Background

The Japanese beetle ( Popillia japonica ) feeds on fruits, vegetables, and ornamental plants and is capable of causing damage to over 300 potential hosts. The Japanese beetle quarantine and regulations, contained in 7 CFR 301.48 through 301.48-8 (referred to below as the regulations), quarantine the States of Alabama, Connecticut, Delaware, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, and the District of Columbia and restrict the interstate movement of aircraft from regulated airports in these States in order to prevent the artificial spread of the Japanese beetle to noninfested States where the beetle could become established (referred to below as protected States). The list of quarantined States, as well as the list of protected States, can be found in § 301.48.

In an interim rule effective and published in the Federal Register on July 6, 2004 (69 FR 40533-40534, Docket No. 04-032-1), we amended the Japanese beetle regulations by adding Arkansas to the list of quarantined States in § 301.48.

Comments on the interim rule were required to be received on or before September 7, 2004. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

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

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

This final rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).

This final rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. See the final rule-related notice titled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034) advising that rural electrification loans and loan guarantees are excluded from the scope of Executive Order 12372.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. RUS has determined that this final rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted, no retroactive effect will be given to this rule, and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912 (e)), administrative appeals procedures, if any are required, must be exhausted before an action against the Department or its agencies may be initiated.

The policies contained in this rule do not have any substantial direct effect on states, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with states is not required.

It has been determined that the Regulatory Flexibility Act is not applicable to this rule since RUS is not required by 5 U.S.C. 551 et seq. or any other provision of law to publish a notice of final rulemaking with respect to the subject matter of this rule.

In accordance with Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), RUS invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB). These requirements have been approved by emergency clearance under OMB Control Number 0572-0140.

Comments on this notice must be received by December 13, 2004.

Comments are invited on (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumption used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques on other forms of information technology.

Comments may be sent to: Dawn Wolfgang, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Room 5166-South, STOP 1522, Washington, DC 20250-1522. Fax: (202) 720-4120. E-mail: dawn.wolfgang@usda.gov.

Title: Electric System Emergency Restoration Plan.

OMB Control Number: 0572-0140.

Type of Request: Request for approval of a currently approved information collection.

Abstract: Electric power systems have been identified in Presidential Decision Directive 63 (PDD-63), May 1998, as one of the critical infrastructures of the United States. The term “critical infrastructure” is defined in section 1016(e) of the USA Patriot Act of 2001 (42 U.S.C. 5195c(e)) as “systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters.” Damage to or loss of critical or significant parts of the U.S. electric power system can cause enormous damage to the environment, loss of life and economic loss and can affect the national security of the United States. Such damage or loss can be caused by acts of nature or human acts, ranging from an accident to an act of terrorism. Of particular concern are physical and cyber threats from terrorists. Protecting America's critical infrastructure is the shared responsibility of Federal, State, and local government in active partnership with the private sector. Homeland Security Presidential Directive 7 (HSPD-7), December 2003, established a national policy for Federal departments and agencies to identify and prioritize United States critical infrastructure and key resources and to protect them from terrorist attacks. America's open and technologically complex society includes a wide array of critical infrastructure and key resources that are potential terrorist targets. The majority of these are owned and operated by the private sector and State or local governments. These critical infrastructures and key resources are both physical and cyber-based and span all sectors of the economy. A substantial portion of the electric infrastructure of the United States resides in, and is maintained by, rural America. To ensure that the electric infrastructure in rural America is adequately protected, RUS is instituting the requirement that all current electric borrowers enhance an existing ERP or, if none exists, develop and maintain an ERP.

Title 7 CFR Part 1730, Electric System and Maintenance, establishes a requirement for electric program distribution, generation, and transmission borrowers to develop an ERP or expand an existing ERP and to provide RUS with a written certification that they have an ERP based upon a VRA.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 30 minutes per response.

Respondents: Not for profit.

Estimated Number of Respondents: 676.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 338 hours.

Copies of this information collection can be obtained from Dawn Wolfgang, Program Development and Regulatory Analysis, Rural Utilities Service at (202) 720-0812.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

This final rule contains no Federal mandates under the regulatory provision of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. Chapter 25) pursuant to exceptions therein for State, local, and tribal governments or the private sector.

The Administrator of RUS has determined that this final rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ). Therefore, this action does not require an environmental impact statement or assessment.

The program described by this final rule is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.850, Rural Electrification Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800.

The term “critical infrastructure” is defined in section 1016(e) of the USA Patriot Act of 2001 (42 U.S.C. 5195c(e)) as “systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters.” Electric power systems have been identified in Presidential Decision Directive 63 (PDD-63), May 1998, as one of the critical infrastructures of the United States.

The United States electric power system (electric power system) consists of three distinct components: Generation facilities, transmission facilities (including bulk transmission and subtransmission facilities) and distribution facilities. Specific definitions of generation, transmission and distribution facilities are located in 7 CFR 1710.2. The other critical infrastructures identified in PDD-63 are all dependant to some degree upon the full and continuous functioning of the electric power system. Damage to or loss of critical or significant parts of the electric power system can cause enormous damage to the environment, loss of life and economic loss and can affect the national security of the United States. Such damage or loss to the electric power system can be caused by acts of nature or human acts, ranging from an accident to an act of terrorism. Of particular concern are physical and cyber threats from terrorists.

RUS borrowers have always had a duty to RUS to maintain their respective systems. In performing this duty, a borrower furthers the purposes of the Rural Electrification Act of 1936, as amended (7 U.S.C. 901 et seq. ) while also preserving the value of its system to serve as collateral for repayment of RUS assistance. Generally speaking, the scope of this duty is frequently measured against prudent utility practices. Thus, it is entirely appropriate for RUS to expect that its borrowers will be aware of and following developing standards for private sector emergency preparedness and business continuity. A voluntary standard is emerging within the private sector and the requirements of this final rule are consistent with that standard. The latest evidence of the emerging standards in this area may be found on page 398 of the Final Report of the National Commission on Terrorist Attacks upon the United States (the “Commission”) issued on July 22, 2004 (the “9/11 Report”).

The 9/11 Report notes that the Commission asked the American National Standards Institute (“ANSI”) to develop a consensus on a “National Standard of Preparedness” for the private sector. As a result of public sessions, ANSI recommended that the Commission endorse a voluntary National Preparedness Standard based on the existing American National Standard on Disaster/Emergency Management and Business Continuity Programs (“NFPA 1600”). The Commission has done so and it has also explicitly encouraged the insurance and credit rating industries to look closely at a company's compliance with the ANSI standard in assessing its insurability and creditworthiness. The Commission wrote: “We believe that compliance with the standard should define the standard of care owed by a company to its employees and the public for legal purposes.”

The RUS purpose in referring to these recent developments is not to suggest that RUS borrowers must comply with NFPA 1600. However, RUS does wish to call attention to the fact that this final rule is being issued at a time when there appears to be a widespread recognition that emergency preparedness and business continuity is “a cost of doing business in the post-9/11 world,” and thus properly the concern of the rural utility sector and of RUS as a major provider of financing to this sector.

A substantial portion of the electric infrastructure of the United States is located, and maintained by, rural America. To ensure that the electric infrastructure in rural America is adequately protected, and that security for RUS electric loans is adequately maintained and protected, RUS is instituting the requirement that all current electric borrowers conduct a Vulnerability and Risk Assessment (VRA) of their respective systems and utilize the results of this assessment to enhance an existing ERP or, if none exists, develop and maintain an ERP. Prior to approving any new RUS electric program grant, loan or loan guarantee, applicants will have to demonstrate that they have an ERP.

The VRA is utilized to identify specific assets and infrastructure owned or served by the electric utility, determine the criticality and risk level associated with such assets and infrastructure including a risk versus cost analysis, identify threats and vulnerabilities, if any, review existing mitigation procedures, and assist in the development of new and additional mitigation procedures, if necessary. The ERP will provide written procedures detailing response and restoration efforts in the event of a major system outage resulting from a natural or man made disaster. An annual Exercise of the ERP will ensure operability and employee competency and serve to identify and correct deficiencies in the existing ERP. This final rule defines “Exercise” to mean a borrower or borrowers' participation in a tabletop execution of, or actual implementation of, the ERP to verify the operability of the ERP. The Exercise may be implemented singly by an individual borrower, or by an individual borrower as a participant in a multi-party (to include utilities, government agencies and other participants or combination thereof) tabletop execution or actual implementation of the ERP. This final rule defines “Tabletop” to mean a hypothetical emergency response scenario in which participants will identify the policy, communication, resources, data, coordination, and organizational elements associated with an emergency response. The Exercise must, at a minimum, verify:

1. Operability of alert and notification systems;

2. Efficacy of plan;

3. Employee competency with ERP procedures;

4. Points of contact (POC) of key personnel, both internally and externally; and

5. Contact numbers for POCs.

On March 19, 2004, RUS published a proposed rule in the Federal Register , at 69 FR 12989, which proposed to require electric program distribution, generation and transmission borrowers to expand a currently established ERP, or if no ERP is currently established, to create an ERP in accordance with 7 CFR part 1730.

RUS received 13 letters and one e-mail on this proposed rule by the comment deadline of May 3, 2004. Comments were received from Enervision, Inc., Gascosage Electric Cooperative, North Dakota Association of Rural Electric Cooperatives, the National Rural Electric Cooperative Association, Wheller, Van Sickle & Associates, S.C. on behalf of Dairyland Power, Alabama Rural Electric Association of Cooperatives, Association of Electric Cooperatives of Virginia, Maryland and Delaware, Arkansas Electric Cooperative Corporation, Sunflower Electric Power Corporation, South Dakota Rural Electric Cooperative Association, Carroll Electric Membership Corporation, Great River Energy, Tri-State Generation & Transmission Association, Inc. and the Electric Cooperatives of South Carolina, Inc. Ninety three percent of the respondents supported the revision to 7 CFR part 1730, which requires electric program distribution, generation and transmission borrowers to establish and annually exercise an ERP.

