Section 707 of the Energy Policy Act of 2005 (Pub. L. 109-58) amended the list of excluded vehicles in section 301(9) of the Energy Policy Act of 1992 (Pub. L. 102-486, 42 U.S.C. 13211(9)) to add a new category of vehicles. Excluded vehicles are not counted when determining if an entity is covered and also are not counted when determining a covered entity's annual alternative fueled vehicle acquisition requirements. The vehicles excluded by this amendment are “* * * vehicles directly used in the emergency repair of transmission lines and in the restoration of electricity service following power outages * * *.”

Written requests for exclusion will be evaluated by DOE and considered on a case-by-case basis. Under this process, the requesting entity must justify that its vehicles are used directly in repair/restoration activities. DOE's review is expected to take no more than 45 days from the time sufficient information is provided to make a decision. Based upon DOE's decision, the requesting party will know how many vehicles it can then exclude (subtract) from its covered light-duty vehicle count, which is used to calculate its annual requirements.

A. Background

On July 11, 2005, SBA published a proposed rule in the Federal Register, 70 FR 39667, to solicit comments on its proposal to promulgate regulations required by the Small Business Reauthorization and Manufacturing Assistance Act of 2004 (reauthorization Act), signed into law on December 8, 2004. Pub. L. 108-447, Division K, 118 Stat. 2809-644 (2004). The statute reauthorized SBA's cosponsorship authority, provided SBA with authority to conduct and charge fees for certain SBA-sponsored activities (Fee Based SBA-Sponsored Activities), and expanded SBA's authority to use certain gift funds for marketing and outreach activities. The statute also made significant changes to the approval process for outreach activities and gift acceptance. With this new authority added to its continuing authority under section 8(b)(1)(a) of the Small Business Act, the Agency has three major vehicles by which it may provide information, training, and/or conduct marketing and outreach for the benefit of or to small businesses: Cosponsored Activities, Fee Based SBA-Sponsored Activities, and Non-Fee Based SBA-Sponsored Activities.

To facilitate these activities and to implement the recent statutory changes, SBA proposed adding part 106 to title 13 of the Code of Federal Regulations. The proposed regulations defined each of these vehicles and set forth the minimum requirements applicable to each. In addition, the proposed regulations set forth minimum requirements and the conflict of interest authority for solicitation and acceptance of gifts under certain Agency gift authorities.

These rules were published as proposed rules on July 11, 2005 in the Federal Register, (70 FR 39667-39672). Comments were solicited in that publication and could be submitted by mail, electronic means, or hand delivery/courier.

No comments were received by e-mail, facsimile, TDD, mail or courier. However, in reviewing the proposed regulations, the Agency noted a redundancy in Paragraphs (d)(1) and (d)(2) of Sections 106.302 and 106.402. In the final regulations, Paragraph (d)(1) of each of the proposed sections, which stated, “SBA will not unnecessarily promote a Donor, or the Donor's products or services” will be deleted. Paragraphs (d)(2) and (d)(3) of each proposed Section will be renumbered (d)(1) and (d)(2) respectively in the final regulations. Therefore, we are publishing the final rule with these minor technical changes.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, for the purposes of Executive Order 13132, SBA determines that this final rule has no federalism implications warranting preparation of a federalism assessment.

The Office of Management and Budget (OMB) has determined that this rule does not constitute a significant regulatory action under Executive Order 12866.

This action meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have retroactive or preemptive effect.

SBA has determined that this final rule does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act, 44 U.S.C., Chapter 35.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601, requires administrative agencies to consider the effect of their actions on small entities, small non-profit enterprises, and small local governments. Pursuant to the RFA, when an agency issues a rulemaking, the agency must prepare a regulatory flexibility analysis which describes the impact of the rule on small entities. However, section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. In this case, the final regulations address the administrative requirements for Agency management of SBA outreach programs. In other words, this final rule will not result in the direct regulation of small entities, so no further analysis is required by the RFA. Therefore, SBA certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of RFA.

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 2001-10-01, amendment 39-12226 (66 FR 24049, May 11, 2001), for certain EMBRAER Model EMB-135 and EMB-145 series airplanes. That NPRM was published in the Federal Register on January 12, 2005 (70 FR 2057). That NPRM proposed to continue to require revising the airplane flight manual (AFM) to prohibit in-flight auxiliary power unit (APU) starts, and installing a placard on or near the APU start/stop switch panel to provide such instructions to the flightcrew. That NPRM also proposed an optional revision to the AFM that allows limited APU starts and a terminating action.

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.

One commenter requests that the applicability be revised to refer to Model T-62T-40C14 as APS 500R. The commenter states that the commercial model designation for APU model T-62T-40C14 is APS 500R. The “S” in APS 500R is not a typographical error, as stated in the NPRM, and is the correct nomenclature.

We agree with the commenter and have revised the applicability of the final rule. This revision does not change the number of airplanes affected by the final rule.

One commenter requests that the description of P/N 120-45060-001 in the second paragraph of the “Relevant Service Information” section of the NPRM be revised. The commenter states that “flush-type APU air inlet” should be revised to “flush-type air inlet frame.”

We agree with the commenter that the part is a flush-type air inlet frame and we have revised paragraph (g) of the final rule to specify installing a “flush-type APU air inlet frame.” We have not revised the “Relevant Service Information” section, as that section is not restated in the final rule.

Two commenters request that the NPRM refer to the latest revision of EMBRAER Service Bulletin 145-49-0018. One commenter states that EMBRAER Service Bulletin 145-49-0018, Change 03, dated January 3, 2002 (referenced as the appropriate source of service information for accomplishing the actions specified in paragraph (h) of the NPRM) should be replaced with Change 04, dated November 26, 2002. The other commenter states that Revision 8 is the latest revision of the service bulletin.

We agree to revise the final rule to reference EMBRAER Service Bulletin 145-49-0018, Change 04, dated November 26, 2002, which is the latest revision. The procedures in Change 04 of the service bulletin are essentially the same as those in Change 03 of the referenced service bulletin. We have also added Change 03 of the service bulletin to paragraph (k) of the final rule to state that actions accomplished before the effective date of this AD per Change 03 of the service bulletin are acceptable for compliance with the requirements of this final rule.

Two commenters request that, where the NPRM refers to P/N 145-48999-401 as a flush-type air inlet, the reference should be revised to say a raised-type APU air inlet frame. One commenter states that EMBRAER Service Bulletin 145-49-0018 (referenced as the appropriate source of service information for accomplishing the actions specified in paragraph (h) of the NPRM) refers to P/N 145-48999-401 as a raised-type APU air inlet frame. In addition, the service bulletin describes P/N 145-52453-401 as a raised-type APU air inlet frame.

We agree with the commenters. Both part numbers are raised-type APU air inlet frames that may be installed in accordance with EMBRAER Service Bulletin 145-49-0018, Change 04, dated November 26, 2002. We have revised paragraph (h) of the final rule to specify installing a “raised-type APU air inlet frame.”

Two commenters request that the NPRM refer to the latest revision of EMBRAER Service Bulletin 145-49-0009. One commenter states that EMBRAER Service Bulletin 145-49-0009, Change 07, dated September 1, 2002 (referenced as the appropriate source of service information for accomplishing the actions specified in paragraph (i) of the NPRM) should be replaced with Change 08, dated September 1, 2003. One commenter also notes that the NPRM did not give credit for actions done in accordance with previous issues because Change 07 of the service bulletin contains additional actions. The commenter states that the only difference in Change 07 is that it mentions the new APU exhaust silencer P/N 4503801C. The commenter also points out that AD 2004-23-09, amendment 39-13864 (69 FR 65535), mandates the modification of the APU exhaust silencer to P/N 4503801C. Thus, the commenter requests that operators be given credit for previous issues of the service bulletin.

We agree to revise paragraph (i) of the final rule to reference EMBRAER Service Bulletin 145-49-0009, Change 09, dated April 12, 2005, which is the latest revision. The procedures in Change 09 of the service bulletin are essentially the same as those in Change 07 of the service bulletin. We have also added Change 03 through Change 08 of the service bulletin to paragraph (k) of the final rule to state that actions accomplished before the effective date of this AD per those revisions of the service bulletin are acceptable for compliance with the corresponding requirements of this final rule.

One commenter requests that AMOC paragraph (l)(2) of the NPRM be revised to allow previous AMOCs to be approved for paragraphs (g) and (h) (in addition to paragraph (f)). The commenter states that the modifications to the APU inlet and exhaust already approved as AMOCs for AD 2001-10-01 ensure a positive pressure differential from forward to aft through the compartment, preventing any exhaust flame from propagating forward into the APU compartment. The commenter understands that the AMOCs are also terminating action for paragraphs (g) and (h), not requiring additional action from the operators.

We do not agree to revise paragraph (l)(3) of the final rule (specified as paragraph (l)(2) in the NPRM). Not all existing AMOCs for AD 2001-10-01 are terminating action for paragraphs (g) and (h). The existing AMOCs have various configurations and service bulletins that are acceptable for compliance with just the revisions, with the revisions and part of the terminating action, or with the terminating action. We have determined that the best way to handle such circumstances is for operators to request an AMOC in accordance with paragraph (l) of the final rule, rather than increasing the complexity of the AD by addressing each existing AMOC's unique situation. We have not revised the final rule in this regard.

