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 November 18, 2010 (75 FR 70623), and proposed to supersede AD 2007-11-03, Amendment 39-15060 (72 FR 28591; May 22, 2007). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 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 FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect 17 products of U.S. registry. We also estimate that it will take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $8,670 or $510 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 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://www.regulations.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) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2009-09-09, Amendment 39-15895 (74 FR 19873, April 30, 2009). That AD applies to the specified products. The SNPRM published in the Federal Register on October 27, 2010 (75 FR 66009). That SNPRM proposed to retain the inspection requirements of AD 2009-09-09, add airplanes to the Applicability section, and add a terminating action for the repetitive inspection requirements using revised service information.

We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM.

We estimate that this proposed AD affects 790 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs that will be required based on the results of the inspection of the rudder hinge and the rudder brackets attachment hardware for correct thread engagement and the rudder travel. We have no way of determining the number of aircraft that might need these repairs:

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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM published in the Federal Register on August 11, 2010 (75 FR 48620). That NPRM proposed to require installing two warning level indicator lights on the P2-2 center instrument panel in the flight compartment for certain airplanes. For a certain other airplane, that NPRM proposed to require activating the cabin altitude warning and takeoff configuration warning lights. For all airplanes, that NPRM proposed to also require revising the airplane flight manual (AFM) to remove certain requirements included by previous AD actions, to require new pressure altitude limitations for certain airplanes, and to advise the flightcrew of the following changes: revised emergency procedures to use when a cabin altitude warning or rapid depressurization occurs, and revised cabin pressurization procedures for normal operations.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and the FAA's response to each comment.

The Air Line Pilots Association, International supports the proposed AD.

Lufthansa requested that the FAA consider the release of Boeing Service Bulletin 737-21-1164 before releasing the AD. Lufthansa stated that Boeing has recommended that operators consider doing the modifications specified in Boeing Service Bulletin 737-21-1164 and Boeing Alert Service Bulletin 737-31A1325, dated January 11, 2010, at the same time, because both modifications require access to the same area of the airplane and extensive airplane downtime. However, Lufthansa pointed out that Boeing Service Bulletin 737-21-1164 has not yet been published; therefore, releasing the AD before Boeing Service Bulletin 737-21-1164 is released would require operators to accomplish the modifications separately, doubling the time and cost of the modifications.

We do not agree to delay this AD pending release of an unrelated service bulletin. Accomplishment of Boeing Service Bulletin 737-21-1164 installs a second 10,000-foot cabin altitude pressure switch, which is not related to the unsafe condition identified by this AD. To delay this action until the manufacturer can release a planned service bulletin would be inappropriate, since we have determined that an unsafe condition exists and that the required actions must be accomplished to ensure continued safety. Once the planned service bulletin is developed, approved, and available, we might consider additional rulemaking. However, under the provisions of paragraph (l) of the final rule, we will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. We have not changed this AD in this regard.

Continental Airlines (Continental) stated that the estimated costs of compliance for doing the modification are significantly low for the following reasons:

• Boeing Alert Service Bulletin 737-31A1325, dated January 11, 2010, specifies an estimate of 32.5 work-hours to do the modification. Continental declared that it has historically found that Boeing estimates given in service bulletins are unachievable. Continental believed it would be possible to accomplish the modification in approximately 50 work hours, if the modification is done during a heavy maintenance visit.

• If the proposed compliance time remains 36 months, Continental asserted that some airplanes will have to be modified on “special holds” and the added cost would be significant because there is much more access, close-up, and testing necessary. Continental estimates that airplanes modified while on “special holds” will require 120 work hours, and that cost of lost revenue while the airplane is out of service for 5 days would be $220,000 per airplane.

• Continental stated that the FAA did not account for material costs, and pointed out that Boeing Service Bulletin 737-31A1325, dated January 11, 2010, lists a kit that costs $2,738 and is required for each airplane.

From these statements, we infer that Continental is requesting that we revise the proposed estimated costs for accomplishing the modification specified in paragraph (g) of the proposed AD. We do not agree. In establishing the requirements of all ADs, we do consider cost impact to operators beyond the estimates of parts and labor costs contained in AD preambles. For example, where safety considerations allow, we attempt to set compliance times that generally coincide with operators' maintenance schedules. However, because operators' schedules vary substantially, we cannot accommodate every operator's optimal scheduling in each AD. Each AD does allow individual operators to obtain approval for extensions of compliance times, based on a showing that the extension will not affect safety adversely. Therefore, we do not consider it appropriate to attribute to the AD the costs associated with the type of special scheduling that might otherwise be required.

Furthermore, we do not consider it appropriate to attribute the costs associated with aircraft “down time” to the AD. Normally, compliance with the AD will not necessitate any additional down time beyond that of a regularly scheduled maintenance hold. Even if additional down time is necessary for some airplanes in some cases, we do not have sufficient information to evaluate the number of airplanes that may be so affected or the amount of additional down time that may be required. Therefore, we are unable to estimate such costs.

Additionally, we point out that Boeing service bulletins generally include task hours necessary to do only the change for each airplane, excluding lost time. Boeing, in service bulletins, also specifically advises operators to adjust the task-hour estimates with operator task-hour data, if necessary.

We have not changed the AD in this regard.

Continental recommended that the proposed compliance time of 36 months for installing warning indicator lights should be extended to 60 months, which would fall during a heavy maintenance visit. Continental asserted that it operates 37 Model 737-500 airplanes that would be affected by the NPRM, and that modifying all of these airplanes within 36 months would impose an undue economic burden.

We do not agree with Continental's request to extend the compliance time. We recognize that in some cases, it might be necessary for operators to accomplish the requirements of the AD outside of normal scheduled maintenance cycles. However, in developing an appropriate compliance time for this action, we considered the urgency associated with the subject unsafe condition, and the practical aspect of accomplishing the required modification within a period of time that corresponds to the normal scheduled maintenance for most affected operators. Based on the available data, we have determined that a compliance time of 36 months is the longest compliance time we can allow that would provide an adequate level of safety. However, under the provisions of paragraph (l) of the final rule, we will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. We have not changed the AD in this regard.

Boeing requested that we consider adding a baseline maximum takeoff and landing altitude of 8,300 feet for Model 737-100 and -200 airplanes. Boeing pointed out that the NPRM contains an 8,400-foot pressure altitude as a function of the baseline maximum takeoff and landing altitude for the Model 737-300, -400, and -500 airplanes. Therefore, Boeing contended that the new baseline maximum takeoff and landing altitude should be added for the Model 737-100 and -200 airplanes to avoid confusion.

We do not agree to add a baseline maximum takeoff and landing altitude of 8,300 feet for Model 737-100 and -200 airplanes. We have verified that there are no Model 737-100 or -200 airplanes with high-altitude deviations approved between 8,300 and 8,400 feet. Therefore, the statement in paragraph (i)(1)(ii) of this AD accurately considers all Model 737 Classic airplanes as appropriate. We have not changed this AD in this regard.

Boeing requested that we revise paragraph (i)(2)(i) of the NPRM to correct the title of the procedure that is to be deleted. Boeing asserted that the procedure title specified in paragraph (i)(2)(i) of the NPRM no longer exists, as the title was changed according to FAA Alternative Method of Compliance (AMOC) Letter 130S-09-134a, dated April 28, 2009.

We partially agree. We do not agree to delete reference to the procedure titled “WARNING HORN—CABIN ALTITUDE OR CONFIGURATION,” because all AFMs might not have been changed according to FAA AMOC Letter 130S-09-134a. Additionally, that procedure title is included in the existing requirements of AD 2006-13-13, and, therefore, it is necessary for this AD to refer to the procedure title specified in that AD. However, some AFMs have been revised according to FAA AMOC Letter 130S-09-134a; therefore, we agree to revise paragraph (i)(2)(i) of this AD to address airplanes with AFMs that have been revised according to FAA AMOC Letter 130S-09-134a.

Boeing requested that we revise the AFM text proposed in paragraph (i)(2)(iv) of the NPRM to change “Descent” to “Rapid Descent.” Boeing requested this change to clarify the proposed AFM wording.