One respondent did not support the proposed rule. The basis for its opposition was that, due to the small size of the utility, recordkeeping would strain the existing workforce. The respondent stated that it has already established an Emergency and Disaster Plan that effectively details guidelines for restoring its system should a disaster occur, provides preventative measures to preclude such an event and incorporates Homeland Security issues.

RUS believes that, like the respondent above, most utilities already have a similar plan in place, commonly referred to as a storm plan, and that the final rule will only require a modification of such plans. Borrowers will only have to modify their existing plan to add those items identified in § 1730.28 that they have not already incorporated. There is not a significant amount of additional recordkeeping required. Section 1730.22, “Borrower Analysis” details the requirements for records of inspection which includes RUS Form 300, “Review Rating Summary,” on which a borrower indicates that it has an ERP. The self-certification of completion of a VRA and ERP can be completed in simple letter form as outlined in § 1730.26(b) of the final rule. This self-certification letter will be the only document submitted to and maintained by RUS with respect to the VRA and ERP.

While the overall comments received from the remainder of the respondents were generally favorable, there were requests for additional clarification on the following items:

1. Timeframe for implementation.

2. Criteria for identification of critical assets (utility critical and National critical).

3. Requirements for self-certification.

4. Can borrowers collectively develop an ERP and exercise such ERP jointly?

Additionally, there were a few specific questions regarding RUS' relationship with the North American Electric Reliability Council (NERC) and any possible contradiction to NERC requirements or other agencies that have a certain degree of responsibility in the electric sector such as the Nuclear Regulatory Commission (NRC). There were additional suggested requests that involved items to be included in a guide bulletin to assist RUS borrowers to comply with the proposed regulation.

RUS provided the clarifications requested on the timeframe for implementation and, as requested, extended the timeframe to complete a VRA. RUS also provided explicit language regarding the basis for identification of critical assets or infrastructure identified as elements of national security, provided detailed instructions for self-certification, and acknowledges that the ERP may be developed jointly by electric utilities. Further, RUS acknowledges that the annual exercise of an ERP may be conducted by a borrower as a participant in a multi-party exercise. RUS agrees with the comments regarding the creation of a guide bulletin which shall include a discussion of RUS' relationship with NERC. A guide bulletin is being developed by RUS and will be made available to electric borrowers to assist in implementing the requirements of the final rule. Nothing in this final rule supercedes any requirements imposed or dictated by the Nuclear Regulatory Commission (NRC).

Background

In an interim rule effective January 12, 1999, and published in the Federal Register on January 15, 1999 (64 FR 2545-2550, Docket No. 98-123-2), we established regulations in 9 CFR part 52 to provide for the payment of indemnity by the Animal and Plant Health Inspection Service (APHIS) for the voluntary depopulation of herds of swine known to be infected with pseudorabies. That interim rule, which was intended to encourage the depopulation of infected herds, was necessary to accelerate pseudorabies eradication efforts and to protect swine not infected with pseudorabies from the disease.

We solicited comments concerning the interim rule for 60 days ending March 16, 1999. In a technical amendment published on March 17, 1999 (64 FR 13064-13065, Docket No. 98-123-3), we extended that comment period by an additional 30 days. We received two comments by the April 16, 1999, close of the extended comment period. They were from a trade organization and a U.S. veterinary medical association. The comments are discussed below.

One commenter requested that APHIS consider amending the regulations to require that premises depopulated of swine because of pseudorabies not be restocked for at least 30 days following cleaning and disinfecting, or until an appropriate length of time has passed as determined by a pseudorabies epidemiologist.

In response to that comment, we published the March 17, 1999, technical amendment mentioned above to clarify the provisions contained in the interim rule regarding the waiting period that must be observed before restocking premises depopulated because of pseudorabies. In that technical amendment, we amended the regulations in part 52 to provide that premises that have been depopulated because of pseudorabies may be restocked with swine 30 days following an approved cleaning and disinfection, unless an official pseudorabies epidemiologist determines that a shorter or longer period of time is adequate or necessary to protect new animals against infection. Because the March 1999 technical amendment addressed the commenter's concern, no further response to that comment is necessary in this document.

Both commenters raised concerns that fell outside of the scope of the January 1999 interim rule. One commenter recommended that APHIS increase surveillance to ensure detection of infected animals and requested that APHIS make available Federal funding for vaccines when State funding proves inadequate. The second commenter urged APHIS to increase the speed at which herds will be depopulated by developing staging areas at slaughter facilities that operate overnight and suggested that APHIS develop a weekly reporting system for herds that have been depopulated so that the disease status of depopulated premises is made available to producers and veterinarians. This commenter further recommended that APHIS develop a final pseudorabies eradication program and encouraged APHIS to establish and fund a pseudorabies acute outbreak team that would be responsible for containing an outbreak and developing a clean-up program.

The January 1999 interim rule established regulations to provide for the payment of indemnity by APHIS for the voluntary depopulation of herds of swine known to be infected with pseudorabies. Issues related to disease surveillance, vaccine program funding, slaughterhouse operations, reporting systems for herd depopulation, and future and final stage pseudorabies eradication efforts fall outside the scope of that rulemaking. Therefore, we are not making any changes to the rule based on these comments.

Finally, one commenter expressed support for APHIS' payment of indemnity to producers for the voluntary depopulation of herds infected with pseudorabies and requested the continued availability of Federal funding for the pseudorabies indemnity program beyond the 6-month timeframe announced in the interim rule.

In a notice published in the Federal Register on November 17, 1999 (64 FR 62569-62570, Docket No. 98-123-5), we announced that additional funds had been allocated for the indemnity program and that the program would continue until funds are depleted or until further notice. In that notice, we acknowledged that some States were still conducting their eradication programs and that we considered it important to the pseudorabies eradication effort in the United States to continue the accelerated eradication program beyond the 6-month timeframe stated in the January 1999 interim rule.

In a subsequent interim rule published on April 18, 2000 (65 FR 20706-20712, Docket No. 98-123-6), we revised the method by which owners of swine will receive fair market value for their animals under the accelerated pseudorabies eradication program in order to extend the funds available to APHIS for the program before these funds are exhausted. That April 2000 interim rule amended the regulations in part 52 to provide that APHIS will pay owners either the fair market value of herds of swine depopulated, or the difference between the net salvage value received for herds of swine disposed of through slaughter and the fair market value of those animals. The April 2000 interim rule also allowed owners of breeding sows identified as being infected with pseudorabies to receive indemnity if those sows are sent directly to slaughter, even if the remainder of the herd the sow is part of is not depopulated. These amendments were intended to allow for the payment of indemnity from accelerated pseudorabies eradication program funds for a greater number of swine disposed of because they are infected with pseudorabies.

We solicited comments concerning the April 2000 interim rule for 60 days ending June 19, 2000. We did not receive any comments on that interim rule.

Therefore, for the reasons given in the interim rules and in this document, we are adopting the interim rules as a final rule without change.

This action also affirms the information contained in the interim rules concerning Executive Order 12866 and the Regulatory Flexibility Act, and Executive Order 12988.

Further, this action has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. 3501 et seq. ), the information collection and recordkeeping requirements in the interim rules have been approved by the Office of Management and Budget (OMB). The assigned OMB control number is 0579-0137.

Section 19(b)(2) of the Federal Reserve Act (12 U.S.C. 461(b)(2)) requires each depository institution to maintain reserves against its transaction accounts and nonpersonal time deposits, as prescribed by Board regulations, for the purpose of implementing monetary policy. Section 11(a)(2) of the Federal Reserve Act (12 U.S.C. 248(a)(2)) authorizes the Board to require reports of liabilities and assets from depository institutions to enable the Board to conduct monetary policy. The Board's actions with respect to each of these provisions are discussed in turn below.

Pursuant to section 19(b)(2) of the Federal Reserve Act, transaction account balances maintained at each depository institution up to a certain amount, known as the low reserve tranche, are subject to a three percent reserve requirement. Net transaction account balances over the low reserve tranche are subject to a ten percent reserve requirement. Section 19(b)(2) also provides that, before December 31 of each year, the Board shall issue a regulation adjusting the low reserve tranche for the next calendar year. The adjustment in the low reserve tranche is to be 80 percent of the percentage increase or decrease in net transaction accounts at all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.

Currently, the low reserve tranche is $45.4 million. Net transaction accounts of all depository institutions rose 6.0 percent (from $654.4 billion to $693.8 billion) between June 30, 2003 and June 30, 2004. Accordingly, the Board is amending Regulation D (12 CFR part 204) to increase the low reserve tranche for net transaction accounts by $2.2 million, from $45.4 million in 2004 to $47.6 million in 2005.

Section 19(b)(11)(A) of the Federal Reserve Act (12 U.S.C. 461(b)(11)(A)) provides that a zero percent reserve requirement shall apply at each depository institution to total reservable liabilities that do not exceed a certain amount, known as the reserve requirement exemption amount.

Section 19(b)(11)(B) provides that, before December 31 of each year, the Board shall issue a regulation adjusting the reserve requirement exemption amount for the next calendar year if total reservable liabilities held at all depository institutions increase from one year to the next. Unlike the low reserve tranche, which can be adjusted upward or downward, no adjustment is made to the reserve requirement exemption amount if total reservable liabilities held at all depository institutions should decrease during the applicable time period. The percentage increase in the reserve requirement exemption amount is to be 80 percent of the increase in total reservable liabilities at all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.