Two commenters request that the NPRM be revised to reference P/Ns or configurations and service bulletins that could be AMOCs. One commenter references multiple AMOCs for AD 2001-10-01 that would be acceptable for compliance for (f), (g), and (h) of the NPRM. The commenter suggests eliminating the reference to the service bulletin in paragraph (h) and listing all acceptable P/Ns for the raised-type APU air inlet frame and revising paragraph (i) of the NPRM to reference either the exhaust silencer or the extended or new exhaust pipes. The commenter contends these changes would address the unsafe condition.

The other commenter notes that the correct configuration of the airplane can be achieved through various revisions of several service bulletins and includes several AMOCs for AD 2001-10-01. This commenter suggests that the NPRM reference the part number 145-48999-401 or 145-52452-401 (or later approved part numbers) and a silencer measurement of 1300 millimeters on C14 APU equipped aircraft. As an alternative to these changes, the commenters suggest that the NPRM should list all configurations and service bulletin versions that are an optional means of terminating the NPRM. The commenter states that either one of its suggestions allow operators to operate their aircraft without having to incur additional and excessive expenses.

We disagree with the request to revise the final rule to reference P/Ns or configurations and service bulletins that could be AMOCs. As stated in the response to the previous comment, due to the number and complexity of AMOCs for AD 2001-10-01 and the revisions to the various service bulletins, we cannot list every configuration that could be terminating action for paragraph (g) and/or paragraph (h) of the final rule. We also cannot list part numbers because terminating action must be done in a method approved by us or in accordance with service information we have reviewed. However, operators may request an AMOC in accordance with paragraph (l) of the final rule. We have not revised the final rule in this regard.

One commenter suggests that U.S. operators be polled to find out if any operator is flying airplanes without the desired configuration. The commenter states that if all operators' airplanes are in the desired configuration, then the NPRM may be withdrawn. The commenter notes that this suggestion has been done on other NPRMs prior to this one.

We do not agree with the commenter. We have not received confirmation that all U.S. operators are in compliance with the requirements of the final rule. Even if the current U.S.-registered fleet is in compliance with the requirements of the final rule, the issuance of the rule is still necessary to ensure that any affected airplane imported and placed on the U.S. register in the future will be required to be in compliance as well. Unless the manufacturer advises us that all of the affected airplanes worldwide have been modified, it is possible that an airplane could be imported to the U.S. in the future without being in compliance with the final rule.

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

We have also revised certain references to the service bulletins in the final rule to clarify that the actions are done in accordance with the accomplishment instructions of the service bulletins.

We have also made minor editorial changes to the format of the tables in the final rule.

We have revised this final rule to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

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

The following table, using an estimated labor rate of $65 per work hour, 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 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 767-300 series airplanes. That NPRM was published in the Federal Register on March 17, 2005 (70 FR 12986). That NPRM proposed to require replacing the frequency converters used to supply power for medical outlets with modified frequency converters, and related actions.

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.

One commenter, the manufacturer, requests that we revise the release date of the service bulletin referenced in the NPRM. The commenter states that the correct reference is Boeing Service Bulletin 767-25-0334, Revision 1, dated June 19, 2003.

We agree. We inadvertently referenced the incorrect release date of Boeing Service Bulletin 767-25-0334, Revision 1. Therefore, we have revised paragraphs (c) and (f) of this AD to include the correct release date.

The same commenter requests that we revise the “Summary” and “Relevant Service Information” sections of the NPRM to specify that the affected frequency converters are also used for supplying power to galley utility outlets.

We agree. We have revised the “Summary” section and paragraph (f) of this AD to clarify that the affected frequency converters are used to supply power to “* * * medical and galley utility outlets * * *.” However, since the “Relevant Service Information” section of the preamble does not reappear in the final rule, we have not made that change.

A second commenter, an operator, requests that we include an option to remove and deactivate the affected frequency converters and wiring, instead of replacing the affected frequency converters. The commenter states that it is not currently using the medical outlets and has removed the affected frequency converters from its airplanes. The commenter also states that, if the medical outlets are later reactivated, the NPRM should require installing modified frequency converters.

We agree that removing and deactivating the affected frequency converters is adequate for addressing the unsafe condition of this AD. We have moved the proposed requirement to replace the affected frequency converters to new paragraph (f)(1) of this supplemental NPRM and have added new paragraph (f)(2) to this supplemental NPRM, which gives operators the option of deactivating the affected frequency converters. Before a deactivated frequency convert can be re-installed on an airplane, paragraph (f)(2) also would require modifying the affected frequency converters in accordance with Boeing Service Bulletin 767-25-0334, Revision 1, dated June 19, 2003.

A third commenter requests that we identify the model and part number of the affected frequency converters in the NPRM. The commenter states that the parts manufacturer of the affected frequency converters produces parts both as an original equipment manufacturer (OEM) supplier and as a direct seller under a PMA. The commenter asserts that, since parts manufacturers are encouraged to use different part numbers for PMA and OEM parts, a PMA part identical to the OEM part, but having a different part number, might be installed on an airplane. The commenter requests that the NPRM account for any PMA parts that might contain the same deficiencies as an OEM part and be installed in its place.

We do not concur with the commenter's request. Our available information indicates that any existing PMA frequency converter installed on any affected airplane retains the OEM original part number and, therefore, would be required to be removed in accordance with the Boeing service bulletin referenced in this AD as the appropriate source of service information. Once the existing parts are removed, the operator must replace it with the part numbers specified in the service bulletin in order to be in compliance with this AD. No change to the final rule is necessary in this regard.

Regarding the commenter's request to address PMA part numbers in ADs, in general, the Transport Airplane Directorate currently is in the process of reviewing this issue as it applies to transport category airplanes. Once we have thoroughly examined all aspects of this issue and have made a final determination, we will consider whether our policy regarding addressing PMA parts in ADs needs to be revised. We consider that to delay this 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 carefully reviewed the available data, including the comments that have been received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 55 airplanes of the affected design in the worldwide fleet. This AD affects about 54 airplanes of U.S. registry. The actions in this AD take about 1 work hour per frequency converter, at an average labor rate of $65 per work hour. There are about 2 frequency converters per airplane. Based on these figures, the estimated cost of the AD for U.S. operators is $7,020, or $130 per airplane.

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 737-600, -700, -700C, and -800 series airplanes. That NPRM was published in the Federal Register on November 24, 2004 (69 FR 68268). That NPRM proposed to require inspecting/measuring the length of the attachment fasteners between the nacelle support fittings and the lower wing skin panels, and related investigative/corrective actions if necessary.

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

One commenter supports the actions described in the NPRM.

One commenter, the manufacturer, notes that there is an error in the variable numbers listed in the effectivity of Boeing Service Bulletin 737-57-1275, dated September 4, 2003 (which was referenced as the appropriate source of service information for accomplishing the proposed actions). The commenter states that this error is corrected in the next revision of the service bulletin and that correcting this error in the service bulletin will not alter the NPRM's applicability.

We agree with the commenter that the applicability of this AD is not affected by the change in variable numbers. The applicability of this AD refers to the airplane line numbers and not to the variable numbers.

Since the issuance of the NPRM, Boeing has issued Service Bulletin 737-57-1275, Revision 1, dated August 18, 2005, which contains the same procedures as the original issue along with the corrected variable numbers. Revision 1 of the service bulletin also divides the effectivity into four groups in order to provide clarification on the different fastener installation configurations. We have revised this AD to reference Revision 1 as the appropriate source of service information for accomplishing the required actions. We have also added paragraph (h) to this AD to give credit for actions done before the effective date of this AD in accordance with the original issue of the service bulletin.

One commenter notes that Figures 1 and 2 of Boeing Service Bulletin 737-57-1275, dated September 4, 2003, specify an obsolete sealant. The commenter states that the “Parts and Materials Supplied by the Operator” section of the service bulletin specifies to refer to the Qualified Parts List (QPL) at the end of the Boeing Material Specification (BMS) for supplier data; however, there is no QPL for BMS 5-26 because it is obsolete. The commenter points out that BMS 5-45 has superseded BMS 5-26.

We agree with the commenter that BMS 5-45 is the correct specification for the sealant. Boeing Service Bulletin 737-57-1275, Revision 1, dated August 18, 2005, does contain the correct references to BMS 5-45. As stated previously, we have revised this AD to reference Revision 1 as the appropriate source of service information for accomplishing the required actions. No further work is necessary for airplanes on which Boeing Service Bulletin 737-57-1275, dated September 4, 2003, was accomplished.

One commenter requests that we revise the compliance time specified in paragraph (f)(2) of the NPRM from prior to the accumulation of “30,000 flight cycles or 30,000 flight hours, whichever is first” to prior to the accumulation of “30,000 flight cycles or 37,000 flight hours, whichever is first.” The commenter states that 15 of its airplanes are not scheduled for a heavy “C” check maintenance within the 30,000-flight-hour window and the proposed compliance time would result in unnecessary financial hardship. No technical justification was provided.

