This final rule is issued pursuant to the Dairy Production Stabilization Act (Act) of 1983, as amended [7 U.S.C. 4501-4514].

The Office of Management and Budget has waived the review process required by Executive Order 12866 for this action.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have a retroactive effect. This rule will not preempt any State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule.

The Dairy Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under Section 4509 of the Dairy Act, any person subject to the Order may file with the Secretary a petition stating that the Order, any provision of the Order, or any obligation imposed in connection with the Order is not in accordance with the law and request a modification of the Order or to be exempted from the Order. Such person is afforded the opportunity for a hearing on the petition. After a hearing, the Secretary would rule on the petition. The Dairy Act provides that the district court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling on the petition, provided a complaint is filed not later than 20 days after the date of the entry of the ruling.

The Agricultural Marketing Service (AMS) has determined that this rule will not have a significant economic impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612).

For the purpose of the Regulatory Flexibility Act, small businesses in the dairy industry have been defined as those employing less than 500 employees. For the purpose of the Regulatory Flexibility Act, a dairy farm is considered a “small business” if it has an annual gross revenue of less than $750,000. In the 48 contiguous States, there are approximately 70,000 dairy farms subject to the provisions of this Order. Most of the parties subject to the Order are considered small entities.

The Order is administered by a 36-member Board representing 13 geographic regions within the contiguous 48 States. The Order provides that the Dairy Board shall review the geographic distribution of milk production throughout the United States and, if warranted, shall recommend to the Secretary a reapportionment of the regions and/or modification of the number of members from regions in order to better reflect the geographic distribution of milk production volume in the 48 contiguous States.

Based on a review of the 2007 geographic distribution of milk production, it has been determined that the number of Dairy Board members for six of the 13 geographic regions should be changed. The Dairy Board was last modified in 2003 based on 2002 milk production.

The amendment will not have a significant economic impact on persons subject to the Order. The proposed changes merely allow representation of the Dairy Board to better reflect geographic milk production in the contiguous 48 States. Finally, no relevant Federal rules have been identified that duplicate, overlap, or conflict with this rule.

In accordance with the Office of Management and Budget (OMB) regulation [5 CFR part 1320] which implements the Paperwork Reduction Act of 1995 [44 U.S.C. chapter 35], the information collection requirements and recordkeeping provisions imposed by the Order have been previously approved by OMB and assigned OMB Control No. 0581-0093.

Proposed Rule: Issued July 24, 2008; published July 30, 2008 (73 FR 44176).

The Order is administered by a 36-member Dairy Board. This final rule amends the Order by modifying the number of members on the Board in six of the 13 geographic regions. The amendment modifies the composition of the Board to better reflect current milk production within each of the 13 geographic regions of the contiguous 48 States.

The Order provides in section 1150.131 that the Dairy Board shall review the geographic distribution of milk production volume throughout the contiguous 48 States and, if warranted, shall recommend to the Secretary a reapportionment of the regions and/or modification of the number of members from regions in order to best reflect the geographic distribution of milk production in the contiguous 48 States. The Dairy Board is required to conduct the review at least every five years and not more than every three years. The Dairy Board was last modified in 2003 based on 2002 milk production.

In determining the number of Dairy Board seats for each of the 13 geographic regions designated in the Order, the total milk production for the contiguous 48 states for the previous calendar year is divided by 36 to determine a factor of pounds of milk represented by each Dairy Board member. The resulting factor is then divided into the pounds of milk produced in each region to determine the number of Dairy Board members for each region. Accordingly, the following table summarizes by region the volume of milk production distribution for 2007, the percentage of total milk production, the current number of Dairy Board seats per region, and the adopted number of Dairy Board seats for each region.

Upon the basis of its review of geographic milk production volume, the Dairy Board proposed that the number of members in six of the 13 geographic regions be changed. The current review conducted by the Dairy Board is based on 2007 data. In 2007, total milk production was 185,558 million pounds, which indicates that each of the Dairy Board members would represent 5,154 million pounds of milk. For 2002, total milk production was 169,643 million pounds of milk and each of the Board members represented 4,712 million pounds of milk.

Based on the 2007 milk production data, the Dairy Board proposed that member representation in Region 2 (California), Region 3 (Arizona, Colorado, Idaho, Montana, Nevada, Utah, and Wyoming), and Region 4 (Arkansas, Kansas, New Mexico, Oklahoma, and Texas) each be increased by one member, and member representation in Region 1 (Oregon and Washington), Region 11 (Delaware, Maryland, New Jersey, and Pennsylvania), and Region 12 (New York) each be decreased by one member.

Milk production in Region 2 increased to 40,683 million pounds in 2007, up from 34,884 million pounds in 2002, indicating eight Dairy Board members (40,683 divided by 5,154 = 8) compared to seven Dairy Board members based on 2002 milk production data. Milk production in Region 3 increased to 21,212 million pounds in 2007, up from 16,291 million pounds in 2002, indicating four Dairy Board members (21,212 divided by 5,154 = 4) compared to three Dairy Board members based on 2002 milk production data. Milk production in Region 4 increased to 18,200 million pounds in 2007, up from 15,313 million pounds in 2002, indicating four Dairy Board members (18,200 divided by 5,154 = 4) compared to three Dairy Board members based on 2002 milk production data.

Milk production in Region 1 increased to 7,764 million pounds in 2007, up from 7,713 million pounds in 2002. The Dairy Board determined that Region 1 milk production data does not continue to support 2 seats. Based on the data, the Dairy Board recommended that one seat from Region 1 be assigned to another region, thereby reducing Region 1 Dairy Board members from two members to one member. In Region 11, milk production decreased to 12,008 million pounds in 2007 down from 12,492 million pounds in 2002, indicating two Dairy Board members for the region (12,008 divided by 5,154 = 2) compared to three members based on 2002 data. Also, in Region 12, milk production decreased to 12,103 million pounds in 2007 down from 12,217 million pounds in 2002, indicating two Dairy Board members for the region (12,103 divided by 5,154 = 2) compared to three members based on 2002 data.

Interested parties were provided an opportunity to file comments on the proposed rule. No comments were received were received by the Department.

This final rule adopts the Dairy Board's proposal that member representation in Region 2 be increased from seven members to eight members, and Region 3 and Region 4 representation each be increased from three members to four members; Region 1 representation be decreased from two members to one member and Region 11 and Region 12 representation each be decreased from three members to two members.

Pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because this rule should be in effect as soon as possible to appoint Board members for the 2008-2011 term.

Section 604 of the Energy Policy Act of 2005, Public Law 109-58, amended section 170 of the AEA (“Price-Anderson Act”) to require the NRC to adjust the maximum total and annual standard deferred premiums not less than once during each 5-year period following August 20, 2003 in accordance with the aggregate percentage change in the Consumer Price Index. The NRC made the initial changes to the Price-Anderson Act amounts required by section 604 of the Energy Policy Act on October 27, 2005 (70 FR 61885). This final rule makes the required inflation adjustments to the maximum total and annual standard deferred premiums.

This rule simply incorporates mandatory statutory requirements. Accordingly, good cause exists under 5 U.S.C. section 553(d)(3) to publish this final rule without soliciting public comment because the Commission has no discretion in these matters and public comment would serve no useful purpose. The NRC is required only to perform ministerial computations. The revisions are being published as a final rule that will become effective 30 days from the date of publication in the Federal Register .

Section 170t. “Inflation Adjustment” of the AEA requires the NRC to “adjust the amount of the maximum total and annual standard deferred premium under subsection b.(1) not less than once during each 5-year period following August 20, 2003 in accordance with the aggregate percentage change in the Consumer Price Index.” The NRC's implementing regulations for the Price-Anderson Act are found in 10 CFR part 140. Accordingly, the Commission is amending 10 CFR 140.11, “Amounts of financial protection for certain reactors”, to adjust for the increase in inflation since August 20, 2003. Specifically, as set forth in section 170t. of the AEA, the Commission is adjusting the amount of the maximum total and annual standard deferred premium.

The current maximum total deferred premium in 10 CFR 140.11(a)(4) is $95,800,000 and the maximum annual deferred premium is $15,000,000. The Consumer Price Index in August 2003 was 183.9. The most recent Consumer Price Index, April 2008, is 214.823. This represents an increase of approximately 16.82%. When this increase is applied to the maximum total and annual standard deferred premium and rounded, the new maximum total deferred premium is $111,900,000, and the maximum annual deferred premium is $17,500,000. Section 140.11(a)(4) is being changed accordingly.

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or is otherwise impractical. In this rule, the NRC is revising its regulations to reflect statutory mandates contained in the Energy Policy Act of 2005. This action does not constitute the establishment of a standard that contains generally applicable requirements.

The Commission has determined that this final rule is the type of action described as a categorical exclusion in 10 CFR 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain information collection requirements and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

A regulatory analysis has not been prepared for this regulation. This rule amends NRC regulations to be consistent with provisions of the Atomic Energy Act of 1954, as amended. This rule does not involve an exercise of Commission discretion and, therefore, does not necessitate preparation of a regulatory analysis.

As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this final rule would not have a significant economic impact upon a substantial number of small entities.

The NRC has determined that the backfit rule, 10 CFR 50.109, 70.76, 72.62, 76.76, does not apply to this final rule because these amendments are mandated by the Energy Policy Act of 2005.

In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2006-06-07, amendment 39-14516 (71 FR 14363, March 22, 2006). The existing AD applies to certain Fokker Model F.28 Mark 0070 and 0100 airplanes. That NPRM was published in the Federal Register on July 2, 2008 (73 FR 37903). That NPRM proposed to continue to require a one-time inspection of the main landing gear (MLG) main fitting for cracks, and repair if necessary. That NPRM also proposed to continue to require installing a placard and revising the airplane flight manual (AFM) to include procedures to prohibit the application of brakes during backward movement of the airplane. That NPRM also proposed to require repetitive eddy current inspections of the MLG main fitting and rework before further flight as applicable.

We provided the public the opportunity to participate in the development of this AD. No comments have been received on the NPRM or on the determination of the cost to the public.

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

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 issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 10, 2008 (73 FR 32659). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on February 21, 2008 (73 FR 9502). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

One commenter, Federal Express, recommends that we give previous credit for eddy current inspections (ECIs) previously performed on RB211-535 HP turbine discs per AD 2006-17-12 and Rolls-Royce plc (RR) Alert Service Bulletin (ASB) No. RB.211-72-AE651, dated November 22, 2004. The commenter states that the same ECI of the HP turbine discs is referenced in that AD, as in the proposed AD.

We agree. Initial inspections done before the effective date of this AD on RB211-535 HP turbine discs per RR ASB No. RB.211-72-AE651, dated November 22, 2004, and done on RB211-22B HP turbine discs per RR ASB RB.211-72-AE717, dated January 21, 2005, and done on RB211-524 HP discs per RR ASB RB.211-72-AE718, dated January 24, 2006, comply with the initial inspection requirements specified in this AD. We added this information to the previous credit paragraph of the AD.

One commenter, Boeing, requests that we exclude RB211-524 HP turbine discs that have incorporated RR Service Bulletin (SB) No. RB.211-72-C109 or RR SB No. RB.211-72-C762 from the AD. The commenter states that these SBs introduced new HP turbine rotors with reduced stress levels and those rotors are not affected by this AD.

We agree. We changed the applicability to exclude RB211-524 HP turbine discs that incorporate these SBs.

Boeing also requests that we update or remove the reference to the revision date of RR Repair Document TSD-594-J Overhaul Process 223, from the AD. The proposed AD references the revision date of May 1, 2001, but the document is now up to the revision date of March 15, 2004.

We agree. We removed the date reference from the AD.

We eliminated the requirement to permanent etch “NMSB 72-AE969” onto the HP turbine disc from the AD, as it is not necessary.

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

Based on the service information, we estimate that this AD will affect about 506 products of U.S. registry. We also estimate that it will take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the AD on U.S. operators to be $161,920.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http:// www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on July 2, 2008 (73 FR 37898). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

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

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

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 2 products of U.S. registry. We also estimate that it will take about 15 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $2,400, or $1,200 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 28, 2008 (73 FR 16575). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

EMBRAER states that Service Bulletin 170-29-0006 was revised to include additional airplanes in the effectivity. Therefore, EMBRAER recommends that the AD applicability refers to Service Bulletin 170-29-0006, Revision 01, dated February 22, 2008. The original issue, dated October 4, 2006, was referred to in the NPRM as the source of service information for accomplishing certain actions. EMBRAER adds that the original issue should be kept as an acceptable means of compliance.

We agree that the applicability in the NPRM should be changed. Revision 01 of the service bulletin includes a reference to “EMBRAER 175 ( ) model aircraft,” which is the marketing designation for a certain version of the Model ERJ 170 airplane. However, no additional airplanes have been added to the service bulletin effectivity. We have changed the service bulletin reference in paragraph (c) of this AD from the original issue to Revision 01.