We partially agree. We do agree to change “Descent” in the AFM text required by paragraph (i)(2)(iv) of this AD. We have determined that “Descent” is not the proper terminology to use in this AFM text. However, we do not agree to change “Descent” to “Rapid Descent,” because that term is also not accurate. We have determined that the correct terminology is “Emergency Descent.” Therefore, we have revised the AFM text required by paragraph (i)(2)(iv) of this AD to refer to “Emergency Descent.”

Boeing requested that we revise paragraph (i)(2)(iv) of the NPRM to add certain steps in the AFM text. Boeing asserted that this change is necessary to standardize the cabin altitude warning procedure across all Boeing airplane models.

We partially agree. We agree that the additional steps proposed by Boeing would be beneficial, add clarity and specificity, and contribute to standardization across Boeing airplane models. However, we do not agree that this AD should require these additional steps. Requiring these additional steps would alter the actions currently required by this AD, so additional rulemaking would be required. We have determined that the proposed AFM text is adequate, and that delaying this action would be inappropriate in light of the identified unsafe condition. However, because we agree that the additional steps would be beneficial, we have revised this AD to add a new paragraph (i)(2)(v) to include the additional steps as an option, so that operators may use the additional steps if they choose.

Boeing requested that we revise paragraph (i)(3)(ii) of the NPRM to remove the requirement to add “For normal operations, the pressurization mode selector should be in AUTO prior to takeoff.” Boeing pointed out that this step is already included in the “Boeing Preflight Procedures—First Officer.”

We do not agree. We have determined that, because there is relevant accident history associated with incorrect setting of this specific switch, continued emphasis on the proper positioning of this switch prior to takeoff is necessary. Therefore, because this step is being eliminated by this AD, which terminates the requirements of AD 2006-13-13, this step must be added back into the AFM to emphasize the correct setting of this switch. We have not changed this AD in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD will affect 741 airplanes of U.S. registry. We estimate the following costs 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.

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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM was published in the Federal Register on October 1, 2010 (75 FR 60669). That NPRM proposed to require a detailed inspection for proper sealant of the left and right pylon firewall structures, and corrective actions if necessary.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed—except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 165 airplanes of U.S. registry.

We estimate the following costs 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.

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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM published in the Federal Register on November 5, 2010 (75 FR 68245). That NPRM proposed to require installing new fire handle shutoff system wiring.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We have revised this AD to identify the legal name of the manufacturer as published in the most recent type certificate data sheet for the affected airplane models.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD with the change described previously. We also determined that this change will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD will affect 25 airplanes of U.S. registry.

We estimate the following costs 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.

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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

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 November 9, 2010 (75 FR 68728). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 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 highlighted in a Note within the AD.

We estimate that this AD will affect 6 products of U.S. registry. We also estimate that it will take about 7 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $3,570, or $595 per product.

In addition, we estimate that any necessary follow-on actions would take about 6 work-hours and require parts costing $4,055, for a cost of $4,565 per product. We have no way of determining the number of products that may need these actions.

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 this AD:

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

2. Is not a “significant rule” under the 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://www.regulations.gov; or in person at the Docket Operations office 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 Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

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 November 10, 2010 (75 FR 69030). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Corrective actions include replacing any broken return springs with new return springs, repairing any chafing of the primary actuator on its casing, and replacing any primary actuator that has damage through its casing with a new actuator. You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 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 highlighted in a Note within the AD.

We estimate that this AD will affect 477 products of U.S. registry. We also estimate that it will take 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $81,090, or $170 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 this AD:

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

2. Is not a “significant rule” under the 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://www.regulations.gov; or in person at the Docket Operations office 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 Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

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 November 19, 2010 (75 FR 70861). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

The corrective action is adjusting the FCP cam until it operates correctly. You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 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 highlighted in a Note within the AD.

We estimate that this AD will affect 6 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $426 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $4,086, or $681 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 this AD:

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

2. Is not a “significant rule” under the 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://www.regulations.gov; or in person at the Docket Operations office 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 Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

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 September 8, 2010 (75 FR 54536), and proposed to supersede AD 2005-20-32, Amendment 39-14329 (70 FR 59263, October 12, 2005). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

• Repetitive endoscopic inspections for damage (such as a scratch, disbonding, or a tear) of the inner skin of the upper and lower elevator panels on both sides of the airplane, and if any damage is found, contacting Airbus for instructions and doing the instructions.

• Repetitive tap tests for debonding in the inner side of the upper and lower elevator panels on both sides, and if any debonding is found, contacting Airbus for instructions and doing the instructions.

• Repetitive thermographic inspections for indications of trapped water in the upper and lower elevator panels on both sides of the airplane, and if any indications of trapped water are found, doing applicable corrective actions (including, but not limited to, repeating the thermographic inspection to determine the size of the damaged area, doing a general visual inspection to determine if there is an existing repair, contacting Airbus for instructions and doing the instructions, re-protecting the affected surfaces, and repairing holes).

• Repetitively re-protect the elevator assembly (including doing a general visual inspection to determine damage and repair if necessary, a general visual inspection to determine if the drainage holes are clean and not obstructed and cleaning the drainage holes if necessary, a general visual inspection to determine the status of the static discharges contour and sealing the static discharges contour if necessary, and installing front spar access hole covers).

You may obtain further information by examining the MCAI in the AD docket.

The NPRM referred to Airbus Service Bulletin A330-55-3032 and Airbus Service Bulletin A340-55-4029, both dated December 22, 2003, as appropriate sources of service information for certain actions. Airbus has revised this service information. Airbus has issued Mandatory Service Bulletins A330-55-3032, Revision 01 including Appendix 01, dated March 29, 2005; and A340-55-4029, Revision 01, dated March 29, 2005; which among minor changes, change the classification of these service bulletins from recommended to mandatory. We have revised this final rule to also refer to Revision 01 of these service bulletins as appropriate sources of service information for certain actions.

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

Delta Air Lines, Inc. (Delta) requested that we mandate a new AD instead of superseding AD 2005-20-32, to eliminate possible confusion for operators in complying with the requirements of the NPRM and the AD being superseded. Delta explained that AD 2005-20-32 applied to a specific range of elevator parts and serial numbers that required inspection, repair, and re-protection, as required by Airbus Service Bulletin A330-55-3032, dated December 22, 2003. Delta reasoned that paragraph (h) of AD 2005-20-32, states that installation of an affected elevator after the AD effective date, November 16, 2005, was not approved unless the subject elevator complied with paragraph (h) of AD 2005-20-32. Delta reasoned further that the NPRM applies to a larger population of elevators and has inspections, repairs (if required), and re-protection, as specified in Airbus Mandatory Service Bulletin A330-55-3039, dated August 7, 2009. Delta stated that the thresholds in the NPRM are based on previous inspections required by Airbus Service Bulletin A330-55-3032, dated December 22, 2003.

We assume that Delta intended to refer to paragraph (i) instead of (h) of AD 2005-20-32, which states that installation of an affected elevator after the AD effective date, November 16, 2005, is not approved unless the subject elevator complies with paragraph (h) of AD 2005-20-32. We disagree with mandating a new AD instead of this final rule, which supersedes AD 2005-20-32. Operators that comply with the new requirements of this final rule terminate the restated requirements of AD 2005-20-32. Restating the requirements of AD 2005-20-32 is necessary because some of the new required inspection thresholds in this final rule are calculated from the date the inspection was performed, as specified in AD 2005-20-32. We have not changed this final rule in this regard.

Delta requested that we remove the reporting requirements of paragraph (n) of the NPRM. Delta explained that requiring operators to report their findings (both positive and negative) to Airbus does not affect safety of flight, but instead puts operators at risk of non-compliance for failure to report findings within the required timeline, and is a duplication of records that is a burden to operators. Delta indicated that they maintain records of accomplishment of mandated work. Delta argued further, that removal of the reporting requirement would be consistent with the FAA's ruling per AD 2005-20-32, which notes:

We disagree to remove the reporting requirements of this final rule. We mandate reporting to Airbus in support of collecting the inspection results, which are helpful to Airbus in developing a final fix to the problem, a potential change in the design of the affected part, or the manufacturing process. We have not changed this final rule in this regard.

Delta requested that we revise paragraph (o) to include a reference to paragraph (k) instead of paragraph (l) in the NPRM. Delta explained that the following sentence in paragraph (o) of the NPRM, which states:

We agree to include a reference to paragraph (k) instead of paragraph (l), in paragraph (o) of the final rule. We have revised the final rule accordingly.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or 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 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 highlighted in a Note within the AD.

