This 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.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), full consideration has been given to the potential economic impact upon small business. All tobacco warehouses and producers fall within the confines of “small business” which are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $500,000 and small agricultural service firms are defined as those whose annual receipts are less than $3,500,000. There are approximately 360 tobacco warehouses and approximately 170,000 producers and most warehouses and producers may be classified as small entities. The AMS has determined that this action would not have a significant economic impact on a substantial number of small entities.

The Tobacco Inspection Act of 1935, as amended, (7 U.S.C. 511-511q), requires the Secretary to fix and collect fees and charges for inspection and certification of quota tobacco, and other services, including administrative and supervisory costs, at designated tobacco auction markets in all tobacco producing areas. The fees collected must, as nearly as possible, cover the Department's costs of performing these services.

The AMS annually reviews its user fee programs to determine if the fees are adequate. The most recent review determined that the existing fee schedule would result in significant losses in crop years 2000 and 2001 and leave the program with inadequate reserve balances. Due to reductions in tobacco quotas and increases in the sale of tobacco through contract sales, obligations for the 2000 crop-year are estimated at $11,607,000 and revenues are expected to reach only $6,843,000, for a loss of $4,764,000 and a reduction in the operating reserve to $4,738,000. If the same level of service and fee structure continues for the 2001 crop-year the estimated loss would exceed $6,154,000 and the operating reserve would drop to a negative $1,416,000.

The major items affecting obligations are Federally mandated increases in salaries and benefits, travel costs, and other administrative costs. Revenue depends on the amount of tobacco sold on the designated auction markets. Production quotas for tobacco were reduced by 228.6 million pounds in 1998, 330.7 million pounds in 1999, and 318.7 million pounds in 2000. This is a total decrease of 878 million pounds in production quotas since 1997. The amount of tobacco graded in 1998 was 1.56 billion pounds, 1.31 billion pounds in 1999, and 938 million pounds is estimated in 2000. Contract sales of tobacco will further reduce the amount graded by about 235 million pounds in 2000. Based on these figures, the current fee level will not generate the amount of revenue sufficient to maintain the level of inspection services requested and maintain funds in the program's reserve account. An analysis of available data indicates that a fee of $.0100 per pound effective for the 2000 crop-year would increase revenue by $1,277,000 and bring the operating reserve up to $6,014,000. The requested fee increase was recommended by the National Advisory Committee for Tobacco Inspection Services at its meeting on April 20, 2000. This committee is made up of representatives of producer interest groups, appointed by the Secretary of Agriculture, to advise on the level of services and user fee rate. This fee increase represents the minimum level needed to cover costs for the 2000 crop-year. In the future, AMS will continue to review the program to ensure that fees are adequate. Accordingly, we believe that the impact of the fee increase would not be significant on users of the inspection and certification services.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule.

The Secretary of Agriculture is authorized by the Tobacco Inspection Act of 1935, as amended, 7 U.S.C. 511-511q et seq. , to fix and collect fees and charges for inspection and certification of quota tobacco, and other services, including administrative and supervisory costs, at designated tobacco auction markets in all tobacco producing areas. The fees collected must, as nearly as possible, cover the Department's costs of performing these services.

The AMS regularly reviews programs to determine if fees are adequate and if costs are reasonable. This interim final rule will increase the fees and charges assessed by the AMS for the mandatory inspection and certification of producer tobacco sold at designated auction markets throughout the tobacco producing areas.

The AMS conducted a recent review of the financial status of this program to determine whether the fee is sufficient. Revenue for the 1999 crop-year was approximately $11,419,000. Obligations for the period are approximately $11,508,000. At the current fee level, insufficient revenue would be generated to meet the costs of the inspection program and to replace funds that had to be used from the program's reserve account. The major factors affecting obligations are mandatory increases in Federal salaries and benefits, travel allowances, and other administrative costs since 1995. An analysis of data available to the AMS indicates that a fee of $.0100 per pound would cover expenses and maintain a reserve that would meet any reasonable contingency.

Due to an estimated 43 percent reduction in tobacco to be inspected and 20-30 percent of tobacco being sold through contract sales, obligations for the 2000 crop-year are estimated at $11,607,000 and revenues are expected to reach only $6,843,000, for a loss of $4,764,000 and a reduction in the operating reserve to $4,738,000. If the same level of service and fee structure continues for the 2001 crop-year the estimated loss would exceed $6,154,000 and the operating reserve would drop to a negative $1,416,000.

Revenue depends on the amount of tobacco sold on the designated auction markets. Production quotas for tobacco were reduced by 228.6 million pounds in 1998, 330.7 million pounds in 1999, and 318.7 million pounds in 2000. This is a total decrease of 878 million pounds of tobacco since 1997. Also, contract sales of tobacco will further reduce the amount graded by about 235 million pounds in 2000. Based on these figures, the current fee level will not generate the amount of revenue sufficient to maintain the level of inspection services requested and maintain funds in the program's reserve account. An analysis of available data indicates that a fee of $.0100 per pound effective for the 2000 crop-year would increase revenue by $1,277,000 and bring the operating reserve up to $6,014,000.

Information on program income and expenses was presented to the National Advisory Committee for Tobacco Inspection Services at its meeting on February 17, 2000, in Raleigh, North Carolina, and again on April 20, 2000, in Washington, D.C. The National Advisory Committee, which is made up of 14 representatives from tobacco producer interest groups and appointed by the Secretary of Agriculture, was established by law in 1981 to advise the Secretary on the level of services needed and the fees necessary to cover those services. By a majority vote, the Committee adopted a motion to recommend to the Secretary an increase in the fee to $.0100 per pound.

It is hereby found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2000 flue-cured marketing season will begin about July 17 and this action is needed, as soon as possible, so as to treat all types of tobacco on an equal basis for the 2000 crop-year; (2) the National Advisory Committee recommended the fee increase by a majority vote; and (3) this interim final rule provides a 30-day comment period, and all comments timely received will be considered prior to finalization of this rule.

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

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Administrator of AMS has considered the economic impact of this proposed action on small entities.

AMS, through its MGC Branch, provides voluntary Federal meat grading and certification services to a total of 370 business of which 264 are small entities. Small entities, which account for approximately 38 percent of the MGC Branch's total revenues, are defined as those that employ less than 500 employees. The breakdown of small entities that AMS provides meat grading and certification services to are as follows: 93 meat processors, 90 livestock slaughterers, 52 facilities that further process federally donated products, 13 trade associations, 9 livestock feeders, 3 trucking companies, and 4 brokers. These small entities are under no obligation to use meat grading and certification services provided under the authority of the Agricultural Marketing Act of 1946 (AMA), as amended, 7 USC 1621 et seq.

Voluntary meat grading and certification services facilitate the orderly marketing of meat and meat products and enable consumers to obtain the quality of meat they desire. Grading services consist of the evaluation of carcass beef, lamb, pork, veal, and calf for conformance with the grades of an official U.S. Standard for each species. Approximately 21 billion pounds of meat is graded each year. Certification services consist of the evaluation of meat and meat products for compliance with specification and contractual requirements. Certification services are used most often by large-scale meat purchasers to ensure that the quality and yields of the products they purchase comply with their stated requirements. Approximately 17 billion pounds of meat and meat products are certified each year.