In addition, we agree to change paragraph (f) of the AD to refer to Revision 01 of the referenced service bulletin. Revision 01 specifies that there is no additional action for airplanes on which the actions in the original issue of the service bulletin have been done. We have also added a new paragraph (f)(3) to this AD to give operators credit for doing the actions in the original issue of the service bulletin.

EMBRAER also recommends changing paragraph (e) of the NPRM to add the phrase, “in conjunction with a lightning strike” following the words “multiple clamps” as specified in that paragraph. EMBRAER did not provide a justification for this change.

We do not agree that paragraph (e) of the NPRM should be changed. Paragraph (e) of this AD quotes the requirements in the MCAI verbatim; therefore, no change to the AD is necessary in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

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

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 88 products of U.S. registry. We also estimate that it will take 18 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $269 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $150,392, or about $1,709 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to all Lockheed Model 382, 382B, 382E, 382F, and 382G series airplanes. That NPRM was published in the Federal Register on June 13, 2008 (73 FR 33740). That NPRM proposed to require revising the FAA-approved maintenance program by incorporating new airworthiness limitations for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 (SFAR 88) requirements. That NPRM also proposed to require the accomplishment of certain fuel system modifications, the initial inspections of certain repetitive fuel system limitations to phase in those inspections, and repair if necessary.

Since we issued the NPRM, Lockheed has issued Service Bulletin 382-28-20, Revision 5, dated June 19, 2008, to reflect changes to the required kits. In the NPRM, we referred to Revision 4 of the service bulletin, dated May 21, 2007, as an additional source of service information for installing ground fault interrupters (GFIs) and flame arrestors for protection of the fuel system. The procedures in Revision 5 of the service bulletin are essentially the same as those in Revision 4. Therefore, we have revised Table 1 of this AD to refer to Revision 5 of the service bulletin as the appropriate source of service information for installing the GFIs and flame arrestors.

We gave the public the opportunity to participate in developing this AD. We considered the comments received from the four commenters.

Lynden Air Cargo (LAC) and Safair request that we extend the compliance time from 24 months to 36 months for doing the modification in paragraph (h) of the NPRM. As justification, the commenters state that additional time is needed to procure parts and to accomplish the modifications during a heavy maintenance visit.

We agree to revise the compliance time in paragraph (h) of this AD to 36 months. Extending the compliance time will not adversely affect safety, and it will allow operators to accomplish the modifications, initial inspections, and repairs during regularly scheduled maintenance at a base where special equipment and trained maintenance personnel will be available if necessary.

LAC requests that we revise paragraph (g)(1) of the NPRM to refer to paragraph 2.C.(3)(e) of Lockheed Service Bulletin 382-28-22, Revision 3, dated March 28, 2008, instead of paragraph 2.C.(3)(c). LAC believes that “2.C.(3)(c)” is a typographical error because all of the other critical design configuration control limitation (CDCCL) items referred to in paragraph (g)(1) of the NPRM address wiring practices and resistance measurements.

We agree with LAC's request and have revised paragraph (g)(1) of this AD accordingly. The CDCCLs referred to in paragraphs 2.C.(3)(e), 2.C.(3)(h), 2.C.(4)(a), 2.C.(5)(c), 2.C.(7)(h), and 2.C.(8) of Lockheed Service Bulletin 382-28-22 are all items that can be accomplished in accordance with Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006.

LAC requests that we revise paragraph (g)(1) of the NPRM as follows: “* * * do the applicable actions in accordance with the procedures specified in Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006, or a method approved in accordance with paragraph (k) of this AD.” Paragraph (g)(1) of the NPRM specifies to “* * * do the applicable actions using a method approved in accordance with the procedures specified in paragraph (k) of this AD. Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006, is one approved method.” LAC states that the language provided in the NPRM could be interpreted to mean that an alternative method of compliance (AMOC) is always required.

We partially agree. We have revised paragraph (g)(1) of this AD to specify doing the “* * * applicable actions in accordance with the Accomplishment Instructions of Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006.” Under the provisions of paragraph (k) of this AD, we will consider requests for approval of an AMOC, so it is not necessary to restate so in paragraph (g)(1) of this AD. We have also deleted the last sentence of paragraph (g)(1) of the NPRM, which states “Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006, is one approved method.” We would like to clarify that the original language in the NPRM would not have required operators to always request an AMOC because that last sentence already provided one approved method.

LAC interprets paragraph (i) of the NPRM to mean that the NPRM will not be revised to incorporate revised service bulletins. LAC also interprets that paragraph to mean that approval of any revised service bulletins by the Atlanta Aircraft Certification Office (ACO) constitutes approval for including these revised service bulletins into its fuel system maintenance program.

We infer that LAC requests that we confirm whether LAC's interpretations are correct. We agree that LAC's interpretations of the language in the NPRM are correct. However, we have revised paragraph (i) of this AD by removing reference to the use of a “later revision” of the applicable service information to be consistent with the FAA policy and Office of the Federal Register regulations. We might consider approving the use of a later revision of the service information as an AMOC to this AD, as provided by paragraph (k) of this AD.

LAC asks if compliance with the NPRM constitutes compliance with section 121.1113 of the Federal Aviation Regulations (14 CFR 121.1113). If so, LAC requests that the AD state so. LAC cites 14 CFR 121.1113(f), which states “* * * any later fuel tank system revisions must be submitted to the Principal Inspector for review and approval.” LAC interprets this regulation to mean that, even after the Atlanta ACO has approved a revised service bulletin, LAC would still be required to obtain approval from the principal inspector to incorporate the revised service bulletin into its fuel system maintenance program.

LAC also points out that the preamble of the NPRM states that the NPRM would also allow accomplishing the maintenance program revision in accordance with later revisions of Lockheed Service Bulletin 382-28-22 as an acceptable method of compliance if they are approved by the Manager, Atlanta ACO. LAC interprets the phrase “would also allow” to mean that LAC has the option, after ACO approval, to incorporate the revised service bulletin into its maintenance program, and that it would neither be mandatory, nor could a principal inspector require the incorporation of the revised service bulletin unless this AD was superseded to mandate the revised service bulletin.

Yes, we agree that even after ACO approval of a later revision of the service bulletin, an operator would still be required to obtain approval from the principal inspector before a later FAA-approved service bulletin could be incorporated into its maintenance program. Further, as stated previously, we have removed the reference for using later revisions of the service bulletin approved by the Atlanta ACO. Operators may request approval for the use of later revisions of the service information as an AMOC to this AD, as provided by paragraph (k) of this AD. No change to the AD is necessary in this regard.

A commenter, William L. Davis, states that we might have inadvertently omitted certain U.S.-registered Model C-130 airplanes from the applicability of the NPRM. The commenter refers us to Type Certificate Data Sheets A15NM, A30NM, A31NM, A33NM, A34SO, A39CE, A5SO, and TQ3CH. The commenter asks if we intentionally excluded these airplanes from the NPRM.

Yes, we have intentionally excluded the airplanes that the commenter refers to because they are restricted category airplanes, which are not affected by this AD. This AD applies only to Model 382, 382B, 382E, 382F, and 382G series airplanes, which are transport category airplanes. We have not changed the AD in this regard.

Lockheed states that its data show that the number of U.S.-registered airplanes that would be affected by the NPRM is 14.

We infer Lockheed requests that we reduce the estimated number of affected airplanes from 21 to 14 in the Costs of Compliance section of this AD. We disagree because we have researched this issue and determined that this AD applies to 24 U.S.-registered airplanes. Of these airplanes, 14 are active and 10 are inactive. The inactive airplanes need to be included in our estimate to provide for any airplanes that might return to service in the future. Therefore, we have revised our estimate in this AD to 24 airplanes, and we have updated the Estimated Costs table of this AD accordingly.

LAC requests that we revise the compliance date in paragraph (g) of the AD from December 16, 2008, to December 17, 2008. LAC points out that, in the Explanation of Compliance Time section of the NPRM, we specified that the compliance date is December 16, 2008, for regulations addressing fuel tank safety issues. However, LAC asserts that the actual date that operators must be in compliance with this AD is December 17, 2008. As justification, LAC cites section 14 CFR 121.1113(c), which states: “After December 16, 2008, no certificate holder may operate an airplane * * * unless the maintenance program for that airplane has been revised to include applicable inspections, procedures, and limitations for fuel tanks systems.”

We disagree with changing the compliance date. “After December 16, 2008” means that operators must revise their maintenance programs to address fuel tank systems on or before December 16, 2008, in order to be in compliance after December 16, 2008. Therefore, the compliance date is December 16, 2008. We have not changed the AD in this regard.

Lockheed points out that the compliance time in paragraph (h) of the NPRM appears to conflict with the compliance date of December 16, 2008, for complying with SFAR 88 regulations, as specified in the Explanation of Compliance Time section and in paragraph (g) of the NPRM.

We infer Lockheed requests that we revise the compliance time in paragraph (h) of this AD to December 16, 2008. We disagree because 14 CFR 121.1113(c) requires only that operators revise their maintenance programs to include applicable inspections, procedures, and limitations for fuel tank systems on or before December 16, 2008. Further, to avoid unduly burdening operators, it is necessary to provide a 36-month grace period for accomplishing the modifications, initial inspections, and repairs specified in paragraph (h) of this AD. We have not changed the AD in this regard.

LAC requests that paragraph 2.C.(8)(a) 2a of Lockheed Service Bulletin 382-28-19, Revision 3, dated November 30, 2006, be revised to specify that “* * * between FS 245.0 and FS 597.0 (along the wing trailing edge) where wires pass through cutouts in the structure, 1/2 to 2 inches in separation is permitted between wire bundles.” The service bulletin currently states this separation allowance is between fuselage station (FS) 245.0 and FS 457.0. However, LAC states the “FS 457.0” appears to be an error because the wing trailing edge is at FS 597.0.

We disagree that FS 457.0 should be revised to FS 597.0. We have verified with the Lockheed that FS 457.0 is the correct location. This fuselage station corresponds to the wing root area, which is outside of the pressure vessel and where the wires pass along the wing trailing edge. Lockheed intends to revise the service bulletin to clarify the wire separation requirement and provide additional information. No change to the AD is necessary in this regard.

LAC states that Lockheed Service Bulletin 382-28-20, Revision 4, dated May 21, 2007, is an informational and planning service bulletin. LAC also states that the service bulletin does not contain any instructions for installing the GFIs and flame arrestors, and that it instead refers to Installation Kit Drawing 3359620 for those instructions. LAC states that it cannot comment without being able to see the drawing and requests that the drawing is made available. Also, LAC asks what approved data is used for the installation of the kits and who approved it.

We acknowledge LAC's comments. The FAA approved the data for the installation kits through design analysis and testing. The installation was then conformed and tested on a Model 382 series airplane. We have coordinated with Lockheed and it has stated that the installation drawings were made available to LAC the first week of August 2008. Also, Lockheed has stated that it intends to include that information directly in a future revision of Lockheed Service Bulletin 382-28-20. If the service bulletin is revised after issuance of this AD, we may consider approving the use of a later revision of the service information as an AMOC with this AD, as provided by paragraph (k) of this AD. No change to the AD is necessary in this regard.

LAC requests that we use the following FAA approval statement in service bulletins: “Approved by FAA Atlanta Certification Office.” LAC states that the approval statements are either inconsistent or non-existent for the service bulletins referenced in the NPRM.

We acknowledge LAC's request. However, this request is best presented to the airplane manufacturer, who develops and includes the applicable approval statement in the service bulletin. No change to the AD is necessary in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 24 airplanes of U.S. registry. The following table provides the estimated costs, at an average labor rate of $80 per hour, 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.

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.

You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on July 2, 2008 (73 FR 37896). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

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

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

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 20 products of U.S. registry. We also estimate that it will take about 10 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $2,339 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $62,780, or $3,139 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

The FAA anticipates that this regulation will not result in adverse or negative comments, and, therefore, issues it as a direct final rule. The FAA has determined that this rule only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the effective date. If the FAA receives, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a direct final rule, and was not preceded by a notice of proposed rulemaking, interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. An electronic copy of this document may be downloaded from and comments may be submitted and reviewed at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov. or the Federal Register 's Web page at http://www.gpoaccess.gov/fr/index.html. Communications should identify both docket numbers and be submitted in triplicate to the address specified under the caption ADDRESSES above or through the Web site. All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. Those wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2008-0836; Airspace Docket No. 08-AEA-23.” The postcard will be date stamped and returned to the commenter.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 merges Class E Airspace at Butler, PA with the already existing Class E Airspace titled East Butler, PA. The controlled airspace required to support the Copter Area Navigation (RNAV) Global Positioning System (GPS) Point in Space (PinS) approach developed for the Butler Memorial Hospital Heliport was mistakenly listed under East Butler, PA. Controlled airspace extending upward from 700 feet Above Ground Level (AGL) is required for Instrument Flight Rules (IFR) operations and to encompass all Instrument Approach Procedures (lAPs) to the extent practical, therefore, the FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 71 to rectify the Class E5 airspace at Butler, PA. The official name is also amended to Butler Co./K. W. Scholter Field Airport. Designations for Class E airspace areas extending upward from 700 feet or more above the surface of the Earth are published in FAA Order 7400.9R, signed August 15, 2007 effective September 15, 2007, which is incorporated by reference in 14 CFR part 71.1. The Class E designations listed in this document will be published subsequently in the Order.