We estimate that this AD will affect about 56 products of U.S. registry.

The actions that are required by AD 2005-20-32 and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the currently required actions is $85 per product.

We estimate that it will take about 14 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $66,640, or $1,190 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 this AD:

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

2. Is not a “significant rule” under the 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://www.regulations.gov; or in person at the Docket Operations office 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 Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

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 23, 2010 (75 FR 51705). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

FedEx Express (FedEx) requested that we add the following sentence to paragraph (g) of the NPRM: “Accomplish modification in accordance with the thresholds specified in [Airbus Mandatory] Service Bulletin A300-53-6146, Revision 01, [dated June 26, 2009,] paragraph E(2), Accomplishment Timescale.” FedEx stated that the threshold table in that service bulletin recommends the number of flight cycles for each model after which the modification should be embodied; if the modification is embodied before the recommended threshold, additional inspections are required according to Airbus instructions. FedEx further stated that the NPRM stipulates accomplishment before 42,500 flight cycles and FedEx agrees that following the Airbus recommendation for the thresholds will avoid extensive inspections similar to the Airworthiness Limitations Items (ALI) Tasks 53.16.04-01-1 and 53.16.22-01-1.

We do not agree to add the quoted sentence to the AD because, by doing the requirements of this AD at or before the compliance time specified in this AD, no further inspections are required by this AD. However, we have added a new Note 1 that states “In case of earlier accomplishment of Airbus Mandatory Service Bulletin A300-53-6146, Revision 01, dated June 26, 2009, before the recommended thresholds contained in the Threshold Table in paragraph 1.E.(2) of Airbus Mandatory Service Bulletin A300-53-6146, Revision 01, dated June 26, 2009, are reached, the operator should contact Airbus to define an additional non-mandatory appropriate inspection program.” We have reidentified subsequent notes accordingly.

Further, we have determined that accomplishing the actions required by this AD terminates ALI Tasks 53.16.04-01-1 and 53.16.22-01-1. Therefore, we have added a new paragraph (h) to this AD to clarify that doing the requirements of this AD terminates ALI Tasks 53.16.04-01-1 and 53.16.22-01-1. We have reidentified subsequent paragraphs accordingly.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or 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 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 highlighted in a Note within the AD.

We estimate that this AD will affect about 124 products of U.S. registry. We also estimate that it will take about 347 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $5,670 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $4,360,460 or $35,165 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 this AD:

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

2. Is not a “significant rule” under the 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://www.regulations.gov; or in person at the Docket Operations office 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 Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq. ) as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and Drug Administration Modernization Act (Pub. L. 107-250) established a comprehensive system for regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

FDA refers to devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), as postamendments devices. Postamendments devices are classified automatically by statute (section 513(f) of the FD&C Act) into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or class II in accordance with section 513(f)(2) of the FD&C Act; or FDA issues an order finding the device to be substantially equivalent, under section 513(i) to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.

Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device that has not previously been classified into class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA will, within 60 days of receiving this request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing this classification.

In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on October 7, 2009, classifying the Zeltiq Lipolysis System for Aesthetic Use into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On October 13, 2009, Zeltiq TM Aesthetic, Inc., submitted a petition requesting classification of the lipolysis system for aesthetic use under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the contact cooling system for aesthetic use can be classified into class II with the establishment of special controls. FDA believes these special controls will provide assurance of the safety and effectiveness of the device.

The device was assigned the generic name “Cooling System for Aesthetic Use” and it is identified as a cooling system for aesthetic use. FDA has identified the following risks to health associated specifically with this type of device and the recommended measures to mitigate these risks.

• Discomfort and pain during and following treatment are possible due to the application of mechanical or vacuum massage at levels in excess of those recommended in the labeling. These effects and tenderness at the treatment site may also occur following treatment. Prevention of these effects are addressed by adequate bench testing demonstrating that the feedback controls for temperature/cooling are functional and do maintain target temperature within the stated value. Proper function of mechanical controls to insure use of the mechanical or vacuum massager within safe limits should be confirmed as part of bench testing.

• Electrical shock is addressed by recommended testing of the device according to recognized U.S. and International Standards specifically designed to determine and measure potential electrical safety. Again, the recommended device labeling also includes specific warnings for the user in terms of device placement, appropriate electrical wiring needs, reminders to periodically check device wiring and accessories for damage, and avoidance of use of the device in environments where electrical shock is possible.

• Use error represents those risks to the patient that can occur from improper use of the device. In order to address this potential risk, we recommend the manufacturer provide a detailed operator manual which contains information on possible risks and hazards and how these should be avoided and clear recommended safe treatment procedures that include information on device settings for treatment, clear information on how the device is to be used during treatment, and recommended post treatment care.

• Tissue damage from uncontrolled cooling is a risk which is addressed by the above stated bench testing of the temperature control system. In addition the labeling provided shall give recommended safe use parameters in terms of temperature setting and duration of treatment with these parameters supported by animal or clinical data.

• Systemic response to cold is a potential hazard for individuals who may have underlying cold sensitive health conditions or reduced skin sensitivity due to other medical conditions. This risk is addressed through the device labeling which provides appropriate cautions, warnings and contradictions for such cold sensitive conditions.

• Skin inflammation or foreign body responses can be an issue for individuals based on the skin contact nature of this device. This type of skin irritation is prevented by appropriate testing for biocompatibility of the contact materials when in contact with skin.

FDA believes that the special controls, in addition to general controls, address the risks to health identified in table 1 of this document and provide reasonable assurance of the safety and effectiveness of the device type. Therefore, on August 24, 2010, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this device classification by adding 21 CFR 878.4340.

Following the effective date of the final classification rule, any firm submitting a 510(k) premarket notification for cooling system for aesthetic use device intended for the disruption of adipocyte cells intended for non-invasive aesthetic use will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirement under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, the type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the cooling system for aesthetic use that they intend to market.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action 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 reclassification of this device from class III to class II will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

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

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain State requirements “different from or in addition to” certain Federal requirements applicable to devices. 21 U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v. Medtronic, 552 U.S. 312 (2008). The special controls established by this final rule create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors have flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F. 3d 737, 740-42 (9th Cir. 1997).

This final rule contains no collections of new information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 is not required. Elsewhere in this issue of the Federal Register , FDA is issuing a notice announcing availability of the guidance for the final rule. This guidance entitled “Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use” references previously approved collections of information found in FDA regulations.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from Zeltiq Aesthetics, October 13, 2009.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

This document contains an amendment to the Income Tax Regulations (26 CFR part 1). On February 8, 2008, a temporary regulation (TD 9379) was published in the Federal Register (73 FR 7464) that provided the time and manner rules for electing capital asset treatment for certain self-created musical works. A notice of proposed rulemaking (REG-153589-06) cross-referencing the temporary regulation also was published in the Federal Register (73 FR 7503) on February 8, 2008. No comments in response to the notice of proposed rulemaking or requests to hold a public hearing were received, and no hearing was held. This Treasury decision adopts the proposed regulation with minor changes and removes the temporary regulation.

Section 1221(a) of the Internal Revenue Code (Code) generally provides that capital assets include all property held by a taxpayer with certain specified exclusions. Section 1221(a)(1) excludes from the definition of a capital asset inventory property or property held by a taxpayer primarily for sale to customers in the ordinary course of the taxpayer's trade or business. Section 1221(a)(3) excludes from the definition of a capital asset certain property—a copyright; a literary, musical, or artistic composition; a letter or memorandum; or similar property—held by a taxpayer whose personal efforts created the property (or held by a taxpayer whose basis in the property is determined by reference to the basis of such property in the hands of the taxpayer whose personal efforts created the property).

Section 1221(b)(3) of the Code, added by section 204 of the Tax Increase Prevention and Reconciliation Act of 2005, Public Law 109-222 (120 Stat. 345 (2005)), and amended by section 412 of the Tax Relief and Health Care Act of 2006, Public Law 109-432 (120 Stat. 2922 (2006)), provides that, at the election of a taxpayer, the section 1221(a)(1) and (a)(3) exclusions from capital asset status will not apply to a musical composition or a copyright in a musical work sold or exchanged by a taxpayer described in section 1221(a)(3). Thus, if a taxpayer who owns a musical composition or copyright in a musical work created by the taxpayer (or transferred to the taxpayer by the composition or work's creator in a transferred basis transaction) elects the application of this provision, gain or loss from the sale or exchange of the musical composition or copyright is treated as capital gain or loss.