AMS regularly reviews its user-fee-financed programs to determine if the fees are adequate. The most recent review determined that the existing fee schedule would not generate sufficient revenues to recover program costs for current and near-term periods while maintaining an adequate reserve balance. Without a fee increase, the projected operating losses for fiscal year (FY) 2000, FY 2001, and FY 2002 will be $1.9 million, $2.9 million, and $4.1 million respectively. Operating losses at these levels will deplete MGC Branch's operating reserve and place the Branch in an unstable financial position that will adversely affect its ability to provide the current level of grading and certification services. Any reduction in Branch services has the potential to substantially harm small and limited resource firms that rely on grading and certification services to market their products and compete in a global marketplace.

This action will raise the fees charged to all users of grading and certification services. AMS estimates that overall, this will yield an additional $175 thousand in revenue for the balance of FY 2000. Of this $175 thousand, small businesses would pay approximately $66,500 or an average of $255 per month. In FY 2001 and 2002, small entities will pay approximately $798,000, an average of $255 per month or $3,058 per year. However, due to increased program and industry efficiencies, the FY 2000-2002 unit costs of program services (revenue/total pounds graded and certified) will remain virtually unchanged at approximately $0.0006 per pound for each fiscal year. Accordingly, the Administrator of AMS has determined that this proposal would not have a significant economic effect on a substantial number of small business entities.

This fee increase, only the second since November 1993, is necessary to offset increased program operating costs resulting from: (1) The congressionally-mandated, governmentwide salary increases for 1998, 1999, and 2000; (2) inflation of nonsalary operating costs; (3) accumulated increases in CONUS per diem rates; (4) increased costs of servicing less than full-time applicants; and (5) costs associated with updating the MGC Branch's automated information management system to ensure compliance with year 2000 operating requirements.

Since 1993, in an ongoing effort to control operating costs, the MGC Branch has closed 3 field offices, reduced mid-level supervisory staff by over 50 percent, and reduced the number of support staff by 38 percent. At the same time, the MGC Branch has become more reliant on automated information management systems for data collection, retrieval, and dissemination, account billing, and disbursement of employee entitlements. The reduction in field offices, supervisory staff, support personnel, and the increased reliance on automated systems has enabled the MGC Branch to absorb a substantial portion of the increased operating costs and minimize increases in user-fees over the past 7 years.

Despite the MGC Branch's vigilant cost reduction efforts since 1993, the operating expenses projected for FY 2000 and beyond can only be balanced by adjusting the hourly fee rate charged to users of meat grading and certification services. Any further reduction in personnel, services, or management infrastructure beyond those already implemented would have a detrimental effect on the program's ability to provide meat grading and certification services and ensure the accurate and uniform application of such services. The hourly rate increase is necessary to recover the costs of providing voluntary Federal meat grading and certification services and for the program to continue serving all segments of the industry.

This action has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. This rule will not pre-empt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

This action will not impose any additional reporting or recordkeeping requirements on either small or large meat slaughters, processors, and other applicants who use Federal meat grading and certification services.

On January 20, 2000, (65 FR 3155) in the Federal Register , the Agency published the proposed rule to increase the fees for Federal Meat Grading and Certification services and requested comments by March 20, 2000. The Agency received two comments. The first respondent requested that AMS work more closely with industry to identify alternatives to current grading and certification operations and procedures to stem future rate increases. The respondent went on to identify the following as possible areas the Industry and AMS could work cooperatively to achieve cost savings or stem future user-fee increases: (1) Incorporating technological advances; (2) identifying appropriate quality control or process verification activities that could be shifted to the Industry; and, (3) identifying plant operation alternatives.

AMS is continually seeking ways to reduce costs to the industry and increase operational efficiency. This fee increase, combined with the previous increase in 1998, equates to an average annual increase of 3.3 percent since 1993. However, during this same time the amount of product graded and certified has dramatically increased by over 9 billion pounds per year in comparison to the total graded and certified in FY 1993. This amounts to a 48 percent per hour increase in efficiency. The increased efficiencies offset the increase in fee rates to leave the overall cost per pound to the industry unchanged at $0.0006 per pound. As requested by the respondent, the Agency is currently and will continue seeking ways to increase efficiency and reduce the total cost of grading and certification services to the industry. In fact, AMS is actively involved in each of the areas identified by the respondent for potential cost savings. For example, AMS is cooperating with an industry research project to test video-imaging technology for grading and certification applications. Additionally, AMS is expanding the role of statistical process control as a basis of program verification activities in many carcass and meat marketing programs.

The second respondent questioned the need for revising the fee rates and emphasized the effect of the user fees on small entities. Small entities generate 38 percent of the Agency's meat grading and certification hourly revenues. The Agency is keenly aware of how fee increases impact small entities. In the more than 70 years meat grading and certification services have been available, the Agency has always ensured that every alternative to a fee increase has been considered. This fee increase, only the second since November 1993, is necessary to offset increased program operating costs resulting from: (1) The congressionally-mandated, governmentwide salary increases for 1998, 1999, and 2000; (2) inflation of nonsalary operating costs; (3) accumulated increases in CONUS per diem rates; (4) increased costs of servicing less than full-time applicants; and, (5) costs associated with updating the MGC Branch's automated information management system to ensure compliance with year 2000 operating requirements. Despite the MGC Branch's cost reduction efforts and increased efficiency, the operating expenses projected for FY2000 and beyond can only be balanced by adjusting the hourly fee rate charged to users of voluntary meat grading and certification services. Any further reduction in personnel, services, or management infrastructure beyond those already in place would have a detrimental effect on the program's ability to provide meat grading and certification services and ensure the accurate application of such services. Further, any reduction in Branch services has the potential to substantially (and disproportionally) harm small and limited resource firms that rely on grading and certification services to market their products and compete in a global marketplace.

The Secretary of Agriculture is authorized by the AMA, 1946 as amended, 7 U.S.C. 1621 et seq. , to provide voluntary Federal meat grading and certification services to facilitate the orderly marketing of meat and meat products and to enable consumers to obtain the quality of meat they desire. The AMA also provides for the collection of fees from users of the Federal meat grading and certification services that are approximately equal to the cost of providing these services. The hourly fees for service are established by equitably distributing the projected annual program operating costs over the estimated hours of service—revenue hours—provided to users of the service. Program operating costs include salaries and fringe benefits of meat graders, supervision, travel, training, and all administrative costs of operating the program. Employee salaries and benefits account for approximately 80 percent of the total budget. Revenue hours include base hours, premium hours, and service performed on Federal legal holidays. As program operating costs continue to rise, the hourly fees must be adjusted to enable the program to remain financially self-supporting as required by law.

In view of these considerations, the Agency will increase the base hourly rate commitment applicants pay for voluntary Federal meat grading and certification services from $39.80 to $45. A commitment applicant is a user of meat grading and certification services who agrees to pay for five continuous 8 hour days, Monday through Friday between the hours of 6 a.m. and 6 p.m., excluding legal holidays. The base hourly rate for noncommitment applicants will increase from $42.20 to $52. A noncommitment applicant is a user of meat grading and certification services for eight consecutive hours or less per day between the hours of 6 a.m. and 6 p.m., excluding legal holidays. The hourly rate for premium hours will increase from $47.80 to $57, and will be charged to users of the service for hours worked in excess of 8 hours per day for each assigned official grader and for work performed before 6 a.m. and after 6 p.m., Monday through Friday, and any time on Saturday or Sunday, except on Federal legal holidays. The holiday rate for all applicants will increase from $79.60 to $90, and will be charged to users of the service for all hours worked on legal holidays.