We do not agree with the commenter to revise the compliance time. In developing an appropriate compliance time, we considered the safety implications, the manufacturer's recommendation, and normal maintenance schedules for timely accomplishment of the inspection. We have determined that the compliance time, as proposed, represents the maximum interval of time allowable for the affected airplanes to continue to safely operate before the inspection is done. However, paragraph (i) of this AD provides affected operators the opportunity to apply for an adjustment of the compliance time if the operator also presents data that justify the adjustment. We have not revised this AD in this regard.

Boeing Commercial Airplanes has received a Delegation Option Authorization (DOA). We have revised this AD to delegate the authority to approve an alternative method of compliance for any repair required by this AD to an Authorized Representative for the Boeing Commercial Airplanes DOA rather than a Designated Engineering Representative (DER).

We have revised this AD to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

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. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 751 airplanes of the affected design in the worldwide fleet. 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.

Discussion

We have received a report that an Airbus Model A320 series airplane landed with the nose landing gear (NLG) turned 90 degrees from centerline. The airplane landed safely with no reported injuries, but the NLG tires were quickly deflated and torn apart, and both wheels were worn up to the wheel axle. A boroscopic inspection of the NLG shock absorber upper attachment area was carried out and indicated that the upper support was damaged, which was confirmed after the NLG was torn down. Two diagonally opposite lugs were found sheared-off and one additional lug found cracked.

The cause of the NLG turning 90 degrees has been determined to be a combination of two failures: a failure of the upper support lugs, which prevented the centering cams from keeping the NLG in the center position when the shock absorber was extended and the steering system was depressurized; and a failure of the braking and steering control unit (BSCU), which prevented the normal steering system from re-centering the NLG. The NLG upper support lugs failed due to cyclic loading of the anti-rotation device by a new pre-land steering check introduced with the BSCU standard enhanced manufacturing and maintainability (EMM) software logic, combined with high shock absorber pressure. The BSCU EMM failed due to the time it takes for the steering system to re-center the NLG on airplanes equipped with a steering system powered by the green hydraulic system. Airplanes with the steering system supplied by the yellow hydraulic system are capable of re-centering the nose landing gear even with broken upper support lugs.

Airbus has issued Technical Note 957.1901/05, dated October 18, 2005, which describes procedures for performing a boroscope inspection of the NLG upper support (backplate) to detect ruptured anti-rotation lugs and repair if necessary.

Airbus has issued A318/A319/A320/A321 aircraft maintenance manual (AMM) Temporary Revision (TR) 12-001, dated November 13, 2005. The TR revises the data for Airbus A318/A319/A320/A321 AMM, Chapter 12, Subject 12-14-32, Revision 52, dated August 1, 2005, which describes procedures for checking the NLG strut inflation pressure and adjusting as applicable.

These airplane models are manufactured in France and are type-certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement.

We are issuing this AD to prevent landings with the NLG turned 90 degrees from centerline, which could result in reduced controllability of the airplane. This AD requires an inspection to determine whether certain BSCUs are installed or have ever been installed. For airplanes on which certain BSCUs are installed or have ever been installed, this AD requires a check of the NLG strut inflation pressure and an adjustment if necessary; and a boroscope inspection of the NLG upper support (backplate) to detect ruptured anti-rotation lugs, and corrective action if necessary. We consider a boroscope inspection necessary because it is the most effective means to detect a ruptured anti-rotation lug. The corrective action includes replacing the NLG with a serviceable NLG if the lugs are completely ruptured or contacting the FAA to determine whether replacement or continuing inspection is necessary if any other damage is found.

For some of these airplanes on which certain BSCUs are installed or have ever been installed, this AD also requires a revision to the aircraft flight manual to incorporate an operating procedure to recover normal steering in event of a steering failure ( i.e. when a “L/G SHOCK ABSORBER FAULT” electronic centralized aircraft monitoring (ECAM) caution is triggered at any time in flight and the “WHEEL N/W STRG FAULT” or “WHEEL N.W. STEER FAULT” ECAM cautions appear after landing gear extension).

We have worked in conjunction with the European Aviation Safety Authority (EASA) (which is the airworthiness authority for the European Union (EU) Member States) and the Direction Générale de l'Aviation Civile (DGAC) (which is the airworthiness authority for France) to develop appropriate actions that will address the identified unsafe condition. We have been advised that EASA and the DGAC are considering issuing airworthiness directives with requirements similar to the requirements of this AD.

Further, although this AD requires a one-time boroscope inspection, EASA and the DGAC have indicated that they do not plan to require the one-time boroscope inspection in their initial airworthiness directive. Rather, they have indicated that they plan to include the boroscope inspection with a longer compliance time in a follow-on airworthiness directive. EASA and the DGAC are aware of this difference, as well as the possibility that this AD may be issued earlier than their airworthiness directives on this subject.

We consider this AD interim action. The investigation into why the nose wheels were turned 90 degrees from the runway centerline is ongoing. Once we have received any further results of the investigation, we may consider additional rulemaking.

An unsafe condition exists that requires the immediate adoption of this AD; therefore, providing notice and opportunity for public comment before the AD is issued is impracticable, and good cause exists to make this AD effective in less than 30 days.

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2005-23087; Directorate Identifier 2005-NM-225-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov .

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

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 the regulation:

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

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

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

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

This amendment adopts a new AD for Boeing Model 107-II helicopters. This action requires a visual and magnetic particle inspection of the quill shaft. This amendment is prompted by the discovery of cracks in a quill shaft during a routine 700-hour TIS clutch replacement in which a magnetic particle inspection of the quill shaft was done. Investigation shows that cracking on the ends of the spline teeth of the quill shaft, around the pinhole, occurs due to a wear step in the mating pinion gear splines. These cracked spline teeth can provide stress concentrations that may lead to fatigue cracks. This condition, if not corrected, could result in separation of the quill shaft between the aft transmission and the mix box assembly, loss of rotor synchronization, and subsequent loss of control of the helicopter.

We have reviewed Boeing Service Bulletin No. 107-63-1005, Revision 1, dated April 27, 2005, which describes procedures for inspections of quill shafts, part number (P/N) 107D2067, all dash numbers. The service bulletin also specifies rejecting any quill shaft with chipped or cracked teeth or any quill shaft with a crack and, although not required by this AD, specifies measuring and recording wear in the spline of the mating pinion gear, P/N 107D2215. Also, Boeing recommends replacing unairworthy quill shafts with airworthy quill shafts, P/N 107D2067-5. These part-numbered quill shafts have been improved with a shot-peen process. However, in this AD, we are only requiring that you replace any unairworthy quill shaft with an airworthy quill shaft with any approved P/N.

This AD is an interim action which covers initial inspections of the quill shaft. We plan to follow this AD with a superseding Notice of Proposed Rulemaking (NPRM) containing longer term requirements. The NPRM will propose adding the pinion gear wear measurements specified in the service bulletin and will propose adding recurring inspections of the quill shaft. Also, because we still have not determined the cause of the wear steps in the mating pinion gear splines, we may consider further rulemaking when the cause is ultimately determined.

This unsafe condition is likely to exist or develop on other helicopters of the same type design. Therefore, this AD is being issued to detect a fatigue crack in a quill shaft and prevent separation of the quill shaft between the aft transmission and the mix box assembly, loss of rotor synchronization, and subsequent loss of control of the helicopter. This AD requires the following for a helicopter with a quill shaft, P/N 107D2067, and a pinion gear, P/N 107D2215, installed:

• Remove the aft transmission assembly, separate the mix box assembly from the aft transmission, and remove the quill shaft from the pinion gear assembly;

• Visually inspect the external spline of the quill shaft for a chipped or cracked tooth around the pinhole; and

• Magnetic particle inspect the quill shaft for a crack.

• Replace any quill shaft that has a crack or a chipped or cracked tooth with an airworthy quill shaft before further flight.

The short compliance time involved is required because these high-usage helicopters can quickly develop pinion gear wear that could lead to cracks in the quill shaft and adversely affect the structural integrity and controllability of the helicopter. Therefore, the actions described previously are required within 50 hours TIS, a short time period of about 2 weeks based on the high usage rate of these model helicopters, and this AD must be issued immediately.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

We estimate that this AD will affect 7 helicopters. We estimate that each helicopter inspection will take about 17 work hours at an average labor rate of $65 per work hour. Required parts will cost $2,500 for each quill shaft. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $10,235, assuming one quill shaft is replaced on the fleet.

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2005-23085; Directorate Identifier 2005-SW-25-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of our docket web site, you can find and read the comments to any of our dockets, including the name of the individual who sent the comment. You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

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 the regulation:

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

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

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

We prepared an economic evaluation of the estimated costs to comply with this AD. See the DMS to examine the economic evaluation.

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.

In the Federal Register of June 19, 2002 (67 FR 41642), we (FDA) published a proposed rule to describe various options for exporting an investigational new drug, including a biological product. We issued the proposed rule to implement statutory changes resulting from the FDA Export Reform and Enhancement Act of 1996 (Pub. L. 104-134, as amended by Pub. L. 104-180) and to modify a pre-existing regulatory program for exporting investigational new drugs.