Total reservable liabilities of all depository institutions increased by 7.1 percent (from $2,786.0 billion to $2,983.8 billion) between June 30, 2003, and June 30, 2004. Accordingly, the Board is amending Regulation D to increase the reserve requirement exemption amount by $0.4 million, from $6.6 million in 2004 to $7.0 million in 2005. 1

For depository institutions that report weekly, the adjusted low reserve tranche and reserve requirement exemption amount will be effective for the fourteen-day reserve computation period beginning Tuesday, November 23, 2004, and for the corresponding fourteen-day reserve maintenance period beginning Thursday, December 23, 2004. For depository institutions that report quarterly, the adjusted low reserve tranche and reserve requirement exemption amount will be effective for the seven-day reserve computation period beginning Tuesday, December 21, 2004, and for the corresponding seven-day reserve maintenance period beginning Thursday, January 20, 2005.

Section 11(b)(2) of the Federal Reserve Act authorizes the Board to require depository institutions to file reports of their liabilities and assets as the Board may determine to be necessary or desirable to enable it to discharge its responsibility to monitor and control the monetary and credit aggregates. The Board screens depository institutions each year to determine whether they must file deposit reports and, if so, how frequently they must file them (weekly, quarterly, or annually). These deposit reporting assignments become effective each September.

The screening of depository institutions for assignment to one of the four deposit reporting categories is based on three amounts: the reserve requirement exemption amount, the nonexempt deposit cutoff level, and the reduced reporting limit. The annual adjustment to the first amount, the reserve requirement exemption amount, is described in Section 1 above. The other two amounts, the nonexempt deposit cutoff level and the reduced reporting limit, are also adjusted annually, by an amount equal to 80 percent of the increase, if any, in total deposits at all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.

Total deposits at all depository institutions increased by 6.7 percent (from $6,534.2 billion to $6,969.8 billion) between June 30, 2003 and June 30, 2004. Accordingly, the Board is adjusting the nonexempt deposit cutoff level upward by $8.6 million, from its current level of $161.2 million in 2004 to $169.8 million in 2005. The Board is also adjusting the reduced reporting limit upward by $57 million, from its current level of $1.074 billion in 2004 to $1.131 billion in 2005. 2

Beginning in September 2005, the boundaries of the four deposit reporting categories will be defined as follows. Those depository institutions with net transaction accounts over $7.0 million (the reserve requirement exemption amount) or total deposits greater than or equal to $1.131 billion (the reduced reporting limit) are subject to detailed reporting, and must file an FR 2900 report either weekly or quarterly. Of this group, those with total deposits greater than or equal to $169.8 million (the nonexempt deposit cutoff level) are required to file the FR 2900 report each week, while those with total deposits less than $169.8 million are required to file the FR 2900 report each quarter. Those depository institutions with net transaction accounts less than or equal to $7.0 million (the reserve requirement exemption amount) and with total deposits less than $1.131 billion (the reduced reporting limit) are eligible for reduced reporting, and must either file a deposit report annually or not at all. Of this group, those with total deposits greater than $7.0 million (but less than $1.131 billion) are required to file the FR 2910a report annually, while those with total deposits less than or equal to $7.0 million are not required to file a deposit report. A depository institution that manipulates its reporting, however, in an attempt to qualify for less frequent reporting or to reduce its reserve requirement may be required to report the FR 2900 on a weekly basis and maintain appropriate reserve balances with its Reserve Bank, regardless of its most recent panel assignment.

The provisions of 5 U.S.C. 553(b) relating to notice of proposed rulemaking have not been followed in connection with the adoption of these amendments. The amendments involve expected, ministerial adjustments prescribed by statute and by the Board's policy concerning reporting practices. The increases in the reserve requirement exemption amount, the low reserve tranche, the nonexempt deposit cutoff level, and the reduced reporting limit serve to reduce regulatory burdens on depository institutions. Accordingly, the Board finds good cause for determining, and so determines, that notice in accordance with 5 U.S.C. 553(b) is unnecessary. Consequently, the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601, do not apply to these amendments.

Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511, has informed FDA that it has transferred ownership of , and all rights and interest in, the following three approved NADAs, to Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503:

Accordingly, the agency is amending the regulations in 21 CFR 520.2325a and 558.586 to reflect the transfer of ownership and a current format.

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

In the Federal Register of April 16, 2003, (68 FR 18575), the Office of the Secretary of Defense published for public comment a proposed rule regarding a number of changes included in the NDAA-02 (Pub. L. 107-107, December 28, 2001). These changes include revisions to the definition of durable medical equipment (DME); adoption of the same pricing methods for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) as are in effect for the Centers for Medicare & Medicaid Services (CMS); clarification that rehabilitative therapy is a TRICARE benefit; addition of augmentative communication devices (ACD)/speech generating devices (SGDs) as a TRICARE benefit; addition of hearing aids for family members of active duty members as a TRICARE Basic Program benefit; and revisions to the definition of prosthetics.

In addition to the above benefit changes, the NDAA 02 gave permanent authority for transitional health care for certain members separated from active duty. Prior to the NDAA 02, the Transitional Assistance Management Program (TAMP)—the program through which certain separating members and their dependents receive transitional health care—was scheduled to cease as of December 30, 2001. The NDAA 02, deleted the expiration date and made the TAMP program a permanent program.

Another change was made to transitional health care by the NDAA 02. Prior to the NDAA 02, certain separating members and their dependents received transitional health care until the earlier of: (1) 30 days after the date of the release of the member from active duty; or (2) the date on which the member and the dependents of the member are covered by a health plan sponsored by an employer. The groups who received transitional health care within the above parameters included: (1) A member of a reserve component called or ordered to active duty in support of a contingency operation; (2) a member involuntarily retained on active duty under section 12305 in support of a contingency operation; or (3) a member who voluntarily agrees to remain on active duty for a period of less than one year in support of a contingency operation.

The changes made in the NDAA 02 deleted the 30 day limit and changed the coverage period to 60 days of coverage for those separated with less than six years of active service or 120 days of coverage for those separated with six or more years of active service.

This final rule also provides for a technical correction found in the Bob Stump NDAA 03.

The NDAA 04, Pub. L. 108-136, contains additional changes to the transitional health care coverage period. These changes expire on December 31, 2004. If these changes are extended or made permanent they will be addressed in a separate rule.

As a result of the publication of the proposed rule, the following comments were received from interested parties, associations and the government agencies that by law TRICARE is required to consult during the rule making process.

We noticed the comments that we received could be classified into four major areas. The first is that there is a perception that the NDAA 02 language somehow eliminates or diminishes the “medical necessity” provision and other provisions found in TRICARE law. The second is a lack of understanding or awareness that the Program for Persons with Disabilities (PWPWD) and the TRICARE Basic Program are separate and distinct programs. The third is disagreement with our statement in the proposed rule that TRICARE's current policies in place at the time provide coverage within the NDAA 02 criteria. The fourth and final area is a concern with our proposed definition of rehabilitative therapy.

We address each of these major areas separately and then address the general comments that we received on the proposed rule.

Several of the changes authorized by Congress permit therapy for the purpose of either improving, restoring, maintaining, or preventing deterioration of function, or an accessory or item of supply that is used in conjunction with a device for the purpose of achieving therapeutic benefit and proper functioning. We received comments from several entities stating that they believe the statutory reference to the “functional status” of a beneficiary is to be used as the sole basis for determining coverage, rather than using the requirement that a service or supply must be medically or psychologically necessary as required by 10 U.S.C. 1079(a)(13). This belief is incorrect. One is to keep in mind that the provisions found in the NDAA 02 must be read in conjunction with the all other statutory provisions and parameters that govern the TRICARE program under title 10, United States Code, chapter 55. The most significant parameter for the TRICARE program is found at 1079(a)(13) and excludes:

The types of health care services authorized by Congress in the NDAA-02 that this rule implements provide for the types of health care that “may be” provided by the TRICARE program. This must be read in conjunction with the medical necessity requirement. Consequently, any therapy for the purpose of either improving, restoring, maintaining, or preventing deterioration of function, or an accessory or item off supply that is used in conjunction with a device for the purpose of achieving therapeutic benefit and proper functioning must be medically necessary before it can be cost shared by TRICARE.

Another provision/parameter of the TRICARE program that must be considered when interpreting the NDAA 02 legislation is the prohibition against providing custodial care. Custodial care is excluded from TRICARE coverage under section 1077(b)(1) and is defined in section 1072(a) as:

In summary, we do not concur with the interpretation that the NDAA 02 language reduces the significance of or eliminates the use of the medical necessity provision and other provisions found in TRICARE law. TRICARE considers the functional status of an individual as a factor, but that factor does not usurp the requirement of medical necessity or custodial care. The medical necessity and custodial care provisions, as well as all other parameters and provisions that govern the TRICARE program, must be considered concurrently with the provisions added in the NDAA 02, consistent with the rules of statutory construction defined in title 10, Untied States Code.

The PFPWD and the TRICARE Basic Program are separate and distinct programs with their own statutory basis, to include separate/different eligibility provisions, cost-sharing provisions, and benefit provisions. The PFPWD, based upon 10 U.S.C. 1079(d)-(f), is implemented in 32 CFR 199.5, and describes eligibility provisions, cost-sharing provisions, and benefit provisions under the PFPWD. The changes to the PFPWD authorized by section 701(d) of the NDAA 02 are being implemented under a separate rule. The TRICARE Basic Program Benefits are implemented in 32 CFR 199.4. While the programs are separate and distinct, the PFPWD is available for use in conjunction with the TRICARE Basic Program. The PFPWD was congressionally established approximately 35 years ago to help defray the costs of services not available either through the TRICARE Basic Program or through other public agencies. This includes, but is not limited to, services such as training, special education and adjunct services ( e.g., equipment adaptation).