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

This 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 entitled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. RUS has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In accordance with the Executive Order and the rule: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) in accordance with § 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeal procedures, if any, are required, must be exhausted prior to initiating litigation against the Department or its agencies.

The Administrator of RUS has determined that a rule relating to the RUS electric loan program is not a rule as defined in the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) and, therefore, the Regulatory Flexibility Act does not apply to this rule. RUS borrowers, as a result of obtaining Federal financing, receive economic benefits that exceed any direct economic costs associated with complying with RUS regulations and requirements.

This rule contains no reporting or recordkeeping provisions requiring Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The Administrator of RUS has determined that this 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 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: (202) 512-1800.

This final rule contains no Federal mandates (under the regulatory provision of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of section 202 and 205 of the Unfunded Mandates Reform Act of 1995.

Pursuant to the Rural Electrification Act of 1936 (7 U.S.C. 901 et seq. ), the Rural Utilities Service (RUS) is amending 7 CFR Chapter XVII, Part 1728, Electric Standards and Specification for Materials and Construction, by revising RUS Bulletin 50-6 (D-806), Specification and Drawings for Underground Electric Distribution. This revised bulletin is renumbered as RUS Bulletin 1728F-806. RUS maintains a system of bulletins that contains construction standards and specifications for materials and equipment which must be complied with when system facilities are constructed by RUS electric and telecommunications borrowers in accordance with the RUS loan contract. These standards and specifications contain standard construction units, material, and equipment units commonly used in RUS electric and telecommunications borrowers' systems.

RUS Bulletin 50-6 provides standard underground electric distribution construction drawings and specifications of 12.5/7.2 kV and 24.9/14.4 kV underground electric distribution lines. RUS is changing the bulletin number from RUS Bulletin 50-6 to RUS Bulletin 1728F-806. The change in the bulletin number and reformatting is necessary to conform to RUS new publications and directives system. This rule incorporates the bulletin by reference in 7 CFR part 1728.97.

Major changes in the bulletin are described below:

(1) Two new drawings, UC2-1 and UC2-2, have been added as alternative construction to existing drawing UC2.

(2) RUS has determined that the URD INSPECTION FORM and 23 drawings are no longer practical. Therefore, RUS has removed the following drawings: UC3, UC4, UG9A, UG23, UM3-47, UM3-48, UM8-3, UM12-1, UM12-2, UM-26, UM50, UX8 through UX10, and UX12 through UX26.

(3) Some of the specifications cited in the bulletin preface have been altered to comply with the latest codes and regulations and to improve field construction.

(4) The titles of the drawings in the Index of Drawings have been modified to have better descriptions.

Approximately 60 drawings have been revised with one or more of the following changes:

(1) Clearance distance B has been changed to be the distance between open vertical conductors (outer edge nearest to pole) and pole center in accordance to the latest codes.

(2) A B MINIMUM table has been added to appropriate drawings to show proper clearances corresponding to different voltages.

(3) Ground rods have been redrawn to proper grade.

(4) The installation of CAUTION, WARNING, and DANGER signs has been changed to meet the latest codes.

(5) In the material tables, item U hw, CAUTION sign, has been changed to WARNING sign.

(6) In the material tables, item U hp, elbow termination, has been added.

(7) Ground wires between ground rods and connectors have been redrawn as dotted lines.

(8) In boxes labeled B MINIMUM, the v in kv has been capitalized.

(9) Some notes below the DESIGNATE AS headings have been deleted where appropriate.

(10) In the material tables, (load break type) has been removed from item af, cutout descriptions.

(11) Several conductor routes have been redrawn for easier construction and increased performance.

(12) Devices, such as surge arresters, have been redrawn and relocated to reflect the improved designs and to meet the latest construction practices and safety codes.

(13) Crossarms, penta-head bolts, one-line diagrams, grounding pads, and pin insulators have been added to certain drawings where appropriate.

(14) Blowups have been added to several drawings to emphasize details.

(15) The notes on some drawings have been revised to remove ambiguity and to meet the latest safety codes and construction standards.

On April 8, 1998, RUS published a proposed rule in the Federal Register , at 63 FR 17128. RUS received numerous comments from several cooperatives and interested individuals. The followings are the submitted comments and RUS responses:

(1) Set all pad-mounted equipment on concrete vaults. The reinforcing steel in the base is tied to the ground rod. Tests have shown this scheme to provide a very good ground.

Response: RUS disagrees as this practice may not be practical and may not significantly improve grounding in most cases.

(2) Section 7.4: Requires “mechanical tamp for only 36 inches from major units”—suggests no tamping requirement for the remainder of the trench. Is that the intent?

Response: No. The 36 inches (0.9 meters) is mandatory and is a minimum requirement.

(3) Section 7.5: Does the term “hole” refer to ground sleeve, or vault? Should RUS change this term?

Response: Section 7.5 has been removed. This practice is not recommended by RUS.

(4) Section 11.2: The “not more than one splice per 2,000 feet” is not practical if conduits and ground sleeves are involved. Splice location markings can be helpful, but not needed as a “must”.

Response: RUS allows the borrower the option to specify. RUS intention is to limit the number of splices of multi (“scrap”) cables.

(5) Section 12.1: Would RUS consider reseal of the jacket?

Response: As a precaution and to maximize reliability, RUS borrowers must use heat or cold shrink sleeves accepted by RUS (Refer to items U hf and U hy in RUS Information Publication 202-1, List of Materials Acceptable for Use on Systems of RUS Electrification Borrowers).

(6) Section 14.4: RUS may want to consider dead front treatment of this type transformer.

Response: RUS does not accept enclosures such as sectionalizers and transformers unless they are of the dead front design.

(7) Section 25.1: Is it the intention to require testing or to recommend testing that would be helpful?

Response: Bulletin 1728F-806 requires that conductor continuity tests be conducted while it recommends that borrowers perform the high potential test. The term “shall” has been changed to “should” for the high potential test in section 25.1.b.

(8) Drawing UC2-2: Cutouts placed on the opposite side of the crossarm would not expel fuse material on the terminations.

Response: RUS agrees and has made the modifications to accommodate the suggested comment.

(9) Drawing UC5 and UC6: Clarify underground source/or reverse switch. Also, jumpers from switch to overhead lines would not route to the pole like a ground wire. End view of equipment bracket needs to clarify separate phase connections; may need to exaggerate center phase offset.

Response: The center primary conductor has been redrawn to depict a primary conductor not a ground wire. The devices are in line when seen from the sideview.

(10) Drawing UG7: Position of primary bushings not typical of transformer supplied.

Response: RUS is more concerned with detailing how the electrical connections should be completed. The philosophy of electrical connections is important because the bushing layout design may change from time to time. The drawing shown depicts an ANSI Type I transformer. As a result of this connection, the neutral has been moved to the bottom bushing.

(11) Drawings UJ1 and UJ2: Dead front requirement is not clear.

