Background

In an interim rule  1 effective on September 29, 2006, and published in the Federal Register on October 3, 2006 (71 FR 58252-58254, Docket No. APHIS-2006-0145), we amended the bovine tuberculosis regulations regarding State and zone classifications in 9 CFR part 77 by raising the designation of Texas from modified accredited advanced to accredited-free. The interim rule was based on our determination that Texas met the criteria for designation as an accredited-free State.

Comments on the interim rule were required to be received on or before December 4, 2006. We received one comment by that date, from a private citizen. The commenter stated his belief that if his herd of cattle is tested, then all neighboring herds should be tested to ensure that all cattle in the area are free of tuberculosis. We noted in the interim rule that State animal health authorities in Texas have demonstrated to us that the State meets the criteria for accredited-free status set forth in the definition of accredited-free State or zone in § 77.5 of the tuberculosis regulations. Those criteria include a requirement for zero percent prevalence of affected cattle or bison herds.

Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

Examining the Docket

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain EMBRAER Model ERJ 170 and ERJ 190 airplanes. That NPRM was published in the Federal Register on August 21, 2006 (71 FR 48490). That NPRM proposed to require repetitive inspections to detect damaged smoke seals in the aft avionics compartment, repair/replacement if any damage is found, and reinforcement if no damage is found. That AD also proposed to require eventual replacement of all smoke seals in the aft avionics compartment with new, improved seals having new part numbers, which would terminate the repetitive inspections.

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

EMBRAER states that an AD does not apply in this case because there is no unsafe condition associated with this failure mode. EMBRAER explains that the smoke seals in the aft avionics compartment are installed to demonstrate compliance with section 25.831(c) of the Federal Aviation Regulations (14 CFR 25.831(c)). EMBRAER states that the configuration of the smoke seals was approved during the ERJ 170/190 certification campaign, based on the procedures established by Advisory Circular AC 25-9A (“Smoke Detection, Penetration, and Evacuation Tests and Related Flight Manual Emergency Procedures”), dated January 6, 1994, which, in part, provides guidelines for conducting certification tests relating to smoke detection, penetration, and evacuation. EMBRAER states that the smoke penetration test was carried out under critical conditions with a very large amount of smoke, and confirmed that the smoke seal is an efficient smoke barrier. EMBRAER also states that the potential source of smoke coming from the aft avionics compartment is residual smoke coming from the electronic equipment, which is designed not to generate fire. Therefore, EMBRAER states that no fire event is expected in the region, only a small amount of smoke.

EMBRAER also addresses the damage on the smoke seal and states that all of the reported cases most likely happened during maintenance. EMBRAER states that these small damaged areas would not prevent the smoke seal from working satisfactorily as a smoke barrier, and that even in case of an unexpected smoke generation in the area, only a small amount of smoke would enter the passenger compartment. EMBRAER points out that the presence of smoke wisps in the passenger compartment was considered in the environmental system safety assessment, and that there are crew actions defined to mitigate this condition.

We disagree that an AD does not apply in this case. EMBRAER has not provided sufficient technical justification that damaged smoke seals in the aft avionics compartment of the affected airplanes are not a potentially serious safety problem. Specifically, EMBRAER does not state whether it has performed smoke penetration testing with damaged or worn seals. EMBRAER also does not state if it has performed flight testing or only ground testing for smoke penetration. Finally, EMBRAER states that it has defined crew actions to mitigate wisps of smoke entering the cabin but does not refer to a documented cabin smoke evacuation procedure in the airplane flight manual to support this claim.

We have determined that an unsafe condition exists, and that issuing an AD is the appropriate way to correct an unsafe condition. In addition, Agencia Nacional de Aviação Civil (ANAC), which is the airworthiness authority for Brazil, issued Brazilian airworthiness directives 2006-05-04 (for Model ERJ 170 airplanes) and 2006-05-07 (for Model ERJ 190 airplanes), both effective June 14, 2006, to address the subject unsafe condition. ANAC has not withdrawn their airworthiness directives, and has not advised us that it plans to do so. If EMBRAER can provide additional information to substantiate its statements, we may consider further rulemaking then. We have not changed the AD in this regard.

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

MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the Federal Register needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under part 21 of the Federal Aviation Regulations (14 CFR part 21), section 21.303 (parts manufacturer approval (PMA)). MARPA adds that the concept of brevity is now nearly archaic, as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS.

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

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

MARPA also states that type certificate holders in their service documents universally ignore the possible existence of PMA parts. MARPA states that this is especially true with foreign manufacturers where the concept may not exist or be implemented in the country of origin. MARPA points out that the service document upon which an airworthiness directive is based frequently will require removing a certain part-numbered part and installing a different part-numbered part as a corrective action. According to MARPA, this runs afoul of section 21.303 (“Parts Manufacturer Approval”) of the Federal Aviation Regulations (14 CFR 21.303), which permits the development, certification, and installation of alternatively certified parts.

MARPA further states that installing a certain part-numbered part to the exclusion of all other parts is not a favored general practice. MARPA states that such an action has the dual effect of preventing, in some cases, the installation of a perfectly good part; while at the same time prohibiting the development of new parts permitted under section 21.303. According to MARPA, such a prohibition runs the risk of taking the AD out of the realm of safety and into the world of economics, since prohibiting the development, sale, and use of a perfectly airworthy part has nothing to do with safety. MARPA states that courts could easily construe such actions as being outside the statutory basis of the AD (safety) and, as such, unenforceable. MARPA adds that courts are reluctant to find portions of a rule unenforceable since they lack the knowledge and authority to re-write requirements, and are thus generally inclined to simply void the entire rule.