Under current § 312.110(b) (21 CFR 312.110(b)), any person who intends to export an unapproved new drug product for use in a clinical investigation must have either an investigational new drug application (IND) or submit a written request to us (FDA). The written request must provide sufficient information about the drug to satisfy us that the drug is appropriate for investigational use in humans, that the drug will be used for investigational purposes only, and that the drug may be legally used by the consignee in the importing country for the proposed investigational use (see § 312.110(b)(2)(i)). The request must also specify the quantity of the drug to be shipped and the frequency of expected shipments (id.). If we authorize exportation of the drug, we notify the government of the importing country (id.). Similar procedures exist for export requests made by foreign governments (see § 312.110(b)(2)(ii)). Section 312.110(b)(3) states that the requirements in paragraph (b) apply only where the drug is to be used for the purpose of a clinical investigation. Section 312.110(b)(4) states that the requirements in paragraph (b) do not apply to the exports of new drugs approved or authorized for export under section 802 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382) or section 351(h)(1)(A) of the Public Health Service Act.

The program for exporting investigational new drugs is commonly known as the “312 program” because the regulation pertaining to the program is located in part 312 (21 CFR part 312). Between fiscal years 1994 and 1997, we received nearly 1,800 export requests under the 312 program. We found that very few requests (less than 1 percent) presented any public health concerns.

In 1996, the FDA Export Reform and Enhancement Act of 1996 became law. The FDA Export Reform and Enhancement Act created, among other things, two new provisions that affect the exportation of investigational drug products, including biological products. One provision, now section 802(b)(1)(A) of the act, authorizes exportation of an unapproved new drug to any country if that drug has valid marketing authorization by the appropriate authority in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the European Union (EU), or a country in the European Economic Area (EEA) and certain other requirements are met. These countries are listed in section 802(b)(1)(A)(i) and (b)(1)(A)(ii) of the act and are sometimes referred to as the “listed countries.” Currently, the EU countries are Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. The EEA countries are the EU countries, and Iceland, Liechtenstein, and Norway. The list of countries in section 802(b)(1)(A)(i) of the act will expand automatically if any country accedes to the EU or becomes a member of the EEA. Exports under section 802(b)(1)(A) of the act can encompass exportation of an unapproved new drug product for investigational use in a foreign country if the exported drug product has marketing authorization in any listed country and the relevant statutory requirements are met. Exports under section 802(b)(1)(A) of the act do not require prior FDA authorization.

The second provision, now section 802(c) of the act, permits exportation of unapproved new drugs intended for investigational use to any listed country in accordance with the laws of that country. Exports of drugs to the listed countries under section 802(c) of the act do not require prior FDA authorization and are exempt from regulation under section 505(i) of the act (21 U.S.C. 355(i)).

All drug products exported under section 802 of the act are, however, subject to certain general requirements. Section 802(f) of the act prohibits export if the unapproved new drug:

• Is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice (CGMP) requirements;

• Is adulterated under certain provisions of section 501 of the act (21 U.S.C. 351);

• Does not comply with section 801(e)(1) of the act (21 U.S.C. 381(e)(1)), which requires that the exported product be intended for export, meet the foreign purchaser's specifications, not be in conflict with the laws in the importing country, be labeled on the outside of the shipping package that the products are intended for export, and not be sold or offered for sale in the United States;

• Is the subject of a determination by FDA that the probability of reimportation of the exported drug would present an imminent hazard to the public health and safety of the United States;

• Presents an imminent hazard to the public health of the foreign country;

• Fails to comply with labeling requirements in the country receiving the exported drug; or

• Is not promoted in accordance with labeling requirements in the importing country and, where applicable, in the listed country in which the drug has valid marketing authorization.

Section 802(g) of the act also imposes certain recordkeeping and notification obligations on drugs exported under section 802 of the act. In the Federal Register of December 19, 2001 (66 FR 65429), we issued a final rule on these recordkeeping and notification requirements, and the rule is codified at § 1.101 (21 CFR 1.101).

The new export provisions in section 802 of the act significantly reduced the number of requests under the 312 program from an annual average of 570 requests to 200 requests. This final rule amends § 312.110 to conform to the FDA Export Reform and Enhancement Act of 1996 and to modify the 312 program.

The proposed rule would amend § 312.110 to provide four mechanisms for exporting investigational new drugs, eliminate unnecessary language in the current regulation, and modify the export requirements for the 312 program. The proposed rule would not contain any new recordkeeping requirements because such records are already required under § 312.57 (if the foreign clinical trial is under an IND) or § 1.101.

We received eight comments on the proposed rule. The comments came from seven sources: A pharmaceutical trade association, four pharmaceutical companies, one consulting firm, and one university student. In general, six comments strongly supported the rule with few or no modifications. One comment opposed exports of investigational new drugs generally, and another comment sought clarification of one statutory provision and did not address the rule itself. We address most comments in greater detail below. (We do not discuss the comment seeking a clarification of the statute because it was not directly related to the rule.) To make it easier to identify comments and our responses, the word “Comment,” in parenthesis, will appear before the comment's description, and the word “Response,” in parenthesis, will appear before our response. We have also numbered each comment to identify them more easily. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received.

Proposed § 312.110(b)(1) would represent the first mechanism for exporting an investigational new drug and would apply if the foreign clinical investigation is to be done under an IND. Proposed § 312.110(b)(1) would provide that an investigational new drug may be exported from the United States if an IND is in effect for the drug under § 312.40, the drug complies with the laws of the country to which it is being exported, and each person who receives the drug is an investigator who will use the drug in a study submitted to and allowed to proceed under the IND. Because this provision is not limited to particular countries, a drug that is the subject of an IND could be exported under the act to any country in the world if the export is for the purpose of conducting a clinical investigation in the importing foreign country. Exporters should be aware, however, that this provision, like all provisions in proposed § 312.110, pertain only to the requirements of the act. Other Federal laws, such as those relating to customs or controlled substances or barring exports to specific countries, may restrict or prohibit an export even if it would be permitted under this rule.

We received no comments on this provision and have finalized it without change.

Proposed § 312.110(b)(2) would represent the second mechanism for investigational new drug exports and would implement section 802(b)(1) of the act with respect to exports of unapproved new drugs for investigational use (although section 802(b)(1) of the act has been in effect since April 1996). Under the proposal, if a drug product that is not approved for use in the United States has valid marketing authorization in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or in any country in the EU or the EEA, the drug may be exported for any use, including investigational use, to any country, provided that the export complies with all applicable requirements pertaining to exports. Prior FDA approval to export the drug would not be required, nor would proposed § 312.110(b)(2) require the drug to be the subject of an IND. The exporter and the exported products, however, would have to comply with the foreign country's laws and with requirements in section 802(f) and (g) of the act. The proposal would also require compliance with the export notification and recordkeeping requirements § 1.101.

We received no comments on this provision and have finalized it without change.

However, regarding the export notification and recordkeeping requirements at § 1.101, we note that we received a petition for reconsideration that challenges, among other things, the recordkeeping requirement at § 1.101(b)(2). Section 1.101(b)(2) describes the records that may be kept to show that an export does not conflict with a foreign country's laws, as required by section 801(e)(1)(B) of the act. Section 1.101(b)(2) states that the records may consist of a letter from an appropriate foreign government agency stating that the product has marketing approval from the foreign government or does not conflict with the foreign country's laws or a notarized certification by a responsible company official in the United States that the product does not conflict with the foreign country's laws. In a letter dated July 22, 2002, we informed the petitioner that we would exercise enforcement discretion regarding the letter and certification described in § 1.101(b)(2), that parties must still comply with the statutory requirement in section 801(e)(1)(B) of the act, and that we would be evaluating whether to issue an advance notice of proposed rulemaking regarding the petitioner's issues (see Letter from Margaret M. Dotzel, Associate Commissioner for Policy, to Peter Barton Hutt, Covington & Burling, dated July 22, 2002; this letter can be found in FDA Docket No. 1998N-0583). We subsequently issued an advance notice of proposed rulemaking regarding the issues raised by the petitioner (see 69 FR 30842, June 1, 2004) and are continuing to evaluate the comments. We are continuing to exercise enforcement discretion regarding § 1.101(b)(2), but we remind would-be exporters that they must continue to comply with the statutory requirement in section 801(e)(1)(B) of the act and the remaining provisions in § 1.101.

Proposed § 312.110(b)(3), the third mechanism for investigational new drug exports, would implement section 802(c) of the act with respect to exports of unapproved new drugs for investigational use (although section 802(c) of the act has been in effect since April 1996). In brief, under proposed § 312.110(b)(3), if an unapproved drug is to be exported for investigational use to any listed country in accordance with the laws of that country, then no prior FDA authorization would be required. Exports of a drug for investigational use under proposed § 312.110(b)(3) would have to comply with the foreign country's laws and the applicable statutory requirements in section 802(c), (f), and (g) of the act. Proposed § 312.110(b)(3) would also require compliance with the relevant recordkeeping requirements at § 1.101.