The regulations adopted herein 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 various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is noncontroversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends and removes controlled airspace at Butler and East Butler, PA.

The Direct Final Rule Procedure

The FAA anticipates that this regulation will not result in adverse or negative comments, and, therefore, issues it as a direct final rule. The FAA has determined that this rule only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the effective date. If the FAA receives, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a direct final rule, and was not preceded by a notice of proposed rulemaking, interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. The direct final rule is used in this case to facilitate the timing of the charting schedule and enhance the operation at the airport, while still allowing and requesting public comment on this rulemaking action. An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov . Communications should identify both docket numbers and be submitted in triplicate to the address specified under the caption ADDRESSES above or through the Web site. All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov or the Federal Register 's Web page at http://www.gpoaccess.gov/fr/index.html .

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. Those wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2008-0817; Airspace Docket No. 08-ANE-101.” The postcard will be date stamped and returned to the commenter.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 revises Class E3 Airspace at Windsor Locks, CT by redefining that extension to the Windsor Locks Class C airspace and by extending that surface Class E. The Class E extension was defined using the CHUPP NDB, which as been decommissioned. In reviewing the controlled airspace to support IFR operations at Bradley International Airport the FAA determined that the Class E3 extension should be redefined and extended to the southwest in order to provide adequate controlled airspace for aircraft executing Instrument Approach Procedures to Bradley International Airport. Designations for Class E Airspace Designated as Surface Areas are published in FAA Order 7400.9R, signed August 15, 2007 effective September 15, 2007, which is incorporated by reference in 14 CFR part 71.1. The Class E designations listed in this document will be published subsequently in the Order.

The regulations adopted herein 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 various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Windsor Locks, CT.

The FAA published a direct final rule with request for comments in the Federal Register August 6, 2008, (73 FR 45605), Docket No. FAA-2008-0339. Subsequent to publication, the FAA found that additional time was needed for charting. The effective date is changed to November 20, 2008, to allow additional time for charting. Also, there is a minor correction to the coordinates for the latitude/longitude of Altus AFB, OK.

On May 19, 2008, the FAA published in the Federal Register a notice of proposed rulemaking to establish Class D airspace at Victoria Regional Airport, Victoria, TX (73 FR 28764, Docket No. FAA-2008-0434). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Class D airspace designations are published in paragraph 5000 of FAA Order 7400.9R signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR Part 71.1. The Class D airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class D airspace extending upward from the surface to and including 2,600 feet MSL within a 4.7-mile radius of Victoria Regional Airport. The establishment of an airport traffic control tower has made this action necessary for the safety and management of IFR aircraft operations at the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Victoria Regional Airport, Victoria, TX.

The FAA published a direct final rule with request for comments in the Federal Register July 7, 2008 (73 FR 38313), Docket No. FAA-2008-0683. The FAA uses the direct final rule procedure for non-controversial rules where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit an adverse comment, was received within the comment period, the regulation would become effective on September 25, 2008. No adverse comments were received; thus, this notice confirms that the direct final rule will become effective on this date.

The Direct Final Rule Procedure

The FAA anticipates that this regulation will not result in adverse or negative comments, and, therefore, issues it as a direct final rule. The FAA has determined that this rule only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the effective date. If the FAA receives, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a direct final rule, and was not preceded by a notice of proposed rulemaking, interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. The direct final rule is used in this case to facilitate the timing of the charting schedule and enhance the operation at the airport, while still allowing and requesting public comment on this rulemaking action. An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov . Communications should identify both docket numbers and be submitted in triplicate to the address specified under the caption ADDRESSES above or through the Web site. All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov or the Federal Register 's Web page at http://www.gpoaccess.gov/fr/index.html .

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. Those wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2008-0203; Airspace Docket No. 08-ANE-99.” The postcard will be date stamped and returned to the commenter.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D and E airspace at Brunswick, ME, by adding to the descriptions of the controlled airspace areas the hours of operation of the Air Traffic Control Tower (ATCT) at Brunswick NAS Airport. The ATCT at Brunswick operates on an other than full-time basis and, therefore, the Class D Airspace and its extensions associated with the tower operations must be modified to reflect the times when the controlled airspace is effective. Controlled airspace extending upward from the surface of the Earth is required to encompass the airspace necessary for instrument approaches for aircraft operating under Instrument Flight Rules (IFR). The current Class D and E airspace areas are sufficient for these approaches, so no additional controlled airspace must be defined. Effective times for the Brunswick Class D and E airspace areas will be published first by Notice to Airman, and then thereafter published continuously in the Airport/Facility Directory. The FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 71 by modifying the Class D and E airspace description at Brunswick NAS to reflect the effective times of the Air Traffic Control Tower's operation. Designations for Class D and E airspace areas extending upward from the surface of the Earth are published in FAA Order 7400.9R, signed August 15, 2007 effective September 15, 2007, which is incorporated by reference in 14 CFR part 71.1. The Class D and E designations listed in this document will be published subsequently in the Order.

The regulations adopted herein 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 various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Brunswick, ME.

The National Flight Data Center has identified these three compulsory reporting points requiring their published description be revised to align with their actual locations. No changes to routing or procedures are taking place. One point, FLUKE is no longer needed for air traffic control and is being revoked. Accordingly, since this is an administrative change and does not involve a change in the dimension or operating procedures of this airspace, notice and public procedure under 5 U.S.C. 553(b) are unnecessary; a Notice of Proposed Rulemaking is not required for this action.

Alaskan Low Altitude Reporting Points are listed in paragraph 7004 of FAA Order 7400.9R signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. Alaskan High Altitude Reporting Points are listed in paragraph 7005 of FAA Order 7400.9R signed August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Reporting Points listed in this document will be revised subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revising the Low Altitude Reporting Points; CRACK, GARRS, and MOCHA; and the High Altitude Reporting Points; GARRS, and MOCHA to match the published description with their actual locations. The high and low altitude reporting point FLUKE is being revoked.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Low and High Altitude Compulsory Reporting Points in Alaska.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In the Federal Register of January 5, 2007 (72 FR 497), FDA published a proposed rule (the calcium and vitamin D proposed rule) to amend § 101.72 (21 CFR 101.72), which authorizes a health claim regarding the relationship between calcium and osteoporosis. The agency proposed the following five amendments: (1) Inclusion of vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; (2) elimination of the requirement in § 101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (3) elimination of the requirement in § 101.72(c)(2)(i)(B) that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; (4) elimination of the requirement in § 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and (5) elimination of the requirement in § 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake, when the level of calcium in the food exceeds a set threshold level. FDA issued this proposed rule in response to a health claim petition submitted on July 12, 2004, by the Beverage Institute for Health and Wellness under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)) (Ref. 1). Section 403(r)(3)(B)(i) of the act states that the Secretary of Health and Human Services (Secretary) (and, by delegation, FDA) shall issue a regulation authorizing a health claim only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (see also 21 CFR 101.14(c)). Section 403(r)(4) of the act sets out the procedures that FDA is to follow upon receiving a health claim petition. FDA filed the petition for comprehensive review in accordance with section 403(r)(4) of the act on October 20, 2004.

FDA solicited comments on the calcium and vitamin D proposed rule. The comment period closed on March 21, 2007. The agency received 27 responses, each containing one or more comments, to the calcium and vitamin D proposed rule. The comments were from trade associations, health-related organizations, academia, and consumers. Most of the comments supported the proposed amendments. A few comments expressed personal opinions on the use of health claims and labeling in general. These comments did not raise any issues about the calcium and vitamin D proposed rule, and therefore, we consider these to be outside the scope of this rulemaking and do not discuss them in this document. Another comment asserted that the standard of significant scientific agreement was not met and provided some citations and studies as support for its assertion. However, the studies that were submitted were not the type of studies that could resolve a question about the relationship between vitamin D and calcium, or calcium only, and osteoporosis that is the subject of the claim. The remaining comments and the agency's responses are discussed below.

(Comment 1) FDA received two comments opposing the elimination of the requirement in § 101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis. One of these comments did not give a reason for its opposition to the elimination of this requirement. The comment also asserted that high levels of calcium will inhibit the intake of manganese, and that the primary cause of osteoporosis in the United States is manganese deficiency. The other comment stated that the “published docket” did not provide adequate support to eliminate references to age, sex, race, and the need for an adequate level of exercise. The comment noted that studies have linked calcium and vitamin D to bone health only in specific demographic categories.

(Response) The comment opposing the elimination of listing sex, race, and age as specific risk factors in the claim language failed to provide any explanation, data, or evidence to support its opposition to eliminating the listing of these risk factors in the claim. Without such explanation, data, or evidence, FDA has no basis upon which to revise its analysis. As such, FDA will continue to rely on the analysis as set forth in the calcium and vitamin D proposed rule (72 FR 497 at 506-507). As to the comment's concern about manganese, the agency is not aware of, nor did the comment provide, any data or evidence to substantiate the statement that high levels of calcium intake will inhibit the intake of manganese or that the primary cause of osteoporosis in the United States is manganese deficiency.

FDA disagrees with the comment that information in the docket does not provide adequate evidence to eliminate the requirement that the claim reference age, sex, and race. The information in the record of this proceeding demonstrates that benefits of adequate calcium and vitamin D in reducing the risk of osteoporosis is not confined to any particular subpopulation in the United States. The scientific evidence from both the 2004 Surgeon General's Report on Bone Health and Osteoporosis and the 2000 National Institutes of Health (NIH) Consensus Statement concludes that osteoporosis occurs in all populations and at all ages (72 FR 497 at 506). Moreover, both the 2000 NIH Consensus Statement and the 2004 Surgeon General's Report on Bone Health and Osteoporosis conclude that achieving and maintaining optimal bone health is a process that is important in both men and women throughout the lifespan and is not a specific need to any particular subpopulation in the United States (72 FR 497 at 506-507). Given that the risk of osteoporosis applies to the general U.S. population, the benefits of adequate calcium and vitamin D in terms of reducing risk of disease apply to both sexes at all ages and race categories. Accordingly, because these benefits do not apply only to specific demographic groups, the language of the health claim in question should not state or suggest otherwise. For this reason, FDA is eliminating the requirement that the calcium and osteoporosis health claim or the calcium, vitamin D, and osteoporosis health claim list sex, race, and age as specific risk factors for the development of osteoporosis.

In any discussion about osteoporosis and bone health, it is important to recognize the difference between risk of bone disease, including osteoporosis, and the prevalence of the disease in various subpopulations in the United States. Risk measures the probability that a disease will occur whereas prevalence measures the number of cases of a disease that are documented in a given population or subpopulation. Both the 2000 NIH Consensus Statement and the 2004 Surgeon General's Report on Bone Health and Osteoporosis state that all populations in the United States are at risk of osteoporosis, although the prevalence of the disease is not equally distributed among all subpopulations. Specifically, osteoporosis is most prevalent in White postmenopausal women. However, as noted, the disease often goes unrecognized in other age and ethnic groups as well as in men (72 FR 497 at 508).

In sum, while the prevalence of osteoporosis varies in different subpopulations in the United States, all populations are at risk of osteoporosis and, in fact, the disease does occur in all populations. Thus, the benefits of calcium or calcium and vitamin D on reducing the risk of bone diseases, including osteoporosis, apply to both sexes at all ages and in all race categories (72 FR 497 at 507). For this reason, FDA is eliminating the requirement that the calcium and osteoporosis health claim or the calcium, vitamin D, and osteoporosis health claim list sex, race, and age as specific risk factors for the development of osteoporosis.

Importantly, however, although this final rule eliminates the requirement that the claim reference age, sex, and race for the development of osteoporosis, § 101.72(d)(4) allows the claim to include optional information related to the prevalence of osteoporosis. In particular, the claim could include information about the number of people in the United States, including the number of people in certain subpopulations in the United States, who have osteoporosis or low bone density. For example, under § 101.72(d)(4), a claim could include a statement that, according to the National Osteoporosis Foundation, 20 percent of non-Hispanic Caucasian and Asian women aged 50 and older are estimated to have osteoporosis.

(Comment 2) FDA received two comments opposing the elimination of the requirement in § 101.72(c)(2)(i)(C) that the calcium and osteoporosis health claim identify the mechanism by which calcium reduces the risk of osteoporosis. One comment did not give a reason for its opposition to the elimination of this requirement. The other comment noted that building a strong bone matrix relies on proper mineral balance and that science is continually evolving to elucidate the specific mechanisms involved. This comment further stated that although calcium is required to develop and sustain proper bone health and to prevent osteoporosis, the scientific community recognizes that calcium alone is not adequate, and a balance of normal minerals and hormones are also critical for bone health. Thus, this comment suggested that there is not enough scientific evidence either to eliminate or make optional the requirement in § 101.72(c)(2)(i)(C) because incomplete information is not accurate information.