We infer that MARPA would like the AD to permit installation of any equivalent PMA parts so that it is not necessary for an operator to request approval of an alternative method of compliance (AMOC) in order to install an “alternatively certified” PMA part. Whether an alternative part resolves the unsafe condition can be determined only on a case-by-case basis, based on a complete understanding of the unsafe condition. We are not currently aware of any such parts. Our policy is that, in order for operators to replace a part with one that is not specified in the AD, they must request an AMOC. This is necessary so that we can make a specific determination that an alternative part is or is not susceptible to the same unsafe condition.

In response to MARPA's statement regarding running afoul of section 21.303 of the Federal Aviation Regulations (14 CFR 21.303), under which the FAA issues PMAs, this statement appears to reflect a misunderstanding of the relationship between ADs and the certification procedural regulations of 14 CFR part 21. Those regulations, including section 21.303, are intended to ensure that aeronautical products comply with the applicable airworthiness standards. But ADs are issued when, notwithstanding those procedures, we become aware of unsafe conditions in these products or parts. Therefore, an AD takes precedence over design approvals when we identify an unsafe condition, and mandating installation of a certain part number in an AD is not at variance with section 21.303.

The AD provides a means of compliance for operators to ensure that the identified unsafe condition is addressed appropriately. For an unsafe condition attributable to a part, the AD normally identifies the replacement parts necessary to obtain that compliance. As stated in section 39.7 of the Federal Aviation Regulations (14 CFR 39.7), “Anyone who operates a product that does not meet the requirements of an applicable airworthiness directive is in violation of this section.” Unless an operator obtains approval for an AMOC, replacing a part with one not specified by the AD would make the operator subject to an enforcement action and result in a civil penalty. No change to the AD is necessary in this regard.

MARPA also points out that the NPRM, as written, does not comply with proposed Order 8040.2 (AD Process for Mandatory Continuing Airworthiness Information (MCAI)), which states in the PMA section: “MCAI that require replacement or installation of certain parts could have replacement parts approved under 14 CFR § 21.303 based on a finding of identicality. We have determined that any parts approved under this regulation and installed should be subject to the actions of our AD and included in the applicability of our AD.”

MARPA states that in this case, certain seals have been determined to be defective and must be replaced with parts not containing the identified defect. MARPA has reviewed both the MARPA PMA database and the FAA's database for possible PMA alternatives to the defective seals, and found none. MARPA states that this does not guarantee that such parts do not now exist or may not exist in the future and believes the proposed regulatory action should address the possibility that there are or will be PMA parts matching those determined not to be airworthy. MARPA has noted that the FAA frequently states its policy of identifying defective parts only when they are known, but MARPA is of the opinion that the FAA's state of mind is irrelevant when constructing enforceable regulatory actions. MARPA believes that incorporating the language specified in proposed FAA Order 8040.2 should adequately address this concern.

MARPA points out that the Small Airplane Directorate has developed a blanket statement that resolves this issue. The statement includes words similar to that in the proposed Order 8040.2. MARPA also points out that the Engine and Rotocraft Directorates avoid the issue by specifying “airworthy parts” be installed, leaving the determination of exactly which parts to the discretion of the installer.

MARPA further states that because the NPRM differs markedly in treatment of this issue from that of the other directorates, the mandates contained in Section 1, paragraph (b)(10) of Executive Order 12866 are not being met. This paragraph requires that all agencies act uniformly on a given issue. MARPA therefore requests that we take steps to bring the universe of PMA parts under the appropriate scope of this AD both with respect to possible defective PMA parts and the use of possible present or future approved parts.

We infer that MARPA would like the Transport Airplane Directorate to include words similar to those quoted from proposed Order 8040.2 in our ADs. We disagree. The order has been approved and released as Order 8040.5 (AD Process for Mandatory Continuing Airworthiness Information (MCAI)), dated September 29, 2006. The approved order does not include the requested language.

MARPA also requests that we append the language in paragraph (f)(2) of the NPRM to add the following words, “or FAA-approved equivalent part number.” MARPA contends that the addition of those words would remove any possible conflict with 14 CFR 21.303 that may be raised with respect to the unmodified text in paragraph (f)(2) of the NPRM.

We recognize the need for standardization on this issue and currently are in the process of reviewing it at the national level. The Transport Airplane Directorate considers that to delay this particular AD action would be inappropriate, since we have determined that an unsafe condition exists and that replacement of certain parts must be accomplished to ensure continued safety. Therefore, no change has been made to the final rule in this regard.

We have revised the applicability of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

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

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

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

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 737-200, -300, -400, and -500 series airplanes. That NPRM was published in the Federal Register on October 6, 2005 (70 FR 58358). That NPRM proposed to require a one-time inspection of frames between station 360 and station 907 to determine if a subject support bracket for the air conditioning outlet extrusion is installed, and related repetitive investigative actions and repair if necessary. That NPRM also proposed to provide an optional preventive modification that would end the repetitive investigative actions. That NPRM also proposed to require a one-time post-modification/repair inspection for cracking of each repaired/modified frame.

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

KLM Royal Dutch Airlines (KLM), and the Air Transport Association (ATA), on behalf of United Airlines (UAL) and US Airways, ask that the compliance time for the inspection be changed to coincide with scheduled maintenance checks.