This rule makes no changes to the PFPWD program found at 32 CFR 199.5. There are some services and supplies that are currently covered under the PFPWD but are not covered under the TRICARE Basic Program. This will continue. For example, training, special education, and eyeglasses may be covered under the PFPWD but they are excluded from the TRICARE Basic Program.

Hearing aids are currently allowed exclusively as a benefit under the PFPWD; however, upon implementation of this final rule, hearing aids will be considered a benefit under the TRICARE Basic Program, although still statutorily limited to dependents of active duty members.

Additionally, upon implementation of this rule, those ACDs/SGDs defined in this rule and that otherwise meet the policies and provisions of the TRICARE Basic Program will be covered as a benefit under the Basic Program. There will be some communicative devices, that do not meet the definition of ACD/SGD, but that are considered communication devices, that have been allowed for coverage under the PFPWD. This will not change and those devices will continue to be provided.

Again, this rule makes no change to the regulatory section that governs the PFPWD.

We received comments stating that the NDAA 02 provisions “Congress intended that this new law would stimulate TRICARE to provide greater access to appropriate assistive devices, technologies and related services.” The comments subsequently expressed concerns with our position that TRICARE's policies in place at this time provide coverage within these criteria. When we made the “current policies” statement, we were referring to the policies found in the TRICARE Policy Manual and the TRICARE Reimbursement Manual. These manuals contain detailed policies on a variety of topics, to include DME and prosthetics. They may be accessed through the TRICARE Web site at http://www.tma.osd.mil. The policies expressed in these manuals are TRICARE's interpretation of its governing statutes (primarily title 10, United States Code, chapter 55) and our regulation implementing these statutes (32 CFR part 199).

We reviewed the proposed rule and found that we made the statement regarding our current policies in the Supplementary Information Section of the rule in two places: the durable medical equipment section and the prosthetics section. Regarding DME, we received comments stressing that TRICARE needs to be aware of the necessity to customize DME to meet an individual's needs. We are. The Durable Medical Equipment policy is found at chapter 7, section 3.1 in the TRICARE Policy Manual. This policy defines DME and provides guidance on when DME may be repaired, replaced, modified, and/or customized. The policy currently reflects the provisions added in the NDAA-02. This final rule incorporates the new statutory authorization into 32 CFR part 199. In the Supplementary Information we were simply saying that our interpretation of previous statutory authorizations and implementing regulations in the TRICARE Policy Manual were consistent with how we interpret the new authorizations. Hence, TRICARE's current policies in place provide coverage within the NDAA 02 criteria.

With regard to prosthetics, section 702 of NDAA-02, gives the Department the authority to provide a prosthetic device that includes the following: (1) Any accessory or item of supply that is used in conjunction with the device for the purpose of achieving therapeutic benefit and proper functioning. (2) Services necessary to train the recipient of the device in the use of the device. (3) Repair of the device for normal wear and tear or damage. (4) Replacement of the device if the device is lost or irreparably damaged or the cost of repair would exceed 60 percent of the cost of replacement. (5) A prosthetic device customized for a patient may be provided under this section only by a prosthetic practitioner who is qualified to customize the device, as determined under regulations prescribed by the Secretary of Defense in consultation with the other Secretaries.

As stated in the proposed rule, TRICARE's current policies do offer benefits for the above criteria 1, 2, 3, and 5. Regarding criterion (4), TRICARE currently allows for replacement when required due to growth or change in the patient's condition. Nonetheless, our policies will be revised to ensure consistency with the language found in section 702 and will reflect a greater opportunity to acquire replacement prosthesis.

Regarding criterion 5, TRICARE has no specific provider requirements for a prosthetic practitioner to be qualified to customize the device. Rather, otherwise authorized TRICARE providers currently provide prostheses and customization of prostheses, such as medical equipment firms, medical supply firms, and Durable Medical Equipment, Prosthetic, Orthotic supplies providers/suppliers. As stated in the proposed rule, we are aware that CMS has established a Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics. The purpose of this committee is to advise CMS on developing a proposed rule that would establish payment provisions and requirements for providers of prostheses and custom-fabricated orthotics under the CMS. Once the Committee provides its findings, we will review them for consideration under the TRICARE program. After our review, we will use the rulemaking process and the public will have an opportunity to comment on our proposed provisions regarding these types of providers. In the meantime, we will continue to allow prostheses customization by otherwise authorized TRICARE providers.

The proposed rule states that where our current policies deviate from the new statutory language, we are adopting the new statutory language and will amend our policies to reflect that language.

We received numerous comments from entities who expressed concern with our definition of rehabilitative therapy. The commenters stated that defining rehabilitative therapy to include only physical therapy (PT), speech therapy (ST), and occupational therapy (OT) violates that intent of the statute. The commenters listed numerous additional therapies that they believe should be available for coverage under the statutory language.

Again, parameters and provisions that govern the TRICARE program must be read in their entirety. By defining rehabilitative therapy as PT, OT, and ST, we did not mean to imply that all other therapies are excluded and are not eligible for TRICARE coverage. Other therapies that are medically necessary and appropriate, that are proven medical treatment, that are not considered as custodial care, that are provided by an authorized TRICARE provider and that are not otherwise excluded as a TRICARE benefit may be considered for TRICARE coverage.

However, in order to avoid any misunderstanding, we have revised the definition of rehabilitative therapy to reflect the statutory language rather than define it as PT, OT, and ST only.

In addition to the four major areas in which we received comments, we received general comments regarding most of the proposed provisions. Those comments are responded to as follows:

Comment 1: One commenter questioned whether including the highly specific definition of an ACD/SGD in the TRICARE regulation is appropriate. The commenter proposed that TRICARE adopt a more general definition of ACD/SGD devices in its regulations, leaving the specific distinctions of the TRICARE Policy Manual.

Response: We concur with this recommendation. The purpose of the CFR is to provide broad guidelines and policies. The publishing of detailed criteria for a speech generating device in section 32 CFR 199.2 may prove difficult to maintain and update, if necessary. To assist our beneficiaries in obtaining benefit coverage in a timely manner, the detailed ACD/SGD definition included in the proposed rule has been replaced with the statutory language. We will, place the specific ACD/SGD criteria that were included in the proposed rule into the TRICARE Policy Manual (TPM). That is, we will be adopting CMS's augmentative communication device guidelines as we indicated in the proposed rule and we will incorporate CMS's guidelines into the TPM. The TPM contains policies to implement 32 CFR Part 199 and must be used in conjunction with the CFR for complete policy information. The TPM can be accessed through the TRICARE Web site at http://www.tricare.osd.mil.

Comment 2: We received comments regarding the specific ACD/SGD criteria. For example, it was pointed out to us that we failed to include one of CMS's criteria in our definition.

Response: The omission of the criterion was an oversight and will be corrected. We have decided to include only the NDAA 02 statutory requirements in the regulation rather than listing the specific ACD/SGD criteria. We plan to include the specifics regarding ACD/SGD coverage ( i.e., criteria similar to CMS's coverage criteria) in the TRICARE Policy Manual.

Comment 3: We received comments regarding our decision to adopt CMS's coverage of SGDs for ACDs. Some of the commenters applauded our decision to adopt CMS's policy. Others expressed dissatisfaction.

Response: The NDAA 02 amended title 10, United States Code, by adding a new subsection 1077(e)(2), which says, “An augmentative communication device may be provided under subsection (a)(15).” Subsection (a)(15) states that the Department may provide, “Prosthetic devices, as determined by the Secretary of Defense to be necessary because of significant conditions resulting from trauma, congenital anomalies, or disease.” The Department, in developing its guidelines, policies, and coverage criteria of ACDs/SGDs, is required to classify them as voice prosthesis, while CMS may classify ACDs/SGDs as durable medical equipment. Although we are required to classify them as voice prosthesis, our decision to adopt CMS's coverage of SGDs for ACDs is consistent with TRICARE seeking consistency with CMS. CMS, like TRICARE, is a federal program, and where appropriate, adoption of their national standard helps ensure delivery of a uniform benefit.

Comment 4: A commenter asked whether argumentative communication devices/or speech generating devices were covered previously only under the PFPWD. They also asked whether tracheostomy valves and cochlear implants were purchased under TRICARE and whether these provisions will remain unchanged.

Response: ACDs/SGDs are currently allowed under the PFPWD when there is a serious physical disability and the individual qualifies for the PFPWD. Since certain ACDs/SGDs will now be a benefit under the Basic Program, the individual will no longer have to qualify for PFPWD. Also, unlike hearing aids, this benefit is not limited to dependents of active duty members. The PFPWD is a program statutorily limited to only active duty dependents, so this is an expansion of benefits.

Tracheostomy valves and cochlear implants have been TRICARE benefits and this remains unchanged.

Comment 5: A commenter recommended that ACDs/SGDs also include non-speech generating devices which also help an individual to maximize communication skills for functional and effective communication.

Response: The statutory language states that ACDs may be provided as a voice prosthesis. We interpret this as speech generating devices only. There will be some communicative devices that do not meet the definition of ACD/SGD, but that are considered communication devices, that have been allowed for coverage under the PFPWD. This will not change and those devices will continue to be provided.

Comment 6: The narrative introduction to the proposed ACD/SGD regulations states that “In proposing this policy, we have also taken into consideration recommendations provided to us by the American Speech Language Hearing Association (ASHA) in defining this benefit.” ASHA's recommendations, submitted in March 22, 2002, did not infer that covered ACDs should be limited to SGDs as currently proposed.