(Response) The comment opposing elimination of the requirement in § 101.72(c)(2)(i)(C) failed to provide any explanation, data, or evidence to support its position. Without any explanation, data, or evidence provided in the comment, we have no basis upon which to revise our analysis or to alter our conclusion to eliminate the requirement that the health claim identify the mechanism by which calcium reduces the risk of osteoporosis; thus we will continue to use the analysis as set forth in the calcium and vitamin D proposed rule (72 FR 497 at 508-509).

FDA agrees with the comment that stated: Building a strong bone matrix relies on proper mineral balance and that science is continually evolving to elucidate specific mechanism(s) involved. Calcium is an important nutrient for achieving and maintaining good skeletal health. FDA discussed the findings that many nutrients are involved in bone health, and tentatively concluded in the proposed rule that a well-balanced diet is important for bone health throughout life (72 FR 497 at 507). Thus, the agency proposed that the claim make clear the importance of calcium intake or calcium and vitamin D intake in a healthful well-balanced diet over a lifetime. Conveying the information about calcium intake in the context of a healthful, well-balanced diet recognizes that calcium alone is not sufficient for bone health. Furthermore, results from a 1995 health claims report showed that consumers had learned elsewhere that calcium intake is related to bone health and that they thought the food label was not the right means for conveying this information (72 FR 497 at 509). This consumer awareness of calcium's ability to “build and maintain good bone health,” as well as the observation that the food label is not necessarily the most appropriate means to convey this information, prompted the agency to request comment in the calcium and vitamin D proposed rule on whether to make information of the mechanism by which calcium reduces the risk of osteoporosis optional in the health claim. Therefore, for the reasons set forth previously in this document, FDA is eliminating the requirement that the claims identify the mechanism by which calcium reduces the risk of osteoporosis, and instead is making such information optional. FDA is also revising the language from the proposed rule for use of the optional statement about slowing the rate of bone loss, by removing the following phrase: “When reference is made to persons with a family history of the disease, post-menopausal women, and elderly men and women * * *” so the language now reads: “The claim may also state that adequate intake of calcium, or when appropriate, adequate intake of calcium and vitamin D, is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss for persons with a family history of the disease, post-menopausal women, and elderly men and women.” This change makes the use of the optional language related to the mechanism of slowing the rate of bone loss consistent with the final rule to remove reference to specific targeted populations as to risk of osteoporosis, but allows reference to family history of the disease, post-menopausal women, and elderly men and women in the context of the mechanism of slowing the rate of bone loss.

(Comment 3) Several comments opposed the elimination of the conditional requirement in § 101.72(c)(2)(i)(E) that the calcium and osteoporosis health claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 mg of calcium) has no further known benefit to bone health. Some of the comments were concerned that eliminating this requirement could potentially mislead consumers because there will be nothing on the label to remind them that “more is not always better when it comes to nutrients, especially in the form of supplements or fortification.” One comment stated that withholding this information could encourage consumers to over consume calcium products while other comments were concerned that withholding this information could be potentially harmful for those individuals who may be taking high doses of supplemental calcium, along with high amounts of vitamin D. One comment highlighted its concern regarding the elimination of this conditional requirement by pointing out that the Institute of Medicine (IOM) of the National Academy of Sciences (NAS) has found that the toxic effects of excess calcium increased the risk of kidney stone formation and that this condition affected 12 percent of individuals in the United States, as well as renal insufficiency and decreased absorption of other essential minerals (iron, zinc, magnesium and phosphorus) (72 FR 497 at 502). Another comment questioned how FDA could be assured that cumulative vitamin D intake from all dietary sources would remain `at non-toxic levels' (e.g., less than the Tolerable Upper Intake Level (UL) for vitamin D) when supplementation is encouraged in a variety of foods, including staples such as milk, cereal, and bread.

(Response) FDA's decision to eliminate the conditional requirement was made, in part, in response to the IOM's 1997 report on “Dietary Reference Intakes (DRIs) for Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride,” which was not available at the time the calcium and osteoporosis health claim was authorized in 1993 (72 FR 497 at 510). IOM conducted a major review of bone-related nutrients to determine the level of nutrient intake for normal, healthy individuals that would prevent the development of a chronic condition (e.g., osteoporosis) associated with calcium (Ref. 2). IOM set the UL for calcium at 2,500 mg per day for all individuals ages 1 and above. The UL, as defined by IOM, is the highest level of nutrient intake that is likely to pose no risks of adverse effects to all individuals in the general population. When IOM set the UL for calcium it divided the lowest- observed-adverse-effect level (LOAEL) of calcium by an uncertainty factor of two to take into account the relatively high prevalence of kidney (renal) stones in the U. S. population, which is 12 percent, and the potential increased risk of hypercalciuria and depletion of other minerals among susceptible individuals (72 FR 497 at 502). An increased risk of kidney stone formation from toxic effects of excess calcium, as noted in one of the comments, was addressed when IOM established the UL for calcium.

Furthermore, inclusion of the conditional requirement was based, in part, on a concept that calcium was a threshold nutrient, which means that there is a level of calcium intake below which bone health is jeopardized and above which no further benefit to bone health occurs (72 FR 497 at 510). Neither IOM in its 1997 report, the 2000 NIH Consensus Statement, nor the 2004 Surgeon General's Report on Bone Health and Osteoporosis discusses a threshold level of calcium beyond which no further bone benefit occurs; instead these reports discuss scientific evidence that is useful for establishing a desirable level of intake for calcium as well as intake levels of calcium that pose no risk of adverse health effects (72 FR 497 at 510).

Moreover, contrary to concerns expressed by some of the comments, the lack of calcium in the American diet is more of a concern than the potential over consumption of the nutrient. For example, the 2005 Dietary Guidelines for Americans identified calcium as a “nutrient of concern” due to low calcium consumption in the U.S. population (Ref. 3).

FDA also notes that a “high” level of calcium and vitamin D is at least 20 percent of the Reference Daily Intake (RDI) of calcium and vitamin D per reference amount customarily consumed (RACC). Since the RDI for calcium is 1,000 mg per day and the RDI for vitamin D is 400 IU (10 micrograms per day (μg per day)), 20 percent of the RDI for calcium (200 mg per day) is well below the UL of 2,500 mg per day intake level of calcium that poses no risk of adverse health effects and 20 percent of the RDI for vitamin D (80 IU (2 μg per day) is well below the 2,000 IU (50 μg per day) intake level of vitamin D that poses no risk of adverse health effects.

To evaluate potential maximum intake levels of calcium and vitamin D in the United States, FDA examined the most recent nationally representative data available from the National Health and Nutrition Examination Survey on median intake values for calcium and vitamin D and common dietary supplement products that contain calcium, or calcium and vitamin D in the calcium and vitamin D proposed rule (72 FR 497 at 500 to 502). Results from this evaluation suggested that consumers who choose foods that bear the calcium, or the calcium and vitamin D, and osteoporosis health claim would be able to incorporate such foods into the diet in a manner that would likely keep their total intake of calcium well below the UL of 2,500 mg per day and their total intake of vitamin D below the UL of 2,000 IU per day (72 FR 497 at 502). Further, FDA determined that consumers who choose conventional foods that bear the calcium or the additional calcium and vitamin D claim and that consume up to 1,500 mg of calcium per day from supplements (the maximum daily intake of calcium suggested in commonly found supplements) and that consume up to 400 IU of vitamin D per day from supplements (the most common daily intake of vitamin D suggested in supplements) would also likely keep their total intake of calcium and vitamin D below the ULs of calcium and vitamin D (id.). None of the comments questioned these findings. Finally, the agency is not aware of any basis for why the elimination of the conditional requirement would be misleading or encourage over-consumption of calcium products.

For these reasons, FDA is eliminating the conditional requirement in § 101.72(c)(2)(i)(E), as proposed.

(Comment 4) One comment noted that retaining in § 101.72(e) and (f) physical activity as part of the calcium and osteoporosis health claim as well as the calcium, vitamin D and osteoporosis health claim, might have the unintended consequence of leading consumers to believe that the benefits to bone health (or reduced risk of osteoporosis) of consuming adequate amounts of calcium or calcium and vitamin D can only be achieved by regularly engaging in physical activity.

(Response) FDA agrees with this comment. The agency's tentative decision to retain physical activity as part of the calcium and osteoporosis claim as well as the calcium, vitamin D and osteoporosis health claim was based primarily on the 2000 NIH Consensus Statement and the 2004 Surgeon's General Report (72 FR 497 at 507), which indicate that physical activity is beneficial to bone health and can have an additive effect on increasing bone mineral density (BMD) in conjunction with adequate intake of calcium and vitamin D. On the other hand, several studies show that consuming adequate levels of calcium and vitamin D supports bone health and reduces the risk of osteoporosis in the absence of physical activity (Refs. 4 to 12). Since consumption of adequate amounts of calcium and vitamin D reduces the risk of osteoporosis without physical activity, FDA will not require physical activity to remain as part of the claim language for the calcium and osteoporosis or the calcium, vitamin D and osteoporosis health claim. However, since the importance of physical activity to bone health is well established, FDA will allow optional reference to physical activity in the health claim.

Given the information discussed in the preamble to the calcium and vitamin D proposed rule and the absence of contrary information in the comments, FDA is adopting the following amendments to § 101.72: (1) Inclusion of vitamin D so that, in addition to the claim for calcium and osteoporosis, a claim can be made for calcium and vitamin D and osteoporosis; (2) elimination of the requirement in § 101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (3) elimination of the requirement in § 101.72(c)(2)(i)(B) that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; (4) elimination of the requirement in § 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis, and instead make it optional; (5) elimination of the conditional requirement in § 101.72(c)(2)(i)(E) that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health, when the level of calcium in the food exceeds a set threshold level; and (6) elimination of the provision in § 101.72(c)(2)(i)(A) about physical activity, and instead make it optional. Therefore, FDA is not including the term “physical activity” in some of the model health claims as proposed. Moreover, FDA is revising § 101.72(e) and (f) by removing the term “regular exercise” in the model health claims.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. The final rule amends the current calcium and osteoporosis health claim language and will require changes to the claim language on products currently bearing the health claim. Thus, the only mandatory costs of this final rule will be the costs to update the current wording of the calcium and osteoporosis health claim on those products that currently bear the claim. Based on FDA's 2001 Food Label and Package Survey (FLAPS) (see discussion in section III.A.2 ``Background'' of this document), very few products bear the calcium and osteoporosis health claim. Therefore, because of the limited use of the current calcium and osteoporosis health claim, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $130 million, using the most current (2007) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount and has determined that this final rule does not constitute a significant rule under the Unfunded Mandates Reform Act.

Current regulations do not permit food producers to claim health benefits for products by linking the intake of vitamin D, when combined with the intake of calcium, with a reduced risk of osteoporosis. However, current regulations do permit food producers to claim health benefits for products by linking calcium intake with a reduced risk of osteoporosis only if they also list the specific risk factors and at-risk subpopulations for osteoporosis, the mechanism by which calcium reduces the risk of osteoporosis, and the limit of the benefits of dietary calcium at certain levels.

Health claims can inform consumers about diet-disease relationships and encourage producers to produce more healthful foods. This final rule will allow producers to make more nutrition information related to osteoporosis available to consumers (linking the intake of calcium and vitamin D to the risk of osteoporosis), while eliminating other information currently required to be given to consumers when claiming health benefits relating to the relationship between calcium intake and the risk of osteoporosis.

Osteoporosis represents a major public health problem in the United States. This disease affects more than 10 million individuals and causes approximately 1.5 million fractures annually. Every year, these lead to more than 2.6 million physician office visits, over 800,000 emergency room visits, and more than 500,000 hospitalizations, and the placement of nearly 180,000 people into nursing homes. The direct care expenditures for osteoporotic fractures alone range from 12 to 18 billion dollars each year (measured in 2002 dollars) (Ref. 13). The indirect health costs of osteoporosis, such as pain, suffering, and lost mobility, are also large. Average calcium and vitamin D intakes are below recommended levels for many consumers (Refs. 13, 14 and 15). Even though many consumers are not achieving recommended intakes of calcium, producers have rarely placed the calcium and osteoporosis health claim on products that qualify for the claim. FDA's 2001 FLAPS (the most recently available data) showed only 1 out of the 87 shelf-stable juice products surveyed, a fortified orange juice, bearing the calcium and osteoporosis health claim. None of the 10 milk products surveyed bore the claim (Ref. 16).