UAL notes that the 6,000-flight-cycle interval for the post-modification/repair inspection (between 18,000 and 24,000 flight cycles) does not fall into a compatible maintenance opportunity. UAL states that, when given the opportunity by Boeing to review the preliminary service bulletin, the requirement for this inspection was “within 30,000 flight cycles.” UAL asks if there is an alternative inspection method, such as an open hole eddy current inspection, which would extend the 6,000-flight-cycle repetitive inspection interval to 9,000 flight cycles to align with a heavy maintenance check.

US Airways adds that the repeat inspection interval will have an adverse impact on operations. US Airways also adds that the repeat inspection interval seems to be arbitrary and unreasonable, and it imposes undue costs to the airline. US Airways has been addressing this issue since 1999, and notes that the existing maintenance program currently has a repeat inspection interval of 12,500 flight hours or approximately 9,375 flight cycles for the inspection for frame cracks in this location. US Airways adds that the inspection program has proven adequate to find and repair these cracks before they have an adverse impact on the structural integrity of the airplane. US Airways concludes that the increased inspection interval mentioned previously also minimizes impact to fleet operations, while still maintaining a sufficient level of safety. US Airways requests that the repeat inspection interval be increased to align with the existing scheduled heavy maintenance visits.

KLM states that page 3 of the NPRM, under “Relevant Service Information,” specifies a compliance time of 5,000 flight cycles after the date of the service bulletin for the initial inspection, and an interval of 6,000 flight cycles for the repetitive inspections. KLM adds that the inspection is applicable to all frames, which amounts to 35 frames on the left- and right-hand sides, for a total of 70 inspection areas on a Boeing Model 737-300 airplane. Due to the extent of this work, the inspection in the NPRM must be accomplished during a planned maintenance check, preferably a D-check when the support brackets are accessible. Based on the current inspection interval, the inspection must be accomplished during a C-check, which necessitates additional work. KLM asks if we have considered possible cycle interval changes in order to relieve the economic burden of this inspection.

We agree with the commenters' request to extend the inspection interval. We have worked with Boeing to expand the standard analysis methodology to better model service experience. The new analysis methodology allows for longer compliance times and longer grace periods for airplanes that did not have lower row lap splice cracking concerns.

The new compliance times are identified in paragraph 1.E., “Compliance,” of Revision 1 of Boeing Special Attention Service Bulletin 737-53-1216, dated June 8, 2006. The new compliance times for the initial general visual, medium frequency eddy current (MFEC) and high frequency eddy current (HFEC) inspections, as applicable, are prior to the accumulation of 40,000 total flight cycles, or within 5,000 or 9,000 flight cycles (depending on the airplane configuration) after issuance of the service bulletin, whichever occurs later. The service bulletin specifies a repetitive interval (for all subject frames) of 9,000 flight cycles. We have reviewed the procedures in Revision 1 and have determined that they are essentially the same as those in the original issue of the service bulletin (which was referenced in the NPRM). The effectivity section in Revision 01 shows changes of airplane operators; however, Revision 01 does not necessitate additional work. Therefore, we have revised this AD to refer to Revision 1 of the service bulletin as the appropriate source of service information for accomplishing the required actions at the new extended compliance times. We have also added a statement to paragraph (l) of this AD that gives credit for actions accomplished before the effective date of this AD in accordance with the original issue of the service bulletin.

Southwest Airlines (SWA) requests that we consider an alternative inspection method—an external detailed visual inspection—that would extend the grace period from 5,000 flight cycles to a total of 10,000 flight cycles, particularly for airplanes that are not susceptible to multi-site damage. SWA notes that the areas of inspection are not easily accessible as those areas are located behind the overhead bins. SWA adds that the majority of operators do not have convenient scheduled maintenance visits that result in access to the interior area behind the overhead bins within a span of 5,000 or 6,000 flight cycles. SWA suggests revising the repetitive inspection requirements (every 6,000 flight cycles) to longer thresholds (every 10,000 flight cycles) for airplanes over 30,000 flight cycles, provided that the external inspections are being accomplished. SWA proposes an alternative inspection option for those airplanes that are not susceptible to multi-site damage, as follows:

• Airplanes with less than 40,000 total flight cycles.

• Airplanes on which Boeing Service Bulletin 737-53A1177, Revision 6, has been done for lap joint repairs, including window belt replacements.

• Airplanes having line numbers 2553 and above, on which the lower row of fasteners of the stringer 10 lap joint is not susceptible to cracking.

SWA provided an example of an alternative compliance/inspection table, which could be used for airplanes having over 30,000 flight cycles.

We agree partially with the commenter's request. As stated previously under “Request to Extend Certain Compliance Times,” we have changed the compliance time in the AD to allow for better maintenance scheduling for operators. However, in order for operators to accomplish an inspection that is not specified in the AD, they must request and receive approval of an alternative method of compliance (AMOC) in accordance with paragraph (m) of this AD. This is necessary so that we can make a specific determination that an alternative inspection does or does not address the identified unsafe condition. If, after reviewing the changes included in this AD, SWA still wants to pursue the alternative inspection proposal, it can request an AMOC.

Boeing asks that the second sentence in paragraph (f) of the NPRM be changed to eliminate the reference to “part number (P/N) 65C7021.” Boeing reiterated the wording in that sentence and suggested it be changed to read, “Subject support brackets are attached to the frame with two rivets.” Boeing states that this change is required because the P/N may not be visible or even exist on the bracket, but the brackets can be easily identified by the number of fasteners attaching them to the frame. The structural detail of concern in the referenced service bulletin is the two fastener attachments. There are some air conditioning brackets (not having P/N 65C7021-( )) attached to the frame with three or more fasteners, but there is no known cracking at these locations.