This final regulation provides rules regarding the time and manner for electing under section 1221(b)(3) to treat gain or loss from the sale or exchange of certain musical compositions or copyrights in musical works as gain or loss from the sale or exchange of a capital asset.

This regulation applies to elections under section 1221(b)(3) in taxable years beginning after May 17, 2006.

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

The principal author of this regulation is Jamie Kim of the Office of Associate Chief Counsel (Income Tax & Accounting). However, other personnel from the IRS and the Treasury Department participated in its development.

Accordingly, 26 CFR part 1 is amended as follows.

NARA is authorized to revoke researchers' privileges under certain circumstances by following the procedures outlined in 36 CFR part 1254. The privileges may be revoked for the following behaviors: Refusing to follow the rules and regulations of a NARA facility; acting or speaking in a way that may be dangerous to documents held by NARA or NARA property; acting or speaking in a way that may be dangerous to other researchers, NARA or contractor employees, or volunteers; or verbally or physically harassing or annoying other researchers, NARA or contractor employees, or volunteers. This change will align the appeal authority for researchers whose research privileges have been revoked with the appeal authority for individuals who have been banned from NARA facilities for the following prohibited activities on NARA properties: Carrying or using guns or weapons, using or in possession of alcohol or illegal drugs; gambling; soliciting; stealing NARA property; willfully damaging or destroying NARA property; creating any hazard to persons or things; throwing anything from or at a NARA building; improperly disposing of rubbish; acting in a disorderly fashion; acting in a manner that creates a loud or unusual noise or a nuisance; acting in a manner that unreasonably obstructs the usual use of NARA facilities; acting in a manner that otherwise impedes or disrupts the performance of official duties by Government and contract employees; acting in a manner that prevents the general public from obtaining NARA-provided services in a timely manner; loitering; or threatening directly ( e.g., in-person communications or physical gestures) or indirectly ( e.g., via regular mail, electronic mail, or phone) any NARA employee, visitor, volunteer, contractor, other building occupants, or property, which is the Deputy Archivist of the United States. Researchers maintain the same rights of appeal.

Revocation actions are taken by staff at the NARA facility where an infraction takes place. In turn, researchers have the right to appeal the revocation to a higher authority than the local NARA facility director; a process which is also described in 36 CFR part 1254. The current appeal authority is the Archivist of the United States, yet the appeal authority for the more severe penalty of banning individuals from NARA facilities under 36 CFR part 1280, is the Deputy Archivist of the United States. This direct final rule will only change the appeal authority for researchers whose privileges have been revoked, from the Archivist of the United States to the Deputy Archivist of the United States, aligning the two disciplinary appeal processes. Researchers retain their full right to appeal revocation decisions.

NARA believes that a Notice of Proposed Rule Making is not necessary for “good cause” as permitted by the Administrative Procedures Act (5 U.S.C. 553(b)(B)) as this rule is a nomenclature change only, and there are no changes to the public's right to appeal revocation decisions.

This direct final rule is not a significant regulatory action for the purposes of Executive Order 12866. As required by the Regulatory Flexibility Act, it is hereby certified that this direct final rule will not have a significant impact on small entities.

For the reasons set forth in the preamble, NARA amends part 1254 of title 36, Code of Federal Regulations, as follows:

Under 38 U.S.C. chapter 37, VA guarantees loans made by private lenders to veterans for the purchase, construction, and refinancing of homes owned and occupied by veterans. On February 1, 2008, VA published in the Federal Register (73 FR 6294) a final rule that extensively revised 38 CFR part 36 to modernize procedures for servicing VA-guaranteed home loans. A new subpart F was added to include § 36.4815, which provided detailed parameters for private loan servicers to modify delinquent loans without seeking prior approval from VA, thereby enabling servicers to quickly assist veteran borrowers in avoiding foreclosure. On June 15, 2010, VA published in the Federal Register (75 FR 33704) a final rule that redesignated subpart F (the 36.4800 series) to replace obsolete subpart B (the 36.4300 series) in its entirety.

Loan modifications typically give a borrower a fresh start by adding all or a portion of the delinquent amounts to the loan balance and resetting the due date for payments. Modifications usually adjust the terms of the loan agreement by: capitalizing delinquent interest, advances, or other amounts due; extending the repayment terms; changing the interest rate payable; or combining some or all of these or other adjustments to the loan terms.

In developing the parameters for acceptable loan modifications, we considered many options to balance the program mission of assisting veteran borrowers in retaining homeownership against the needs of private investors to receive a fair profit on their investments. We believed we had adequately addressed those concerns in the 2008 amendments to VA's loan guaranty regulations. However, since those amendments, we have encountered two sets of circumstances that have caused difficulty in easily modifying loans to assist veterans in retaining their homes.

In light of the continuing difficulties in the housing industry that are affecting the ability of many veterans to retain ownership of their homes, and in keeping with the Administration's plan to help borrowers retain home ownership through affordable loan modifications, this interim final rule is issued to immediately rectify those two issues. In addition, this interim final rule revises the regulation to clarify in § 36.4315(b) that holders may seek VA approval for a loan modification if the proposed modification does not otherwise meet the conditions prescribed in § 36.4315(a).

The first problem noted since the 2008 amendments concerns interest rates on modified loans. Current 38 CFR 36.4315(c) establishes the maximum interest rate on a modified loan as the previous month's Government National Mortgage Association (GNMA) coupon plus 1/2 percent. We understood that the vast majority of VA-guaranteed loans were placed in GNMA pools, and by allowing the maximum rate on a modified loan to equal that of a newly originated loan, we believed the mortgage industry would be able to easily modify loans to help veterans avoid foreclosure and place those modified loans in new GNMA pools. However, we have learned that this requirement is not quite as effective as planned in helping veterans to avoid foreclosure through loan modification. VA-guaranteed loans that are held by State housing-finance authorities often specifically prohibit changes in the interest rate when modifying loans. In the present low-interest-rate environment, current § 36.4315(c) creates difficulties in modifying loans that were originated with State housing-finance authority assistance at higher interest rates. Therefore, we are modifying § 36.4315 to allow the interest rate on a modified loan to remain the same as the original interest rate when the loan is held by a State housing-finance authority where the law precludes a rate revision. See 38 CFR 36.4315(a)(8)(iii).

We are further modifying § 36.4315 to allow for easier calculation of the maximum interest rate on all other modified loans ( i.e. , those loans not held by a State housing-finance authority). In September 2009, the Department of Housing and Urban Development (HUD) issued Mortgagee Letter 2009-35 to change the maximum interest rate on modified loans to no more than 50 basis points above the most recent Freddie Mac Weekly Primary Mortgage Market Survey Rate for 30-year fixed-rate conforming mortgages (U.S. average), rounded to the nearest one-eighth of one percent (0.125%), as of the date the Modification Agreement is executed. Because the information on GNMA coupon rates is not as widely available as that of the Freddie Mac Market Survey Rate (which may be found online at http://www.freddiemac.com/pmms/ , as well as in the list of Selected Interest Rates that the Federal Reserve Board publishes weekly in its Statistical Release H.15 at http://www.federalreserve.gov/releases/h15/ ), we are amending § 36.4315 to adopt a similar standard. Under § 36.4315(a)(8)(i), the interest rate on a modified VA-guaranteed loan (not held by a State housing-finance authority) may not exceed 50 basis points above the most recent Freddie Mac Weekly Primary Mortgage Market Survey Rate for 30-year fixed-rate conforming mortgages (U.S. average), rounded to the nearest one-eighth of one percent (0.125%), as of the date the Modification Agreement is executed.