Response: These drawings apply to secondary connector blocks. Dead front construction does not apply here. However, to minimize chances for confusion, a note stating “insulated cover removed” has been added to the drawings.

(12) Drawing UK6: Pentahead bolts on a below grade enclosure would seem unnecessary.

Response: Public access and safety concerns for accessible underground facilities are no different than above grade construction.

(13) Sections 10 and 11 Method of Calculating Minimum Conduit Size and Installation in Conduit or Duct: Should RUS provide an explanation of why these two sections were deleted and where a borrower can find information on the installation of wire in conduit?

Response: The previous RUS published method of calculating conduit size is not the best available method. RUS recommends that borrowers contact cable and conduit manufacturers for design and installation instructions.

(14) Drawing UG9A: Should this drawing be retained. It may be useful, as a reference, when retiring this unit from the field.

Response: This construction standard is no longer recommended and has been removed from Bulletin 1728F-806. RUS suggests borrowers refer to RUS Bulletin 1767B-2 for reference of retirement units.

(15) In general, the print size should be increased, especially item letters attached to drawings. It's easy to confuse e and c or a and o.

Response: The font sizes have been increased.

(16) On all terminal drawings, delete reference to parallel arresters. Those haven't been used since MOV arresters came into being in 1982-83. Maybe RUS should reinforce use of MOV's on underground in the material list under Uae surge arrester—MOV only.

Response: RUS agrees and has removed all notes referring to parallel arresters as they are no longer applicable to this RUS construction standard.

(17) Do not specify elbows as part of transformer drawings to be consistent with UM3 and UM33 drawings. If RUS would like to specify, UG7 needs 2 elbows not 1.

Response: RUS agrees to specify two elbows on drawing UG7 to be consistent with other drawings.

(18) On UM3-14 delete UM3-15 and UM3-16. Only difference between -14 and -16 is the pad, which is spaced separately. -15 is obsolete. Change drawing to UM3. Redraw UM3-14 now as UM3 and show a 3-point junction to reflect the real world way the inside of the cabinet would look. What's illustrated doesn't exist.

Response: Drawings UM3-15 and UM3-16 are obsolete and have been removed. For the ground connections to the enclosures, the ground wires are hidden. RUS changed the mounting arrangement to reflect field application.

(19) In drawing UX4, since we show loops in ground rod connections for transformers and pad mount equipment, shouldn't there be 2 connections to the ground rod?

Response: Two connections in an enclosure are required to provide additional mechanical protection and to complete the ground loop. Connections to ground rods should be isolated and, mechanically, should not be disturbed. Therefore, dual connections to the ground rods are not needed.

(20) On UX11 drawing, the note about 3 ft. max. is not needed. This connection has lead length of effectively 0 feet. The note is misapplied.

Response: The note has been removed for the reasons presented in this comment.

(21) Section 18: There is no reference to concrete vaults and their associated covers.

Response: Due to the wide variation of concrete vaults available, RUS does not have specific requirements for concrete vaults.

(22) Units UB1, UB3, UB2-1, UC2-1: The jumper between the top of the terminator and the top of the arrester crosses over the top of the crossarm. This will undoubtedly kill lots of birds.

Response: Due to limitations of what and how we can show details on drawings, jumpers in drawings are for demonstration purpose and may not reflect actual field installation. Usually raptors choose the highest point to perch in search of prey and rest. On the structure referred to in this comment, most raptors can be expected to perch on the pole top rather than the lower crossarm. However, in locations where there is a possibility that raptors may use the lower crossarm, borrowers may utilize insulated jumper wires for the connection cited by the commentor.

(23) Drawings UG17 and UG17B: Shows only one ground rod. Note that UM 48-2 shows two (2) ground rods which will help get below 25 ohms.

Response: The ground rods on the drawings referred to by the commentor are not part of the cited drawings as is intended by their dotted appearance on these drawings. The ground rods are shown on these drawings only for reference perspective purposes. Grounding is required but for details on the grounding, borrowers would refer to the applicable RUS standard drawings on which grounding and ground rod use are included as part of the unit and included in the materials list. The applicable grounding drawings include notes that advise borrowers that depending on the condition and type of soil, installation of multiple ground rods may be necessary to attain a desirable ground resistance. These drawing notes also advise that, because use is site specific, numbers and type of ground rods are to be specified separately by the engineer.

(24) Drawings UM 3-44 and UM 3-45: Live bushing equipment in this type of enclosure is not a good safety practice. Suggest it not be allowed.

Response: The drawings were not shown as intended. As can be seen from the material listings for “be” and “el”, these items are to be supplied with bushing wells and thus the drawings need to be shown using elbows. The drawings were changed to agree with materials used.

(25) Drawing UM6 Page 5 of 8: In the Notes, items Uhf are referred to for resealing concentric neutral wires. What are they?

Response: Item U hf is a cable sealing kit. A note has been added to the drawing to better explain this item and its use. RUS accepted U hf products of various manufacturers are included in RUS Informational Publication 202-1, List of Materials Acceptable for Use on Systems of RUS Electrification Borrowers.

(26) Drawing UA1—UC6: RUS Bulletin 50-6 recommends, p connectors as required, where as, RUS Bulletin 50-3 required, p compression connectors. It would be desirable to maintain a consistent standard in the type of connector required in making the connection from the primary neutral to the pole ground.

Response: RUS requires compression connectors be used for grounding connections on underground construction. Many connector options may be use for overhead connections where conditions will generally be less adverse than underground construction. Compression connectors improve the chances for more permanent connections in underground construction.

(27) Drawing UM48-2: This drawing previously required #2 copper for the grounding wire. This requirement does not seem to be clearly spelled out in the current drawing.

Response: The minimum size of grounding wire to use is specified in the National Electrical Safety Code (NESC). As the size of grounding wire required will vary, RUS no longer includes wire size in the drawing and leaves determination and specification to the design engineer. RUS does not object to using wire sizes which exceed the minimum NESC requirements.

(28) Section 6.4 and 17.1: The two inches of sand is not recommended by the cable manufacturers. Sand serves as a thermal insulator and de-rates the cable ampacity. Also, for cable runs of a 1/4 mile or more, a potential galvanic action problem may be created for grounding the cable as required by NESC.

Response: Normally, good soil removed during digging of a trench is used as backfilling material. Sand is used as backfill in situations where removed soil is not suitable backfill material and consists of large rocks and/or sharp objects that could damage the buried cable. Sand may not be the ideal substitute as backfilling material. However, in most rural low load factor circuit use situations sand availability and economic feasibility make it a choice backfilling substitute.

(29) Drawing UK5: Locking mechanism should have provisions for company pad lock.

Response: NESC Rule 381G. requires enclosures to be either locked or otherwise secure against unauthorized entry. RUS requires and accepts enclosures that include the standard penta-head bolt, which provides the NESC intended security. Borrowers wishing to also use padlocking facilities in addition to having and using the required penta-head bolt may do so.

(30) Can a note be included on some drawings (such as UB1 where the neutral is so high) allowing the neutral to be lowered to get it down out of the primary?

Response: The neutral may be moved as long as the resulting installation meets proper clearances and does not violate safety codes.

(31) Several sections state that it is the responsibility of the borrower to ensure that the Contractor and the Owner. Is the borrower not the owner? Maybe this needs to be clarified.