We agree with the commenter's request for the reasons provided by the commenter. We have changed paragraph (f) of this AD accordingly.

ATA, on behalf of Alaska Airlines, requests clarification of inspection requirements. Alaska states that the NPRM is not clear on the inspection requirements for the subject frames, and asks that clarification be provided in the final rule. Alaska also asks if access/identification of the brackets at the frame locations specified in the referenced service bulletin is required.

In addition, Alaska asks for clarification of the requirements for the optional preventive modification specified in paragraph (i) of the NPRM. Alaska states that the frames that do not require inspection may have two rivet attachments.

We agree that clarification is needed for the reason provided by the commenter. The frames between stations 360 and 907 that have a support bracket with a two-rivet configuration attached need to be identified and inspected. The specific bracket does not need to be identified by part number. Inspection of the frames at stations 540, 663.75, 685, and 727 is not necessary. In addition, inspection of the frames at stations 616 and 601 on Model 737-200/-300/-400/-500 airplanes and the frames at stations 578 and 601 on Model 737-400 airplanes is not necessary. These frames are not susceptible to cracking at the bracket attachment. The optional preventive modification is not necessary for frames not susceptible to cracking. We have revised paragraph (f) of this AD to clarify the frames that do require an inspection. The change for paragraph (f) of this AD also clarifies the provision for the optional preventive modification as specified in paragraph (i) of this AD.

United Airlines (UAL) states that neither the referenced service bulletin nor the NPRM addresses the disposition of a frame that has been repaired previously per the structural repair manual (SRM). UAL adds that inspection requirements are included in the service bulletin, but the corrective action necessary for cracking found during an inspection of a frame repaired previously per the SRM is not included. In addition, an option to install a new repair on a frame that was repaired previously per the SRM in order to end the repetitive inspection requirement is not included.

We agree partially with the commenter. We infer that the commenter wants further instruction on corrective action for discrepancies found in previously repaired frames and an option to install a new repair on those frames. We understand that installation of the generic frame repairs described in the SRM may vary extensively, depending on the original damage being repaired; however, guidelines do not exist to allow evaluation of these frame repairs for appropriate follow-on action. We agree that guidelines could be created that would allow the operator to evaluate the frame repair that is installed currently for appropriate follow-on actions. Such guidelines could be evaluated for issuance of an AMOC. Operators may request approval of an AMOC for repairs that are not identified in this AD under the provisions of paragraph (m)(1) of this AD. We have made no change to the AD in this regard.

ATA, on behalf of Delta Airlines (DAL), states that on August 20, 2002, Boeing issued All Operator Message M-7200-02-01292. The message specifies accomplishing medium frequency eddy current inspections of affected brackets for airplanes with less than 30,000 total flight cycles, or within 5,000 flight cycles after issuance of the message, whichever occurred later. The inspections are to be repeated every 6,000 flight cycles (except where repairs or modifications were installed). The message also describes typical repairs and a terminating modification. DAL adds that neither the NPRM or the referenced service bulletin refer to the message or to the inspections and repairs accomplished per the message. DAL notes that this is a serious omission, as operators have been accomplishing inspections and repairs per the message during the twenty-eight months between issuance of the message and issuance of the referenced service bulletin. DAL states that credit for inspection/repairs and modifications accomplished in accordance with the message should be given in the AD.

We agree with the commenter's request for the reasons provided. We have reviewed Boeing Communication M-7200-02-01292, dated August 20, 2002, and find that the procedures therein are essentially the same as the procedures specified in the referenced service bulletin. Therefore, we have added a new paragraph (j) to the AD, and re-identified subsequent paragraphs, to give credit for actions accomplished before the effective date of this AD per the Boeing communication. The Boeing communication does not specify any post repair or modification inspection, therefore, operators are still required to accomplish those actions required by paragraph (k) of this AD.

KLM, and ATA, on behalf of UAL and U.S. Airways, ask that the work hours included in the Costs of Compliance section of the NPRM be increased.

UAL states that there is an enormous amount of open-up required to do the inspection that is not taken into account in the Costs of Compliance section of the NPRM.

US Airways states that the cost section does not accurately reflect the actual cost of the NPRM to the airline industry. U.S. Airways notes that the frames between station 360 and station 907 are affected by the subject inspection and encompass essentially all of section 43 and section 46 of the airplane. Passenger seats, passenger service units, overhead bins, and sidewall liners must be removed to accommodate the inspection. This excessive teardown of the interior passenger cabin will add considerable downtime to this inspection. These interior passenger cabin items are not routinely removed at the intervals required by the initial inspection, nor the repeat inspection intervals (6,000 flight cycles), identified by the NPRM. Additionally, the Costs of Compliance section does not reflect an accurate time required to perform repairs should any cracks be found. U.S. Airways requests that the Costs of Compliance section be revised to accurately reflect the impact this NPRM would have on the industry by including factors for interior tear down and assembly for the initial and repeat inspections, plus a more accurate downtime cost incurred to accomplish repairs.

KLM states that the work hours specified for the preventive modification and repair specified in the Costs of Compliance section are conservative. The estimated costs are based upon the inspection itself, while all activities to gain access to the support brackets are not taken into account. KLM adds that the work hours required to gain access in accordance with the referenced service bulletin are conservative when taking into account that passenger seats, service units, overhead stowage bins, and sidewall lining need to be removed. KLM requests that a more realistic number of work hours be specified in the Costs of Compliance section.