Proposed § 312.110(b)(3) would add that investigational new drugs that are not under an IND and are exported under section 802(c) of the act do not have to bear a label stating, “Caution: New Drug-Limited by Federal (or United States) law to investigational use.” This proposed requirement reflected the fact that the label statement is required under section 505(i) of the act, and that, absent an IND, drugs exported under section 802(c) of the act are not subject to section 505(i) of the act.

The preamble to the proposed rule discussed our interpretation of section 802(c) of the act and the issue of “transshipment.” “Transshipment” refers to the practice of shipping a product to a country from which it will later be shipped to another country. We stated that we were aware that some firms have interpreted section 802(c) of the act as permitting transshipment to unlisted countries as long as the shipment went through a listed country (see 67 FR 41642 at 41643). (We knew about the firms' position on transshipment from comments we had received on a draft export guidance document that appeared in the Federal Register of June 12, 1998 (63 FR 32219).) We noted that section 802(c) of the act is silent with respect to transshipment, and a more reasonable interpretation is that the provision does not allow transshipments. We added that interpreting section 802(c) of the act to allow transshipment would be inconsistent with our traditional practice under § 312.110 and would presume, in the absence of any supporting language in the statute or its legislative history, that the listed countries may serve as mere transfer points or conduits for investigational new drugs and devices destined for unlisted countries (67 FR 41642 at 41643).

Nevertheless, because we knew that some firms insisted that section 802(c) of the act allows transshipment, the preamble to the proposed rule stated that we would interpret section 802(c) of the act as permitting investigational new drugs to be sent to principal investigators in a listed country who then use the investigational new drug in an unlisted country, provided that the principal investigator conducts the clinical investigations in accordance with the requirements of both the listed country and the unlisted country where the investigation is conducted. For example, if firm A exported an investigational new drug to principal investigator X in Norway (a listed country), we stated that we would interpret section 802(c) of the act as permitting exportation of the investigational new drug, without prior FDA authorization, as long as firm A and the exported drug met all other statutory conditions pertaining to the exportation. Principal investigator X could then administer the investigational new drug in an unlisted country so long as principal investigator X conducted the clinical investigation in accordance with Norwegian requirements and any requirements in the unlisted country where the investigational new drug is administered.

(Comment 1) Three comments disagreed with this limited transshipment position. The comments acknowledged that the law is subject to various interpretations, but argued against allowing transshipment from listed countries to unlisted countries. The comments explained that a clinical investigator may have little ability to control how a drug is moved, stored, or used “if he or she is not supported by the laws of the land” and so expecting the clinical investigator “to enforce the laws, regulations and practices of the listed country in the unlisted country (even assuming there are no contradictions between them) is, we believe, quite unrealistic and exposes the investigator, the sponsor and, not least, the patients to significant risks.” Consequently, two comments recommended that we not allow transshipment from listed countries to unlisted countries. Another comment stated that we should not allow transshipment from listed countries to unlisted countries, but then stated that transshipment of investigational new drugs should be “the responsibility of the sponsor alone.”

(Response) We have reconsidered our interpretation of section 802(c) of the act and agree that transshipment should not be permitted under section 802(c) of the act. Although our limited transshipment policy was intended to accommodate the industry, we agree with the pharmaceutical industry comments that a clinical investigator's ability to apply a listed country's laws and regulations in an unlisted country may be difficult at best. Therefore, we do not interpret section 802(c) of the act or § 312.110(b)(3) as allowing transshipment from listed countries to unlisted countries.

Furthermore, we do not agree that transshipment should be the sponsor's responsibility alone because that would mean that a sponsor could consider itself free to transship an investigational new drug regardless of our interpretation of section 802(c) of the act.

As for proposed § 312.110(b)(3) itself, we received no comments on the provision and have finalized it without change.

Proposed § 312.110(b)(4) would represent the fourth mechanism for exporting an investigational new drug and would pertain to unapproved new drugs exported to any country for investigational use without an IND, and we expected that the provision would be used by persons who intend to export a drug that does not have valid marketing authorization from a listed country for investigational use to an unlisted country. Proposed § 312.110(b)(4) would modify the 312 program by eliminating the requirement of prior FDA authorization. The proposal would require a person seeking to export an unapproved new drug for investigational use without an IND to send a written certification to us. The certification would be submitted at the time the drug is first exported and would describe the drug being exported (i.e., trade name (if any), generic name, and dosage form), identify the country or countries to which it is being exported, and affirm that various conditions or criteria had been met, such as:

• The drug is intended for export;

• The drug is intended for investigational use in a foreign country;

• The drug meets the foreign purchaser's or consignee's specifications;

• The drug is not in conflict with the importing country's laws;

• The outer shipping package is labeled to show that the package is intended for export from the United States;

• The drug is not sold or offered for sale in the United States;

• The clinical investigation will be conducted in accordance with § 312.120;

• The drug is manufactured, processed, packaged, and held in substantial conformity with CGMPs;

• The drug is not adulterated within the meaning of section 501(a)(1), (a)(2)(A), (a)(3), (c), or (d) of the act;

• The drug does not present an imminent hazard to public health, either in the United States if the drug were to be reimported or in the foreign country;

• The drug is labeled in accordance with the foreign country's laws; and

• The drug is promoted in accordance with its labeling.

The preamble to the proposed rule explained that we were proposing to accept certifications because our experience with the 312 program indicated that very few investigational new drug exports under the existing program raise any public health concerns. The certification would eliminate the requirement of prior FDA authorization of a request to export a drug for investigational use (67 FR 41642 at 41644). Additionally, by conditioning exports to unlisted countries under the 312 program on the conduct of clinical investigations in accordance with § 312.120, the use of investigational new drugs under the 312 program would be subject to internationally recognized requirements for clinical investigations (id. at 41645). The proposal would also require the exporter of the investigational new drug to retain records showing its compliance with the provision's requirements.

(Comment 2) Several comments expressed strong support for streamlining the 312 program. For example, one comment called the proposal a “bold but considered move” that would reduce administrative burdens on FDA and sponsors without waiving any significant obligations.

Three comments questioned why proposed § 312.110(b)(4)(xii) would require the exporter to certify that the investigational new drug “is promoted in accordance with its labeling.” The comments said that the requirement is unnecessary because investigational new drugs are not the subject of promotion and requested that we clarify or delete the requirement.

(Response) We agree with the comments that investigational new drugs are not to be promoted, and we have deleted the language regarding promotion from § 312.110(b)(4).

However, one comment's claim that proposed § 312.110(b)(4) would reduce administrative burdens without waiving any significant obligations prompted us to consider whether a person exporting a drug under § 312.110(b)(4) should be able to export an investigational new drug in an emergency without satisfying certain criteria. For example, in recent years, we have seen growing concern over the possible use of biological, chemical, or other weapons in a terrorist attack. These concerns have prompted interest by some foreign countries in stockpiling drugs and biological products for possible use if such an attack occurs. We have also seen the sudden emergence of new diseases, such as Severe Acute Respiratory Syndrome (SARS), and can foresee situations where a foreign country might seek importation of an investigational new drug to respond to a sudden and immediate disease outbreak. In such situations, the need to stockpile drugs or to provide potentially helpful treatment quickly to a large number of patients may be incompatible with certain criteria in § 312.110(b)(4).

Therefore, the final rule includes a new § 312.110(b)(5) to address the exportation of investigational new drugs due to a national emergency in a foreign country. New § 312.110(b)(5) contemplates two different national emergency scenarios. The first scenario, at § 312.110(b)(5)(i), provides for exportation of an investigational new drug in a foreign country to be stored for possible use if and when a national emergency in that foreign country arises. Under § 312.110(b)(5)(i), a person may export the investigational new drug under § 312.110(b)(4) and may exclude from its certification an affirmation with respect to any one or more of paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), and/or (b)(4)(ix), provided that he or she:

• Provides a written statement, under § 312.110(b)(5)(i)(A)( 1 ), explaining why compliance with each such paragraph is not feasible or is contrary to the best interests of the individuals who may receive the investigational new drug;

• Provides a written statement from an authorized official of the importing country's government. The statement must attest that the official agrees with the exporter's statement made under § 312.110(b)(5)(i)(A)( 1 ); explain that the drug is to be stockpiled solely for use of the importing country in a national emergency; and describe the potential national emergency that warrants exportation of the investigational new drug under this provision; and

• Provides a written statement showing that the Secretary of Health and Human Services (the Secretary), or his or her designee, agrees with the findings of the authorized official of the importing country's government.