Response: We apologize for inferring that the ASHA recommended that ACDs should be limited to those SGDs outlined in the proposed rule.

Comment 7: A commenter recommended that the services of speech-language pathologists be required as related to ACD/SGD evaluation and establishment of a treatment plan. Such is the requirement specified in the DMERC Supplier Manual reference above. If it is not appropriate to include this requirement in the regulation, then it should appear in the policy manual.

Response: TRICARE will allow otherwise covered medically necessary and appropriate services required and prescribed by a physician that are associated with the ACD/SGD.

Comment 8: One commenter restated the changes regarding prosthetics and expressed concern that the same coverage policies are not being applied to TRICARE's orthotic benefit.

Response: The NDAA 02 statutory language refers only to prosthetic devices and makes no mention of orthotic care. Therefore, orthotic care is not addressed in this regulation.

Comment 9: We have concerns about the future findings of the CMS established Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Orthotics.

Response: If TRICARE decides to make any changes based on CMS's negotiated rulemaking, we will publish a proposed rule with a comment period giving the public an opportunity to voice their concerns.

Comment 10: Two commenters stated that they agree that there is not industry standard or industry definition of “profound” hearing loss and they proposed changing the dB level of profound hearing loss for children. The dB level in the proposed rule was 26 dB. The commenter asked us to change it to 15dB.

Response: The statutory language provides coverage for a hearing aid when a “profound hearing loss” is present. There is no industry standard or industry definition of “profound”, we consulted with TRICARE, Veterans Affairs, and Service physicians and Audiology Consultants who informed us a 26dB level falls within a mild hearing loss range. Consequently, we believe 26dB is a reasonable and generous interpretation of profound hearing loss. Under PFPWD, the dB level was 45dB or greater in one ear or 30dB in both ears. By lowering the dB level to 26 we are making this benefit much more generous than what was previously available under the PFPWD.

Comment 11: We were asked to include a statement that testing areas should be in compliance with ANSI standard S3.1-1999, Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms, or any future revision thereof.

Response: We have taken this under advisement. If necessary and appropriate, we will include such a statement in the TRICARE Policy Manual hearing aid issuance.

Comment 12: A commenter urged TRICARE to require that any hearing aid fitting services for a TRICARE beneficiary be provided by an ASHA-certified, and where applicable, licensed audiologist. We believe that audiologists holding the Certificate of Clinical Competence in Audiology (CCC-A) as granted by ASHA will help assure a high level of quality in the delivery of this important benefit.

Response: TRICARE has established the regulatory criteria for being an authorized TRICARE provider based upon the broad statutory guidelines contained in title 10, United States Code, chapter 55, and primarily 10 U.S.C. 1079(a)(13) and 1079(a)(8). For individual paramedical providers under TRICARE, 32 CFR 199.6(c)(3)(iii)(I)( 4 ) lists audiologists. Paramedical providers may be reimbursed for services provided on a fee-for-service basis only if the beneficiary is referred by a physician for the treatment of a medically diagnosed condition and a physician must also provide continuing and ongoing oversight and supervision of the program or episode of treatment provided by the audiologists. All paramedical providers must be licensed if required in that state, and where a state does not license a specific category or paramedical, certification by a Qualified Accreditation Organization as defined in § 199.2 is required. Certification must be at full clinical practice level.

Comment 13. One commenter stated that they prefer that the limitation exists that anyone with hearing loss “that interferes with communication” would be eligible for coverage.

Response: The term “profound” hearing loss appears in the statute and TRICARE has used its discretion in interpreting that term. Prior to the implementation of this rule, and when the benefit was available under PFPWD, the dB level was 45dB or greater in one ear or 30dB in both ears. By lowering the dB level to 26 we are making this benefit much more generous than what was previously available under the PFPWD.

Comment 14: One commenter stated that the proposed criteria for adults and children listed in this new rule will appropriately allow patients with vocational, social, psychological and environmental needs to receive benefits from hearing amplification. However, they also stated that the evaluation and treatment process would be greatly enhanced by the development of a comprehensive protocol utilizing non-audiometric data. They state that a comprehensive protocol for determining hearing aid candidacy and treatment strategies would include data such as the client's physical status (dexterity, visual status), psychological status (attitude, motivation, cognitive and mental status), and communication status (auditory-visual speech perception abilities, auditory speech perception abilities) and the unique communication environments in which the client must function.

Response: In addition to now paying for a hearing aid for a dependent of an active duty member who has a profound hearing loss, TRICARE will also cover all medically necessary and appropriate services and supplies associated with the hearing aid.

Comment 15: A commenter advised us that we may receive some comments which dispute the proposed rule's proposed definition of what constitutes a “profound” hearing loss, since typical clinical categorizations (using pure tone hearing thresholds alone) would not typically associate “profound” with the range of hearing thresholds listed in section 199.2. They stated that they are aware of, and agree with, the intentions of the audiologist consultants from the Department of Defense and the Department of Veterans Affairs who provided guidance in the drafting of this rule. They also agree that there is no universal standard for “profound” loss. The comment continued by stating that if hearing aids were only made available to individuals with audiometric thresholds exceeding 90dBHL (considered by many physicians to represent a profound loss, using only pure tone audiometry results), most hearing impaired patients would be inappropriately excluded.

Response: We thank the commenter for their support and acknowledgement of the sufficiency and appropriateness of our criteria of 40dB and 26db when defining a profound hearing loss.

Comment 16: A comment was received recommending that the Supplementary Information portion of Section V. Hearing Aids include the requirements for a qualified audiologist.

Response: Audiologists are currently authorized providers under TRICARE. See 32 CFR 199.6 (c)(3)(iii)(I). Now that hearing aids are a Basic Program benefit for active duty family members, otherwise covered services and supplies associated with audiologists and speech therapists may be covered. Consequently, we have deleted the Basic Program exclusion found at 32 CFR 199.4 (g)(45) regarding audiologists and speech therapists. While we are deleting the exclusion, it is necessary to point out that otherwise covered services and supplies from these types of providers may be provided only if the beneficiary is referred by a physician for the treatment of a medically diagnosed condition and a physician must also provide continuing and ongoing oversight and supervision of these providers.

Comment 17: We find no reference in the rule to how TRICARE payment methods would apply. We anticipate that TRICARE payments for hearing aids will remain consistent with what the standard had been under the PFPWD. Under this program, the active duty sponsor was responsible for a co-payment based on their rank ( e.g. ranging from $25 to $250 per $1000, per device).

Response: Under the TRICARE Basic Program, the beneficiary's cost share (and deductible, if any) will be based upon which program they are participating in (TRICARE Prime, Standard, or Extra), and their status as the dependent of an active duty member (statutorily hearing aids are available to only the dependent of an active duty family member). Cost shares and deductibles are also statutorily based upon these two factors. The copayments and cost-shares for the TRICARE Basic Program have a different statutory basis than the PFPWD. Because hearing aids will now be obtained by dependents of an active duty family member under the Basic Program, the Basic Program cost-sharing provisions must apply. These copayments are as follows: TRICARE Prime active duty beneficiaries will have no copayment (i.e., a $0.00 copayment); those who use TRICARE Standard will have a 20% cost share after meeting their statutory fiscal year deductible ($150 for an individual/$300 for a family; $50/$100 for dependents of E—4 or below); those who use TRICARE Extra will have 15% cost-sharing after meeting their statutory deductible.

Comment 18: Is this really an expansion of hearing aid benefits to AD dependents since it is already being provided under the PFPWD guidelines and all who need an aid qualify for PFPWD?

Response: Hearing aids will be offered under the Basic Program only and will not be offered as a benefit under the PFPWD once this rule is implemented. It is an enhancement of benefits because we have relaxed the hearing levels necessary to qualify for a hearing aid and have offered hearing aids to all active duty family members who meet the criteria. Additionally, those enrolled in TRICARE Prime will have no cost share, as opposed to the statutory cost share based on rank that they pay today when they access the benefit under the PFPWD.

Comment 19: Does the change mean that the military treatment facility (MTFs) will be fitting and purchasing the aids through our VA contract, rather than in the civilian sector, thus saving tax dollars and that is the reason for the change?

Response: The reason for the change is that the NDAA-02 authorized hearing aids as a TRICARE benefit under the Basic program. The use of a VA contract to fit and purchase hearing aids is a decision that needs to be made by the MTF.

Comment 20: Currently assistive listening devices are purchased via the PFPWD. The exclusion of auditory sensory enhancing devices in the proposed rule will not affect what we currently purchase through the PFPWD correct?

Response: Correct. The exclusion found in the proposed rule applies to the TRICARE Basic program, not the PFPWD.

Comment 21: Under the new statute, we would anticipate, assuming that other conditions of coverage are met, that TRICARE would cover certain sensory or communication aids such as screen readers, Closed Circuit TVs, or other optical scanners for people with vision impairments. Similarly we would expect that TRICARE would potentially cover certain home modifications such as grab bars and raised toilet seats that facilitate better functioning with self care, safety, and may prevent conditions such as hip fractures and other injuries from falls.

Response: As previously discussed, under 10 U.S.C. 1079(a)(13), TRICARE may not provide any service or supply which is not medically or psychologically necessary to prevent, diagnose, or treat a mental or physical illness, injury, or bodily malfunction as assessed or diagnosed by a physician or other authorized provider. Those items of DME as defined in section 199.2 that are also medically necessary and appropriate are covered. There are some items that may serve a preventive purpose, but TRICARE has a very limited preventive benefit that is based on statute. Consequently, some of those items listed by the commenter do not meet coverage provisions.