We do not agree with the commenters' requests. The cost information below describes only the direct costs of the specific actions required by this AD. Based on the best data available, the manufacturer provided the number of work hours (2 work hours per frame) necessary to do the required actions. This number represents the time necessary to perform only the actions actually required by this AD. We recognize that, in doing the actions required by an AD, operators may incur incidental costs in addition to the direct costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs such as the time required to gain access and close up, time necessary for planning, or time necessitated by other administrative actions. Those incidental costs, which may vary significantly among operators, are almost impossible to calculate. We have not changed the AD in this regard.

We do not agree that the on-condition costs specified in the NPRM for time required to perform repairs if any cracks are found is inaccurate. As we noted above, the information provided by the manufacturer is the latest information we have, and that information has been used as the time required to perform repairs. We have not changed the AD in this regard.

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

There are about 2,131 airplanes of the affected design in the worldwide fleet. This AD affects about 938 airplanes of U.S. registry. The inspection to identify subject support brackets, and subsequent MFEC and HFEC inspections take about 2 work hours per frame, with approximately 32 to 45 frames to be inspected per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is between $3,902,080 and $5,487,300, or between $4,160 and $5,850 per airplane.

The following table provides the estimated costs for U.S. operators to comply with the inspections of each frame for cracking, the preventive modification, and the repair specified in this AD, at an average labor rate of $65 per work hour. Note that the estimated cost specified in the table is per frame, not per airplane, as it is unknown how many frames on each airplane will have a subject bracket installed.

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

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

Examining the Docket

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2005-06-08, amendment 39-14016 (70 FR 13345, March 21, 2005). The existing AD applies to all Airbus Model A330, A340-200, and A340-300 series airplanes. That NPRM was published in the Federal Register on July 19, 2006 (71 FR 40942). That NPRM proposed to continue to require repetitive inspections of a certain bracket that attaches the flight deck instrument panel to the airplane structure; replacement of the bracket with a new, improved bracket; and related investigative and corrective actions if necessary. The NPRM also proposed to add a requirement for replacement of the existing bracket with a titanium-reinforced bracket, which would end the repetitive inspections in the existing AD. The NPRM also proposed to require related investigative and corrective actions while accomplishing the replacement, and to reduce the applicability in the existing AD.

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

Airbus suggests that the referenced service bulletins in paragraph (k) of the NPRM be added to the applicability in paragraph (c) of the NPRM. Airbus states that airplanes modified in service would then be excluded from the applicability after the service bulletins are done.

We disagree with Airbus. The applicability of European Aviation Safety Agency (EASA) airworthiness directives 2006-0045 and 2006-0047, both dated February 16, 2006, excludes airplanes on which Airbus Service Bulletins A330-25-3249 and A340-25-4245, both dated May 3, 2005, have been accomplished in service. However, we have not excluded those airplanes in the applicability of the AD; rather, the AD includes a requirement to accomplish the actions specified in those service bulletins. This requirement will ensure that the actions specified in the service bulletins and required by this AD are accomplished on all affected airplanes. Operators must continue to operate the airplane in the configuration required by this AD unless an alternative method of compliance (AMOC) is approved. We have made no change to the AD in this regard.

Airbus suggests that paragraph (k) of the NPRM refer to Airbus (inspection) Service Bulletins A330-25-3227 and A340-25-4230, both Revision 01, both dated May 3, 2005, to avoid confusion with Airbus (modification) Service Bulletins A330-25-3249 and A340-25-4245, both dated May 3, 2005.

We agree with Airbus. We have changed paragraph (f) of this AD to limit the (inspection) service bulletin reference to paragraphs (g), (h), and (i) of this AD. In addition, we have changed paragraph (k) of this AD to refer to (modification) Airbus Service Bulletins A330-25-3249 and A340-25-4245, both dated May 3, 2005.

Airbus also suggests that the description of the related investigative and corrective actions specified in parenthesis in paragraph (k) be expanded, for clarification, to include the horizontal beam.

We do not agree with Airbus. The description in parenthesis is informational only; there is no need to expand it further as the description is not meant to be all inclusive. We have made no change to the AD in this regard.

Airbus recommends removing the reference to titanium-reinforced brackets having part number (P/N) F2511305220096, as specified in paragraph (k) of the NPRM. Airbus states that referring to a specific part number for the replacement brackets may suggest that no other part number is acceptable. Airbus adds that, if a new or upgraded part is released in the field (illustrated parts catalog), installation of a new part number may lead to operator requests for information for the difference between the part number specified in the NPRM and any new part number. Airbus notes that this information would be technical documentation for demonstration of continued conformity to the AD. Airbus concludes that recording application of the referenced service bulletin should be adapted for compliance with the NPRM.

We do not agree with Airbus. Replacement of brackets, as specified in paragraph (k) of this AD, is to be accomplished in accordance with the Accomplishment Instructions of Airbus Service Bulletins A330-25-3249 and A340-25-4245, both dated May 3, 2005. Each of these service bulletins provides instructions for removal of the old bracket and installation of the new, reinforced bracket having P/N F2511305220096. Any other part number for the bracket, even if upgraded from those in the subject service bulletins, will need to be approved as an AMOC to paragraph (k) of this AD, in accordance with the requirements in paragraph (l) of this AD. We have made no change to the AD in this regard.