Using the Freddie Mac Market Rate as a basis for computing the maximum interest rate on a modified loan establishes uniformity with another large Federal home loan program, and will enable loan servicers to more easily determine maximum allowable rates for loan modifications. This will enable veterans to receive the benefits of capitalization and/or extension on a modified loan, even if the present interest rate environment is higher than at loan origination. The majority of VA-guaranteed loans are in GNMA pools, which require servicers to “buy-out” the loans from the pools in order to modify them. GNMA determines the guidelines for determining when loans can be bought out of pools, and this interim final rule does not release loan holders from requirements under the contracts they have with GNMA. (For more details see http://www.ginniemae.gov/apm/apm_pdf/10-01.pdf ). A servicer is then faced with the task of attempting to find another group of loans with similar interest rates in order to “repool” the modified loan. By allowing the modified loan rate to be the Freddie Mac rate plus 50 basis points, which is similar to that of other new VA-guaranteed loans being originated, the servicer will be better able to repool a modified loan and should be more willing to complete a modification.

Although monthly loan payments may increase slightly under the interim final rule due to capitalization or small increases in interest rates, elimination of the delinquency by modification will benefit individual veterans by avoiding foreclosure and receiving a fresh start after resolving financial difficulties. However, we will require the servicer to submit to VA for prior approval any loan modification where the interest rate will increase more than one percent over the existing interest rate on the loan. This will provide us an opportunity to determine if it is perhaps more appropriate to utilize our authority under 38 U.S.C. 3732 to refund (purchase) the loan and modify the loan at a lower-than-market interest rate.

The second problem noted after the 2008 amendments concerns those items that may be included in a modified loan amount. After we proposed former § 36.4815 (redesignated as current § 36.4315), public comments suggested that the new modification procedures should provide for other expenses of modification. Under former § 36.4815, loan modification expenses could not be included in the modified loan amount. In the 2008 amendments, we allowed inclusion of unpaid principal, accrued interest, and deficits in the taxes and insurance impound accounts in the modified indebtedness. Also permitted were advances required to preserve the lien position, such as homeowner association fees, special assessments, and water and sewer liens. We specifically excluded other costs such as late fees, legal fees, and related foreclosure costs.

In Mortgagee Letter 2008-21, HUD issued a change in its position that allows foreclosure costs actually incurred to be capitalized into the modified loan balance. The Letter states that, in some cases where foreclosure had been initiated and the borrowers' circumstances had improved to the point that a modification could allow them to resume making regular monthly payments, HUD found the borrowers had insufficient funds to pay legal fees and other foreclosure costs. Therefore, the borrowers could not complete loan modifications without a change in the HUD loss-mitigation program. While the hope remains that modifications can be completed early in the course of a default—before accrual of costly fees and expenses—we realize that may not always be the case.

In order to allow veteran borrowers to avail themselves of the opportunity to retain homeownership by means of a loan modification (even after the foreclosure process has started), we are amending current § 36.4315 to allow legal fees and foreclosure costs to be capitalized into the modified loan balance. See § 36.4315(a)(10). Under paragraph (a)(10), VA is also allowing capitalization of the cost of a title insurance policy endorsement or other form of update on the modified loan. HUD requires that any late charges should be waived in connection with a modification to give the borrower a fresh start. VA agrees with this beneficial approach and has included it in § 36.4315(a)(11). The incentive paid for a successful loan modification should more than offset any lost late charge income due to the amendment requiring waiver of late charges when a loan is modified.

Finally, we are reorganizing § 36.4315 to clarify in paragraph (b) that holders may seek VA approval for a loan modification if the proposed modification does not otherwise meet the conditions prescribed in paragraph (a). Current § 36.4315(a) and (b) specifically include language stating that, without the prior approval of the Secretary of Veterans Affairs, a loan may be modified if the conditions of those sections are met. However, this structure does not adequately reflect our intent that a holder may seek prior approval for a loan modification that does not meet other conditions for modification. Therefore, this interim final rule redesignates current § 36.4315(b) through (i) as § 36.4315(a)(7) through (a)(14) to clarify that, if the paragraph (a) conditions are met, a loan may be modified without prior approval of the Secretary and that the holder may seek prior approval for a modification not meeting one of those conditions. In light of these clarifying amendments, we are deleting language in current paragraphs (a) and (b) that is unnecessary. A new paragraph (b) has been added to specifically state, rather than leave for inference, that if a loan fails to meet one or more of the conditions within the section, the holder must submit the loan file to the Secretary for approval before entering into any loan modification agreement. This new paragraph provides a guiding principle that the Secretary will approve such a request when he determines that it is in the best interests of the veteran and the Government after balancing the risks of non-approval versus approval despite the absence of one or more of the conditions identified in paragraph (a). Current § 36.4315(j) has been redesignated as § 36.4315(c) and notes that the provisions of § 36.4315 do not create a right to a loan modification, but simply authorizes the holder to modify a loan in certain situations without prior approval of the Secretary or upon the Secretary's approval in other situations.

Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), we find that there is good cause to dispense with advance public notice and opportunity to comment on this rule and good cause to publish this rule with an immediate effective date. This interim final rule is necessary to immediately allow private loan holders to assist more veteran borrowers by authorizing loan modifications under the new rules.

VA has seen monthly foreclosures of VA-guaranteed loans increase from 545 in September 2007 (the end of fiscal year 2007) to 1,328 in December 2009, to 2,054 in August of 2010 (the most recent data as of preparation of this document). Delay in the implementation of this rule could prevent some veteran borrowers from obtaining loan modifications, which will lead to additional foreclosures. This means that more veterans will lose their homes and their entitlement to VA loan guaranty benefits (unless the loss is repaid). It also means that more families will be displaced and have to begin the long road to financial and credit recovery, which can take years. Moreover, for each additional guaranty claim VA must make, the taxpayer must shoulder some of the financial responsibility.

Immediate implementation of the rule will not only assist veterans and other taxpayers, but will do so without having an adverse impact on the mortgage industry. The new rule will enable servicers to offer more loss mitigation opportunities and continue servicing VA-guaranteed loans, rather than seeing their servicing fees terminated as the loans are foreclosed.

We started tracking completed loan modifications after the 2008 amendments to VA's loan guaranty regulations. During fiscal year 2009 the number of modifications completed averaged 360 per month. However, there have been many direct inquiries from loan servicers asking about other loss mitigation options when State housing-finance authorities are unable to modify loans at lower interest rates. Other than VA refunding (purchasing) some of those loans and reducing the interest rates, there have been no other viable alternatives to help Veterans in those situations avoid foreclosure. Refunding by VA essentially replaces private financing with Government funds, and requires a substantial initial investment that takes as long as 30 years to recover, so it may not always be the best option for the Government. The ability to complete loan modifications at existing interest rates will enable private loan servicers to help more veteran borrowers remain in their homes and avoid foreclosure. When veterans are able to reinstate delinquent loans by modifying their loans and avoiding foreclosure, VA will be required to pay fewer claims under its loan guaranty. In addition, by allowing inclusion of legal fees for actual termination expenses incurred prior to modification, more veterans will be able to afford the other up-front expenses associated with modification and avoid foreclosure.

For the foregoing reasons, we have determined that delay in implementing these regulations is unnecessary, impractical under the circumstances, and contrary to the public interest. Accordingly, we are issuing this rule as an interim final rule with immediate effect.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any given year. This rule will have no such effect on State, local, and Tribal governments, or on the private sector.

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 Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this interim final rule have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, this rule was submitted to OMB for review.

The Secretary hereby certifies that this interim final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The vast majority of VA loans are serviced by very large financial companies. Only a handful of small entities service VA loans and they service only a very small number of loans. This interim final rule, which only impacts Veterans, other individual obligors with guaranteed loans, and companies that service VA loans, will have very minor economic impact on a very small number of small entities servicing such loans. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.114, Veterans Housing—Guaranteed and Insured Loans.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on November 1, 2010, for publication.

For the reasons stated in the preamble, VA amends 38 CFR part 36 as follows:

I. Background

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. On November 5, 2010 (75 FR 68251), EPA published a notice of proposed rulemaking (or proposed rulemaking) for the Commonwealth of Pennsylvania. The notice of proposed rulemaking proposed EPA's approval of Pennsylvania's 2002 base year emissions inventory, RFP plan, RFP contingency measures, RACM, and MVEBs for the Commonwealth's portion of the Philadelphia-Wilmington-Atlantic City moderate 1997 8-hour ozone nonattainment area. EPA is approving the SIP revision because it satisfies the emissions inventory, RFP, RACM, RFP contingency measures, and transportation conformity requirements of section 110 and part D of the CAA and associated EPA regulations. This SIP revision was formally submitted by the Pennsylvania Department of Environmental Protection (PA DEP) on August 29, 2007, and was formally amended by PA DEP on December 10, 2009 and again on April 12, 2010.