Comment 22: A commenter stated that the Medicaid program makes no express reference to DME in contrast to the CMS. They continued to express that for the Medicaid program, the operative term is equipment. In their opinion, the TRICARE program continues to require covered DME to be “primarily and customarily designed and intended to serve a medical purpose rather than primarily for transportation, comfort or convenience. The regulations also continue to prohibit coverage for “luxury” or “deluxe” items. These requirements appear out of step with the new statute's standard of maximizing function and preventing deterioration of function.

Response: Medicaid and TRICARE are separate programs each with their own governing statutes and provisions. Medical necessity is a requirement for the TRICARE program and the NDAA 02 statutory language must be read in conjunction with the existing medical necessity requirement. DME with deluxe, luxury, or immaterial features which increase the cost of the item to the government relative to a similar item without those features is excluded. See 32 CFR 199.4(d)(3)(ii)((D)( 3 ).

Comment 23: A commenter opined that technology has blurred the line between what can legitimately be called a convenience or luxury and what improves the functionality of quality of life of the person, thereby improving his or her health status.

Response: We will allow DME that meets the definition described in this final rule, is medically or psychologically necessary, and meets all parameters of TRICARE coverage.

Comment 24: One commenter indicated that in the final rule, TRICARE should specifically address the issue of accessing power mobility before a long term manual wheelchair user is no longer able to propel him or herself due to secondary injury as a result of such wheelchair use.

Response: Current regulatory provisions (32 CFR 199.4(d)(3)(iv)(C)) cover a wheelchair, or a CHAMPUS approved alternative, which is medically necessary to provide basic mobility, including additional cost for medically necessary modifications to accommodate a particular disability. These may be covered as durable medical equipment. Additionally, the Policy Manual allows for electric-powered, cart-type transports as an alternative to an electric wheelchair. DME with deluxe, luxury, or immaterial features which increase the cost of the term to the government relative to a similar item without those features remains a TRICARE exclusion.

Comment 25: A commenter suggested that we change the current definition of DME to conform to CMS's definition of DME. CMS defines DME as equipment furnished by a supplier or a home health agency that—(1) Can withstand repeated use; (2) is primarily and customarily used to serve a medical use; (3) generally is not useful to an individual in the absence of an illness or injury; (4) is appropriate for use in the home. Alternatively, the commenter suggested that TRICARE revise its definition of DME by deleting the wording “* * * rather than primarily for transportation, comfort or convenience * * *” and adding a separate criterion that DME “generally is not useful to an individual in the absence of an illness or injury”.

Response: The proposed rule stated that we intended to modify the DME definition to incorporate the NDAA 02 language into the DME definition. The revised DME definition was proposed to read as follows: Equipment for which the allowable charge is over $100 and which:

(1) Is medically necessary for the treatment of a covered illness or injury;

(2) Improves, restores, or maintains the function of a malformed, diseased, or injured body part, or can otherwise minimize or prevent the deterioration of the patient's function or condition;

(3) Can maximize the patient's function consistent with the patient's physiological or medical needs.

(4) Is primarily and customarily designed and intended to serve a medical purpose rather than primarily for transportation, comfort, or convenience

(5) Can withstand repeated use;

(6) Provides the medically appropriate level of performance and quality for the medical condition present (that is, nonluxury or nondeluxe);

(7) Is other than spectacles, eyeglasses, contact lenses, or other optical devices, hearing aids (unless otherwise provided as a covered TRICARE benefit), or other communication devices (unless otherwise provided as a covered TRICARE benefit); and

(8) Is other than exercise equipment, spas, whirlpools, hot tubs, swimming pools or other such items.

When we received this comment, we reviewed both our current and proposed DME definition. It became clear to us that some of the criteria included in the definition were actually coverage criteria rather than criteria that identify DME. We then compared the current and proposed TRICARE definitions for DME to the definition used by CMS. Based on that side-by-side comparison, we decided to update our DME definition by adopting the same first three criteria listed in CMS's definition for use in TRICARE's definition as that these criteria have a crosswalk to criteria found in our current DME definition. We did not adopt the fourth criteria in the CMS definition regarding in-home use because it provides a restriction not currently found under the TRICARE program. Additionally, we moved the coverage criteria currently found in the DME definition at 32 CFR 199.2, to 32 CFR 199.4(d)(3)(ii)(A) which outlines the scope of the DME benefit. This final rule has been revised accordingly.

Comment 26: A commenter expressed concern with the statement in the “Regulatory Procedures” section of the proposed rule stating that this regulation is “not economically significant.” They interpreted this to mean that the TRICARE program “does not anticipate spending any more resources on this benefit category than the program did before this new law was adopted.”

Response: The language does not mean that the TRICARE program does not anticipate spending any more resources on this benefit category than the program did before the new law. The statement is a requirement in rulemaking under the Regulatory Flexibility Act (RFA). There are three specific RFA requirements applicable to rulemaking:

1. Analysis of the impact of each rulemaking on small entities and evaluation of alternatives that would accomplish regulatory objectives without unduly burdening small entities or erecting barriers to competition.

2. The periodic review of existing agency rules which have a significant economic impact on a substantial number of small entities.

3. Preparation and publication of a semiannual agenda listing rules under development that may have a significant economic impact on a substantial number of small entities.

Additionally, Executive Order 12866 requires that comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts.

Neither the RFA or Executive Order 12866 provide spending limits for these additional benefits and our statement in the proposed rule shall have no impact on the resources provided for this new benefit. TRICARE shall provide the benefits within the provisions outlined in this final rule.

Comment 27: Add “Bob Stump” in front of NDAA-03.

Response: Done.

The following modifications were made as a result of suggestions received during the public comment period:

(1) We revised the definition of ACD/SGD to comply with the statutory language. Additionally, we eliminated the specific criteria for an ACD/SGD and will be placing that into the TRICARE Policy Manual.

(2) We adopted a modified version of CMS's definition of DME and moved criteria found in the current DME definition to 32 CFR 199.4.

(3) We revised the definition of prosthetics to comply with the statutory language.

(4) We revised the definition of rehabilitative therapy to comply with the statutory language.

(5) We clarified that rehabilitative therapy are therapies that are medically necessary and appropriate, that are proven medical treatment, that are not considered custodial care, that are provided by an authorized TRICARE provider and that are not otherwise excluded as a TRICARE benefit may be considered for TRICARE coverage.

Executive Order 12866 requires that a regulatory impact analysis be performed on any economically significant rule. An economically significant rule is defined as one that would result in the annual effect on the national economy of $100 million or more, or have other substantial impact. The Regulatory Flexibility Act (RFA) requires that each Federal Agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues regulations which would have a significant impact on a substantial number of small entities.

As previously mentioned this final rule is not a major rule under the Congressional Review Act, because its economic impact will be less than $100 million. The changes set forth in this final rule are revisions to existing regulation. The changes made in this final rule involve an expansion of TRICARE benefits. In addition, this final rule will have minor impact and will not significantly affect a substantial number of small entities. In light of the above, no regulatory impact analysis is required.

This final rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 55).

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds good cause exists for not publishing an NPRM. Public comment is not necessary since the bridge that the regulation governed is out of service and mariners are no longer required to request an opening to transit through the bridge.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds good cause exists for making this rule effective in less than 30 days after publication in the Federal Register . There is no need to delay the implementation of this rule because the bridge it governs is already out of service and mariners are no longer required to request an opening.

The movable span of the railroad bridge across the Tensas River, mile 27.2, which had previously serviced the area has been removed and the remaining portions of the bridge presently remain in place. These remaining portions of the bridge will be removed in the near future or permitted to remain in place by the U.S. Army Corps of Engineers. Since the movable span has been removed, mariners are no longer required to request openings for the bridge. The regulation governing the operation of the bridge is found in 33 CFR 117.503(a). The purpose of this rule is to remove 33 CFR 117.503(a) from the Code of Federal Regulations since it governs a bridge that is no longer in service and the movable span has been removed.

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

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

This rule removes the special regulation for a bridge that is already out of service.

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

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

This rule will have no impact on any small entities because the regulation being removed applies to a bridge that has already been taken out of service and will be removed.

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

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that 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 the preamble.

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation. This final rule only involves removal of the drawbridge operation regulation for a drawbridge that has been removed from service. It will not have any impact on the environment.

The information in this section is organized as follows:

A delisting petition is a request from a generator to exclude waste from the list of hazardous wastes under RCRA regulations. In a delisting petition, the petitioner must show that waste generated at a particular facility does not meet any of the criteria for which EPA listed the waste as set forth in Title 40, Code of Federal Regulations (CFR) 261.11 and in the background document for the waste. A petitioner must demonstrate that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and must present sufficient information for us to decide whether any factors other than those for which the waste was listed warrant retaining it as a hazardous waste.

A generator remains obligated under RCRA to confirm that its waste remains nonhazardous even if EPA has “delisted” the waste.

Under 40 CFR 260.20 and 260.22, a generator may petition the EPA to remove its wastes from hazardous waste control by excluding it from the lists of hazardous wastes contained in §§ 261.31 and 261.32. Specifically, § 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268, and 273 of Title 40 of the Code of Federal Regulations. 40 CFR 260.22 provides a generator the opportunity to petition the Administrator to exclude a waste on a “generator specific” basis from the hazardous waste lists.

In February, 1999 GM submitted a petition to exclude wastewater treatment sludge from the conversion coating of aluminum, RCRA hazardous F019, generated at its Lordstown Assembly Plant in Lordstown Ohio from the list of hazardous wastes contained in 40 CFR 261.31.