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

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

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

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

MARPA states that type certificate holders in their service documents universally ignore the possible existence of PMA parts. According to MARPA, this is especially true with foreign manufacturers where the concept may not exist or be implemented in the country of origin. MARPA states that frequently the service bulletin upon which an AD is based will require the removal of a certain part number and the installation of a different part number as a corrective action. MARPA states that this practice runs afoul of section 21.303 (“Replacement of modification parts”) of the Federal Aviation Regulations (14 CFR 21.303), which permits the development, certification, and installation of alternatively certified parts (PMA). MARPA states that mandating the installation of a certain part number to the exclusion of all other parts is not a favored general practice. According to MARPA, such action has the dual effect of preventing, in some cases, the installation of perfectly good parts, while at the same time prohibiting the development of new parts permitted under 14 CFR 21.303. MARPA states that such a prohibition runs the risk of taking the AD out of the realm of safety and into the world of economics since prohibiting the development, sale, and use of a perfectly airworthy part has nothing to do with safety. MARPA adds that courts could easily construe such actions as being outside the statutory basis of the AD (safety), and thus unenforceable. MARPA concludes that courts are reluctant to find portions of a rule unenforceable since they lack the knowledge and authority to rewrite requirements, and are generally inclined to void the entire rule.

In addition, MARPA believes that the practice of requiring an AMOC to install a PMA part should be stopped. MARPA states that this is somehow tantamount to illogically stating that all PMA parts are inherently defective and require an additional layer of approval when the original equipment manufacturer (OEM) part is determined to be defective. MARPA suspects that FAA personnel who diligently labored to certify the PMA part might disagree with such a narrow, OEM slanted view. MARPA adds that if the PMA part is defective then it must be deemed so in the AD, and not simply implied by a catch-all AMOC requirement. MARPA states that it has repeatedly requested that language be adopted to trap such defective parts. MARPA suggests that, to accomplish this, the Transport Airplane Directorate adopt the language used by the Small Airplane Directorate. MARPA adds that this action, as written, does not comply with proposed FAA Order 8040.2, which requires replacement or installation of certain parts, could have replacement parts approved under Federal Aviation Regulation 14 CFR 21.203, based on a finding of the part being identical.

MARPA also points out that another AD issued from a Directorate other than the Transport Airplane Directorate contains a blanket statement that resolves the PMA issue by adding the phrase, “or FAA-approved equivalent P/N” to the part number mandated to be installed. MARPA requests that the FAA modify the NPRM to include this language.

The NPRM did not address PMA parts, as provided in draft FAA Order 8040.2, because the Order was only a draft that was out for comment at the time. After issuance of the NPRM, the Order was revised and issued as FAA Order 8040.5 with an effective date of September 29, 2006. FAA Order 8040.5 does not address PMA parts in ADs.

The FAA recognizes the need for standardization of this issue and is currently in the process of reviewing issues that address the use of PMAs in ADs at the national level. However, the Transport Airplane Directorate considers that to delay this particular AD action would be inappropriate, since we have determined that an unsafe condition exists and that replacement of certain parts must be accomplished to ensure continued safety. Therefore, no change has been made to the AD in this regard.

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

This AD affects about 24 Model A330 series airplanes of U.S. registry.

The inspections that are required by AD 2005-06-08 and retained in this AD take about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the currently required actions is $80 per airplane, per inspection cycle.

The new replacement and investigative actions take about 9 work hours per airplane, at an average labor rate of $80 per work hour. Required parts will cost about $330 per airplane. Based on these figures, the estimated cost of the new actions specified in this AD for U.S. operators is $25,200, or $1,050 per airplane.

There are currently no affected Model A340-200 and -300 series airplanes of U.S. registry. However, if one of these airplanes is imported and put on the U.S. Register in the future, these cost estimates will also apply to those airplanes.

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

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

Modern Veterinary Therapeutics, LLC, 18301 SW. 86th Ave., Miami, FL 33157, filed ANADA 200-435 that provides for use of RESPIRAM (doxapram hydrochloride), an injectable solution, in dogs, cats, and horses to stimulate respiration during and after general anesthesia. Modern Veterinary Therapeutics, LLC's RESPIRAM is approved as a generic copy of DOPRAM-V Injectable, sponsored by Fort Dodge Animal Health, Division of Wyeth, under NADA 034 879. The ANADA is approved as of November 21, 2006, and the regulations are amended in 21 CFR 522.775 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

In addition, Modern Veterinary Therapeutics, LLC, has not been previously listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this firm.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to NADA 141-120 that provides for the veterinary prescription use of CLOMICALM (clomipramine hydrochloride) Tablets for treatment of separation anxiety in dogs. The supplement provides for a 5-milligram tablet size of clomipramine hydrochloride. The supplemental NADA is approved as of November 22, 2006, and 21 CFR 520.455 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit NJ 07901, filed a supplement to NADA 141-206 for NUFLOR (florfenicol) 2.3% Concentrate Solution used to make medicated drinking water for administration to swine for the treatment of respiratory disease associated with several bacterial pathogens. The supplemental NADA revises the nomenclature for a respiratory pathogen in the label claim. The supplemental NADA is approved as of December 8, 2006, and the regulations in 21 CFR 520.955 are amended to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed NADA 141-260 for SLENTROL (dirlotapide) Oral Solution. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity. The application is approved as of December 12, 2006, and the regulations are amended in 21 CFR part 520 by adding new § 520.666 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning December 12, 2006.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed NADA 141-267 for DEXDOMITOR (dexmedetomidine hydrochloride). The NADA provides for the veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs. The application is approved as of December 1, 2006, and 21 CFR part 522 is amended by adding new § 522.558 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under § 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning December 1, 2006.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed a supplement to NADA 141-033 for ANTISEDAN (atipamezole hydrochloride), an injectable solution approved for reversal of the sedative and analgesic effects of medetomidine hydrochloride in dogs. The supplemental NADA adds a claim for reversal of sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs. The application is approved as of December 1, 2006, and the regulations are amended in 21 CFR 522.147 to reflect the approval and a current format.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and effectiveness data and information submitted to support approval of these applications may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning December 1, 2006.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 9-782 for NOLVASAN (chlorhexidine acetate) Antiseptic Ointment, approved as a topical antiseptic for superficial wounds of dogs, cats, and horses. The supplemental NADA provides for a revised food safety warning on labeling. The supplemental application is approved as of November 28, 2006, and the regulations are amended in 21 CFR 524.402 to reflect the approval and a current format.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

On January 20, 2006, the State of Tennessee, through TDEC, submitted revisions to the Knox County portion of the Tennessee SIP to include changes to KCAQR Section 46.0—“Regulation of Volatile Organic Compounds.” The change adds four compounds to the list of those excluded from the definition of VOC on the basis that they make a negligible contribution to ozone formation. The definition in Section 46.0, now reads that 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (n-C 3 F 7 OCH 3 , HFE-7000), 3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethy) hexane (HFE-7500), 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea) and methyl formate (HCOOCH 3 ) will be considered to be negligibly reactive. Notably, as part of the January 20, 2006, submittal, the State of Tennessee requested that EPA approve changes to the Knox County portion of the Tennessee SIP to reflect changes made to KCAQR Section 26.0—“Permits,” and Section 45.0—“Prevention of Significant Deterioration.” EPA is not taking action on these rules at this time, but will address them in the future.

Tropospheric ozone occurs when VOC and nitrogen oxides (NO X ) react in the atmosphere. Because of the harmful health effects of ozone, EPA regulations limit the amount of VOC and NO X that can be released into the atmosphere. VOC are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides, or carbonates, and ammonium carbonate) which, in addition to NO X , form ozone through atmospheric photochemical reactions. Compounds of carbon (i.e., or organic compounds) have different levels of reactivity. As a result, they do not react at the same speed, and do not form ozone to the same extent.

In accordance with EPA policy, compounds of carbon with a negligible level of reactivity need not be regulated to reduce ozone (see, 42 FR 35314, July 8, 1977). EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these negligibly reactive compounds in its regulations at 40 CFR 51.100(s), and excludes them from the definition of VOC. EPA may periodically revise the list of negligibly reactive compounds to add or delete compounds from the list.

On November 29, 2004 (69 FR 69298), EPA finalized a rule approving the addition of the four compounds that were added to KCAQR Section 46.0., to the list of those excluded from the definition of VOC. The instant SIP submittal is consistent with EPA's rule change in November 2004.

EPA is taking direct final action to approve the January 20, 2006, SIP revision submitted by TDEC regarding changes to KCAQR Section 46.0—“Regulation of Volatile Organic Compounds.” These changes are at least as stringent as the corresponding federal regulations. As a result, the revision is approvable pursuant to section 110 of the CAA.

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

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on March 5, 2007 and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. As a result, it does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

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

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

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On June 3, 2005, ICAPCD's Architectural Coatings Rule was found to meet the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review. And on November 22, 2005, SCAQMD's Organic Liquid Storage Rule was found to meet the completeness criteria in 40 CFR Part 51, Appendix V.

We approved a version of ICAPCD Rule 424 into the SIP on May 3, 1984. There are no later versions of Rule 424 in the SIP although ICAPCD adopted revisions to the SIP approved version of Rule 424 on September 14, 1999, and CARB submitted it to us on May 26, 2000. We approved a revised version of SCAQMD Rule 463 into the SIP on October 23, 1996. No later versions were submitted to us. While we can act on only the most recently submitted version, we have reviewed materials provided with previous submittals.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Rule 424, Architectural Coatings, controls emissions of VOCs from various categories of coatings. Rule 463, Organic Liquid Storage, controls emissions of VOCs from above-ground storage tanks used for storage of organic liquids. Rule 424 was extensively revised to match the Suggested Control Measure (SCM) for Architectural Coatings approved by CARB on June 22, 2000. The SCM is a model rule which seeks to provide statewide consistency for the regulation of architectural coatings. The SCM was reviewed by EPA during its development. This revision adopts all provisions of the SCM except the special provisions for industrial maintenance coatings (relevant only in certain northern California air districts) and the averaging provisions. The revisions submitted to SCAQMD Rule 463 would amend several definitions, allow the use under certain circumstances of an alternative vapor control device, removes the hydrogen sulfide concentration standard for crude oil stored in a floating roof tank, and add language to enhance enforceability of the requirements for various organic compounds through the use of vapor pressure information. Rule 463 revisions also include language amending the reporting and recordkeeping requirements, to allow the use of alternative test methods under certain circumstances, to remove a requirement to use a test method for meeting the hydrogen sulfide standard, and to add test methods for determining true vapor pressure and API gravity. EPA's technical support documents (TSD) have more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for VOC sources covered by a Control Technique Guideline (CTG) and for major sources in nonattainment areas (see section 182(a)(2)(A) and 182(b)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). ICAPCD and SCAQMD regulate ozone nonattainment areas (see 40 CFR part 81). However, because ICAPCD Rule 424 regulates sources that are not covered by a CTG and that are nonmajor area sources, they are not subject to CAA RACT requirements.

Guidance and policy documents that we use to help evaluate specific enforceability and RACT requirements consistently include the following:

1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook).

3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

4. CARB's “Suggested Control Measures for Architectural Coatings” (June 22, 2000).

5. The National Volatile Organic Compound Emission Standard for Architectural Coatings (40 CFR Part 59, Subpart D).

6. “Control of Volatile Organic Emissions from Petroleum Liquid Storage in External Floating Roof Tanks,” EPA-450/2-78-047.

7. “Control of Volatile Organic Emissions from Storage of Petroleum Liquid in Fixed Roof Tanks,” EPA-450/2-77-036.

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSDs have more information on our evaluation.

The TSDs describe additional rule revisions that do not affect EPA's current action but are recommended for the next time the local agency modifies the rules.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by February 5, 2007, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on March 5, 2007. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This emergency closure was implemented at the request of the FDA after samples of shellfish from the inshore and offshore waters off of the coasts of New Hampshire and Massachusetts tested positive for the toxins (saxotoxins) that cause Paralytic Shellfish Poisoning (PSP). These toxins are produced by the algae Alexandrium fundyense that can form blooms commonly referred to as red tides. Red tide blooms, also known as harmful algal blooms (HABs), can produce toxins that accumulate in filter-feeding shellfish. Shellfish contaminated with the toxin, if eaten in large enough quantity, can cause illness or death from PSP.

On June 10, 2005, the FDA requested that NMFS close an area of Federal waters off the coasts of New Hampshire and Massachusetts to fishing for bivalve shellfish intended for human consumption. On June 16, 2005, NMFS published an emergency rule (70 FR 35047) closing the area recommended by the FDA, i.e. , the Temporary PSP Closure Area, through September 30, 2005. On July 7, 2005 (70 FR 39192), the emergency rule was modified to facilitate the testing of shellfish for the toxin that causes PSP by the FDA and/or FDA-approved laboratories through the issuance of a Letter of Authorization (LOA) from the Regional Administrator. On September 9, 2005 (70 FR 53580), the emergency regulation was once again modified by the division of the Temporary PSP Closure Area into northern and southern components. The northern area remained closed to the harvest of all bivalve molluscan shellfish while the southern component was reopened to the harvest of Atlantic surfclams and ocean quahogs but remained closed to the harvest of whole or roe-on scallops. The rule was extended as published on September 9, 2005, on October 3, 2005 (70 FR 57517), reinstated on October 18, 2005 (70 FR 60450) to correct a technical error, extended on December 28, 2005 (70 FR 76713), and subsequently on June 30, 2006 (71 FR 37505), through December 31, 2006. On December 27, 2006, the FDA indicated that they could not support the re-opening of the Temporary PSP Closure Area due to insufficient analytical data from the area.

The boundaries of the northern component of the temporary closure area comprise Federal waters bound by the following coordinates in the order stated: (1) 43°00′ N. lat., 71°00′ W. long.; (2) 43°00′ N. lat., 69°00′ W. long.; (3) 41°39′ N. lat., 69°00′ W. long.; (4) 41°39′ N. lat., 71°00′ W. long., and then ending at the first point. Under this emergency rule this area would remain closed to the harvest of Atlantic surfclams, ocean quahogs, and whole or roe-on scallops. The boundaries of the southern component of the temporary closure area comprise Federal waters bound by the following coordinates in the order stated: (1) 41°39′ N. lat., 71°00′ W. long.; (2) 41°39′ N. lat., 69°00′ W. long.; (3) 40°00′ N. lat., 69°00′ W. long.; (4) 40°00′ N. lat., 71°00′ W. long., and then ending at the first point. Under this temporary emergency rule, this southern component of the area would remain closed only to the harvest of whole or roe-on scallops.

This action is issued pursuant to section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1855(c) (Magnuson-Stevens Act). The original emergency closure was in response to a public health emergency. Pursuant to section 305(c)(3)(C) of the Magnuson-Stevens Act, the closure to the harvest of shellfish, as modified on September 9, 2005, and re-instated on October 18, 2005, may remain in effect until the circumstances that created the emergency no longer exist, provided the public has had an opportunity to comment after the regulation was published, and, in the case of a public health emergency, the Secretary of Health and Human Services concurs with the Commerce Secretary's action. During the initial comment period, June 16, 2005, through August 1, 2005, no comments were received. One comment was received after the re-opening of the southern component of the Temporary PSP Closure Area on September 9, 2005. The commenter expressed reluctance to re-opening a portion of the closure area without seeing the results of the FDA tests. Data used to make determinations regarding closing and opening of areas to certain types of fishing activity are collected from Federal, state, and private laboratories. NOAA maintains a Red Tide Information Center ( http://www.cop.noaa.gov/news/fs/ne_hab_200605.html ) which can be accessed directly or through the Web site listed in the ADDRESSES section. Information on test results, modeling of algal bloom movement, and general background on red tide can be accessed through this information center. While NMFS is the agency with the authority to promulgate the emergency regulations, it modified the regulations on September 9, 2005, at the request of the FDA, after the FDA has determined that the results of its tests warranted such action. If necessary, the regulations may be terminated at an earlier date, pursuant to section 305(c)(3)(D) of the Magnuson-Stevens Act, by publication in the Federal Register of a notice of termination, or extended further to ensure the safety of human health.

The rule, as last published on October 18, 2005, was determined to be not significant for the purposes of Executive Order 12866.