The SIP revision (and subsequent SIP amendments) address the emissions inventory, RFP, RACM, and RFP contingency measures requirements for the 1997 8-hour ozone NAAQS for the Pennsylvania portion of the Philadelphia-Wilmington-Atlantic City 8-hour ozone moderate nonattainment area. The SIP revision also establishes MVEBs for 2008. Other specific requirements of Pennsylvania's August 29, 2007 SIP revision (as amended in December 2009 and April 2010) for the Philadelphia-Wilmington-Atlantic City 8-hour ozone nonattainment area and EPA's rationale for our proposed action are explained in the November 5, 2010 proposed rulemaking and will not be restated here. A more detailed description of the August 2007 SIP revision, as well as the substance of each of the subsequent SIP amendments is discussed in detail in EPA's November 5, 2010 proposed rulemaking. No public comments were received on EPA's November 2010 proposed rulemaking.

EPA is approving the 2002 base year emissions inventory; the 2008 ozone projected emission inventory; the 2008 RFP plan; RFP contingency measures; RACM analysis; and 2008 transportation conformity budgets for the Pennsylvania portion of the Philadelphia-Wilmington-Atlantic City 8-hour ozone nonattainment area, contained in Pennsylvania's August 29, 2007 SIP revision (as formally amended by Pennsylvania in December 2009 and April 2010) for the Philadelphia-Wilmington-Atlantic City 8-hour ozone nonattainment area. The SIP revision satisfies the requirements for 1997 8-hour ozone NAAQS nonattainment areas classified as moderate and demonstrates reasonable further progress in reducing ozone precursors.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 action 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 April 8, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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 the emission inventory, RFP demonstration, RACM determination, RFP contingency measures, and MVEBs may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

40 CFR part 52 is amended as follows:

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273 and 279.

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

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

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

• Enforce RCRA requirements and suspend or revoke permits, and

• Take enforcement actions regardless of whether the State has taken its own actions.

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

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

If EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw that part of this rule but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

North Carolina initially received Final authorization on December 14, 1984, effective December 31, 1984 (49 FR 48694) to implement its base hazardous waste management program. EPA granted authorization for changes on March 25, 1986, effective April 8, 1986 (51 FR 10211); August 5, 1988, effective October 4, 1988 (53 FR 1988); February 9, 1989, effective April 10,1989 (54 FR 6290); September 22, 1989, effective November 21, 1989 (54 FR 38993); January 18, 1991, effective March 19, 1991 (56 FR 1929); April 10, 1991, effective June 9, 1991 (56 FR 14474); July 19, 1991, effective September 17, 1991 (56 FR 33206); April 27, 1992, effective June 26, 1992 (57 FR 15254); December 12, 1992, effective February 16, 1993 (57 FR 59825); January 27, 1994, effective March 28, 1994 (59 FR 3792); April 4, 1994, effective June 3, 1994 (59 FR 15633); June 23, 1994, effective August 22, 1994 (59 FR 32378); November 10, 1994, effective January 9, 1995 (59 FR 56000); September 27, 1995, effective November 27, 1995 (60 FR 49800); April 25, 1996. effective June 24, 1996 (61 FR 18284); October 23, 1998, effective December 22, 1998 (63 FR 56834); August 25, 1999, effective October 25, 1999 (64 FR 46298); February 28, 2002, effective April 29, 2002 (67 FR 9219); December 14, 2004, effective February 14, 2005 (69 FR 74444) and March 23, 2005, effective May 23, 2005 (70 FR 14556).

On September 1, 2006 and February 13, 2007, North Carolina submitted a final complete program revision application, seeking authorization of its changes in accordance with 40 CFR 271.21. EPA makes an immediate final decision, subject to receipt of comments that oppose this action, that North Carolina's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant final authorization for the following program changes:

There are no State requirements that are more stringent or broader in scope than the Federal requirements.

North Carolina will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization until they expire or are terminated. We will not issue any more permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which North Carolina is not authorized.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by referencing the authorized State rules in 40 CFR part 272. EPA reserves the amendment of 40 CFR part 272, subpart II for this authorization of North Carolina's program changes until a later date.

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this action authorizes 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 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 document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective April 8, 2011, unless objections to this authorization are received.

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273 and 279.

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

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

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

• Enforce RCRA requirements and suspend or revoke permits, and

• Take enforcement actions regardless of whether the State has taken its own actions.

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

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

If EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw that part of this rule but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Florida initially received Final authorization on January 29, 1985, effective February 12, 1985 (50 FR 3908), to implement the RCRA hazardous waste management program. We granted authorization for changes to their program on December 1, 1987, effective March 3, 1988 (52 FR 45634); December 16, 1988, effective January 3, 1989 (53 FR 50529); December 14, 1990, effective February 12, 1991 (55 FR 51416); February 5, 1992, effective April 6, 1992 (57 FR 4371); February 7, 1992, effective April 7, 1992 (57 FR 4738); May 20, 1992, effective July 20, 1992 (57 FR 21351); November 9, 1993, effective January 10, 1994 (58 FR 59367); July 11, 1994, effective September 9, 1994 (59 FR 35266); April 16, 1994, effective October 17, 1994 (59 FR 41979); October 26, 1994, effective December 27, 1994 (59 FR 53753); April 1, 1997, effective June 2, 1997 (62 FR 15407); August 23, 2001, effective October 22, 2001 (66 FR 44307); August 20, 2002, effective October 21, 2002 (67 FR 53886 and 67 FR 53889); October 14, 2004, effective December 13, 2004 (69 FR 60964). The authorized Florida program, through RCRA Cluster IV, was incorporated by reference into the CFR on January 20, 1998, effective March 23, 1998 (63 FR 2896). Florida received authorization for the corrective action program on September 18, 2000, effective November 18, 2000 (65 FR 56256). Florida received additional authorization to its program for RCRA Clusters XI through XV on August 10, 2007, effective October 9, 2007 (72 FR 44973).

On August 27, 2007 and August 28, 2008, Florida submitted final complete program revision applications, seeking authorization of its changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of comments that oppose this action, that Florida's hazardous waste program revision satisfies all of the requirements necessary to qualify for final authorization. Therefore, we grant final authorization for the following program changes:

Florida has added hazardous pharmaceutical waste to the list of wastes that may be managed under the Universal Waste rule. This makes Florida's Universal Waste rule broader in scope than the Federal regulation.

Florida will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization until they expire or are terminated. EPA will not issue any more permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Florida is not authorized.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart K for this authorization of Florida's program changes until a later date.

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this action authorizes 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 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 document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective April 8, 2011, unless objections to this authorization are received.

The International Pacific Halibut Commission (IPHC) and National Marine Fisheries Service (NMFS) manage fishing for Pacific halibut ( Hippoglossus stenolepis ) through regulations established under authority of the Northern Pacific Halibut Act of 1982 (Halibut Act). The IPHC promulgates regulations governing the Pacific halibut fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed in Ottawa, Ontario, on March 2, 1953, as amended by a Protocol Amending the Convention (signed in Washington, DC, on March 29, 1979).

Regulations developed by the IPHC are subject to approval by the Secretary of State with concurrence of the Secretary of Commerce (Secretary). After approval by the Secretary of State and the Secretary, the IPHC regulations are published in the Federal Register as annual management measures pursuant to 50 CFR 300.62. The current IPHC annual management measures were published on March 18, 2010 (75 FR 13024). IPHC regulations affecting sport fishing for halibut and charter vessels in Areas 2C (Southeast Alaska) and 3A (Central Gulf of Alaska) may be found in sections 3, 25, and 28 (75 FR 13024; March 18, 2010).