A generator must provide sufficient information to allow the EPA to determine that the waste does not meet any of the criteria for which it was listed as a hazardous waste, and that there are no other factors, including additional constituents, that could cause the waste to be hazardous. To support its petition, GM submitted descriptions and schematic diagrams of its manufacturing processes and the results of the chemical analysis of the petitioned waste.

Today the EPA is finalizing an exclusion for up to 2,000 cubic yards of wastewater treatment sludge generated annually at the GM Lordstown Assembly Plant in Lordstown, Ohio.

GM petitioned EPA to exclude, or delist, the wastewater treatment sludge because GM believed that the petitioned waste does not meet the criteria for which it was listed and that there are no additional constituents or factors which could cause the waste to be hazardous. Review of this petition included consideration of the original listing criteria, as well as the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 222 of HSWA, 42 United States Code (U.S.C.) 6921(f), and 40 CFR 260.22(d)(2)-(4).

On June 25, 2004 EPA proposed to exclude or delist the wastewater treatment sludge generated at GM's Lordstown facility from the list of hazardous wastes in 40 CFR 261.31 and accepted public comment on the proposed rule (65 FR 58015). EPA considered all comments received, and for reasons stated in both the proposal and this document, we believe that the wastewater treatment sludge from GM's Lordstown facility should be excluded from hazardous waste control.

GM must dispose of the wastewater treatment sludge in a Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial waste. Any amount exceeding 2,000 cubic yards, annually, is not delisted under this exclusion. GM must verify on a quarterly basis that the concentrations of the constituents of concern do not exceed the allowable levels set forth in this exclusion. This exclusion is effective only if all conditions contained in today's rule are satisfied.

This rule is effective October 12, 2004. The Hazardous and Solid Waste Amendments of 1984 amended section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. This rule reduces rather than increases the existing requirements and, therefore, is effective immediately upon publication under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).

Because EPA is issuing today's exclusion under the Federal RCRA delisting program, only States subject to Federal RCRA delisting provisions would be affected. This exclusion may not be effective in States having a dual system that includes Federal RCRA requirements and their own requirements, or in States which have received our authorization to make their own delisting decisions.

EPA allows States to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA. These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the State. Because a dual system (that is, both Federal and State programs) may regulate a petitioner's waste, we urge petitioners to contact the State regulatory authority to establish the status of their wastes under the State law.

EPA has also authorized some States to administer a delisting program in place of the Federal program, that is, to make State delisting decisions. Therefore, this exclusion does not apply in those authorized States. If GM transports the petitioned waste to or manages the waste in any State with delisting authorization, GM must obtain a delisting from that State before it can manage the waste as nonhazardous in the State.

Comments were received from Alliance of Automobile Manufacturers and General Motors, Worldwide Facilities Group. Both commenters were supportive of the proposed rule.

Comment: Commenter supports the proposed delisting and the current efforts of the Agency to develop a national solution to the F019 problem, recognizing that the process used by the automotive industry does not use the constituents of concern.

Response: The Agency is currently reviewing available data in order to assess how best to address the waste generated by zinc phosphating operations at automotive assembly plants.

Comment: Commenter expressed concern over the exceptionally long period of time required to delist this waste and urged the Region to expedite the final decision on this petition.

Response: The Region proceeded to prepare the final decision on this petition as soon as the comment period ended.

Comment: The version of the software used to evaluate a petition should be available to the public.

Response: The software initially used to evaluate this petition is available online. However, in the course of evaluating this petition, several errors were discovered in the software. Rather than wait until all errors could be identified and corrected in the software and the risk data could be updated, several allowable limits in this final rule were calculated manually. The software is currently being revised and an updated version will be available to the public again after data inputs have been updated and corrections have been made.

Comment: Total concentrations do not indicate the potential of a constituent to leach in a landfill and should not be used in setting allowable levels for this waste.

Response: Although total concentrations do not indicate leachability to groundwater, they are used to estimate potential risk from surface pathways including runoff to surface water, air dispersion, and volatilization in the plausible mismanagement scenario that the waste in the landfill is not always covered on a daily basis and that the surface water runoff is not always controlled.

Comment: The Alliance previously requested that EPA issue an interpretive rule to exclude this waste from the F019 classification. Because EPA did not act on the request or address the industry's concern, facilities have had to prepare costly and resource intensive individual petitions to delist this waste.

Response: The Agency is currently reviewing available data in order to assess how best to address the waste generated by zinc phosphating operations at automotive assembly plants.

Comment: EPA has not reduced the regulatory burden despite the pollution prevention efforts and the elimination of hexavalent chromium and cyanide from the waste.

Response: The Agency is reviewing the available data in order to assess how best to address the wastes generated by zinc phosphating operations at automotive assembly plants. The Agency must consider all factors including other constituents which could cause the waste to be hazardous.

Comment: By failing to address this concern, the EPA is penalizing the industry for the introduction of aluminum panels which could yield environmental benefits.

Response: EPA recognizes the value of introducing aluminum but must consider the presence of any constituent in the waste that could cause it to be hazardous. See above response.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore is not a regulatory action subject to review by the Office of Management and Budget. Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Because this rule will affect only a particular facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA, or communities of tribal governments, as specified in Executive Order 13175 (65 FR 67249, November 6, 2000). For the same reason, this rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability.

EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will become effective on the date of publication in the Federal Register .

This is a synopsis of the Commission's Report and Order, MB Docket No. 04-188, adopted September 23, 2004, and released October 1, 2004. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 301-816-2820, facsimile 301-816-0169, or via-e-mail joshir@erols.com .

This document does not contain [new or modified] information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will send a copy of this [Report & Order etc.] in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order , MM Docket 01-135, adopted September 1, 2004, and released September 3, 2004. The full text of this decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com . The Commission will send a copy of the Report and Order in this proceeding in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

The reference coordinates for Channel 240C at Bunkerville, NV, and Channel 228C at Logandale, NV are 36-50-52 and 114-28-37, are 36-50-52 and . To accommodate these reallotments, the document (1) substitutes Channel 229A for vacant Channel Channel 240A at Mohave Valley, AZ, at reference coordinates 34-55-40 and 114-35-51; and (2) substitutes Channel 291C2 for Channel 228C2 at St. George, UT, at reference coordinates 36-50-49 and 113-29-28 and modifies the license for Station KSNN(FM) accordingly.

This is a summary of the Commission's Order, FCC 04-212, adopted on September 1, 2004, and released on September 8, 2004. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov . Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365 or at bmillin@fcc.gov .

1. In the Order, the Commission concludes that to the extent that the AAPC petition requests these offset channels be eliminated it is untimely filed. The Report and Order did not establish these channels; they have been available for years. Also, eliminating these channels was not an issue squarely raised in the context of the proceeding. In addition, we note that the Commission previously addressed the issue of whether to extend part 22 rules to reclassified part 90 services. A request to eliminate licensing of the subject eight offset channels would have been the proper subject of a reconsideration petition then or in the Reframing Report and Order when the Commission decided to establish a new band plan for the PLMR 450-470 MHz band. Likewise, to the extent the AAPC petition indirectly challenges earlier Commission decisions it is also procedurally flawed because it is an impermissible collateral attack on final Commission decisions.

2. Additionally, the Commission declined to conform rules applicable to part 90 and part 22 CMRS operations.

3. The Order does not contain any new or modified information collection.

4. As required by the Regulatory Flexibility Act (“RFA”) of 1980, as amended, an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Notice of Proposed Rulemaking (“NPRM”). The FCC sought written public comment on the proposals in the NPRM, including comment on the IRFA. The present Final Regulatory Flexibility Analysis (“FRFA”) conforms to the RFA.

4. Accordingly, it is ordered that, pursuant to the authority of Sections 4(i) and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i) and 303(r), and section 1.115 of the Commission's Rules, 47 CFR 1.115, the petition for reconsideration filed by American Association of Paging Carriers is denied, and the proceeding is hereby terminated.

5. The Commission will not send a copy of this Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability. The Commission declined to change rules adopted in a previous proceeding.

This rule updates the Code of Federal Regulations (CFR) section that sets forth authority delegated from the Secretary of Transportation to other Departmental officials, including the Assistant Secretary for Administration. This rule aligns 49 CFR Part 1 with the Office of Federal Procurement Policy Act (41 U.S.C. 414) (as amended by SARA, Pub. L. 108-136, Sect. 1421 (Nov. 24, 2003)).

The Federal Acquisition Regulation (48 CFR Part 2) defines the agency head as, among others, a “chief official or assistant chief official of an executive agency” and the “Senior Procurement Executive” as the individual responsible for the management direction of the acquisition system of the executive agency. Accordingly, this rule delegates to the Assistant Secretary for Administration the ability to carry out the duties and responsibilities of agency head for Departmental procurement and re-delegates this authority to DOT's Senior Procurement Executive. This authority excludes duties, responsibilities, and powers expressly reserved by statute or regulation.

Section 1421 of SARA amended the Office of Federal Procurement Policy Act to require the designation of a Chief Acquisition Officer (CAO) by the head of each executive agency. This rule reflects the Secretary's designation of the Deputy Secretary as DOT's CAO and the Assistant Secretary for Administration as the Deputy CAO, with the authority to re-delegate any CAO function. This rule also reflects the re-delegation to the Senior Procurement Executive, who resides within the Office of the Assistant Secretary for Administration, the authority to carry out the functions of agency head for departmental procurement, and the authority to carry out the functions of CAO, except for those expressly reserved for the Deputy Secretary in his role as CAO. Finally, this rule will reflect the issuance of DOT Order 1101.12B, dated May 17, 1999, which eliminated the Office of Acquisition and Grant Management, but retained the Senior Procurement Executive and some personnel.