FDA identified four regulatory options for this final rule: (1) Take no new regulatory action; (2) reduce the required language in the existing calcium and osteoporosis health claim; (3) expand the existing calcium and osteoporosis health claim to include vitamin D; or (4) reduce the required language in the existing calcium and osteoporosis health claim and include vitamin D as an option to the claim, as described in this final rule.

This final rule will require that any food manufacturers wishing their products' labels to make the calcium, or calcium and vitamin D, and osteoporosis health claim be redesigned. Labels must be redesigned in order for a food to carry the health claim since information on populations at particular risk for osteoporosis would no longer be required or allowed for the claim (see § 101.72(c)(2)(A) and (c)(2)(B)).

Manufacturers that wish to continue making a calcium and osteoporosis health claim on their products will not need to reformulate their products under the final rule. The nature of the food eligible to make a calcium and osteoporosis health claim remains food that meets or exceeds a ``high'' level of calcium (as defined in 21 CFR 101.54(b)). Manufacturers wishing to take advantage of the expanded calcium, vitamin D, and osteoporosis health claim may voluntarily choose to reformulate their products. If some producers choose to reformulate their products to take advantage of the calcium, vitamin D, and osteoporosis health claim, they reveal that they expect the private benefit that the claims give them to exceed the expense of making the claims. If this is not the case, no producer will voluntarily choose to use the claims. Likewise, consumers who choose to purchase the products with the amended health claims reveal that they value the products more highly than other alternatives, including not purchasing the products.

We considered five potential effects in estimating the relative public health benefits of the options: (1) The extent to which the option encourages producers to use the health claims on their food labels; (2) the extent to which the option encourages producers to reformulate their products to make the health claims; (3) the extent to which the option provides information to consumers; (4) potential risk-risk tradeoffs (where the action taken to reduce the risk posed by one hazard causes an increase in the risk posed by another hazard) with each option; and (5) the availability of information on the relationship between osteoporosis and calcium and vitamin D to consumers who do not consume dairy products.

a. Producer responses . There are four likely responses to this final rule from producers: (1) Make no changes (i.e., continue not making the calcium or calcium and vitamin D health claim; (2) create new product labels to continue making the calcium and osteoporosis health claim (for products already making the existing claim); (3) add the health claims to their products that qualify for the health claims (increase usage of the claim due to the new wording requirements); and (4) reformulate their products (by fortifying with calcium or vitamin D, for example) to qualify for the health claims.

Several factors affect whether producers choose to use health claims, including the flexibility of the health claims and how appealing the health claims are to consumers. Revising the existing calcium and osteoporosis health claim language to make it shorter will make it more appealing to put the health claims on labels. Package space is limited, so more flexible and shorter claims are easier to use. Also, Wansink, et al. (2004) found that shorter health claims on the front of the package led to more favorable beliefs about the product and a more positive image of the product among consumers (Ref. 17).

Approving a calcium, vitamin D, and osteoporosis health claim should encourage the manufacturers of foods that are eligible for fortification with vitamin D to do so because they will be able to publicize the relationship between calcium, vitamin D, and osteoporosis on their labels. If producers fortify more products with vitamin D, consumers can get more vitamin D in their diet without making changes in their dietary choices.

b. Consumer responses . Providing information about the relationship between calcium, vitamin D, and osteoporosis on food packages provides a number of benefits to consumers, including: (1) Informing them about the nutrient-disease relationship; (2) helping them identify products that are high in calcium and vitamin D; and (3) helping them make dietary choices that reduce their risk of osteoporosis. The extent to which consumers realize these benefits will depend on the consumer's knowledge of the relationship between calcium, vitamin D, and bone health; how many products bear the calcium or calcium and vitamin D health claims; how many consumers read the health claims; and how much they change their behavior to include such products in their diets. There is evidence that consumers who read nutrition information on packages eat healthier diets (Refs. 18 and 19). However, there is a great deal of uncertainty about how much consumers change their behavior in response to label information.

c. Risk-risk tradeoffs . A potential concern is that allowing these osteoporosis health claims on juice drinks will result in consumers switching away from milk to juice drinks, which are higher in calories, for dietary sources of calcium and vitamin D. Table 1 of this document presents the caloric and nutrient profile of non-fat and low-fat milk products and an orange juice drink product as reported in the U.S. Department of Agriculture (USDA) National Nutrient Database for Standard Reference. Orange juice drinks are higher in calories and contain less of some important nutrients than either non-fat or low-fat milk (table 1 of this document).

The likelihood of consumers switching from non-fat or low-fat milk or to higher caloric juice drinks because of this rule is expected to be small because non-fat and low-fat milk and juice drinks that are eligible can already make the existing calcium and osteoporosis health claim. Permitting the same set of products to make the final, simpler calcium and osteoporosis health claim should not change the relative appeal of the claim to producers of one type of beverage over another. The allowance of the new calcium, vitamin D, and osteoporosis health claim could expand the set of products making an osteoporosis health claim; however, the relative appeal of the new claim (calcium and vitamin D) to producers of non-fat and low-fat milk and juice drinks should be similar to the appeal of the existing calcium and osteoporosis health claim.

There is little evidence to support that consumers would switch from non-fat or low-fat milk to juice drinks as a result of this final rule. As stated in the Surgeon General's Report on Bone Health and Osteoporosis, consuming adequate levels of calcium and vitamin D throughout life are critically important to an individual's bone health. However, the report's review of national surveys suggests that the average calcium intake of individuals is far below the levels recommended for optimal bone health. One reason cited by the report for these low levels of calcium intake relates to current lifestyle and food preferences, which have resulted in reduced intake of dairy products and other naturally occurring calcium-rich foods. The report also posits that for some individuals lactose intolerance 1 may also play a role in not consuming adequate levels of calcium. Given this information on the current preference and tolerance for dairy products, expanding the calcium and osteoporosis health claim to include vitamin D as a result of this final rule should only lead to an increase in the overall consumption of these essential, under consumed nutrients.

In addition, according to the American Beverage Association, U.S. sales of calcium-fortified orange juice have grown dramatically over recent years, reaching nearly $1 billion in 2003 (Ref. 20), while overall sales of juice have not grown. Therefore, FDA expects that the nutritional profile of diets would most likely improve as a consequence of changes in consumption resulting from this final rule. Switching from unfortified to fortified juices would increase needed consumption of calcium and vitamin D.

The simplification of the current health claim for calcium and osteoporosis, along with the additional health claim for calcium, vitamin D, and osteoporosis should increase and expand the current usage of the health claim and therefore improve the U.S. population's intake of these two important nutrients. Therefore, all the options considered below would improve public health relative to the baseline of taking no new regulatory action. In our analysis of the benefits and costs of the options, we compare the benefits and costs of each option with each other option based on their relative effects on consumer and producer behavior.

This option would result in no change to the current situation. This is the baseline for comparison of options and entails no costs or benefits.

Compared with Option 1, this option would increase the appeal of the claim for producers, increase the use of the claim on products, and thereby provide consumers with more information on the calcium and osteoporosis diet-disease relationship. It could encourage more reformulation of products to fortify with calcium than has occurred with the existing claim. Like Option 1, this option provides consumers with no information about the relationship of vitamin D to osteoporosis.

With this option, manufacturers of some products making the current calcium and osteoporosis health claim may have to re-label their products to reflect the updated wording provided by the claim. The potential costs associated with a required label change will vary depending on when the new effective compliance date is established. Table 2 of this document shows the possible range of costs by product type of having to re-label to be in compliance with the revised calcium and osteoporosis health claim. The product re-labeling costs were estimated using the FDA Labeling Cost Model (Ref. 21). The costs of re-labeling included are administrative, graphic, prepress, engraving, and inventory costs. Re-labeling costs are shown for both a 12-month and 24-month compliance period.

Failing to shorten the existing calcium and osteoporosis health claim will not make the health claim as appealing to producers and consumers as Option 2, leading to less claim use and reformulation and less information provided to consumers than Option 2. This option would provide consumers with more information on vitamin D than Option 2, should producers decide to voluntarily re-label and/or reformulate their products to make use of the added vitamin D language.

Like Option 2, this option would increase the appeal of the calcium and osteoporosis health claim for producers and thereby provide consumers with more information on the calcium and osteoporosis diet-disease relationship. Also like Option 2, producers of products with existing calcium and osteoporosis health claim labeling will have to revise their labeling in order to comply with the revised claim language. Like Option 3, this option would provide consumers with more information on vitamin D than Option 2 because the new, simplified calcium and osteoporosis health claim can now contain information about vitamin D as well. It could also encourage more reformulation of products to fortify with vitamin D than would Option 2 and as many products to fortify with calcium as Option 2.

FDA is unable to quantify the benefits of this final rule due to uncertainty about the degrees of changes in consumer and producer behavior. However according to information compiled in the Surgeon General's 2004 Report on Bone Health and Osteoporosis, there are about 1.5 million osteoporotic fractures in the United States each year that carry annual direct care expenditures of 12 to 18 billion dollars per year (2002 dollars). These fractures cause more than half a million hospitalizations, over 800,000 emergency room encounters, more than 2.6 million physician office visits, and the placement of nearly 180,000 individuals into nursing homes annually (Ref. 13). The direct costs of other complications from osteoporosis, and the indirect costs of these fractures and other osteoporotic ailments (e.g., the value of functional disability to the patient, the value of the pain and suffering to the patient, the costs experienced by the care giver) if calculated, would add substantially to the annual costs of this disease. Any increase in calcium and vitamin D intake by consumers insufficient in these nutrients as a result of this final rule could possibly lower the incidence of osteoporosis and therefore the annual costs associated with the disease.

Table 3 of this document provides a summary of the effects of the rule, and which options create the smallest and largest behavior changes for consumers and producers. All options should produce positive net benefits, with the largest net benefit arising from Option 4, the final rule. With Option 4, the largest number of products and labels would change, leading to the largest reduction in the risk of osteoporosis.

FDA has examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities consistent with statutory objectives. FDA does not believe that this final rule will have a significant economic impact on a substantial number of small entities because the only mandatory costs of this rule are the costs to update the current wording of the calcium and osteoporosis health claim for manufacturers of products that currently make the claim and wish to continue doing so. Also previously mentioned, FDA's 2001 Food Label and Package Survey showed only 1 out of 87 shelf-stable juice products surveyed bore the current calcium and osteoporosis health claim while none of the 10 milk products surveyed bore the claim. This implies that not many products eligible to bear the current claim would need to be re-labeled as a result of this final rule.

In addition, FDA establishes uniform compliance dates for final food labeling regulations in 2-year intervals. Therefore, companies whose products currently make the calcium and osteoporosis health claim and wish to continue doing so will have between 1 and 2 years to use existing label inventory and expense the costs of designing revised labeling. FDA estimates that on average, the cost to re-label a product according to the revised health claim language will be $7,900 to $16,600 per product if the compliance period is 12 months; and $6,100 to $13,600 per product if the compliance period is 24 months. In the calcium and vitamin D proposed rule, FDA requested comments on whether the rule would have a significant impact on a substantial number of small entities. FDA received no comments on the issue of significant impacts on any size business. Manufacturers that wish to begin using the revised calcium and osteoporosis health claim or the new calcium, vitamin D, and osteoporosis health claim will only do so if the benefits of labeling their products to inform consumers of the claim outweigh the costs of doing so.

FDA has determined under 21 CFR 25.32(p) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA concludes that the labeling provisions of this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food labeling health claims on the association between calcium and osteoporosis or calcium, vitamin D, and osteoporosis is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public.” (5 CFR 1320.3(c)(2)).

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule will have a preemptive effect on State law. Section 4(a) of the Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)) provides that: “* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—* * * (5) any requirement respecting any claim of the type described in section 403(r)(1) made in the label or labeling of food that is not identical to the requirement of section 403(r) * * *.”

This final rule amends the existing food labeling regulations on health claims for calcium and osteoporosis. Although this rule has a preemptive effect in that it precludes States from issuing any health claim labeling requirements for calcium and osteoporosis or calcium, vitamin D, and osteoporosis that are not identical to those required by this final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(5) of the act displaces both State legislative requirements and State common law duties. Riegel v. Medtronic , 128 S. Ct. 999 (2008).

FDA believes that the preemptive effect of the final rule is consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.'” On February 17, 2006, FDA's Division of Federal and State Relations provided notice by fax and e-mail transmission to State health commissioners, State agriculture commissioners, food program directors, and drug program directors as well as FDA field personnel, of FDA's intended amendments to the calcium and osteoporosis health claim (21 CFR 101.72). FDA received no comments in response to this notice.

In addition, the agency sought input from all stakeholders through publication of the proposed rule in the Federal Register on January 5, 2007 (72 FR 497). FDA received no comments from any States on the proposed rulemaking.