The Halibut Act also provides regulatory authority to the Secretary and the North Pacific Fishery Management Council (Council). The Secretary, under 16 U.S.C. 773c(a) and (b), has the general responsibility to carry out the Convention and the Halibut Act. In adopting regulations that may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act, the Secretary is directed to consult with the Secretary of the department in which the U.S. Coast Guard is operating. Under 16 U.S.C. 773c(c), the Council may develop halibut fishery regulations, for its geographic area of concern, that apply to U.S. nationals or vessels. Such an action by the Council is limited to regulations that are in addition to, and not in conflict with, IPHC regulations. Council-developed regulations may be implemented by NMFS only after approval by the Secretary. Using its authority under the Halibut Act, the Council is developing a regulatory program to manage the guided sport charter vessel fishery for halibut. One step in the development of that program was the implementation of a one-halibut daily bag limit on charter vessel anglers in IPHC Area 2C in order to limit their overall harvest to approximately the established guideline harvest level (74 FR 21194; May 6, 2009).

The final regulations implementing the one-halibut daily bag limit program include recordkeeping and reporting measures codified at 50 CFR 300.65 that require the submission of Alaska Department of Fish and Game (ADF&G) Saltwater Sport Fishing Charter Trip Logbook (charter logbook) data sheets for halibut charter vessels operating in IPHC Areas 2C and 3A (74 FR 21194; May 6, 2009). This action amends these recordkeeping and reporting measures, and is necessary to (1) improve consistency between Federal regulations and State of Alaska (State) logbook instructions for the submission of the data sheets, and (2) address recent changes by the State to the charter logbook reporting format. This action is administrative in nature; it revises the recordkeeping and reporting burden on guided charter operators in IPHC Areas 2C and 3A, reduces potential confusion by the regulated public, and facilitates efficient reporting of halibut caught and retained in these areas.

The proposed rule for this action was published in the Federal Register on April 27, 2010 (75 FR 22070), and the public comment period ended on May 12, 2010. The preamble to the proposed rule describes the need for this action and the proposed regulatory amendments. The final rule makes changes to the proposed regulatory text in response to public comments received on the proposed rule and to clarify the intent of the regulations.

1. A definition of “Fishing week” is added to § 300.61 for purposes of § 300.65(d). This definition is added to the final rule and is discussed under the heading “Changes from the Proposed Rule.”

2. In § 300.65(d)(1)(i), the location and deadlines for submitting charter logbook data sheets are revised to match State regulations that allow the data sheets to be submitted to any regional or area ADF&G office within a specified amount of time from when the fishing activity occurred. The Federal deadlines are changed from those presented in the proposed rule as a result of comments received, and are further described in the section “Changes from the Proposed Rule.”

3. Paragraph (d)(1)(iii) is added to § 300.65 and replaces paragraphs (d)(2)(iv)(B)( 4 ) and (d)(3) of this section, which are removed. The new paragraph retains the requirement to complete and submit separate logbook data sheets for each regulatory area if halibut were caught and retained in IPHC Regulatory Areas 2C and 3A during the same charter vessel fishing trip. The instruction for recording the IPHC regulatory area fished on the data sheet is revised because of recent changes by the State to the data sheet format. Minor changes were made to the regulatory text presented in the proposed rule as a result of comments received. These changes are described in the section “Changes from the Proposed Rule.”

4. Section 300.65(d)(2)(iv) is revised to clarify recordkeeping and reporting requirements, and to more accurately reflect the intent of this regulation. These revisions were not included in the proposed rule, and are discussed under the heading “Changes from the Proposed Rule.”

5. Two additional revisions are necessary because of the revised data sheet format. The final rule revises the instruction, in § 300.65(d)(2)(iv)(A), regarding the location of the charter vessel angler's signature on the data sheet and eliminates the requirement, in § 300.65(d)(2)(iv)(B)( 1 ), to record the sport fishing operator business license number on the data sheet as the revised data sheet no longer includes this field.

In the final rule, the following regulatory and technical changes are made from the proposed rule. These changes clarify the Federal regulations and increase consistency between the Federal and State charter logbook recordkeeping and reporting requirements.

1. A definition of “Fishing week” is added to § 300.61. The State's charter logbook submission deadlines are based on the week that the fishing activity occurs for fishing activity conducted on or after the first Monday in April through December 31. Therefore, to ensure consistency between the Federal and State charter logbook submission requirements, a definition of “Fishing week” that corresponds to the State's usage is added to § 300.61 to clarify the Federal submission deadlines specified in § 300.65(d)(1)(i).

2. In response to comments from ADF&G ( see comment 1 under “Comments and Responses” section), the charter logbook data sheet submission deadlines in § 300.65(d)(1)(i) are changed to match the State deadlines. These deadlines were implemented previously with the final rule implementing the one-halibut daily bag limit for charter vessel anglers in IPHC Area 2C (74 FR 21194; May 6, 2009). As stated in the preamble to the proposed rule for that final rule, the “logbook data sheets would be required to be submitted to the appropriate ADF&G office according to the time schedule described in the instructions at the beginning of the logbook” (74 FR 78279; December 22, 2008). However, neither the deadlines originally implemented nor the revisions proposed in the proposed rule for this final rule, matched the State's schedule. The instructions and submission schedule in the ADF&G charter logbook require that data sheets be submitted no later than the second Monday in April for fishing activity that occurs prior to the first Sunday in April, and no later than 14 days after the first day of the week in which the fishing activity occurred for fishing activity that occurs on or after the first Monday in April through December 31.

The final rule changes the deadline dates in § 300.65(d)(1)(i) to match the State's deadlines, and changes the event on which the deadlines are based from the date the charter vessel fishing trip ends to when the halibut are caught and retained. Although the phrase “fishing activity” is used in the charter logbook instructions to identify the event that triggers the deadline, the final rule uses “when the halibut were caught and retained,” as the regulations in § 300.65(d) are applicable only to guided halibut fishing. These changes from the proposed rule will not create an additional reporting burden on charter vessel operators because they are already required by the State to meet these deadlines.

3. In response to comments from ADF&G ( see comment 3 under “Comments and Responses” section), revisions are made to the regulatory text in § 300.65(d)(1)(iii). These revisions use the language suggested by ADF&G in their letter of comment and do not change the requirements in this paragraph from those presented in the proposed rule. The final rule continues to require that separate charter logbook data sheets be completed for IPHC Area 2C and Area 3A if halibut were caught and retained in both regulatory areas during the same charter vessel fishing trip. The final rule also continues to require that the completed data sheets for each IPHC regulatory area must indicate the primary statistical area in which the halibut were caught and retained.

4. Section 300.65(d)(2)(iv) is revised to clarify the recordkeeping and reporting requirements and to more accurately reflect the intent of this regulation. Paragraph (d)(2)(iv) describes the Federal recordkeeping and reporting requirements that must be complied with by each charter vessel angler and charter vessel guide onboard a vessel in IPHC Area 2C if halibut were caught and retained. These requirements were originally added in the 2009 final rule, which implemented the one-halibut daily bag limit for charter vessel anglers in IPHC Area 2C (74 FR 21194; May 6, 2009). As discussed in the preamble to the proposed rule for that rule, these requirements are necessary to enforce that rule (73 FR 78279; December 22, 2008).

This final rule adds language to the introductory text in paragraph (d)(2)(iv) to specify that these requirements must be complied with by the end of the day or by the end of the charter vessel fishing trip, whichever comes first. As this additional regulatory text is applicable to all of paragraph (iv), paragraphs (d)(2)(iv)(A) and (B) are revised to eliminate redundant language and to clarify the recordkeeping and reporting requirements. The additional text corresponds to requirements in the charter logbook instructions, which specify that the logbook data page must be completed at the end of each trip or, for multiple-day trips, at the end of each day. The additional text is consistent with the original intent of the regulation (74 FR 21194; May 6, 2009). Ensuring that data is recorded contemporaneously or as close as possible to the action being recorded will help enforcement personnel identify violations, and will lead to more reliable logbook data and more accurate estimates of guided charter harvests.

The proposed rule was published in the Federal Register on April 27, 2010 (75 FR 22070), with a 15-day comment period that ended on May 12, 2010. NMFS received a total of two letters. One letter was from an individual and contained comments that were outside the scope of this action. The second letter, which was submitted by ADF&G, supported the objectives of this action and recommended changes to the regulatory text. A summary of the comments from ADF&G and NMFS' responses follows.

Comment 1: The proposed rule states, “The submission deadline for a charter vessel fishing trip ending April 5 through December 31, during which halibut were retained, would be extended from 7 to 14 days after the end of the trip.” This change to the submission deadlines for trips ending between April 5 and December 31 would remain inconsistent with state requirements, being more liberal than state regulations whenever a trip ended on a Tuesday through Sunday.