This rule does not impose substantive requirements; it simply updates the CFR to accurately reflect the statutory and organizational posture of the Department. The rule is ministerial in nature and relates only to Departmental management, procedure, and practice as it relates to the acquisition function. Therefore, the Department has determined that notice and comment are unnecessary and that the rule is exempt from prior notice and comment requirements under 5 U.S.C. 553(b)(3)(A). These changes will not have substantive impact and the Department does not expect to receive substantive comments on the rule. Therefore, the Department finds that there is good cause under 5 U.S.C. 553 (d)(3) to make this rule effective upon publication pursuant to 5 U.S.C. 553(d)(2).

The final rule is not considered a significant regulatory action under Executive Order 12866 and the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034). There are no costs associated with this rule.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999. This final rule does not have a substantial direct effect on, or sufficient federalism implications for, the States, nor would it limit the policymaking discretion of the States. Therefore, the consultation and funding requirements do not apply.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13084 (“Consultation and Coordination with Indian Tribal Governments”). Because this final rule does not significantly or uniquely affect the communities of the Indian tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13084 do not apply.

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

The Department has determined that the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply to this rulemaking.

On August 11, 2004, NHTSA published a final rule (69 FR 48818; Docket No. 18793) that provided the last of a number of planned responses to petitions for reconsideration of final rules establishing and amending Federal Motor Vehicle Safety Standard (FMVSS) No. 225, “Child restraint anchorage systems” (FMVSS No. 225, 49 CFR 571.225). 1 FMVSS No. 225 requires new vehicles to be equipped with child restraint anchorage systems consisting of two lower anchorage bars and a top tether anchor. Among other matters, the August 11, 2004 document denied a petition for reconsideration from Keiper GmbH & Co. (Keiper) to allow the installation of stowable lower anchorage bars past August 31, 2004.

NHTSA denied the request to allow stowable anchorage bars on a permanent basis out of a concern that a general use of these anchorage systems might impede efforts to achieve maximum compatibility between child restraint systems and the vehicle anchorage system. NHTSA acknowledged that stowable anchorages were being used by DaimerChrysler on limited models (69 FR 48821). 2

On September 7, 2004, Mercedes-Benz U.S.A. (MBUSA) submitted a petition for reconsideration of the decision on the Keiper petition. MBUSA asked for an extension of time, to March 1, 2005, to comply with the agency's directive that lower anchorages cannot be stowable. MBUSA stated that its C-Class, CLK-Class and Maybach models are equipped with stowable anchorages and that the changes necessary to make their anchorages non-stowable (described below) will take until March 1, 2005 to implement, even when using the fastest possible implementation schedule. The manufacturer also stated that there have been no consumer complaints about the stowable system, which led MBUSA to believe that there would be no adverse safety consequence to extending the date to March 1, 2005.

In a notice of proposed rulemaking that proposed to establish a new Federal motor vehicle safety standard mandating tire pressure monitoring systems (69 FR 55895, September 16, 2004, Docket 19054), NHTSA clarified some of the implications of submitting petitions for reconsideration of final rules. That discussion warrants repeating here. The agency carefully reviews the petitions it receives before deciding the appropriate response to a petition. While petitions are pending, the final rule is effective as originally promulgated. Manufacturers cannot assume that the agency will make the changes requested in their petitions. Accordingly, they must plan to comply with the final rule as issued, without reservation.

To allow manufacturers to do otherwise would be contrary to the public interest. The effective date of a final rule, and the societal benefits associated with it, cannot be delayed by the mere filing of petitions for reconsideration.

At the same time, NHTSA recognizes that it has a responsibility to provide a timely response to petitions. In the case at hand, the agency did not respond to the petition for reconsideration until only three weeks remained in the period during which the stowable anchorages were allowed. Further, in denying the petition, NHTSA did not assess the difficulty MBUSA would have in making its anchorages non-stowable at that late juncture.

In light of this, NHTSA has decided to allow vehicle manufacturers until March 1, 2005 to make necessary design changes and cease use of stowable anchorages. MBUSA stated in its petition that it has sought to make its anchorages non-stowable in the quickest time possible and that it cannot immediately achieve non-stowability of the anchorages. MBUSA said that it considered simply locking the anchorages in the extended position, but found this to be unfeasible because a portion of the anchorage is large enough to make use of the rear seat by adult occupants extremely uncomfortable. The manufacturer also considered locking in place smaller “attachment clips,” but found this too to be unfeasible because the smaller clips did not provide sufficient clearance for a child restraint fastener to extend fully over them. MBUSA believes that it must develop a new child restraint attachment assembly. The manufacturer stated that it needs to develop new tooling for the anchorage, change the tooling for the cross-member and produce a new welding tool. It also has to reduce the following aspects of production to the shortest amount of time: the technical clearance of design of the new anchorage assembly; feasibility testing; parts ordering; sample checking; manufacturing process; and delivery to the assembly line. MBUSA stated that the necessary modifications cannot be implemented before March 1, 2005.

The agency believes that the only quick fixes MBUSA could develop proved unworkable. Because a rapid fix is not available, MBUSA is expediting the development of a new child restraint attachment assembly. Extending the deadline to March 1, 2005 fairly implements the denial of the Keiper petition. Accordingly, the deadline is extended to March 1, 2005.

Although the August 11, 2004 denial of Keiper's petition intended to prohibit the installation of stowable anchorages past September 1, 2004, it is not evident from the regulatory text of FMVSS No. 225 that stowability of the anchorages after that date (which has been changed to March 1, 2005 by this document) is impermissible. To make that impermissibility clearer, the agency is adding a provision to S9.1.1 that specifies that the anchorage bars on vehicles manufactured on or after March 1, 2005 must not be stowable (i.e., foldable or otherwise stowable).

The agency is making today's amendment effective on publication. This final rule provides a 6-month period to meet the requirement that lower anchorages not be stowable. MBUSA could not now sell the three models of vehicles that have stowable lower anchorages if the amendments were not effective on publication. NHTSA thus finds for good cause to make this amendment effective in less than 180 days.

This rulemaking document was not reviewed under E.O. 12866, “Regulatory Planning and Review.” This document simply provides manufacturers (and MBUSA is the sole manufacturer using stowable bars) some time to render their lower anchorage bars non-stowable. Stowable anchorages have been permitted for a number of years and have not been used on a widespread basis. Vehicle manufacturers are unlikely to begin installing stowable bars in vehicles that do not now have them knowing that their installation would only be allowed until March 1, 2005. Based on our review of the potential impacts of this action, we have determined that this action is not significant within the meaning of the Department of Transportation's regulatory policies and procedures. We have further determined that the effects of this rulemaking do not warrant preparation of a full final regulatory evaluation.

NHTSA has considered the effects of this rulemaking action under the Regulatory Flexibility Act. I hereby certify that it will not have a significant economic impact on a substantial number of small entities. This rule affects motor vehicle manufacturers, almost all of which are not small businesses. Even if there are motor vehicle manufacturers that qualify as small entities, this rule will not have a significant economic impact on them because it generally does not change the manufacturers' responsibilities to install non-stowable child restraint anchorage systems pursuant to FMVSS No. 225. This rule just provides more time in which to make stowable lower bars non-stowable. Accordingly, the agency has not prepared a regulatory flexibility analysis.

This rulemaking action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132. This rulemaking will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Accordingly, NHTSA has determined that this rulemaking does not contain provisions that have federalism implications or that preempt State law.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. This rulemaking does not impose any unfunded mandates as defined by that Act.

Under the National Technology Transfer and Advancement Act of 1995 (NTTAA)(Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” The August 11, 2004 final rule addressed the NTTAA regarding NHTSA's decision to deny Keiper's petition on installing stowable anchorages on a permanent basis. There are no technical standards relating to the specific issue addressed by today's document.

NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action will not have any significant impact on the quality of the human environment.

This rulemaking does not have any retroactive effect. Under section 49 U.S.C. 30103, whenever a Federal motor vehicle safety standard is in effect, a state may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the state requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 30161 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

This rule does not contain any collection of information requirements requiring review under the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

You may read the submissions received by Docket Management at Room PL-401, 400 Seventh Street, SW., Washington, DC, 20590 (telephone 202-366-9324). You may visit the Docket from 10 a.m. to 5 p.m., Monday through Friday.

You may also see the submissions on the Internet. Go to the Docket Management System (DMS) Web page of the Department of Transportation (http://dms.dot.gov/) .

Anyone is able to search the electronic form of all submission received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov .

NMFS published a final rule in the Federal Register on November 3, 2003 (68 FR 62250), implementing Framework 3. Framework 3 implemented a process, for years in which the full Winter I commercial scup quota is not harvested, to allow unused quota from the Winter I period to be added to the quota for the Winter II period, and to allow adjustment of the commercial possession limits for the Winter II period based on the amount of quota rolled over from the Winter I period. Table 5 of the final 2004 quota specifications for summer flounder, scup, and black sea bass (69 FR 2074, January 14, 2004) presented detailed information regarding Winter II possession limits, based on the amount of scup to be rolled over from Winter I to Winter II.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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 2004 allowance of the pollock TAC in Statistical Area 610 of the GOA is 22,930 metric tons (mt) as established by the final 2004 harvest specifications for groundfish of the GOA (69 FR 9261, February 27, 2004).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS, has determined that the 2004 allowance of the pollock TAC in Statistical Area 610 will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 22,850 mt, and is setting aside the remaining 80 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA.

After the effective date of this closure the maximum retainable amounts at 50 CFR 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 the 2004 pollock TAC in Statistical Area 610.

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 is exempt from review under Executive Order 12866.