We decided that in a national emergency, “stockpiling” scenario, exporters should be able to drop the affirmations in paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), and/or (b)(4)(ix) from their certifications if, due to the potential national emergency for which the drug is being stockpiled, compliance with that paragraph is infeasible or contrary to the best interests of the individuals who may receive the investigational new drug. For example, several foreign governments have asked for our help in exporting investigational vaccines to their countries to reduce their citizens' vulnerability to a certain pathogen. Vaccine production is very complex, so it is unlikely that a manufacturer could respond quickly to a large-scale national emergency in a foreign country. Thus, if we were to insist that all investigational vaccines exported in a national emergency scenario be “intended for export” (as otherwise required by § 312.110(b)(4)(i)), vaccines that had been intended for domestic use could not be exported to address a national emergency in a foreign country because those vaccines would not have been “intended for export” when they were first made. Providing for the deletion of the “intended for export” requirement in a national emergency, stockpiling scenario makes it possible to export products originally intended for domestic use to meet a more important foreign need.

In the national emergency, “stockpiling” scenario, exportation may not proceed without prior FDA authorization. We decided to require FDA authorization to ensure that exportation of a drug based on this scenario is limited to the requirements set out in § 312.110(b)(5)(i) and not used for other situations for which other regulatory requirements apply.

The second national emergency scenario is at § 312.110(b)(5)(ii). This provision would apply where the national emergency is both sudden and immediate. For example, § 312.110(b)(5)(ii) could be used when a bioterrorist attack has occurred in a foreign country and has created an immediate need to export an investigational new drug for use in the foreign country. It could also apply where the national emergency is imminent, but has not yet occurred. For example, § 312.110(b)(5)(ii) might be applicable where a foreign government has evidence showing that a particular novel disease outbreak is about to occur and that prompt administration of an investigational new drug is needed to treat or immunize its citizens before the disease assumes epidemic proportions. Thus, in these examples, the words “sudden” and “immediate” are meant to convey a sense that the national emergency resulted from unforeseen circumstances and that the exported drug is needed quickly in order to address the national emergency, and we expect § 312.110(b)(5)(ii) to be used in very rare circumstances. In other words, § 312.110(b)(5)(ii) should not be used in situations where a person simply wants to export a drug to address longstanding public health concerns (such as a disease which is and has been prevalent in the foreign country for years).

Under § 312.110(b)(5)(ii), a person may export an investigational new drug under § 312.110(b)(4) and exclude from its certification an affirmation with respect to any one or more of paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(v), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), (b)(4)(ix), and/or (b)(4)(xi), provided that he or she:

• Provides a written statement, under § 312.110(b)(5)(ii)(A)( 1 ), explaining why compliance with each such paragraph is not feasible or is contrary to the best interests of the individuals who are expected to receive the investigational new drug; and

• Provides sufficient information from an authorized official of the importing country's government to enable the Secretary, or his or her designee, to decide whether a national emergency has developed or is developing in the importing country, whether the investigational new drug will be used solely for that national emergency, and whether prompt exportation of the investigational new drug is necessary.

We decided that, in the case of a sudden and immediate national emergency in a foreign country, the exporter's certification may omit an affirmation addressing paragraphs (b)(4)(i), (b)(4)(iv), (b)(4)(v), (b)(4)(vi), (b)(4)(vii), (b)(4)(viii), (b)(4)(ix) and/or (b)(4)(xi) if, due to the sudden and immediate national emergency, compliance with that paragraph or paragraphs are infeasible or contrary to the best interests of the individuals who may receive the investigational new drug. For example, it would not be necessary to insist that the exported drug be labeled in accordance with the foreign country's laws where the foreign country itself had agreed that compliance with its labeling requirements was unnecessary during the national emergency.

Additionally, in contrast to the “stockpiling” scenario in § 312.110(b)(5)(i), exportation to meet a sudden and immediate national emergency may not proceed until the Secretary has decided whether a national emergency has developed or is developing in the importing country, whether the investigational new drug will be used solely for that national emergency, and whether prompt exportation of the investigational new drug is necessary. We reiterate that, given its reference to a “sudden and immediate” national emergency, § 312.110(b)(5)(ii) should be very rarely used.

Persons who wish to obtain a written statement from the Secretary under § 312.110(b)(5)(i) or to request that the Secretary make the determinations under § 312.110(b)(5)(ii) should direct their requests to: Secretary's Operations Center, Office of Emergency Operations and Security Programs, Office of Public Health Emergency Preparedness, Office of the Secretary, Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC 20201.

Requests may be also be sent by FAX: 202-619-7870 or by e-mail: HHS.SOC@hhs.gov .

To complement these changes, we have revised § 312.110(c)(4) to state that exportation is not allowed under § 312.110(b)(4) if the conditions underlying the certification or the statements submitted under § 312.110(b)(5) are no longer met.

(Comment 3) One comment appeared to inquire whether transshipment could occur under the 312 program. The comment suggested that transshipment should be allowed if the sponsor amended its “certification” requesting shipment of an investigational new drug from either a listed or unlisted country to another unlisted country “where the protocol is unchanged and all applicable laws are met.” The comment added that only products under the sponsor's direct control would be permitted for transshipment.

(Response) The comment may have misinterpreted the rule. Exports of an investigational new drug to a listed country fall within section 802(c) of the act and § 312.110(b)(3), and no certification is required. Consequently, if an investigational new drug is exported to a listed country under section 802(c) of the act, there is no “certification” to amend, and, as our response to comment 1 of this document stated, we will not interpret section 802(c) of the act as allowing transshipment from a listed country to an unlisted country.

As for exports under the 312 program and § 312.110(b)(4), we concede that our proposed revision of the 312 program did not prohibit its use for exports to listed countries. However, if a sponsor decided to use § 312.110(b)(4) to export an investigational new drug to a listed country, it would create unnecessary work for itself because, under § 312.110(b)(3), it could export the investigational new drug to the listed country without providing any documentation to us.

If the comment sought to use § 312.110(b)(4) to export an investigational new drug to an unlisted country and then transship that drug to another unlisted country, we would agree that § 312.110(b)(4) could be used, but only if both unlisted countries are identified in the original certification to us. In other words, the original certification would have to state that the investigational new drug is being sent to one unlisted country and then shipped to another unlisted country. We do not intend to permit sponsors to use § 312.110(b)(4) to ship investigational new drugs to an unlisted country and, at some later, unspecified date, amend the certification in the manner described by the comment. We are concerned that allowing amendments to certifications that would change the country receiving the exported drug would enable an unscrupulous person to avoid several critical obligations, particularly those that are specific to the receiving country, such as ensuring that:

• The clinical investigation will be conducted in accordance with § 312.120;

• The drug meets the foreign purchaser's or consignee's specifications; and

• The drug does not present an imminent hazard to the public health in the foreign country.

Given these concerns, we decline to revise the rule to allow amended certifications under § 312.110(b)(4) that would enable sponsors to transship investigational new drugs without observing several important obligations in § 312.110(b)(4) itself.

Proposed § 312.110(c) would prohibit exports under certain conditions. For example, for drugs under an IND that are exported under proposed 312.110(b)(1), exportation would not be allowed if the IND is no longer in effect. For drugs exported under proposed § 312.110(b)(2), (b)(3), or (b)(4), exportation would not be allowed if the requisite conditions underlying or authorizing the exportation are no longer met. For all investigational new drugs exported under proposed § 312.110, exportation would not be allowed if the drug no longer complied with the laws of the importing country.

We received no comments on this provision. However, as explained in section II.E of this document, we have created a § 312.110(b)(5) to address exportation of investigational new drugs to meet national emergencies in a foreign country. This new provision establishes new conditions on the export requirements under § 312.110(b)(4) in such national emergencies. Consequently, we have revised § 312.110(c)(4) to state that exportation is not allowed under § 312.110(b)(4) if the conditions underlying the certification or the statements submitted under § 312.110(b)(5) are no longer met.

The proposed rule would also make several minor amendments to reflect or update statutory requirements and to redesignate paragraphs (to accommodate other proposed changes). In brief, the proposal would:

• Redesignate § 312.110(b)(4) as new § 312.110(d) to state that the export requirements in § 312.110 do not apply to insulin or to antibiotic drug products exported for investigational use. This provision would reflect section 802(i) of the act which provides that insulin and antibiotics may be exported in accordance with the export requirements in section 801(e)(1) of the act without complying with section 802 of the act.

• Eliminate a potentially confusing and incorrect reference to new drugs “* * *approved or authorized for export under section 802 of the act * * * or section 351(h)(1)(A) of the Public Health Service Act” because the FDA Export Reform and Enhancement Act eliminated most FDA approval requirements for exported drugs. As for section 351(h) of the Public Health Service Act, it pertains to exports of partially processed biological products that are: (1) Not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man; (2) not intended for sale in the United States; and (3) intended for further manufacture into final dosage form outside the United States. Thus, partially processed biological products exported under section 351(h) of the Public Health Service Act are not exported for investigational use, so they do not have to be mentioned in § 312.110. We also noted that the FDA Export Reform and Enhancement Act of 1996 revised and renumbered section 351(h) of the Public Health Service Act, and so the revised section no longer contains a paragraph (h)(1)(A) (see 67 FR 41642 at 41645).

• Amend the authority citation for part 312 to reflect additional statutory provisions, such as sections 801, 802, 803, and 903 of the act (21 U.S.C. 381, 382, 383, and 393), that affect investigational new drug exports, FDA's international activities, and rulemaking.

• Remove the text at § 312.110(b)(3) stating that the export requirements in § 312.110(b) apply only where the drug is to be used for the purpose of a clinical investigation. We proposed to delete this language because the proposed rule expressly refers to exports of investigational new drugs for use in clinical investigations.

We received no comments on these provisions or changes and have finalized them without change.

Several comments responded to specific questions we had presented in the preamble to the proposed rule or discussed other issues related to the export of investigational new drugs or the conduct of foreign clinical trials.

The preamble to the proposed rule noted that section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) directs the Secretary to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (67 FR 41642 at 41645). We invited comment on whether we should make available information on clinical trials involving investigational new drugs exported under proposed § 312.110(b)(4).

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NRPM. Publishing a NPRM, which would incorporate a comment period before a final rule could be issued, and delay the rule's effective date, is contrary to the public interest because immediate action is necessary to protect the public and waters of the United States.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The Coast Guard will issue a broadcast notice to mariners and will place Coast Guard vessels in the vicinity of this zone to advise mariners of the restrictions.

This rule is needed to protect foreign navy submarines from damage or injury from sabotage or other subversive acts, accidents or other causes of a similar nature, or to secure the observance of rights and obligations of the United States. Although this rule is effective from 8 a.m. on November 9, 2005, until 11:59 p.m. on December 1, 2005, the Coast Guard will only enforce this rule when a foreign navy submarine is transiting within the area between 12 nautical miles seaward from the baseline at the mouth of the St. John's River to Ribault Bay. Anchoring, mooring, or transiting within this zone is prohibited, unless authorized by the Captain of the Port, Jacksonville, Florida, or his designated representative. The temporary security zone encompasses all waters within 500 yards around the foreign naval submarine. Vessels or persons authorized to enter the zone must proceed at a minimum safe speed, must comply with all orders issued by the COTP or his designated representative, and must not proceed any closer than 100 yards, in any direction, to the submarine.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under the order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time and the impact on routine navigation is expected to be minimal.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulation will only be enforced for a short period of time within a 22-day window, during vessel transits, and the impact on routine navigation is expected to be minimal. Vessels may still transit safely around the zone and, upon permission of the Captain of the Port or his designated representative, may transit at minimum safe speed through that portion of the security zone between 100 and 500 yards from the submarine.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that my result in the expenditure by State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Although this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this regulation effective less than 30 days after its publication in the Federal Register . Any delay encountered in this regulation's effective date would be contrary to public interest because immediate action is needed to prevent unauthorized vessel traffic from hindering salvage operations.

The Coast Guard will terminate the zone when salvage operations are complete and the area adjacent to the grounded vessel is considered safe to vessel traffic.

The M/V SELENDANG AYU ran aground at a position of 53.634° N, 167.125° W on December 9, 2004. The vessel then broke in half and discharged its fuel oil into the water. A marine salvor is removing sections of the wreck from the bow and stern sections of the grounded vessel, as well as from the adjacent shoreline. The safety zone is necessary to prevent unauthorized vessels from impeding salvage operations.

The Unified Command, which is responding to the grounding of the M/V Selendang Ayu, identified the safety zone in the area where subsequent salvage operations will be taking place. This area is defined by a circle centered at 53 degrees, 38 minutes North; 167 degrees, 7 minutes, 20 seconds West with a radius of 750 yards. All coordinates reference Datum: NAD 1983.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DHS is unnecessary.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the area defined by a circle centered at 53 degrees, 38 minutes North; 167 degrees, 7 minutes, 20 seconds West with a radius of 750 yards.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic transiting from the north to south side of Unalaska Island can pass safely around the safety zone. We will terminate the safety zone once salvage operations are complete and the area adjacent to the grounded vessel is considered safe for vessel traffic. The safety zone is not located in a navigable channel.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

In 1999, the Architectural and Transportation Barriers Compliance Board (Access Board) established the Public Rights-of-Way Access Advisory Committee (Committee) to make recommendations on accessibility guidelines for newly constructed and altered public rights-of-way covered by the Americans with Disabilities Act of 1990 and the Architectural Barriers Act of 1968. The Committee was comprised of representatives from disability organizations, public works departments, transportation and traffic engineering groups, design professionals and civil engineers, pedestrian and bicycle organizations, Federal agencies, and standard-setting bodies. The Committee met on five occasions between December 1999 and January 2001. On January 10, 2001, the Committee presented its recommendations on accessible public rights-of-way in a report entitled “Building a True Community.” The Committee's report provided recommendations on access to sidewalks, street crossings, and other related pedestrian facilities and addressed various issues and design constraints specific to public rights-of-way. The report is available on the Access Board's Web site at http://www.access-board.gov/prowac/commrept/index.htm or can be ordered by calling the Access Board at (202) 272-0080. Persons using a TTY should call (202) 272-0082. The report is available in alternate formats upon request. Persons who want a copy in an alternate format should specify the type of format (cassette tape, braille, large print, or ASCII disk).

The Access Board convened an ad hoc committee of Board members to review the Committee's recommendations. After reviewing the report in detail, the Board's ad hoc committee prepared recommendations for guidelines addressing accessibility in the public right-of-way. On June 17, 2002, the Board made the recommendations of the ad hoc committee available for public comment and review by notice in the Federal Register (67 FR 41206).

Over 1,400 comments were received from the public in response to the publication of the draft. Of this total, almost 900 comments were from persons with disabilities and groups representing them; the great preponderance of comments in this category came from people who indicated that they were blind or had low vision. Respondents from the transportation industry, including design engineers and consultants, submitted slightly over 200 comments. Another 100 were received from State and local government administrative agencies. Comments are posted on the Board's Web site at http://www.access-board.gov/prowac/comments/index.htm. Further discussion of the comments received is available in the supplementary information accompanying the draft guidelines.

The members of the Board's ad hoc committee subsequently reviewed and considered the comments received in response to the 2002 Federal Register notice. The draft guidelines made available today on the Board's Web site are the result of those deliberations. The Access Board is making the draft guidelines available in order to facilitate the gathering of additional information for a regulatory assessment prior to publishing a notice of proposed rulemaking and to assist in the development of technical assistance materials. The Board is not soliciting comments on the draft guidelines. The Board will solicit comments when a proposed rule is issued in conjunction with the regulatory assessment. The draft guidelines along with supplementary information have been placed in the rulemaking docket (Docket No. 02-1) for public review. The draft guidelines and supplementary information are also available on the Access Board's Web site at http://www.access-board.gov/prowac/draft.htm. You may also obtain a copy of the draft guidelines and supplementary information by contacting the Access Board at (202) 272-0080. Persons using a TTY should call (202) 272-0082. The documents are available in alternate formats upon request. Persons who want a copy in an alternate format should specify the type of format (cassette tape, braille, large print, or ASCII disk).

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, these rule submittals were found to meet the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review.

We approved versions of these rules into the SIP on the dates listed: ICAPCD Rule 101 on March 7, 2003 and SBCAPCD Rule 102 on July 23, 2004.

Imperial County Rule 101 is amended by adding new definitions, revising some existing definitions, and deleting obsolete definitions. New and revised definitions for Rule 424, Architectural Coatings, are added into Rule 101.

Santa Barbara Rule 102 is amended by revising the definition of reactive organic compounds to exempt methyl acetate and perchloroethylene.

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. These rules were developed as part of the local agency's program to control these pollutants.

EPA's technical support document has more information about these rules.

These rules describe administrative provisions and definitions that support emission controls found in other local agency requirements. In combination with other requirements, these rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). EPA policy that we used to help evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988) and the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSD has more information on our evaluation.

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 December 23, 2005, 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 January 23, 2006. 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. section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 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 January 23, 2006. 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).)

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET (http://www.epa.gov/edocket/) , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of June 22, 2005 (70 FR 36162) (FRL-7715-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F4631) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC, 27419-8300. The petition requested that 40 CFR 180.548 be amended by establishing a tolerance for residues of the herbicide tralkoxydim, 2-(Cyclohexen-1-one, 2-[1-(ethoxyimino)propyl]-3-hydroxy-5-(2,4,6-trimethylphenyl)-(9Cl), in or on barley grain, barley hay, wheat grain, and wheat hay at 0.02 parts per million (ppm) and barley straw, wheat forage, and wheat straw at 0.05 ppm. That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant.

Public comments were received from B. Sachau who objected to the “sale or marketing” of this product. She asserted that the registrant's statement in the notice of filing that “it is unlikely” that secondary residues would occur in animal commodities is not a “strong enough” standard. B. Sachau's comments contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to tralkoxydim, including all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has determined that there is no reasonable expectation of dietary risk due to residues of tralkoxydim occurring in meat, milk, poultry, or eggs from its use on wheat and barley based on low levels of residues in wheat and barley and risk assessments that were conducted by the Agency. EPA has responded to B. Sachau's generalized comments on numerous previous occasions (see 70 FR 1349, 1354 (January 7, 2005); 69 FR 63083, 63096 (October 29, 2004).

Time limited tolerances for these commodities were previously established in the Federal Register of August 13, 2003 (68 FR 48299) (FRL-7315-9). The tolerances expired on May 1, 2005. The tolerances were time limited because a second species carcinogenicity study needed to be submitted and reviewed. The study was submitted and reviewed and is discussed below.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of tralkoxydim on barley grain, barley hay, wheat grain, and wheat hay at 0.02 parts per million (ppm) and barley straw, wheat forage, and wheat straw at 0.05 ppm.

EPA's assessment of exposures and risks associated with establishing the tolerance was discussed in the Federal Register final rule of December 16, 1998 (63 FR 69194) (FRL-6048-4).

The only new data that have been submitted since this prior action are data from the second species carcinogenicity study. Based on this study, EPA downgraded the cancer classification of tralkoxydim from “likely human carcinogen” to “suggestive evidence of carcinogenicity.” This classification was based on the occurrence of benign testicular tumors at the high dose in male rats and equivocal evidence of carcinogenicity in female hamsters. In light of the prior cancer classification, EPA had previously conducted a quantitative cancer risk assessment for tralkoxydim and concluded that the cancer risk was negligible. Given that the new data indicate that tralkoxydim is less likely to be carcinogenic, EPA finds that its earlier cancer risk assessment more than adequately demonstrates that tralkoxydim poses a negligible cancer risk. Accordingly, in reliance on its previous risk assessment, as presented in the December 16, 1998 notice, and the new cancer study, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to tralkoxydim residues.

Therefore, the tolerance is established for residues of tralkoxydim, 2-(Cyclohexen-1-one, 2-[1-(ethoxyimino)propyl]-3-hydroxy-5-(2,4,6-trimethylphenyl)-(9Cl), in or on the raw agricultural commodity barley grain, barley hay, wheat grain, and wheat hay at 0.02 ppm and barley straw, wheat forage, and wheat straw at 0.05 ppm.

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0175 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before January 23, 2006.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14 th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2005-0175, to: Public Information and Records Integrity Branch, Information Technology and Resource Management Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

On June 30, 2005, U.S. EPA published a proposed rule proposing to grant Indiana authorization for changes to its Resource Conservation and Recovery Act program, listed in Section F of that notice, which was subject to public comment. No comments were received. We hereby determine that Indiana's hazardous waste program revisions satisfy all of the requirements necessary to qualify for final authorization.

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

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

This decision means that a facility in Indiana subject to RCRA will now have to comply with the authorized State requirements (listed in section F of this notice) instead of the equivalent Federal requirements in order to comply with RCRA. Indiana has enforcement responsibilities under its State hazardous waste program for violations of such program, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

1. Do inspections, and require monitoring, tests, analyses or reports.

2. Enforce RCRA requirements and suspend or revoke permits.

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

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

On June 30, 2005 (70 FR 37726), EPA published a proposed rule. In that rule we proposed granting authorization of changes to Indiana's hazardous waste program and opened our decision to public comment. The Agency received no comments on this proposal. EPA found Indiana's RCRA program to be satisfactory.

Indiana initially received Final authorization on January 31, 1986, effective January 31, 1986 (51 FR 3955), to implement the RCRA hazardous waste management program. We granted authorization for changes to their program on October 31, 1986, effective December 31, 1986 (51 FR 39752); January 5, 1988, effective January 19, 1988 (53 FR 128); July 13, 1989, effective September 11, 1989 (54 FR 29557); July 23, 1991, effective September 23, 1991 (56 FR 33717); July 24, 1991, effective September 23, 1991 (56 FR 33866); July 29, 1991, effective September 27, 1991 (56 FR 35831); July 30, 1991, effective September 30, 1991 (56 FR 36010); August 20, 1996, effective October 21, 1996 (61 FR 43018); September 1, 1999, effective November 30, 1999 (64 FR 47692); January 4, 2001 effective January 4, 2001, (66 FR 733); December 6, 2001, effective December 6, 2001 (66 FR 63331); and October 29, 2004, effective October 29, 2004 (69 FR 63100).

On August 30, 2004, Indiana submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make a final decision, that Indiana's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we propose to grant Indiana Final authorization for the following program changes:

Indiana has excluded the non-delegable Federal requirements at 40 CFR 268.5, 268.6, 268.42(b), 268.44, and 270.3 in their Incorporation by Reference at 3.1-12-2 and 3.1-13-2(4). EPA will continue to implement those requirements. This action involves no more stringent or broader in scope State requirements.

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

Indiana is not authorized to carry out its hazardous waste program in “Indian Country”, as defined in 18 U.S.C. 1151. Indian Country includes:

1. All lands within the exterior boundaries of Indian reservations within the State of Indiana;

2. Any land held in trust by the U.S. for an Indian tribe; and

3. Any other land, whether on or off an Indian reservation that qualifies as Indian Country. Therefore, EPA retains the authority to implement and administer the RCRA program in Indian Country. However, at this time, there is no Indian Country within the State of Indiana.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized State rules in 40 CFR part 272. Indiana's rules, up to and including those revised January 4, 2001, have previously been codified through the incorporation-by-reference effective December 24, 2001 (66 FR 53728, October 24, 2001). We reserve the amendment of 40 CFR part 272, subpart P for the codification of Indiana's program changes until a later date.

This rule only authorizes hazardous waste requirements pursuant to RCRA 3006 and imposes no requirements other than those imposed by State law (see Supplementary Information, Section A. Why are Revisions to State Programs Necessary?). Therefore this rule complies with applicable executive orders and statutory provisions as follows:

The Office of Management and Budget has exempted this rule from its review under Executive Order 12866 (58 FR 51735, October 4, 1993).

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. ).

After considering the economic impacts of today's rule on small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), I certify that this rule will not have a significant economic impact on a substantial number of small entities.

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).

Executive Order 13132 (64 FR 43255, August 10, 1999) does not apply to this rule because it will not have federalism implications ( i.e., 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).

Executive Order 13175 (65 FR 67249, November 9, 2000) does not apply to this rule because it will not have tribal implications ( i.e., substantial direct effects on one or more Indian Tribes, or 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.)

This rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it is not based on environmental health or safety risks.

This rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action as defined in Executive Order 12866.

EPA approves State programs as long as they meet criteria required by RCRA, so it would be inconsistent with applicable law for EPA, in its review of a State program, to require the use of any particular voluntary consensus standard in place of another standard that meets requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note ) do not apply to this rule.

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings issued under the Executive Order.

EPA will submit a report containing this rule and other information required by the Congressional Review Act (5 U.S.C. 801 et seq. ) To the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

This is a synopsis of the Commission's Memorandum Opinion and Order , MB Docket No. 04-328, adopted November 4, 2005, and released November 7, 2005. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www.BCPIWEB.com . The Commission will not send a copy of this Memorandum Opinion and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the aforementioned Petition for Reconsideration was denied.

This is a synopsis of the Commission's Memorandum Opinion and Order, MM Docket No. 01-107, adopted November 2, 2005, and released November 4, 2005. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www.BCPIWEB.com . This document is not subject to the Congressional Review Act. (The Commission, is, therefore, not required to submit a copy of this Report and Order to GAO, pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A) because the petition for reconsideration was denied.)

This is a synopsis of the Commission's Report and Order , MB Docket No. 02-123, adopted November 4, 2005, and released November 7, 2005. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, (800) 378-3160, or via the company's Web site, http://www.bcpiweb.com . The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see U.S.C. 801(a)(1)(A).

This is a summary of the Commission's Report and Order , adopted November 9, 2005, and released November 10, 2005. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will not send a copy of the Report & Order in this proceeding pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability.

Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.100.

The initial total commercial quota for summer flounder for the 2005 calendar year was set equal to 18,180,002 lb (8,246,395 kg) (70 FR 303, January 4, 2005). The percent allocated to vessels landing summer flounder in Massachusetts is 6.82046 percent, resulting in a commercial quota of 1,239,960 lb (562,442 kg). However, the 2005 allocation to Massachusetts was reduced to 1,177,554 lb (534,130 kg) due to research set-aside and 2004 quota overages. The states of North Carolina, New Jersey, and Rhode Island and the Commonwealth of Virginia have transferred a total of 53,176 lb (24,121 kg) to Massachusetts in accordance with the Atlantic States Marine Fisheries Commission (ASMFC) Addendum XV to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP), bringing the total quota to 1,230,730 lb (558,259 kg).

Section 648.101(b) requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor state commercial quotas and to determine when a state's commercial quota has been harvested. NMFS then publishes a notification in the Federal Register to advise the state and to notify Federal vessel and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing summer flounder in that state. In consultation with the MA DMF, the Regional Administrator has determined, based upon dealer reports and other available information, that Massachusetts has harvested its quota for 2005. Furthermore, this closure action in Federal waters is necessary to coordinate with the closure announced for state waters by the MA DMF to maintain consistency in the fishery.

The regulations at § 648.4(b) provide that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, November 18, 2005, further landings of summer flounder in Massachusetts by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2005 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 0001 hours, November 18, 2005, federally permitted dealers may not purchase summer flounder from federally permitted vessels that land in Massachusetts for the remainder of the calendar year, or until additional quota becomes available through a transfer.

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