In conclusion, the agency believes that it has complied with all of the applicable requirements under the Executive order and has determined that the preemptive effects of this rule are consistent with Executive Order 13132.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

On September 27, 2007, the President signed into law FDAAA (Public Law 110-85, 121 Stat. 823). Section 920 of FDAAA adds new section 505(t) to the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(t)) and requires that FDA take the following actions:

• Publish on its Internet site a complete list of all authorized generic drugs included in an annual report submitted to the agency after January 1, 1999, consisting of the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market;

• Update the list quarterly; and

• Notify relevant Federal agencies, including the Centers for Medicare and Medicaid Services and the Federal Trade Commission, that the list has been published and will be updated quarterly.

For purposes of publishing the list, section 505(t)(3) of the act defines the term “authorized generic drug” as a “listed drug (as that term is used in [section 505(j) of the act]) that has been approved [under section 505(c) of the act] and is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.”

Currently, there is no requirement that an NDA holder specifically report that it is marketing an “authorized generic drug.” NDA holders are required to include information about distribution or certain changes to manufacturing or labeling in annual reports, which may indicate that an authorized generic is being marketed. However, annual reports may not include all the information necessary for FDA to publish the list required by FDAAA. For example, sponsors rarely include the date the authorized generic entered the market.

To allow FDA to accurately report a complete list of all authorized generic drugs included in annual reports and to update the list in a timely fashion, we are adding a requirement that annual reports specifically and clearly include the information we are required to report. In addition, we are requiring that the NDA holder report the date the authorized generic drug ceased being distributed to ensure that the list is as accurate and up-to-date as possible. The first annual report submitted after implementation of this regulation must provide information regarding any authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999.

There are currently 15 divisions in FDA that receive annual reports for over 2,200 active NDAs. When information is included in an annual report about an authorized generic drug, we are requiring that a copy of that portion of the annual report be sent to a central office in the agency that will compile the list and update it quarterly.

We have determined that the subject of this rulemaking is suitable for a direct final rule. FDA expects this amendment to be noncontroversial, and the agency does not anticipate receiving any significant adverse comments on this rule. We have determined that publishing a direct final rule is the most appropriate method to meet the requirement, under section 505(t) of the act, that the agency publish a list of all authorized generic drugs.

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

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

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

We are defining the term “authorized generic drug” as a listed drug (as defined in § 314.3 (21 CFR 314.3)) that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.

We are amending our regulations in § 314.81 (21 CFR 314.81) to require that an NDA holder specifically report that it has marketed an authorized generic drug during the applicable time period. Section 314.81(b)(2) requires that an NDA holder submit an annual report within 60 days of the anniversary date of approval of an NDA for every NDA it holds. We are amending § 314.81 by redesignating paragraph (b)(2)(ii) regarding distribution data, as paragraph (b)(2)(ii)( a ), and adding a new paragraph (b)(2)(ii)( b ) regarding marketing of authorized generic drugs. This new paragraph states that, if an authorized generic drug was marketed under an NDA, or ceased to be marketed, during the reporting year, the annual report must list the date each authorized generic drug entered the market, the date each authorized generic drug ceased being distributed, and the corresponding trade or brand name. Each dosage form and/or strength is a different authorized generic drug and should be listed separately. The first annual report submitted after implementation of this regulation must include the required marketing information for any authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999.

If information is included in the annual report with respect to any authorized generic drug, a copy of the portion of the annual report with that information must be sent to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 10903 New Hampshire Ave., Bldg. 51, rm. 4183, Silver Spring, MD 20993-0002, and marked “Authorized Generic Submission.” This final rule assumes that the copy of the relevant portion of the annual report may currently be submitted in any number of formats (e.g., a paper copy, a PDF document on a computer disc). Current capabilities do not permit direct electronic submission through a Web-based system. However, FDA is committed to adapting its business practices to evolving technology, including using the significant advancements in Web-based, electronic systems. We anticipate that, in future rulemakings, Web-based submission of annual reports will eventually be required. In anticipation of that future change, this final rule provides that once an electronic submission format is adopted for annual reports, the submission to the agency of the information required under this regulation will also be required in that electronic format. We anticipate that when such a change is implemented, future guidance will address any technical questions related to such submissions.

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), provides authority for FDA to issue this direct final rule. Section 505(t) of the act (21 U.S.C. 355(t); FDAAA section 920) requires that FDA publish a complete list of all authorized generic drugs included in an annual report submitted to the agency after January 1, 1999, and to update that list quarterly. In addition, section 701(a) of the act (21 U.S.C. 371(a)) provides general authority for FDA to issue regulations for the efficient enforcement of the act. This direct final rule would amend FDA's existing regulations regarding annual reports in order to ensure that the information necessary for the agency to fulfill its obligation under section 505(t) is clearly reported.

We have carefully considered, under 21 CFR part 25, the potential environmental effects of this action. We have concluded that this action will not have a significant impact on the human environment and that an environmental impact statement is not required.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this direct final rule imposes only minimal regulatory obligations, the agency certifies that the direct rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $130 million, using the most current (2007) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this direct final rule to result in any 1-year expenditure that would meet or exceed this amount.

The only costs of this direct final rule are associated with the Paperwork Reduction Act burden, described in section VII of this document. If we assume an average hourly wage plus benefits of $56 for the reporting personnel, the annual cost is about $29,000 ($56 per hour x 520 hours).

This direct final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown with an estimate of the annual reporting and recordkeeping burden in Table 1 of this document. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title : Applications for FDA Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs.

Description : This rulemaking requires the holder of an NDA to notify the agency if an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central office. We are taking this action as part of our implementation of FDAAA, which requires that FDA publish a list of all authorized generic drugs included in an annual report after January 1, 1999, and that the agency update the list quarterly. We plan to publish this list on the Internet and to notify relevant Federal agencies that the list has been published and will be updated.

Description of Respondents : Current holders of an NDA under which an authorized generic drug was marketed during the time period covered by an annual report submitted after January 1, 1999.

During the past several years, FDA has reviewed a small sample of annual reports it has received under § 314.81(b)(2) to discern whether an authorized generic drug is being marketed by the NDA holder. Based on information learned from this review and based on the number of annual reports the agency currently receives under § 314.81(b)(2), 1 we estimate that, after the implementation of § 314.81(b)(2)(ii)( b ), we will receive approximately 400 annual reports containing the information required under § 314.81(b)(2)(ii)( b ) for authorized generic drugs that were marketed during the time period covered by an annual report submitted after January 1, 1999. Based on the number of sponsors that currently submit all annual reports, we estimate that approximately 60 sponsors will submit these 400 annual reports with authorized generics. As indicated in Table 1 of this document, we are estimating that the same number of annual reports will be submitted each subsequent year from the same number of sponsors containing the information required under § 314.81(b)(2)(ii)( b ), and that the same number of copies of that portion of each annual report containing the authorized generic drug information will be submitted from the same number of sponsors. Concerning the hours per response, based on our estimate of 40 hours to prepare each annual report currently submitted under § 314.81(b)(2), 2 we estimate that sponsors will need approximately 1 hour to prepare the information required under § 314.81(b)(2)(ii)( b ) for each authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999; approximately 15 minutes to prepare the information required under § 314.81(b)(2)(ii)( b ) for each subsequent annual report; and approximately 3 minutes to submit to FDA a copy of that portion of each annual report containing the authorized generic drug information.

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

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

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov .

I. Background

OSHRC is making several corrections and technical amendments to its Rules of Procedure found at 29 CFR part 2200, and its Regulations Implementing the Government in Sunshine Act found at 29 CFR part 2203.

As to 29 CFR part 2200, OSHRC is correcting a typographical error in § 2200.63(b) by removing “zequesten¢” and adding in its place “requested.” Also, in §§ 2200.57(a) and 2200.96, OSHRC is amending the reference to its nine-digit ZIP code, which has been changed from 20036-3419 to 20036-3457. Finally, OSHRC is correcting cross-references that should have been amended when OSHRC revised its Rules of Procedure on July 3, 1997 (62 FR 35961). In that revision, OSHRC reduced the period specified in § 2200.90(b)(2) for transmitting a judge's decision to the Executive Secretary from 20 days to 10 days. This 20-day period was previously cross-referenced in §§ 2200.91(c) and 2200.209(g), but was inadvertently left unchanged. Therefore, § 2200.91(c), which refers to “the 20 days provided by § 2200.90(b),” is corrected to read “the 10 days provided by § 2200.90(b)”; and § 2200.209(g), which refers to the “21 day period provided for in rule § 2200.90(b)(2),” is corrected to read the “11-day period provided for in rule § 2200.90(b)(2).”

As to 29 CFR part 2203, OSHRC is amending the time of its regularly-scheduled meetings. Sections 2203.2 (definition of “Regularly-scheduled meetings”) and 2203.4(c) presently state that such meetings are held at 10 a.m. every Thursday, except for legal holidays. In both sections, this meeting time is being amended to “10:30 a.m.” every Thursday, except for legal holidays. Also, in §§ 2203.4(c) and 2203.7(b), OSHRC is amending the reference to its nine-digit ZIP code from 20036-3419 to 20036-3457.

Waiver of Proposed Rulemaking: For good cause, OSHRC finds that prior notice and opportunity for comment on these changes are unnecessary pursuant to 5 U.S.C. 553(b)(3)(B), because the amendments and corrections to the affected sections are merely technical in nature and propose no substantive changes on which public comment could be solicited.

Waiver of 30-Day Delayed Effective Date Requirement: OSHRC finds that good cause exists for the final rule to be exempt from the 30-day delayed effective date requirement of 5 U.S.C. 553(d) because a delay in clarifying these rules would be contrary to the public interest.

Executive Orders 12866 and 13132, and the Unfunded Mandates Reform Act of 1995: OSHRC is an independent regulatory agency, and, as such, is not subject to the requirements of E.O. 12866, E.O. 13132, or the Unfunded Mandates Reform Act, 2 U.S.C. 1501 et seq.

Regulatory Flexibility Act: OSHRC has determined that this rulemaking is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 604(a), because, as noted, a general notice of proposed rulemaking is not required under 5 U.S.C. 553(b).

Paperwork Reduction Act of 1995: OSHRC has determined that the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., is not applicable here because this final rule contains no information collection requirements that require the approval of OMB.

Congressional Notification: OSHRC has determined that the Congressional Review Act, 5 U.S.C. 801, is not applicable here because, pursuant to 5 U.S.C. 804(3)(C), this final rule “does not substantially affect the rights or obligations of non-agency parties.”

Table of Contents I. Acronyms II. Regulatory History and Good Cause for Immediate Effectiveness III. Background, Purpose, and Discussion of Rule IV. Discussion of Comments V. Request for Additional Comments VI. Regulatory Evaluation A. Executive Order 12866 B. Small Entities C. Assistance for Small Business D. Collection of Information E. Federalism F. Unfunded Mandates Reform Act G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment I. Acronyms APA Administrative Procedure Act DCR Dry Cargo Residue DEIS Draft Environmental Impact Statement FEIS Final Environmental Impact Statement IEP Interim Enforcement Policy NPRM Notice of Proposed Rulemaking ROD Record of Decision II. Regulatory History and Good Cause for Immediate Effectiveness

In the Federal Register on May 23, 2008, we published a notice of proposed rulemaking (NPRM) and a notice of availability for the accompanying Draft Environmental Impact Statement (DEIS) (73 FR 30014). We received written comments on the proposed rule from 55 sources, and heard from 3 commenters at public meetings. The public meetings were announced in the Federal Register on June 6, 2008 (73 FR 32273) and held in Duluth, MN, and Cleveland, OH, on July 15 and 17, 2008, respectively. Availability of the Final Environmental Impact Statement (FEIS) was announced on August 22, 2008, by the Environmental Protection Agency (73 FR 49667) and by the Coast Guard (73 FR 49694), and the Record of Decision (ROD) adopting the findings of the FEIS was signed on [DATE].

This interim rule takes effect immediately upon its publication in the Federal Register . Under the Administrative Procedure Act (APA), 5 U.S.C. 553(d), a substantive rule such as this must be published not less than 30 days before its effective date, unless the agency finds good cause for an earlier effective date and publishes that finding with the rule. As we subsequently discuss in more detail, this rule generally allows the continuation of existing practices in the Great Lakes. Those practices have been sanctioned by Congress and, although they have minor indirect adverse impacts on the Great Lakes environment, their discontinuation could impose a substantial economic burden on Great Lakes maritime commerce. Congressional sanction for the existing practices expires on September 30, 2008, and it was Congress's intent that the Coast Guard review existing practices and issue new regulations governing those practices by that date. If the APA's 30-day provision were given effect, then there would be a period of up to a month during which existing practices would be prohibited, and the resulting burden on Great Lakes maritime commerce would be significant in relation to the duration of the prohibition and the potential environmental benefits of such a short prohibition. The Coast Guard has concluded the APA's 30-day provision is unnecessary and contrary to the public interest due to the disruption entailed by so short a period of prohibition. Therefore, the Coast Guard finds good cause for this interim rule to take effect upon publication in the Federal Register .

This interim rule adopts the regulatory text proposed in our May 2008 NPRM, with only minor changes. For a fuller discussion of the background and purpose of this rulemaking, please consult the NPRM.

A substantial portion of Great Lakes shipping involves “bulk dry cargos:” principally limestone, iron ore, and coal, but also lesser quantities of other substances like cement and salt. During ship loading or unloading operations, small portions of these cargos often fall on ship decks or within ship unloading tunnels. This fallen dry cargo residue (DCR) can contaminate other cargos or cause crew members to slip or otherwise injure themselves on a ship's deck. Traditionally, Great Lakes carriers have managed DCR by periodically washing both the deck and cargo unloading tunnels with water in a practice commonly known as “cargo sweeping.” In order to reduce costs and minimize in-port time, ships typically conduct this cargo sweeping underway while transiting between ports.

Prior to the adoption of this interim rule, Coast Guard regulations that implement the Act to Prevent Pollution from Ships (APPS), 33 U.S.C. 1901 et seq. , have treated DCR as an operational waste, which constitutes garbage. The discharge of any garbage, anywhere on the navigable waters of the United States, was prohibited. Strict enforcement of this regulatory scheme on the Great Lakes would have put an end to the practice of cargo sweeping. However, in recognition of the special characteristics of Great Lakes dry cargo shipping, an “interim enforcement policy” (IEP) allowed “incidental discharges” of non-toxic and non-hazardous DCR on the Great Lakes from 1993 until 2008. The IEP was originally adopted by the Coast Guard's Ninth District, and then mandated by Congress in 1998, 2000, and 2004 (Pub. L. 105-383, sec. 415; Pub. L. 106-554, sec. 1117; Pub. L. 108-293, sec. 623). The IEP allowed cargo sweeping only in defined waters, most of which are relatively deep and far from shore. Additionally, it prohibited or restricted discharges in special areas that are considered environmentally sensitive. The congressionally mandated enforcement of the IEP expires September 30, 2008, or upon the promulgation of new regulations, whichever date comes first.

The 2004 legislation gave the Coast Guard authority to regulate the discharge of DCR on the Great Lakes, notwithstanding any other law (Pub. L. 108-293, sec. 623(b)). The Coast Guard interprets this authority to allow regulation on the Great Lakes, on water or on shore, of any operation related to the loading, transfer, or unloading of dry bulk cargo, or to cargo sweeping or other discharge of dry bulk cargo residue. All of these operations relate to and are part and parcel of the discharge of dry bulk cargo, as contemplated by Congress in the 2004 legislation. House Report 108-617, the conference report prepared in support of the 2004 legislation, states:

This interim rule amends Coast Guard regulations so that DCR discharges may continue in the U.S. waters of the Great Lakes, so long as those discharges are in compliance with regulatory conditions that derive, with modifications, from the IEP. One modification is non-substantive: We are clarifying the current policy but not changing it, to exclude non-self propelled barges that are not part of an integrated tug and barge unit. Integrated tugs and barges remain included because they are designed and operated similarly to self propelled vessels of the same size and service. We are substantively modifying the IEP to add new recordkeeping and reporting requirements for dry cargo carriers. We are adding, to the list of locations in the Great Lakes where DCR discharges will not be allowed, additional areas that the Final Environmental Impact Study designates as protected and sensitive. Finally, we are strongly encouraging carriers to voluntarily adopt control measures for reducing the amount of DCR that accumulates on or within vessels and that would ultimately be discharged into the Great Lakes.

Based on our Final Environmental Impact Statement, we have concluded that continued discharges of DCR will have only a minor indirect impact on most areas within the Great Lakes environment. The FEIS indicated that unconstrained discharges could have a direct significant adverse impact on protected and sensitive areas. We will mitigate that impact by prohibiting most discharges in those areas, and within three miles of land-based protected and sensitive areas. Only discharges under certain conditions and in specified areas will be allowed in the Western Basin of Lake Erie, in order to avoid the adverse economic impact that the FEIS indicates could accompany the complete prohibition of discharges in that area. Vessels operating exclusively in the Western Basin will be allowed to discharge limestone, clean stone, coal, iron ore, and salt in dredged navigation channels between Toledo Harbor Light and Detroit River Light, where environmental conditions are already disturbed frequently due to dredging.

We received 55 comments during the public comment period on our May 2008 NPRM, as well as comments from 3 individuals at our two public meetings. Few, if any, commenters distinguished between the DEIS and NPRM in their comment, and therefore all comments were considered for both documents. We have addressed the comments in detail in the FEIS, which was made available to the public on August 22, 2008. In response to public comments, we are extending the areas where DCR discharges are prohibited to include waters within three miles of shore at the following sites: Indiana Dunes and Sleeping Bear National Lakeshores on Lake Michigan and Grand Portage National Monument and Apostle Islands and Pictured Rocks National Lakeshores on Lake Superior. Otherwise, we are adopting the regulatory text we proposed in the NPRM without substantive change.

A table presenting the substance of each comment received, and the Coast Guard's response, appears in the FEIS which can be found in the docket at http://www.regulations.gov . The comments, and our responses, are summarized in the following discussion. During the drafting of this interim rule, we received late comments which did not raise new substantive issues and did not affect the following discussion.

Comments in favor of prohibiting continued DCR discharges. Forty-six commenters favored prohibiting continued DCR discharges in the Great Lakes. We agree with these commenters that our environmental analysis shows that prohibition could minimize the potential for adverse environmental impacts, but disagree that DCR discharges should be completely prohibited. In giving the Coast Guard permanent regulatory authority over Great Lakes DCR discharges, Congress expected us to strike an appropriate balance between maritime commercial and environmental protection needs. By balancing the adverse environmental impact of continued DCR discharges in the Great Lakes against the potentially substantial economic cost of prohibiting discharges anywhere in the Great Lakes, we believe this interim rule best achieves Congress' intent.

Comments on the toxicity of DCR. Fifteen commenters expressed concern regarding toxic chemicals in DCR and their effects on humans, animals, and plants. As recounted in detail in the FEIS, we have carefully evaluated the toxic potential of DCR. In general, we found that any toxic components of DCR deposits in the Great Lakes do not exist in concentrations known to be toxic to organisms. In those few instances where a cargo's residue concentration can be found near or above potentially harmful levels, natural sedimentation lowers the concentration to well below potentially harmful levels. There is little or no potential for any fish with toxic concentrations in their tissues to enter the food chain. Moreover, the inclusion of mandatory recordkeeping in our interim rule will enable us to track future DCR discharges, and should environmental conditions change significantly in the future, we retain the regulatory authority needed to address those changed conditions.

Comments on the impact of DCR on invasive mussels and the aquatic environment. Eight commenters expressed concern regarding invasive mussels and the aquatic environment. The FEIS contains detailed information about how we evaluated the impact of DCR on the aquatic environment, especially with respect to invasive mussels. We found minor adverse effects on sediment physical structure, the benthic community, and invasive species. Except in portions of Lakes Michigan and Huron where the potential impact is minor, the discharge of DCR will not change the distribution or density of mussels in most of the Great Lakes, either because mussels are already ubiquitous (e.g., in Lakes Erie and Ontario) or because water depth, temperature, and calcium levels limit mussel distribution and density (e.g., in Lake Superior). Once again, we believe our interim rule best achieves the legislative intention behind our regulatory authority by balancing the minor adverse impact of continued DCR discharges on sediment physical structure, the benthic community, and invasive species against the potential economic cost of prohibiting those discharges.

Comments on the legality of the Coast Guard's proposal. Thirty-six commenters objected to the continued allowance of DCR discharge on the grounds that it is already illegal under U.S. or international laws, treaties, or agreements. Among the authorities listed by these commenters are the International Convention for the Prevention of Pollution from Ships (MARPOL), APPS, the Great Lakes Water Quality Agreement (GLWQA), and State laws in Michigan, Minnesota, and Pennsylvania. We discuss the possible interplay between this interim rule and State law more fully in “Federalism,” Part V.E. of this preamble.

This interim rule replaces the IEP with new regulations. We initially adopted the IEP in response to concerns that strict enforcement of existing authorities such as APPS would prohibit continued DCR discharge in the Great Lakes. Congress subsequently addressed that same concern by passing legislation in 1998, 2000, and 2004 that required the Coast Guard to implement and enforce the IEP on the Great Lakes. In 2004, Congress also gave the Coast Guard authority “notwithstanding any other law” to regulate the discharge of DCR in the Great Lakes. The legislative history of the 2004 legislation shows that Congress expected the Coast Guard to make the IEP permanent or replace the IEP with an alternative regime that appropriately balances maritime commercial and environmental protection needs. The 2004 legislation is the latest expression of Congress's intentions with respect to regulating Great Lakes DCR discharge, and the basis for the Coast Guard's rulemaking.

Comments relating to recordkeeping and reporting. Seventeen commenters either opposed mandatory recordkeeping and reporting as unnecessary, or asked for modifications in the record form or in the frequency of reporting. We agree that some minor modifications to the reporting form are appropriate which will be reflected in Form CG-33. However, we disagree that the quarterly reporting schedule requires excessively frequent reporting. We have found through the numerous rules and programs we administer that recordkeeping is an integral and important part of ensuring regulatory compliance. The Coast Guard is not requiring the recording or reporting of any data that constitutes trade secrets or privileged and confidential commercial or financial information. We consider the economic cost of our new recordkeeping and reporting requirements to be reasonable, especially considering the value of comprehensive DCR practice data and its potential relationship with natural resources. Data reported to the Coast Guard will be useful as we evaluate the costs and benefits of DCR control measures. Quarterly reporting ensures that data is assembled quickly. Once our data collection needs are satisfied, we will likely retain the recordkeeping requirement, but may modify or eliminate the reporting requirement.

We have removed the facsimile of Form CG-33 from the regulation, but included information on how to obtain the form itself in the regulatory text.

In our May 2008 NPRM, we promised to open a new rulemaking to begin a new phase of DCR study, simultaneously with publication of the final rule for the present rulemaking. The new phase would consider what additional conditions, if any, should be imposed on DCR discharges in order to offset any long term impacts they might have.

We have decided to conduct this new phase as part of the present rulemaking rather than as a separate project. Therefore, in this interim rule we announce the opening of the new phase, and strongly encourage you to submit public comments to assist us. We want to determine if, in the long term, the optimal balancing of commercial and environmental interests requires the mandatory use of DCR control measures, the adjustment of the geographical boundaries within which discharges are currently allowed, or other regulatory changes.

The outcome of this new phase is not predetermined. We might find a clear case for imposing new DCR control measure requirements and altering geographical boundaries. Alternatively, we might find that the costs of any new regulatory measures outweigh the environmental benefits the new measures would provide, and leave our regulations unchanged. In determining the regulatory outcome, we intend to be guided by data on DCR discharges and on DCR control measures that are already in voluntary use, and by careful consideration of public comments. The DCR control measures we have identified for analysis are listed in the Table below.

To better focus our efforts, we invite you to respond to the following questions:

1. Is there a control measure, other than those listed in the Table, that we should study?

2. Do you have data on the cost of installing, operating and maintaining control measures or their effectiveness in reducing the volume of DCR discharged? Can you identify a data source we should consult?

3. If control measures were to be required, are you in favor of a phase-in, and if so, how might the phase-in be structured?

4. Are you in favor of limiting the areas in which control measures should be required, and if so, what are the areas where those requirements should apply?

5. Are there other changes the Coast Guard should make in order to regulate the long term discharge of DCR in the Great Lakes in a way that is both economically and environmentally sustainable?

Please see the ADDRESSES section of this document for information on how you can share your responses to these questions with us.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Public comments on the NPRM are summarized in Part IV of this preamble. We received no public comments that would alter our assessment of impacts in the NPRM. We have adopted the assessment in the NPRM as final. See the “Regulatory Evaluation” section of the NPRM for the complete analysis. A summary of the assessment follows.

The recordkeeping provisions in this rule require owners and operators of self propelled vessels to maintain records and report information on dry cargo operations. This rule does not require the use of control measures to reduce the amount of residue swept into the Great Lakes.

There are minimal costs involved in requiring owners and operators of vessels to keep records of their bulk dry cargo residue sweeping operations and to make those records available to the Coast Guard. Moreover, many vessel operators already record this information voluntarily. We identified 55 U.S., 33 Canadian, and 186 non-Canadian foreign vessels operating on the Great Lakes affected by the recordkeeping and reporting requirements of this rule.

We estimate the annual recurring cost of this rule to industry, both U.S. and foreign, to be $88,828 (non-discounted). The total combined U.S. and foreign 10-year (2009-2018) present value cost of this rule is $623,891 discounted at 7 percent and $757,721 discounted at 3 percent.

We estimate the annual recurring cost of this rule to U.S. industry to be $60,077 (non-discounted). The total U.S. 10-year (2009-2018) present value cost of this rule is $421,956 discounted at 7 percent and $512,469 discounted at 3 percent. See the “Regulatory Evaluation” section of the NPRM for additional details of the population and cost estimates.

This rule will increase the Coast Guard's ability to understand the practice of dry cargo sweeping, monitor the practice, and, if necessary, subject the practice of dry cargo sweeping to further controls in the future.

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.

In the NPRM, we certified under 5 U.S.C. 605(b) that the proposed rule would not have a significant economic impact on a substantial number of small entities and we requested public comments on this certification. We received no comments on this certification and adopt it as final.

In the NPRM, we identified 13 small entities affected by this rule involving inland water freight transportation, marine cargo handling, packaging and labeling services, and other navigation related industries. We estimated the per vessel annual cost impact of this rulemaking on small entities to be about $1,092. We determined that the cost of the recordkeeping and reporting requirements would not significantly impact the annual operating revenues of the affected small entities. See the “Small Entities” section of the NPRM for more details.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance; please consult Lt St. Pierre (see FOR FURTHER INFORMATION CONTACT ).

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other, similar actions. A summary of the title and description of the information collection, a description of those who must collect the information, and an estimate of the total annual burden follow. This information has not changed from the NPRM. The estimate covers the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection. See the “Collection of Information” section of the NPRM for additional details.

Title: Dry Cargo Residue Sweepings in the Great Lakes.

Summary of the Collection of Information: These DCR recordkeeping provisions will require vessel operators to maintain a DCR log to document what dry cargos are loaded, unloaded, and swept, when they are swept, how they are swept, how much is swept, what control measures, if any, are in place, and where, when, and how fast the vessel is traveling when the sweepings take place.

Need for Information: By making DCR recordkeeping mandatory, we will greatly increase our ability to understand the practice of dry cargo sweeping, monitor the practice, and if necessary, subject the practice of DCR sweeping to further controls in the future.

Proposed Use of Information: The DCR recordkeeping and reporting requirements will provide additional data to support Coast Guard analysis of policies to reduce DCR discharges over the long term, beyond the next 6 to 10 years.

Description of the Respondents: The respondents are owners and operators of U.S., Canadian, and foreign flag vessels carrying dry-bulk cargos operated on the Great Lakes. The respondents will conduct DCR recordkeeping and handle the submissions.

Number of Respondents: Based on estimates from the NPRM, the total number of vessels that handle Great Lakes dry bulk cargo shipments is 274 (= 55 U.S. vessels + 33 Canadian vessels + 186 non-Canadian foreign vessels). We estimate the number of respondents equal the number of vessels since there will be crew on each vessel recording the information.

Frequency of Response: Based on estimates from the NPRM, the annual frequency of response is 10,615 for U.S. vessels and 5,153 for foreign vessels.

Burden of Response: Based on estimates from the NPRM, the total annual burden hours for this rule are 886 hours for U.S. vessel operators and 448 hours for foreign vessel operators. We estimate the annual costs of this burden to be $60,077 (non-discounted) for U.S. operators and $28,751 for foreign operators.

During public hearings, one commenter questioned the usefulness of collecting man hour data stating that recording man hours can vary greatly by interpretation and that the data will be unusable. The Coast Guard disagrees with the commenter. The man hour data provided by vessel masters will enable the Coast Guard to better estimate the burden of implementing DCR control measures. The information will provide a benchmark for measuring DCR-related man hours for the different alternatives under consideration. We have provided instructions and guidance for recording man hours. As discussed in the NPRM, we found many vessel operators already record this information voluntarily.

As required by 44 U.S.C. 3507(d), we submitted a copy of the proposed rule to the Office of Management and Budget for its review of the collection of information. OMB approved the collection for 33 CFR part 151 and Form CG-33 on September 4, 2008, and the corresponding approval number from OMB is OMB Control Number 1625-0072, which expires on September 11, 2011.

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. The Coast Guard received 10 comments in response to our NPRM regarding the possible interplay between Coast Guard regulations and State laws that may relate to DCR discharges. We understand that at least some States in the Great Lakes region already have legislation that may prohibit certain solid waste discharges in their Great Lakes waters, and that certain of those States take the position that DCR may be or at least may contain solid waste. However, we do not agree with the commenters that the Federal regulation either expressly preempts or necessarily conflicts with those laws. Rather, and to clarify our Federalism statement in accordance with the responsibilities and the principles contained in EO 13132 regarding Federalism, the Coast Guard states that this regulation does not expressly preempt those State laws. Nor does the Coast Guard by promulgating this regulation take the position that such State laws facially frustrate an over-riding federal purpose. However, the ultimate question regarding preemption of State laws is a legal question that is subject to court interpretation and decision based on the application of particular facts to those individual laws. Because no court has ruled on the questions raised, the Coast Guard cautions carriers that they must comply with all applicable Federal and State laws regulating DCR discharges. We will work with States and carriers to make sure carriers are informed of any State laws that could impose more restrictions on DCR discharges than we have proposed.

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. This rule will not result in such expenditure.

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 will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, 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.

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 5100.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Final Environmental Impact Statement and Record of Decision appear in the docket.

Mailers who are presently authorized to pay postage via permit imprint may use their existing permit to mail BPM at the Post Office TM where the permit is held. Mailers who wish to obtain a new authorization to pay postage via permit imprint must complete an application and pay a one-time application fee at each office of mailing to mail BPM on or after September 11, 2008. Authorization is obtained by submitting PS Form 3615, Mailing Permit Application and Customer Profile, and the applicable fee to the Post Office where mailings are to be deposited. As long as a permit remains active, there is no additional fee for use of a permit imprint indicia, but other fees (e.g., an annual destination entry mailing fee) may be due depending on where the mail is deposited.

Payment for postage must be made for each mailing through an advance deposit account before the mailing can be released for processing. Funds to pay postage must be deposited as directed by the USPS®.

Nonpresorted BPM mailings, except discount mailings (e.g., barcode discounts), will be exempt from the general minimum volume requirement for a permit imprint mailing of at least 200 pieces or 50 pounds of mail and will not have a minimum volume requirement. However, the current requirements for all other commercial nonpresorted and presorted minimum volumes will remain (e.g., nonpresorted barcoded—50 pieces and presorted—300 pieces).

As a reminder, prices for BPM pieces vary by weight and zone of destination. Supporting documentation of postage is required for all nonidentical-weight pieces and for identical-weight pieces that are not separated by price and zone.

This requirement, which limits the payment of postage for all BPM to permit imprint, is effective September 11, 2008.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard finds this rule is exempt from notice and comment rulemaking requirements because these changes involve agency organization and practices, and good cause exists for not publishing an NPRM for all revisions in the rule because they are all non-substantive changes. This rule consists only of corrections and editorial, organizational, and conforming amendments. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

Each year the printed edition of Title 46 of the Code of Federal Regulations is updated on October 1. This rule, which becomes effective September 29, 2008, makes technical and editorial corrections throughout Title 46. This rule does not create any substantive requirements.

This rule updates the address and contact information for the National Maritime Center (NMC) in 10 sections: the Marine Index Bureau in 1 section; the National Cargo Bureau in 1 section; and the International Cargo Bureau in 8 sections. We updated internal Coast Guard office designators in nine sections, and typographical errors were corrected in §§ 10.219, 28.50, 28.275(a)(2), 28.390(c), and 176.816. Further, certain sections of Title 46 previously included a list of Regional Examination locations; however, as a result of other rulemakings, these sections currently state that the list of Regional Examination locations is available through the Coast Guard Web site at http://www.uscg.mil . We updated cross-references to these sections in §§ 12.02-23(e), 12.02-27(a)(2), 13.107(f), 10.105 and 13.109(c) to ensure the public may easily locate the list of Regional Examination locations.

Additional amendments to parts 10, 14, 15, 28, 71, 91, 401, and 402 are:

46 CFR 10.464 . We amended § 10.464(f)(3) for clarity and to make it consistent with § 10.464(f)(2).

46 CFR Part 14 . We updated the address for the NMC throughout Title 46 to reflect their move to West Virginia. In addition to updating the address, we removed the outdated facsimile number in § 14.103(b), and replaced it with NMC's public contact e-mail address. The facsimile number listed is no longer valid, and the NMC is now accepting communications via electronic mail. We also added paragraph (c) to § 14.103 to provide the NMC's World Wide Web address.

46 CFR 15.610 . We removed § 15.610(c) because it expired on May 21, 2006. We re-designated § 15.610(d) as § 15.610(c) due to the removal of paragraph (c).

46 CFR 28.575 . We amended 46 CFR 28.575 to correct two typographical errors. The first typographical error appears in the formula in paragraph (b). Specifically, the figure two in the formula should be a superscripted figure two. The correct formula, with the superscripted figure, was added to the CFR in 1991 (56 FR 40413). The typographical error appeared in the CFR in 1997. The Coast Guard amended § 28.575 twice between 1991 and 1997 (56 FR 47679 and 60 FR 50461); however neither amendment affected the superscripted figure, and as such the cause for the error is unknown. Further, we have contacted members of the public that may have been impacted by the typographical error; and they have indicated that, in completing the calculation, they have relied on the original formula published in 1991 rather than the formula published since 1997. This amendment will merely restore the formula to that which was published in 1991. The second typographical error appears in Figure 28.575, which is the graphical representation for § 28.575. Figure 28.575 shows a heel angle of 40 degrees while the text of the rule in paragraph (e)(3) states a heel angle of 50 degrees. Thus, we corrected Figure 28.575 to accurately reflect the rule text.

46 CFR Parts 71 and 91 . 73 FR 35959 amended § 31.10-16 by adding the National Cargo Bureau, Inc., as a recognized inspection organization. Previously this section only listed the International Cargo Gear Bureau, Inc., as a recognized inspection organization. Sections 71.65-1 and 91.55-1 referenced § 31.10-16 to identify the International Cargo Gear Bureau, Inc., as the cargo gear organization authorized to approve cargo gear plans and specifications. The International Cargo Gear Bureau, Inc., remains the only authorized organization, other than recognized classification societies authorized to perform the approval of plans as described in §§ 71.65-1 and 91.55-1. We amended §§ 71.65-1 and 91.55-1 to eliminate confusion, and ensure that mariners continue to be directed to appropriate cargo gear plans and specifications approval organizations.

46 CFR Part 401 . In §§ 401.200 and 401.211, we removed a provision requiring pilots to submit fingerprint charts with registration applications. We removed these provisions because they duplicate the same requirement found in § 401.210(a)(1). In § 401.450, we amended a reference to a pilot change point located in Canada. Previously, the Canadians identified Lock No. 7, Welland Canal, as an appropriate pilot change point. The Canadians have relocated the pilot change point and it is now located at Port Colburne. Both Welland Canal and Port Colburn are under Canadian jurisdiction—rather than U.S. jurisdiction—and as such this amendment imposes no, U.S. based, substantive burden on the regulated public. This amendment merely conveys Canadian operating procedures to mariners that may traverse Canadian waters. Pilots traversing Canadian waters have been complying with this change for many years. Lastly, we amended § 401.720 to reflect the re-codification of 46 U.S.C. 216b(e). Public Law 109-304 (An Act to complete the codification of title 46, United States Code, “Shipping”, as positive law) re-codified 46 U.S.C. 216b(e) as 46 U.S.C. 9304.

46 Part 402 . We revised the authorities section by removing a reference to a Department of Transportation regulation that no longer applies to the Coast Guard. We 2104(a) amended § 402.220 by removing a reference to a memorandum of agreement between Canada and the United States, dated 1961, regarding Great Lakes pilotage, and replaced it with a more current version of that agreement dated 1977. There were no substantive changes between the two agreements impacting the public. Lastly, we revised § 402.320 to reflect the most current “working rules” on file with the Coast Guard. These working rules are compiled by voluntary U.S. registered pilot associations authorized to establish pilotage pools. This amendment provides the public with information regarding the current working rules compiled by those organizations.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be so minimal that a full Regulatory Analysis is unnecessary. As this rule involves internal agency practices and procedures and non-substantive changes, it will not impose any costs on the public.

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. This rule does not require a general notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. However, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 5100.1 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that under the Instruction 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, paragraphs (34)(a) and (b), of the Instruction from further environmental documentation because this rule involves editorial, procedural, and internal agency functions. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2008 Pacific ocean perch TAC allocated as a directed fishing allowance to vessels participating in the BSAI trawl limited access fishery in the Western Aleutian District of the BSAI is 136 metric tons (mt) as established by the 2007 and 2008 final harvest specifications for groundfish in the BSAI (72 FR 9451, March 2, 2007) and revision (72 FR 71802, December 19, 2007). See § 679.20(a)(10)(i), § 679.20(a)(10)(iii), and § 679.91(c)(1) and (2).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2008 Pacific ocean perch TAC allocated to vessels participating in the BSAI trawl limited access fishery in the Western Aleutian District of the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch by vessels participating in the BSAI trawl limited access fishery in the Western Aleutian District of the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch by vessels participating in the BSAI trawl limited access fishery in the Western Aleutian District of the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 23, 2008.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and § 679.91 and is exempt from review under Executive Order 12866.