A possible result of implementing these regulatory changes is that charter operators fishing after early April could be cited by the state for overdue logbooks, even though they would be in compliance with Federal submission requirements.

The proposed rule also states, “The submission deadline for data sheets for a charter vessel fishing trip ending February 1 through April 4, during which halibut were retained, would be submitted no later than April 12.” While this requirement is consistent with the ADF&G logbook submission requirements for 2010, it will remain inconsistent in most other years unless regulations are revised annually. ADF&G logbook submission requirements are different early in the year (February 1 through early April) and later in the year (after early April). The cutoff date for this early period is the first Sunday in April; therefore, the date can change every year.

Charter operators fishing in early April could be cited under state or Federal rules during most years when state and Federal logbook submission deadlines are inconsistent.

Response: NMFS agrees with the comment. As one objective of this rule is to improve consistency between Federal and State charter logbook data sheet submission requirements, this final rule revises the Federal deadlines in § 300.65(d)(1)(i) to match the State deadlines. A definition of “Fishing week” is added in § 300.61 to clarify the deadlines for submitting the data sheets. These changes are described in the section “Changes from the Proposed Rule.”

Comment 2: ADF&G revised statistical areas along the boundary between IPHC Regulatory Areas 2C and 3A so that regulatory areas where halibut were caught and retained can be identified. ADF&G updated the maps to reflect the revised statistical areas, and has been distributing the updated maps with logbooks to Southeast Alaska charter operators. Charter businesses are being advised to use only maps with the year 2010 printed on them.

Response: NMFS notes that ADF&G has updated the statistical area maps and is distributing these to Southeast Alaska charter operators. As described in the proposed rule, because the updated charter logbook maps are available to charter vessel operators, this rule removes § 300.65(d)(2)(iv)(B)( 4 ) and § 300.65(d)(3) and adds § 300.65(d)(1)(iii) to instruct how to record halibut caught and retained in IPHC Regulatory Areas 2C and 3A.

Comment 3: The proposed rule states, “This paragraph [§ 300.65(d)(1)(iii)] would require the charter vessel guide to record on the charter vessel logbook data sheets the primary ADF&G statistical area where halibut were caught and retained.” The requirement that all operators in Area 2C or Area 3A report the statistical area where halibut were caught contradicts the instructions and examples provided in the 2010 ADF&G charter logbook. ADF&G logbook instructions require operators to report the statistical area where most of the salmon or bottomfish (not halibut specifically) were caught or targeted. Operators are instructed to report a salmon statistical area if salmon were targeted, a bottomfish statistical area if bottomfish were targeted, and both a salmon and bottomfish statistical area if both were targeted. Operators are not required under State rules to report the statistical area where halibut or any other bottomfish are caught incidentally while targeting salmon. State rules do not require operators to report the statistical area of halibut harvest specifically. In many, but not all cases, halibut are likely to be the primary bottomfish species caught.

For example, if a vessel targets salmon but incidentally catches a few halibut, the operator is instructed to report the primary statistical area where salmon were targeted, and the number of boat hours fished for salmon. They are not required to report the statistical area of the halibut harvest. Likewise, if a vessel targeted lingcod and a few halibut were caught incidentally, the operator would be required to report the primary statistical area where most bottomfish (not specifically halibut) were targeted. In many cases it would be the same statistical area, but not necessarily so.

Response: Section 300.65(d)(1)(iii) requires that if halibut are caught and retained in IPHC regulatory Area 2C and Area 3A during the same charter vessel fishing trip, a separate charter logbook data sheet must be completed for each IPHC regulatory area, to record the halibut kept in each IPHC regulatory area. As the State's revisions to the data sheet eliminated the field to record the IPHC regulatory area, § 300.65(d)(1)(iii) requires that the data sheets for each IPHC regulatory area must indicate the primary statistical area where the halibut were caught and retained. This information is necessary to identify the IPHC regulatory area where the halibut were caught and retained. The final rule revises § 300.65(d)(1)(iii) to use regulatory language suggested by ADF&G in their letter of comment, but does not change the requirements in this paragraph from those presented in the proposed rule.

Comment 4: ADF&G supports the requirement for vessels that harvest halibut in both Area 2C and Area 3A on a given trip to complete a separate logbook page for each regulatory area to associate halibut harvest with the appropriate IPHC regulatory area. This requirement is included on page vi of the 2010 ADF&G charter logbook instructions.

Response: NMFS notes the support for this requirement.

Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the Council, and the Secretary. Section 5 of the Halibut Act allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The Halibut Act at section 773c(a) and (b) provides the Secretary with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act. The Secretary has delegated his Halibut Act authority to NMFS. This action is consistent with the North Pacific Halibut Act and other applicable laws.

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

A final regulatory flexibility analysis (FRFA) was prepared, which describes the economic impact of this final rule on small entities. The FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA and NMFS' responses to those comments, if any, and a summary of the analyses completed to support the action. A copy of the FRFA is available from NMFS ( see ADDRESSES ). A description of this action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble.

The IRFA was described in the Classification section to the proposed rule, and the public was notified of how to obtain a copy of the IRFA. The public comment period ended on May 12, 2010. No comments were received on the IRFA or on the economic impacts of the rule.

This action increases consistency between Federal and State charter logbook recordkeeping and reporting requirements for halibut charter vessels operating in IPHC Area 2C and Area 3A and is expected to impose de minimis costs. The only substantive change (modification of regulatory limits on directly regulated entities) revises requirements on the location and time frame for submission of logbook data sheets for charter vessel fishing trips during which halibut were caught and retained.

This action only affects halibut charters operating in IPHC Area 2C and Area 3A. Based on State charter logbook data, NMFS estimates that 404 business entities will be directly regulated by this action in Area 2C, and that 450 business entities will be directly regulated by this action in Area 3A. The Secretary has published a final rule that will implement limited entry in the Pacific halibut guided sport charter fisheries in Areas 2C and 3A (75 FR 554, January 5, 2010). NMFS expects that when the limited entry program is fully implemented in 2011, the number of business entities directly regulated by this action will be 231 in Area 2C and 296 in Area 3A.

The largest of these business entities, which are lodges, may be large entities under Small Business Act (SBA) standards, but that determination cannot be empirically confirmed at present. Therefore, these operations are treated as small entities for the purpose of this analysis. All the other charter operations are also considered small entities, based on SBA criteria, since they are believed to have gross revenues of less than $7.0 million on an annual basis, from all sources, including affiliates.

The FRFA did not identify any new projected reporting, recordkeeping, and other compliance requirements associated with these regulatory changes. It is expected that by conforming the Federal regulatory requirements with those of the State, affected entities will see increased efficiencies and decreased costs of compliance for both sets of rules.

The FRFA did not reveal any Federal rules that duplicate, overlap, or conflict with the proposed action.

There is no alternative to the proposed action that would accomplish its goals of conservation of the halibut resource and that would have a smaller burden on directly regulated small entities. Of the two alternatives considered, this action and status quo, the regulatory burden under status quo would be higher because the public would need to comply with two different sets of regulatory requirements. This action reduces the regulatory burden by increasing consistency between the Federal and State recordkeeping and reporting requirements, which minimizes the potential negative impacts that could arise under status quo.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, NMFS Alaska Region has developed an Internet site that provides easy access to details of this final rule, including a link to the final rule and links to additional information and regulations applicable to guided sport fishing for halibut in Alaska. The relevant information available on the Web site is the Small Entity Compliance Guide. The Web site address is http://www.alaskafisheries.noaa.gov/sustainablefisheries/halibut/sport.htm. Copies of this final rule are available upon request from the NMFS Alaska Regional Office ( see ADDRESSES ).

This final rule contains a collection of information requirement subject to the Paperwork Reduction Act (PRA), which has been approved by the Office of Management and Budget (OMB) under control number 0648-0575. The public reporting burden for charter vessel guide respondents to fill out and submit logbook data sheets is estimated to average four minutes per response. The public reporting burden for charter vessel anglers to sign the logbook is estimated to be one minute per response. These estimates include the time required for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS ( see ADDRESSES ) and by e-mail to OIRA_Submission@omb.eop.gov or fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

For the reasons set out in the preamble, 50 CFR part 300 is amended as follows: