cannot be considered. MARPA is concerned that failure to incorporate essential service information could result in a court decision invalidating the AD.

MARPA also states that service documents incorporated by reference should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates those documents. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the Federal Register needlessly by publishing documents already in the hands of the affected individuals. MARPA adds that, traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that, a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing, and/or servicing alternatively certified parts under part 21 of the Federal Aviation Regulations (14 CFR part 21), section 21.303 (“parts manufacturer approval” (PMA)). MARPA notes that distribution to owners when the owner is a financing or leasing institution, may not actually reach the people responsible for accomplishing the AD. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument and published in DMS.

We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register (OFR) requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the document necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, as noted by the commenter, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information.

In regard to MARPA's request to post service bulletins on the Department of Transportation's DMS, we are currently in the process of reviewing issues surrounding the posting of service bulletins on the DMS as part of an AD docket. Once we have thoroughly examined all aspects of this issue and have made a final determination, we will consider whether our current practice needs to be revised. No change to the AD is necessary in response to these comments.

The Air Transport Association (ATA), on behalf of one of its members, American Airlines, asks that the applicability in the NPRM be changed. American Airlines states that it does not believe the NPRM is applicable to Model A300-B4-605R airplanes, but could not conclude that directly from the NPRM. The ATA states that, in the actions and compliance section of the NPRM, the FAA references the instructions of Airbus Service Bulletin A300-22-0121, dated July 11, 2005, which confirms it is valid for Model A300 airplanes, except for the forward facing crew cockpit (FFCC) versions and Model A300-600 series airplanes. The ATA adds that the applicability section in the NPRM should be changed to correctly call out only the airplanes that are covered by the service bulletin.

We find that clarification of the applicability section in the AD is necessary. The applicability section in this AD duplicates that of the referenced French airworthiness directive, which applies only to Model A300 airplanes, except for Model A300 B4-203 and A300 B2-203 in the FFCC configuration. Model A300-600 series airplanes are not subject to the requirements of that airworthiness directive. To ensure clear and enforceable language in the applicability of this AD, we have revised the applicability section to specify the affected models as listed on the type certificate data sheet.

Since issuance of the NPRM, we have determined that the estimated cost did not include the cost for the 3 work hours necessary to accomplish the repair and follow-on test; however, the number of work hours was specified. The cost impact information, below, has been revised to indicate the higher amount.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the change described previously. This change will neither increase the economic burden on any operator nor increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable in a U.S. court of law. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements, if any, take precedence over the actions copied from the MCAI.

We estimate that this AD will affect 29 products of U.S. registry. We also estimate that it will take about 1 work hour per product to do the periodic test and 3 work hours to do the repair and follow-on test, and that the average labor rate is $80 per work hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of the AD to the U.S. operators to be $9,280, or $320 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket.

You may examine the AD docket on the Internet at http://dms.dot.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5227) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 am and 5 pm, Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 90-03-08, amendment 39-6481 (55 FR 1799, January 19, 1990). The existing AD applies to all Airbus Model A300 series airplanes. That NPRM was published in the Federal Register on August 1, 2006 (71 FR 43386). That NPRM proposed to continue to require repetitive inspections for cracking and corrosion in the lower rim area of the rear pressure bulkhead and adjacent areas, repetitive inspections for cracking or corrosion in the service apertures and the upper rim area of the rear pressure bulkhead, and corrective actions if necessary. That NPRM also proposed to remove certain repetitive inspections and reduce the repetitive interval of one inspection. That NPRM also proposed to require an inspection for missing or damaged sealant in the area between the outer attachment angle and circumferential joint doubler, and corrective action if necessary. That NPRM also proposed to require additional inspections for corrosion of certain areas and repetitive inspections for airplanes on which repairs have been done.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been received on the NPRM.

Airbus requests that Service Bulletin A300-53-0218, Revision 03, dated August 3, 2006, be referenced in the NPRM. (Airbus Service Bulletin A300-53-0218, Revision 02, dated May 10, 2005, was referenced as the appropriate source of service information for doing the actions specified in the NPRM.) Airbus also states that the compliance time for doing the repetitive sealant inspection has been revised from 6,000 landings to 8,000 landings to match the compliance times specified in French airworthiness directive F-2005-093 R1, dated August 3, 2005 (which was referenced in the NPRM as the related French airworthiness directive).

We agree with the commenter to refer to Revision 03 of the service bulletin. Revision 03 of the service bulletin contains essentially the same procedures as Revision 02 of the service bulletin for doing the actions specified the NPRM. We have revised the final rule accordingly. We have also added paragraph (o) of the final rule to allow actions done before the effective date of this AD in accordance with Revision 02 of the service bulletin to be acceptable for compliance.

We also agree to revise the compliance time of the repetitive sealant inspection. The French airworthiness directive specifies that the repetitive interval is 8,000 landings for the upper part of rear pressure bulkhead surrounding area. The sealant inspection is done on the aft face of the rear pressure bulkhead. Therefore we have revised paragraph (i) of this final rule accordingly.

The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporated by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings.

MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the Federal Register needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under section 21.303 (“Replacement and modification parts”) of the Federal Aviation Regulations (14 CFR 21.303). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument and published in the DMS.

We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register (OFR) requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the documents necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information.

In regard to the commenter's request to post service bulletins on the Department of Transportation's DMS, we are currently in the process of reviewing issues surrounding the posting of service bulletins on the DMS as part of an AD docket. Once we have thoroughly examined all aspects of this issue and have made a final determination, we will consider whether our current practice needs to be revised. No change to the final rule is necessary in response to this comment.

We have added the phrase “as applicable” to paragraph (f)(2) of the final rule to clarify that the actions specified in paragraph (f)(2)(i) and (f)(2)(ii) of the final rule are required to be done only for the applicable airplanes identified in paragraphs (f)(2)(i) and (f)(2)(ii) of the final rule. We have also added the word “inclusive” to the range of manufacturer serial numbers specified in paragraphs (f)(2)(i) and (f)(2)(ii) of the final rule in order to clarify the range of the applicable airplanes.

We made a typographical error in paragraph (h)(5) of the NPRM when we referred to paragraphs (g)(5)(i) and (g)(5)(ii). The correct paragraph reference is (h)(5)(i) and (h)(5)(ii). We have revised paragraph (h)(5) of the final rule accordingly.

We have carefully reviewed the available data, including the comments that have been received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Gulfstream Model G-159 airplanes was published as a second supplemental notice of proposed rulemaking (NPRM) in the Federal Register on July 12, 2006 (71 FR 39242). That action proposed to require repetitive non-destructive testing inspections to detect corrosion of the skin of certain structural assemblies, and corrective action if necessary. That action also proposed to require x-ray and ultrasonic inspections to detect corrosion and cracking of the splicing of certain structural assemblies, and repair if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter, the Modification and Replacement Parts Association (MARPA), requests that service documents deemed essential to the accomplishment of the proposed action be incorporated by reference into the regulatory instrument. The commenter states that once a service document is incorporated by reference into a public document such as an airworthiness directive (AD), it loses its private, protected status and becomes itself a public document. The commenter also states that there is concern that failure to incorporate essential service information could result in a court decision invalidating the AD.

We do not agree that documents should be incorporated by reference during the NPRM phase of rulemaking. The Office of the Federal Register requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the document necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information. No change is necessary to the AD in this regard.

The same commenter, MARPA, also requests that service information necessary to accomplish actions specified in ADs be published in the Docket Management System (DMS).

We are currently in the process of reviewing issues surrounding the posting of service bulletins on the Department of Transportation's DMS as part of an AD docket. Once we have thoroughly examined all aspects of this issue and have made a final determination, we will consider whether our current practice needs to be revised. No change is necessary to the AD in this regard.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed in the second supplemental NPRM.

There are approximately 52 airplanes of the affected design in the worldwide fleet. The FAA estimates that 25 airplanes of U.S. registry will be affected by this AD, that it will take approximately between 300 and 450 work hours per airplane, depending upon how many spot-welded skins have been replaced with bonded skin panels, to accomplish the required actions, and that the average labor rate is $80 per work hour. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be between $600,000 and $900,000, or between $24,000 and $36,000 per airplane, per inspection cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

FDA, in consultation with EPA, determines whether a medical product is essential for purposes of Title VI of the Clean Air Act (42 U.S.C. 7671 et seq. ). If a medical product, including a drug, is determined to be essential and meets the other elements of the definition found in section 601 of the Clean Air Act, the product will be considered a “medical device.” “Medical devices” are exempt from the general prohibition on nonessential uses of chlorofluorocarbons (CFCs) (a class of ODSs) found in section 610 of the Clean Air Act. ODSs produced for use in “medical devices” may also be exempt, if other conditions are met, from the general prohibitions on production and consumption of ODSs found in sections 604 and 605 of the Clean Air Act.

In 1978, we published a rule listing several essential uses of CFCs and providing criteria for adding new essential uses (43 FR 11301 at 11316, March 17, 1978). The rule was codified as § 2.125 (21 CFR 2.125) and § 2.125 was amended at various times to add new essential uses.

Over the years, alternatives were developed to ODS products whose uses were listed in § 2.125 as being essential, while other listed ODS products were removed from the market. In light of these facts, and in furtherance of our obligations under the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer (September 16, 1987, 26 I.L.M. 1541 (1987)), we determined that it would be appropriate to revise § 2.125 to remove the essential use designations of some products and provide criteria for the removal of additional essential use designations in the future. Thus, the rule revising § 2.125 was published in the Federal Register of July 24, 2002 (67 FR 48370). Among other provisions, the rule removed the essential use designations of various specific products that, at the time the rule was being prepared, were no longer being marketed. The rule went into effect on January 20, 2003. That rule also revised § 2.125(g)(1) (21 CFR 2.125(g)(1)) to provide that if any product that releases an ODS is no longer being marketed, the product may have its essential use designation revoked through notice-and-comment rulemaking.

In a citizen petition dated November 15, 2005, GlaxoSmithKline (GSK) requested that MDIs containing the single active moieties beclomethasone, fluticasone, and salmeterol be removed from the essential use list of ODSs. GSK stated that because beclomethasone, fluticasone, and salmeterol are no longer being marketed in MDIs that release ODSs, all three active moieties meet the criterion under revised § 2.125(g) for being removed from the essential use list. GSK requested that the essential use designation for beclomethasone, fluticasone, and salmeterol be revoked through a direct final rule.

In addition, we have determined that dexamethasone, bitolterol, ergotamine tartrate, and ipratropium bromide are no longer being marketed in MDIs that release ODSs, which provides grounds for removing their essential use designation.

We have determined that the subject of this rulemaking is suitable for a direct final rule. The actions taken should be noncontroversial, and the agency does not anticipate receiving any significant adverse comments on this rule. However, in the even that significant adverse comment is received, we are also publishing a companion proposed rule to satisfy the requirement under § 2.125(g) that essential uses be removed through notice-and-comment rulemaking.

If we receive no significant adverse comment, we will publish a document in the Federal Register , confirming the effective date of the direct final rule. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment recommending a rule change in addition to this rule will not be considered a significant adverse comment, unless the comment states why this rule would be ineffective without the additional change. If timely significant adverse comments are received, we will publish a notice of significant adverse comment in the Federal Register withdrawing this direct final rule within 30 days after the comment period ends.

Elsewhere in this issue of the Federal Register , we are publishing a companion proposed rule, identical in substance to this direct final rule, that provides a procedural framework from which to proceed with standard notice and comment rulemaking in the event the direct final rule is withdrawn because of significant adverse comment. The comment period for the direct final rule runs concurrently with that of the companion proposed rule. Any comments received under the companion proposed rule will be treated as comments regarding the direct final rule. Likewise, significant adverse comments submitted to the direct final rule will be considered as comments to the companion proposed rule, and we will consider those comments in developing a final rule. We will not provide additional opportunity for comment on the companion proposed rule.

If a significant adverse comment applies to part of this rule and that part may be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment. A full description of our policy on direct final rule procedures may be found in a guidance document published in the Federal Register of November 21, 1997 (62 FR 62466).

The manufacturers of all approved beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide oral pressurized MDIs containing an ODS have provided information that leads us to conclude that they have removed these products from the market. 1 Accordingly, we are amending our regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide from the list of essential use drugs found in § 2.125(e) (21 CFR 2.125(e)). Essential uses for metered-dose corticosteroid human drugs for oral inhalation, metered-dose short-acting adrenergic bronchodilator human drugs for oral inhalation, and metered-dose salmeterol, ergotamine tartrate, and ipratropium bromide drug products for oral inhalation, are listed in § 2.125(e)(1), (e)(2), and (e)(4) by active moiety. “Active moiety” is defined in 21 CFR 314.108(a) as follows: “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.”

MDIs that contain the active moieties beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, use certain forms of these moieties. Specifically, MDIs that have beclomethasone or fluticasone as their active moieties use those moieties in the forms of beclomethasone dipropionate and fluticasone propionate, respectively. Similarly, MDIs that have dexamethasone, bitolterol, or salmeterol as their active moieties use those moieties in the forms of dexamethasone sodium phosphate, bitolterol mesylate, and salmeterol xinafoate, respectively. Ergotamine tartrate is a salt of ergotamine, and it was used in oral MDIs for the treatment of migraines. Its essential use designation is for the ergotamine tartrate salt rather than the active moiety ergotamine.

Oral pressurized MDIs that contain beclomethasone are listed in § 2.125(e)(1)(i) as an essential use. BECLOVENT and VANCERIL are the only two oral pressurized MDIs that have been marketed and contain beclomethasone with an ODS. On January 10, 2002, GSK, the manufacturer of BECLOVENT, requested that we withdraw approval of their new drug application (NDA) for BECLOVENT ODS MDIs (NDA 18-153) and informed us that they had stopped marketing BECLOVENT ODS MDIs. On May 2, 2001, Schering-Plough Corp. (Schering), the manufacturer of VANCERIL, requested that we withdraw approval of NDA, for VANCERIL ODS MDIs, 84 micrograms per inhalation (μg/inh), and informed us that they had stopped marketing VANCERIL 84 μg/inh MDIs in November 1999. Also, on July 25, 2002, Schering informed us that they were removing VANCERIL 42 μg/inh from the market. On April 14, 2005, Schering requested withdrawal of approval of NDA 17-573 for VANCERIL 42 μg/inh.

Oral pressurized MDIs that contain dexamethasone are listed in § 2.125(e)(1)(ii) as an essential use. DEXACORT ORAL MDI is the only oral pressurized MDI that has been marketed and contains dexamethasone with an ODS. On September 13, 2002, Celltech Pharmaceuticals, Inc., the manufacturer of DEXACORT ORAL MDI, requested that we withdraw approval of NDA 01-3413 for DEXACORT ORAL MDIs and informed us that they had stopped marketing DEXACORT ORAL MDIs on August 15, 1996.

Oral pressurized MDIs that contain fluticasone are listed in § 2.125(e)(1)(iv) as an essential use. FLOVENT CFC MDI is the only oral pressurized MDI that has been marketed and contains fluticasone with an ODS. GSK, the manufacturer of FLOVENT CFC MDIs, has informed us that they stopped marketing FLOVENT CFC MDIs in November 2004.

Oral pressurized MDIs that contain bitolterol are listed in § 2.125(e)(2)(ii) as an essential use. TORNALATE MDI is the only oral pressurized MDI that has been marketed and contains bitolterol with an ODS. On January 28, 2003, Sanofi-Synthelabo, Inc., the manufacturer of TORNALATE MDIs, informed us that they had stopped marketing TORNALATE MDIs on October 1, 2000.

Metered-dose salmeterol drug products are listed in § 2.125(e)(4)(i) as an essential use. SEREVENT MDI is the only metered-dose salmeterol drug product with an ODS that has been marketed. GSK, the manufacturer of SEREVENT MDIs, has informed us that they stopped marketing SEREVENT MDIs in January 2003.

Oral pressurized MDIs that contain ergotamine tartrate are listed in § 2.125(e)(4)(ii) as an essential use. MEDIHALER ERGOTAMINE is the only oral pressurized MDI that has been marketed and contains ergotamine tartrate with an ODS. 3M Pharmaceuticals, the manufacturer of MEDIHALER ERGOTAMINE, has informed us that they stopped marketing MEDIHALER ERGOTAMINE in November 1991.

Oral pressurized MDIs that contain ipratropium bromide are listed in § 2.125(e)(4)(v) as an essential use. ATROVENT CFC MDI is the only oral pressurized MDI that has been marketed and contains ipratropium bromide with an ODS. Boehringer Ingelheim Pharmaceuticals, the manufacturer of ATROVENT CFC MDI, has informed us that they stopped marketing ATROVENT CFC MDIs in January 2006. This direct final rule does not affect MDIs containing ipratropium bromide and albuterol sulfate in combination, marketed as COMBIVENT, which are listed in § 2.125(e)(4)(viii) as a separate essential use.

Based on information given to us by the manufacturers, we have concluded that any beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, and ergotamine tartrate ODS MDIs that may be in retail or wholesale stocks will have passed their expiration dates by the effective date for removal of § 2.125(e)(1)(i), (e)(1)(ii), (e)(1)(iv), (e)(2)(ii), (e)(4)(i), and (e)(4)(ii). Boehringer Ingelheim Pharmaceuticals, the manufacturer of ipratropium bromide, has informed us that any ipratropium bromide that may be in retail or wholesale stocks will have passed its expiration date by July 2007. Accordingly, we have set the effective date for removal of § 2.125(e)(4)(v) as August 1, 2007.

We have carefully considered, under 21 CFR part 25, the potential environmental effects of this action. We have concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. Our finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday.

FDA has examined the impacts of the direct 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 (Public Law 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 direct final rule is not a significant regulatory action as defined by 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 we are removing the essential use designations for certain drug products that are either no longer being marketed or are no longer being marketed in a formulation containing ODSs, the agency certifies that the direct 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 $118 million, using the most current (2004) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this direct final rule to result in any 1-year expenditure that would meet or exceed this amount.

This direct final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

FDA has analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, we do not plan to prepare a federalism summary impact statement for this rulemaking procedure. We invite comments on the federalism implications of this direct final rule.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two copies of any written comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of March 29, 2005 (70 FR 15755), FDA issued an IFR to amend the color additive regulations by increasing the fees for certification services in 21 CFR 80.10. The change in fees was necessary so that FDA could continue to provide, maintain, and equip an adequate color certification program as required by section 721(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379(e)). The fees are intended to recover the full costs of operation of FDA's color certification program. The IFR went into effect on April 28, 2005. FDA requested written or electronic comments by May 31, 2005.

FDA subsequently discovered: (1) That the referenced 2003 color certification fee study had inadvertently been omitted from the docket and (2) that there was a typographical error regarding the fees for repacks of certified color additives and color additive mixtures in the codified portion of the IFR.

The agency has made available the color certification fee study that describes the cost estimates reflected in the March 29, 2005, IFR. FDA stated in the IFR that the document entitled “2003 Color Certification Fee Study” is on file at the Division of Dockets Management. FDA subsequently discovered that we had inadvertently omitted the document from the docket at the time of publication. The agency made the document available at the Division of Dockets Management (see ADDRESSES ) on May 16, 2005.

The agency is also amending the March 29, 2005, IFR (70 FR 15755 at 15756) regarding fees for repacks of certified color additives and color additive mixtures. Before issuance of the IFR, § 80.10(b) provided, in relevant part, “ Fees for repacks of certified color additives and color additive mixtures . The fees for the services provided under the regulations in this part in the case of each request for certification * * * shall be: * * * (2) Over 100 pounds but not over 1,000 pounds—$ 30 plus six cents for each pound over 100 pounds” (emphasis added). In revising that portion of the codified, we intended to increase the fees for repacks of certified color additives and color additive mixtures for the first 100 pounds, i.e., from $30 to $35, but maintain the fee of 6 cents for each pound over 100 pounds. However, we inadvertently specified “$0.05” rather than specifying “$0.06.” This provision should read, in relevant part, “(2) Over 100 pounds but not over 1,000 pounds—$35 plus $ 0.06 for each pound over 100 pounds.” FDA is correcting this typographical error in the codified language by way of this technical amendment.

FDA has examined the impacts of the March 29, 2005, IFR under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandate Reforms Flexibility Act (Public Law 104-4) (70 FR 15755 at 15756). Based on this analysis of the impact of the IFR, the technical amendment to the IFR described in section III would generate a cost of $0 to $2,000 per year. Therefore, this technical amendment is not a significant regulatory action as defined by the Executive Order.

The technical amendment does not necessitate a change in our certification, under the Regulatory Flexibility Act. The IFR, as amended, will not have a significant economic impact on a substantial number of small entities. In addition, the IFR, as amended, does not change our expectation that this rule will not result in any 1-year expenditure that would meet or exceed the threshold amount triggering a written statement under the Unfunded Mandates Reform Act.

The agency has determined under 21 CFR 25.22(a) that, as amended in this document, the March 29, 2005, IFR is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Under 5 U.S.C. 553(b)(B) and 21 CFR 10.40(e), FDA found in the March 29, 2005, IFR that providing for notice and public comment before the establishment of these fees, and for revising the basis on which these fees are calculated, is contrary to the public interest (70 FR 15755 at 15756). FDA continues to find it necessary to implement the amended fee increase as soon as possible to preserve adequate funds for the program. The agency believes, however, that it is appropriate to invite and consider additional public comments on these requirements. Any comments already received by FDA on the March 29, 2005, IFR do not need to be resubmitted to the agency. The agency is considering them at this time and will address them at a later date.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The final regulations that are the subject of this correction are under section 41 of the Internal Revenue Code.

As published, final regulations (TD 9296) contain errors that may prove to be misleading and are in need of clarification.

The final regulations that are the subject of this correction are under sections 367(b) and 381 of the Internal Revenue Code.

As published, final regulations (TD 9273) contain errors that may prove to be misleading and are in need of clarification.

The final and temporary regulations that are the subject of this correction are under section 199 of the Internal Revenue Code.

As published, final and temporary regulations (TD 9293) contain errors that may prove to be misleading and are in need of clarification.

The correction notice that is the subject of this document is under section 704 of the Internal Revenue Code.

As published, final regulations (TD 9292) contain errors that may prove to be misleading and are in need of clarification.

Regulatory History

On June 7, 2006, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations, Arkansas Waterway, AR in the Federal Register (71 FR 32883). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

The Arkansas Waterway is a part of the McClellan-Kerr Arkansas River Navigation System. The System rises in the vicinity of Catoosa, Oklahoma, and embraces improved natural waterways and a canal to empty into the Mississippi River in southeast Arkansas. The Arkansas Waterway drawbridge operation regulations contained in § 117.123(a), state that the Cotton Belt Railroad (Rob Roy) Bridge, mile 67.4, requires the use of ship's horns and flashing lights on the bridge to communicate between mariners requesting openings and railroad dispatchers remotely operating the bridge. Although not stated in § 117.123(a), records indicate that the method of communication outlined in § 117.123(a) was to be used by mariners and the remote bridge operator as a back-up means of communications. The Coast Guard, however, has determined that the primary method of communications outlined in § 117.123(a) has not been used during the past 20 years. It is doubtful that the system of horns and flashing lights was ever used. Instead, mariners and remote bridge operators have communicated via VHF-FM radiotelephone for opening the Rob Roy Drawbridge. The Coast Guard also determined that editorial changes were needed to correct inaccuracies in the specific requirements for the Baring Cross Railroad Drawbridge and the Van Buren Railroad Drawbridge. Three bridges on the Arkansas Waterway—the Missouri Pacific Railroad Drawbridge (Benzal Railroad Drawbridge) at mile 7.6, the Rock Island Railroad Drawbridge at Mile 118.2, and the Junction Railroad Drawbridge at Mile 118.7—have all been removed from rail service. Meetings with the owners indicate that all three bridges have been permanently locked in the open-to-navigation position and that there are plans to convert them into fixed pedestrian bridges in the future. Therefore, they are considered fixed bridges and will be removed from drawbridge regulations section of the CFR. Section (a) of § 117.139 references the § 117.123 cite for the Missouri Pacific Railroad Drawbridge (Benzal Railroad Drawbridge), mile 7.6, so section (a) also requires removal from the regulations. Therefore, paragraphs (b) and (c) of § 117.139 will be redesignated as (a) and (b).

There were no comments on nor changes made from the proposed rule.

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. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security.

The Coast Guard expects that these changes will have a minimal economic impact on commercial traffic operating on the Arkansas Waterway. The procedures are already in place at the three active drawbridges, the other three drawbridges have been locked in the open-to-navigation position, and the changes to the CFR documents the procedures.

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 is neutral to all business entities since it affects only how the vessel operators request bridge openings.

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

This rule would call 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 would 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 would 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 would 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 Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore this rule is categorically excluded under figure 2-1, paragraph 32(e) of the Instruction from further environmental documentation. Paragraph 32(e) excludes the promulgation of operating regulations or procedures for drawbridges from the environmental documentation requirements of the National Environmental Policy Act (NEPA). Since this regulation would alter the normal operating conditions of the drawbridge, it falls within this exclusion. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

I. Today's Action Revisions Submitted on April 13, 2005

On April 13, 2005, SC DHEC submitted proposed SIP revisions to EPA for review and approval into the South Carolina SIP. The proposed revisions include changes made by the State of South Carolina to Regulation 61-62.1, regarding CERR reporting requirements. The rules became state effective on February 25, 2005. The purpose of the CERR is to simplify emissions reporting, establish new reporting requirements for PM2.5 and establish statewide reporting of area source and mobile source emissions. Currently, the CERR requires that all facilities needing to obtain a Title V permit must submit an emissions inventory every two years. Approximately 50 of the 354 current Title V sources (Type A sources) will be required to increase their emissions inventory reporting to an annual basis. However, the majority of the Title V sources (Type B sources) with fewer emissions, approximately 80 of 354 current sources, will only need to submit their emissions inventory every three years. Thus, the reporting requirements for these sources will decrease from every other year to every third year. The remaining Title V sources, except those that emit significant hazardous air pollutants (HAPs) will gain an even greater decrease in the reporting requirements. If those sources have submitted an initial inventory, no further reporting will be required. Those sources that emit significant HAPs will also have a decrease in reporting requirements, from every other year to every three years. SC DHEC is revising these revisions to be consistent with the new Federal emissions reporting requirements, and to revise existing State specific requirements to streamline the reporting process. EPA is now taking direct final action to approve the proposed revisions, which include revising the CERR emissions reporting regulations. The proposed revisions summarized above are approvable pursuant to section 110 of the CAA.

Tropospheric ozone, a major component of smog, is formed when VOCs and nitrogen oxides react in the atmosphere. Because of the harmful health effects of ozone, EPA limits the amount of VOCs and that can be released into the atmosphere. VOCs are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides, or carbonates, and ammonium carbonate) which form ozone through atmospheric photochemical reactions. Compounds of carbon (or organic compounds) have different levels of reactivity; they do not react at the same speed, or do not form ozone to the same extent. It has been EPA's policy that compounds of carbon with a negligible level of reactivity need not be regulated to reduce ozone (see 42 FR 35314, July 8, 1977). EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations (at 40 CFR 51.100(s)) and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive.” EPA may periodically revise the list of negligibly reactive compounds to add compounds to or delete them from the list. EPA promulgated such changes on November 29, 2004 (69 FR 69298).

On October 24, 2005, SC DHEC submitted proposed SIP revisions to EPA for review and approval into the South Carolina SIP. The proposed revisions include changes made by the State of South Carolina to Regulation 61-62.1, regarding the definition of VOC, to reflect EPA's November 29, 2004, changes. The rules became state effective on August 26, 2005. Specifically, South Carolina is removing the following compounds from the definition of VOC:

South Carolina is adding the following compounds to the definition of VOC:

(i) Cyclic, branched, or linear, completely fluorinated alkanes;

(ii) Cyclic, branched, or linear, completely fluorinated alkanes;

(iii) Cyclic, branched, or linear, completely fluorinated ethers with no unsaturations;

(iv) Sulfur containing perfluorocarbons with no unsaturations and with sulfur bonds only to carbon and fluorine.

EPA is approving revisions to South Carolina's Regulation 61-62.1 “Definitions and General Requirements.” These revisions include changes to the CERR reporting requirements, and the definition of VOCs. These changes are consistent with the CAA.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective February 5, 2007 without further notice unless the Agency receives adverse comments by January 8, 2007.

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on February 5, 2007 and no further action will be taken on the proposed rule.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, U.S.C. section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 5, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

I. Background

On June 15, 2006, Delaware submitted a formal revision to its State Implementation Plan (SIP). The SIP revision consists of “Regulation 1102—Permits” adopted by the State of Delaware on May 15, 2006 and effective June 11, 2006. The State amended the regulation in order to (1) ensure that the regulatory language is clear that all Regulation 1102 permits are federally enforceable, regardless of whether they are intended to limit potential to emit; and, (2) the renumbering of the regulation to be consistent with the style manual of the Code of Delaware Regulations.

Delaware is seeking approval of these amendments to this rule pursuant to 40 CFR Part 51 Subpart I and Section 110(a)(2)(C) of the federal Clean Air Act (CAA) as amended November 15, 1990.

EPA is proposing to approve this revision to incorporate into the Delaware SIP amendments to Regulation 1102 (formerly Regulation 2)—“Permits” as submitted by Delaware Natural Resources and Environmental Control (DNREC) on June 15, 2006. This approval action will effectively replace the previously-approved version of “Regulation 2—Permits,” renumbered with this revision to be “Regulation 1102—Permits,” as approved into Delaware's SIP on January 11, 2006 (65 FR 2048).

On June 15, 2006, DNEC submitted regulatory revision to EPA for approval. The submittal consists of Delaware Rule entitled “Regulation 1102—Permits” adopted on May 15, 2006 and effective June 11, 2006.

EPA is approving Delaware's revisions to Regulation 1102—Permits. These revisions clarify Delaware's intention that all permits issued pursuant to Regulation 1102 be federally enforceable regardless of whether they are intended to limit potential to emit.

EPA is approving Delaware's revision to Regulation 1102—Permits as a revision to Delaware's SIP.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment because these revisions are to clarify that all Regulation 1102 permits are federally enforceable. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on February 5, 2007 without further notice unless EPA receives adverse comment by January 8, 2007. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 5, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to approve Delaware's Regulation 1102—Permits may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by the other Federal, State, or regional entities. The changes BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This interim rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This interim rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This interim rule involves no policies that have federalism implications under Executive Order 13132, Federalism.

Executive Order 12988, Civil Justice Reform. This interim rule meets the applicable standards of Executive Order 12988.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

OMB Control No.: 3060-1094.

OMB Approval Date: 10/31/2006.

OMB Expiration Date: 10/31/2009.

Title: Licensing, Operation, and Transition of the 2500-2690 MHz Band.

Form No.: N/A.

Estimated Annual Burden: 2,500 respondents; 8,355 annual burden hours; 0.25-5 hours per respondent.

Needs and Uses: In the Commission's Third Memorandum Opinion and Order and Second Report and Order (FCC 06-46), New Broadband Radio Service (BRS) and Educational Broadband Service (EBS) band plan transitions take place in Basic Trading Areas (BTAs), which will provide both incumbent licensees and potential new entrants in the 2495-2690 MHz band with greatly enhanced flexibility to encourage the efficient and effective use of spectrum domestically and internationally and the growth and rapid development of innovative and efficient communications technologies and services. The information collection requirements are contained in the following rule sections: (1) The pre-transition data request (47 CFR 27.1231(d)); (2) the transition notice (47 CFR 27.1231(e)); (3) the Initiation Plan (47 CFR 27.1231(f)); and (4) the post-transition notification (47 CFR 27.1235). The Pre-transition data request will be collected by a third-party proponent (proponent) to assist in the transitioning the 2500-2690 MHz band. The proponent may use a variety of methods, including a computerized database. The proponent will send the transition notice to all BRS and EBS licensees in the BTA that the proponent is transitioning. The FCC will collect the Initiation Plan and the Post-transition Notification from the proponent to enable the FCC to assess when transitions have begun and when they have ended. The FCC will use our electronic comment and filing system (ECFS) database to collect this information from the proponents.

Regulations governing the Atlantic bluefish fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Florida through Maine. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.160.

Two or more states, under mutual agreement and with the concurrence of the Administrator, Northeast Region, NMFS (Regional Administrator), can transfer or combine bluefish commercial quota under § 648.160(f). The Regional Administrator is required to consider the criteria set forth in § 648.160(f)(1) in the evaluation of requests for quota transfers or combinations.

Virginia has agreed to transfer 300,000 lb (136,078 kg) of its 2006 commercial quota to North Carolina. Maine has agreed to transfer 52,000 lb (23,587 kg) of its 2006 commercial quota to North Carolina. The Regional Administrator has determined that the criteria set forth in § 648.160(f)(1) have been met for each of these transfers. The revised quotas for calendar year 2006 are: North Carolina, 3,204,869 lb (1,453,704 kg); Virginia, 420,915 lb (190,924 kg); and Maine, 1,230 lb (558 kg).

This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.