Response: The commenter is correct in that the “Owner” and “Borrower” are generally the same entity. The “Owner” is the term used in RUS standard contracts to refer to the RUS borrower that executes the contract with the contractor. Borrower refers to a RUS borrower that has obtained financing assistance from RUS and has executed a loan contract with RUS. For accuracy purposes, specific bulletin sections deliberately refer to the contract terminology noted.

(32) Several sections state that it is the responsibility of the borrower to ensure. This needs to be changed to include the contractor as well.

Response: RUS does not have a regulatory relationship that allows establishment of requirements for contractors. Thus, RUS requires the borrower to ensure that the contractor complies with contract provisions. Borrowers are able to do so easily by use of RUS construction contracts which both the borrower and the contractor sign. RUS contracts make the design specification (RUS Bulletin 1728F-806 in this case) an integral part of the contract under which the contractor is contractually obligated to comply with the specification provisions.

(33) Section 17: Need to define what proper compaction is.

Response: Proper compaction provisions vary greatly and depend on local conditions. Compaction provision should be established by the borrower and completed in accordance with the borrower's satisfaction.

(34) Section 17.1: Is one inch too large for having in backfill?

Response: Backfill with pieces of less than one-inch (25 millimeter) size is recommended.

(35) Section 18.1: Gravel or sand is not needed under pads in all cases. This should be optional.

Response: RUS agrees and the term “shall” has been changed to “may.”

(36) Drawings UB2 and UC2: Why is the crossarm shown on a different side of the pole on these two drawings as compared with UB1 and UC1? Why are left side terminals and cutouts not out to end of arms to balance construction?

Response: Drawings UB1 and UC1 detail construction utilizing crossarm mounting arresters while drawings UB2 and UC2 detail construction utilizing bracket mounting arresters. Brackets mount on opposite sides of the pole to provide for accessibility and clearances. Equipment and hardware on the structures have been redrawn to depict balanced construction as suggested.

(37) Drawings UC5 and UC6: Intermediate arresters are shown (we guess that is why they are so large). Most cooperatives use riser pole arresters.

Response: We agree that the arrester size is confusing and revised the drawings to depict pole arrester use.

(38) Drawings UG6, UG7, UG17, UG17-2 and UG17-3: No slack is shown in primary cable. Most cooperatives loop the primary over from the secondary side to give slack so that cables can be parked or switched. Bulletin 50-6 showed the cable this way.

Response: We agree with the utility suggestion in this comment and revised the drawing by adding a note to allow slack in the primary cable installation.

(39) Drawing UG17: Requiring three phase switches as implied by note 6 should be optional.

Response: Note 6 on Drawing UG17 advises that three phase switching “should” be installed where ferroresonance may occur. The note is cautionary to help avoid equipment damage on three-phase installations where ferroresonance is a possibility. Because the word “should” is used and not “must”, three-phase switching would not need to be installed in situations where a borrower's engineer determined that ferroresonance would not occur.

(40) Drawing UJ1: A note is needed on the drawing stating that the connector blocks must be insulated to have a “dead-front” unit.

Response: These are drawings depicting various types of secondary connector blocks. It is not the intent of the bulletin to show dead front in this drawing. To help dispel possible confusion, the drawing includes a note that states “insulated covers are not shown”.

(41) Drawing UK6: If this handhole is metal, how is it to be grounded? Sign should be a warning not danger.

Response: RUS accepted metal pedestals must have grounding lugs available on the inside wall. A note has been added advising that all pedestals shall be grounded in accordance with the NESC. The placement of the safety sign has been relocated to the pedestal side (with the penta-head bolt lock) that opens. Both DANGER and WARNING signs have been added to the drawing's material listings. A WARNING sign should be placed on the outside of the enclosure where there is a potential hazard. A DANGER sign should be placed on the inside of the enclosure where there is an imminent hazard.

(42) Drawing UM1-6C: Having three or four different size pads might fit these size transformers better. Note #1 requires 4000# concrete, but most use 3000# which would be adequate for this.

Response: RUS agrees and has amended Note 1 of the drawing to specify the minimum at 3000 pounds per square inch (20 megapascals).

(43) Drawings UM3-44 and UM3-46: This is a dangerous installation since it is not dead front. A bushing insert can be installed in the recloser and then primary cable run to it to make everything deadfront.

Response: The drawings were not shown as intended. As can be seen from the material listings for “be” and “el”, these items are to be supplied with bushing wells and thus the drawings needs to be shown using elbows. The drawings were changed to agree with the materials used.

(44) Drawing UM6-27: Needs to be omitted.

Response: RUS agrees and has deleted this obsolete drawing.

(45) Drawing UM8-2: Ground rod connector has to be above grade as per code. Does the post need to be a minimum size, such as 4 x 4 inches?

Response: Section 250-52(c)(3) of the National Electrical Code requires that the upper end of a driven ground rod be flush with or below ground level unless the rod end and the grounding electrode conductor attachment are protected against physical damage. The RUS drawing shows the top of the rod well beneath grade to depict greater protection for the rod end and the grounding attachment.

RUS has included a note to require a minimum post size of 4 inches (10 centimeters) square or diameter.

(46) Drawing UM8-4: Why not show conduit coming in bottom of meter base to eliminate the elbow?

Response: RUS agrees and has revised the drawing to show cable entering from the base instead of from the side of the meter.

(47) Drawing UM8-6: Why cannot a meter be mounted to transformer? Utilities do this all the time.

Response: RUS does not believe such installations to be prudent. Mounting metering equipment onto the wall of padmounted transformers will require some cutting and drilling which will expose untreated transformer metal surfaces. These surfaces overtime will corrode prematurely and may cause serious problems.

In addition, vibrations from the transformer may affect the meter operation. Also, anytime a transformer is changed out, the meter has to be changed as well.

(48) Drawing UM12: Should this sign meet ANSI Z535 standards also? Would it be a Notice or a Warning or a Caution?

Response: RUS agrees there may be confusion with this drawing and revised the drawing by adding the signal word “WARNING” to the label. A note was also added requiring the sign to comply with ANSI Z535.

(49) Drawing UM26: Needs to be omitted. Nobody uses these anymore.

Response: RUS agrees that this drawing depicts outdated construction and removed the drawing.

(50) Drawing UM48-3: Is anode needed for jacketed cable?

Response: The sacrificial anode (Item U si) shown as a hidden line is optional. Some RUS borrowers prefer to install anodes at all ground points because gophers might chew through the jacket and expose the copper neutrals. The sacrificial anode will provide corrosion protection to such exposed neutral wires preventing a loss of neutral integrity.

(51) Drawing UX5: Need to show a minimum distance between ground rods as are done on other drawings.

Response: RUS agrees and has revised the drawing to show a minimum spacing of 6 ft. (1.8 m) between multiple ground rods. (As a general rule, RUS recommends that separation of ground rods be no closer than the length of the ground rods used. When rods are closer to one another than their length they will magnetically influence one another and degrade grounding effectiveness.) A note was also added to advise that multiple rods may not fit inside the enclosure. Where spacing inside an enclosure does not allow the 6 ft. (1.8 m) separation between multiple ground rods, one rod is to be installed inside the enclosure and the other outside. The ground loop has been redrawn to show a complete loop with a conductor feed from the loop down to the ground rod.

(52) Drawing UM7-1: There is no minimum ground clearance shown on any pole structures. If RUS does not want to show minimum clearances, perhaps a note regarding the source for clearance information would be in order.

Response: RUS agrees there is possible confusion here. Clearances were omitted purposefully because alternative working methods may be implemented along with appropriate alternative working clearances as a means of providing safety. To allay concerns of this comment, RUS revised the drawing by adding a note which states that clearances must meet NESC requirements.

(53) Certain existing drawings (UC5) are a different design from the proposed drawings. Certain materials used are different and the specification will also have different record units.

Response: RUS agrees and has changed the drawing numbers to the applicable drawings.

(54) When RUS changes a construction specification, maybe RUS should add a suffix to indicate that change (example: UC5 change to UC5A or UC5-1, or UC5-98)

Response: RUS agrees and has changed the drawing numbers to the applicable drawings.

(55) Drawing UM48-2: The drawing shows the use of two ground rods in the elevation view, however, the quantity of rods is left open in the material list. I and a number of fellow workers and clients feel that it would be helpful to add a note 3 stating that the quantity of rods is to be determined by the specifier and that the use of two rods rather than one at a multi-phase transformer or enclosure is not a standard or a requirement by RUS.

Response: RUS agrees. Depending on the condition and type of soil, installation of multiple ground rods may be necessary to attain a desirable ground resistance. Thus, ground rods need to be specified separately.

In response to this comment, RUS added the following note to the drawing: “The quantity of rods is to be determined by the specifier. The use of two rods rather than one at a multi-phase transformer or enclosure is not a standard or a requirement by RUS.”

Pursuant to the authority of sections 10(b), 13, 14, 19, et al., of the Federal Reserve Act, the Board has amended its Regulation A (12 CFR part 201) to incorporate changes in discount rates on Federal Reserve Bank extensions of credit. The discount rates are the interest rates charged to depository institutions when they borrow from their district Reserve Banks.

The “basic discount rate” is a fixed rate charged by Reserve Banks for adjustment credit and, at the Reserve Banks' discretion, for extended credit for up to 30 days. In increasing the basic discount rate from 5.5 percent to 6.0 percent, the Board acted on requests submitted by the Boards of Directors of the twelve Federal Reserve Banks. The new rates were effective on the dates specified below. The 50-basis-point increase in the discount rate was associated with a similar increase in the federal funds rate approved by the Federal Open Market Committee and announced at the same time.

Increases in demand have remained in excess of even the rapid pace of productivity-driven gains in potential supply, exerting continued pressure on resources. The Board and the Reserve Banks are concerned that this disparity in the growth of demand and potential supply will continue, which could foster inflationary imbalances that would undermine the economy's outstanding performance. Against the background of the long-term goals of price stability and sustainable economic growth and of the information currently available, the Board and the Reserve Banks believe the risks are weighted mainly toward conditions that may generate heightened inflation pressures in the foreseeable future.

Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Board certifies that the change in the basic discount rate will not have a significant adverse economic impact on a substantial number of small entities. The rule does not impose any additional requirements on entities affected by the regulation.

The provisions of 5 U.S.C. 553(b) relating to notice and public participation were not followed in connection with the adoption of the amendment because the Board for good cause finds that delaying the change in the basic discount rate in order to allow notice and public comment on the change is impracticable, unnecessary, and contrary to the public interest in fostering price stability and sustainable economic growth.

The provisions of 5 U.S.C. 553(d) that prescribe 30 days prior notice of the effective date of a rule have not been followed because section 553(d) provides that such prior notice is not necessary whenever there is good cause for finding that such notice is contrary to the public interest. As previously stated, the Board determined that delaying the changes in the basic discount rate is contrary to the public interest.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 747 series airplanes was published in the Federal Register on February 4, 2000 (65 FR 5459). That action proposed to require inspections, tests, and certain modifications of the thrust reverser control and indication system and wiring on each engine, and corrective action, if necessary. That action also proposed to require installation of a terminating modification, and repetitive functional tests of that installation to detect discrepancies, and repair, if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 7 Model 747 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 6 airplanes of U.S. registry will be affected by this AD.

It will take approximately 32 work hours (8 work hours per engine) per airplane, to accomplish the required thrust reverser inspection, modification, and test, described in 747-78A2149, Revision 1, or Revision 2, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $11,520, or $1,920 per airplane.

It will take approximately 8 work hours (2 work hours per engine) per airplane, to accomplish the required 1,000-flight-hour inspections described in Boeing Service Bulletin 747-78A2159, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the inspection required by this AD on U.S. operators is estimated to be $2,880, or $480 per airplane, per inspection cycle.

It will take approximately 20 work hours (5 work hours per engine) per airplane, to accomplish the required 18-month thrust reverser system checks described in Boeing Service Bulletin 747-78A2159, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the test required by this AD on U.S. operators is estimated to be $7,200, or $1,200 per airplane, per test cycle.

It will take approximately 544 work hours per airplane, to accomplish the required provisional wiring, at an average labor rate of $60 per work hour. Required parts will be provided by the manufacturer at no cost to the operators. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $195,840, or $32,640 per airplane.

It will take approximately 593 work hours per airplane, to accomplish the required sync lock installation, at an average labor rate of $60 per work hour. Required parts will be provided by the manufacturer at no cost to the operators. Based on these figures, the cost impact of the installation required by this AD on U.S. operators is estimated to be $213,480, or $35,580 per airplane.

It will take approximately 4 work hours per airplane, to accomplish the required functional test of the additional locking system, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the test required by this AD on U.S. operators is estimated to be $1,680, or $240 per airplane, per test cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Israel Aircraft Industries, Ltd., Model 1125 Westwind Astra and Astra SPX series airplanes was published in the Federal Register on January 24, 2000 (65 FR 3617). That action proposed to require replacement of the existing pneumatic de-icing boot pressure indicator switch with a newly designed switch.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

Since issuance of the proposed AD, the manufacturer has issued Astra Alert Service Bulletin 1125-30A-199, dated April 17, 2000, which describes procedures for replacement of the wing and tail de-icing boot pressure indicator switches with improved switches. The Civil Aviation Administration of Israel (CAAI), which is the airworthiness authority for Israel, classified this service bulletin as mandatory. Additionally, the CAAI previously issued Israeli airworthiness directive 30-00-02-05, dated February 24, 2000, in order to assure the continued airworthiness of these airplanes in Israel.

The FAA has determined that the replacement described in the service bulletin provides an adequate method of addressing the unsafe condition identified in this AD. Paragraph (a) of the AD has been revised to include that replacement as an acceptable means of compliance to the requirements of the AD. The applicability of the AD has also been revised to exclude airplanes having serial number 116 and up, on which the replacement will be installed in production.

The FAA has also revised the “Cost Impact” section of the AD to provide the estimated cost of the replacement in accordance with the previously described service bulletin, and to revise the number of affected airplanes of U.S. registry.

After careful review of the available data, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The FAA estimates that 89 airplanes of U.S. registry will be affected by this AD.

Should an operator elect to accomplish the replacement in accordance with Astra Alert Service Bulletin 1125-30A-199, it will take approximately 2 work hours per airplane to accomplish it, at an average labor rate of $60 per work hour. Required parts may cost as much as $1,455 per airplane. Based on these figures, the cost impact of the replacement on U.S. operators is estimated to be as much as $1,575 per airplane.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 96-11-05, amendment 39-9630 (61 FR 26091, May 24, 1996), which is applicable to certain Airbus Industrie Model A300, A300-600, and A310 series airplanes, was published in the Federal Register on February 14, 2000 (65 FR 7316). The action proposed to continue to require inspections to detect cracks in the lower spar axis of the engine pylons for Airbus Model A300 and A300-600 series airplanes, and to require accomplishment of the actions specified in Airbus Service Bulletin A310-54-2017, Revision 03, for Model A310 series airplanes.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter, an operator, states that it is not affected by the proposed AD, and therefore has no objection or additional comments.

One commenter, the manufacturer, requests that the proposed AD be revised to include a reference to a related French airworthiness directive. The commenter states that the proposed AD refers to French airworthiness directive 1999-239-287(B), which addresses Airbus Model A310 series airplanes, but does not mention 1993-228-154(B)R3, which addresses Airbus Model A300 and A300-600 series airplanes (actions for those airplanes are required in existing FAA AD 96-11-05).

The FAA acknowledges that the actions required by existing FAA AD 96-11-05 are related to French airworthiness directive 1993-228-154(B). The FAA has no objection to including the reference in this AD, which continues to require those actions for Model A300 and A300-600 series airplanes. “NOTE 3” of the AD has been revised accordingly. However, although the FAA generally references the latest pertinent airworthiness directive issued by another airworthiness authority as an informational Note in the AD, this information is not intended to be an exhaustive list of all related mandatory continuing airworthiness information, and should not be considered as such.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the change previously described. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 146 airplanes of U.S. registry that will be affected by this AD.

The requirements of this AD will not add any new additional economic burden on affected operators, other than the costs that are associated with accomplishing inspections for certain airplanes at an earlier time than would have been required by AD 96-11-05. The current costs associated with this AD are reiterated (as follows) for the convenience of affected operators.

The inspections that are currently required by AD 96-11-05, and retained in this AD, take approximately 8 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $480 per airplane, per inspection cycle.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-14-11, amendment 39-10644 (63 FR 36834, July 8, 1998), which is applicable to all Airbus Model A319, A320, and A321 series airplanes, was published in the Federal Register on February 24, 2000 (65 FR 9225). The action proposed to continue to require repetitive inspections for discrepancies of the lock bolt for the pintle pin on the main landing gear (MLG), and follow-on corrective actions, if necessary; and to require additional follow-on actions, including a retorque of the lock bolt for the pintle pin.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comment received.

Two commenters request that the proposed AD include reference to Airbus Modifications 28903 (for Model A319 and A320 series airplanes) and 30044 (for Model A321 series airplanes) as terminating action to the requirements of this AD. Airbus Service Bulletin A320-32-1213, dated March 21, 2000, describes procedures for accomplishment of the modification, which involves installation of a dual lock bolt configuration. One commenter notes that the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority of France, has approved this modification as terminating action for the inspections and actions described in Airbus Service Bulletin A320-32-1187.

The FAA concurs that the modification described in Airbus Service Bulletin A320-32-1213 constitutes acceptable terminating action to the requirements of this AD. A new paragraph (c) has been added to the AD to provide this option to operators, and the applicability of the AD has been limited to those airplanes not having the modification. Additionally, since terminating action is now available, the FAA has removed the “Interim Action” discussion from the AD; however, the FAA may consider further rulemaking if a determination is made at a later date that the terminating modification should be mandated.

After careful review of the available data, including the comment noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 341 airplanes of U.S. registry that will be affected by this AD. It will take approximately 2 work hours to accomplish the required inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the inspection required by this AD on U.S. operators is estimated to be $40,920, or $120 per airplane, per inspection cycle.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 97-26-21, amendment 39-10264 (62 FR 67550, December 29 1997), which is applicable to certain Boeing Model 747-100, -200, -300, 747SR, and 747SP series airplanes, was published in the Federal Register on February 22, 2000 (65 FR 8667). The action proposed to continue to require a one-time inspection to detect cracking of the longeron splice fittings at stringer 11, on the left and right sides at body station 2598, and replacement of any cracked fitting with a new fitting. The action also proposed to reduce the compliance time for accomplishment of the currently required inspection and add a new requirement for repetitive inspections.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 685 airplanes of the affected design in the worldwide fleet. The FAA estimates that 99 airplanes of U.S. registry will be affected by this AD.

The inspection that is currently required by AD 97-26-21 takes approximately 32 work hours per airplane to accomplish, at an average labor rate of $60 per work hour.

Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $190,080, or $1,920 per airplane.

This AD requires the same inspection currently required by AD 97-26-21 to be accomplished repetitively. Therefore, the cost impact of the requirements of this AD on U.S. operators is estimated to be $190,080, or $1,920 per airplane, per inspection cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The FAA has received reports indicating instances of the pilot seat sliding to the aft-most position during acceleration and take-off on certain Boeing Model 737 series airplanes. Investigation revealed that the screws attaching the rear tracklock bracket to the seat track had broken, allowing excessive lateral movement and disengagement of the locking pin from the floor-mounted seat track. A disengaged locking pin can cause misalignment of the seat tracks. Such misalignment of the seat tracks, if not corrected, could result in uncommanded movement of the flightcrew seats during acceleration and take-off of the airplane, which could result in reduced controllability of the airplane.

The FAA has reviewed and approved Boeing Alert Service Bulletin 737-25A1363, dated November 5, 1998, which describes procedures for a one-time general visual inspection of the seat locks and seat tracks of the flightcrew seats to ensure that the seats lock in position and to verify that lock nuts and bolts of adequate length are installed on the rear tracklock bracket. If lock nuts and bolts of adequate length are not installed on the rear tracklock bracket, the service bulletin describes installation of lock nuts and bolts of adequate length on the tracklock bracket, and re-alignment of the seat tracks. Accomplishment of the actions specified in the alert service bulletin is intended to adequately address the identified unsafe condition.

Since an unsafe condition has been identified that is likely to exist or develop on other Boeing Model 737 series airplanes of the same type design, this AD is being issued to prevent uncommanded movement of the flightcrew seats during acceleration and take-off of the airplane, and consequent reduced controllability of the airplane. This AD requires a one-time general visual inspection of the seat locks and seat tracks of the flightcrew seats to ensure that the seats lock in position and to verify that lock nuts and bolts of adequate length are installed on the rear tracklock bracket, and corrective action, if necessary. The actions are required to be accomplished in accordance with the alert service bulletin described previously, except as discussed below.

Operators should note that, although the alert service bulletin recommends accomplishment of the actions as soon as manpower and materials are available, the FAA has determined that a 90-day compliance time would address the identified unsafe condition in a timely manner. In developing an appropriate compliance time for this AD, the FAA considered not only the manufacturer's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, the average utilization of the affected fleet, and the time necessary to perform the actions. In light of all of these factors, the FAA finds a 90-day compliance time for completion of the actions to be warranted, in that it represents an appropriate interval of time allowable for affected airplanes to continue to operate without compromising safety.

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

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire.

Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-111-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Applicability: Model 737-300, -400, and -500 series airplanes equipped with

IPECO flightcrew seats; as listed in Boeing Alert Service Bulletin 737-25A1363, dated November 5, 1998; certificated in any category.

Compliance: Required as indicated, unless accomplished previously.

To prevent uncommanded movement of the flightcrew seats during acceleration and take-off of the airplane, accomplish the following:

(a) Within 90 days after the effective date of this AD, perform a one-time general visual inspection of the seat locks and seat tracks of the flightcrew seats to ensure that the seats lock in position and to verify that lock nuts and bolts of adequate length are installed on the rear tracklock bracket, in accordance with Boeing Alert Service Bulletin 737-25A1363, dated November 5, 1998.

(1) If the seat lock pin fully engages in all lock positions of the seat track, and the rear tracklock bracket is correctly installed, no further action is required by this AD.

(2) If the seat lock pin does not fully engage in all positions of the seat track, and lock nuts and bolts of adequate length are not installed on the rear tracklock bracket, prior to further flight, install lock nuts and bolts of adequate length on the tracklock bracket and re-align the seat tracks, in accordance with the alert service bulletin.

(b) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA, Transport Airplane Directorate. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, Seattle ACO.

(c) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.

(d) The actions shall be done in accordance with Boeing Alert Service Bulletin 737-25A1363, dated November 5, 1998. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle, Washington 98124-2207. Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(e) This amendment becomes effective on June 12, 2000.

This AD is the result of a report of fatigue cracks that were found at the second-most inboard wing attachment bolt hole on a REVO Lake Model 250 airplane. The cracks were detected during wing repair where the wing spar and wing skin were disassembled. Further analysis indicated that the cracks initiated at a machined notch at the flange termination point of the spar cap.

The REVO Models Lake LA-4, Lake LA-4A, Lake LA-4P, and Lake LA-4-200 airplanes are of the same type design as the Lake Model 250 airplanes. Fatigue cracking similar to that of the above-referenced report has been found on seven more of these airplanes.

Cracks in the wing spars, if not detected and corrected in a timely manner, could result in the wing separating from the airplane with consequent loss of control.

We issued a notice of proposed rulemaking (NPRM) to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain REVO Models Lake LA-4, Lake LA-4A, Lake LA-4P, Lake LA-4-200, and Lake Model 250 airplanes. We published this NPRM in the Federal Register on October 6, 1999 (64 FR 54234). The NPRM proposed to require you to accomplish the following:

REVO Service Bulletin B-79, dated June 12, 1999, includes the procedures necessary for you to accomplish the proposed inspection and modification.

The FAA offered interested persons the opportunity to participate in the making of this amendment. The following paragraphs present the comments received on the NPRM. Also included is FAA's response to each comment, including any changes incorporated into the final rule based on the comments.

What are the Commenters' Concerns? Numerous commenters question FAA's justification for issuing an AD. Several commenters do not believe our service difficulty database provides accurate information. A few commenters recommend that we conduct additional research on the cause of the wing spar cracks and determine if the cracks are unique to a particular configuration of the affected airplanes. Other commenters propose various causes of the cracks, including:

What is FAA's Response to the Concerns? We do not concur that the AD is not justified. We began our investigation of the wing spar cracks on the affected airplanes when the Australian Civil Aviation Safety Authority reported cracks in both the spar cap and doubler in the lower spar of a Lake Model 250 airplane. We then received several reports of similar cracking from personnel of maintenance and repair facilities that were working on the affected airplanes. Reports indicated that both the upper and lower spars were cracked. These subsequent reports did not specify corrosion damage. All of the wing spar cracks initiated at a machined notch at the flange termination point of the spar cap at the second-most inboard wing attachment bolt hole.

We also initiated laboratory examinations of the cracked spars. These examinations revealed that fatigue caused the cracks and were associated with the roughness of the notch area. The certification basis for the affected airplanes did not require an evaluation of fatigue characteristics. A database of either analytical results or test data does not exist. However, we performed a fatigue analysis of the affected airplanes in the notch area in developing the proposed inspection compliance times. Our analysis of this situation included working with the manufacturer to develop inspection procedures for the spar doublers and spar cap angles and a modification (doubler kit) for the wing spar. We then determined that enough information existed to implement AD action in order to assure the continued airworthiness of the affected airplanes. Thus, we issued an NPRM to propose inspections for cracks and repair, replacement, and modification, as necessary.

We are not changing the AD as a result of these comments.

What are the Commenters' Concerns? Several commenters recommend that FAA not require the spar cap inspection in accordance with REVO, Inc. Service Bulletin B-79, dated June 12, 1999. The commenters offer the following explanations for eliminating this inspection:

What are FAA's Responses to the Concerns? We concur that the spar cap inspection is not necessary. The inspection of the spar cap was intended to look for additional cracks outside of the notch area. We are eliminating the spar cap inspection from the AD for the following reasons:

We are only requiring a visual inspection of the wing spar doublers instead of a dye penetrant inspection. REVO, Inc. has revised Service Bulletin B-79 (R1—Revised January 5, 2000) to incorporate the visual inspection change.

What are the Commenters' Concerns ? Several commenters recommend alternative methods of compliance to meet the safety intent of the AD. These alternatives are:

What is FAA's Response to the Concerns ? We do not concur that any of the alternatives alone are valid to meet the safety intent of this AD. Inspecting the wing spar doubler in accordance with the procedures in REVO, Inc. Service Bulletin B-79, dated June 12, 1999, assures the airworthiness of this component prior to installing the doubler kit (Aerofab B-79 kit). Installing this doubler kit gives the spar an adequate fatigue life and eliminates the need for repetitive inspections. We do not concur that cutting holes in the wing skin for inspections is an acceptable alternative because of the sensitive nature of the wing skin.

We also do not concur with allowing repetitive inspections instead of mandatory incorporation of the Aerofab B-79 kit. Constant removal of the bolts could cause unnecessary damage. The FAA's policy is to require a modification when incorporation of that modification could eliminate or reduce the number of required inspections.

We are not changing the AD as a result of these comments.

What are the Commenters' Concerns ? Several commenters request that FAA not include the Model Lake LA-4 airplanes in the applicability of the final rule AD. The commenters state that the applicability should be based on the weight, auxiliary fuel, and brake differences of the airplanes.

One commenter concurs with the applicability of the NPRM.

What is FAA's Response to the Concerns ? We have determined that this AD should apply to the Model Lake LA-4 airplanes. The service difficulty database clearly shows the need to address the wing spar condition on the Model Lake LA-4-200 and Lake Model 250 airplanes. The Model Lake LA-4 airplanes are included because:

For these reasons, we have determined that the Model Lake LA-4 airplanes are also susceptible to wing spar fatigue cracking and the AD must apply to these airplanes.

We are not changing the AD as a result of these comments.

What are the Commenters' Concerns ? Several commenters suggest revisions to the Aerofab B-79 doubler kit. These suggestions include:

What are FAA's Responses to the Concerns ? We concur with these suggestions, as follows:

1. We concur and will require accomplishment in accordance with Revo, Inc. Service Bulletin B-79 R1, Revised January 5, 2000. This revised service bulletin incorporates the proposed rivet removal methods;

2. We concur. Revo, Inc. Service Bulletin B-79 R1, Revised January 5, 2000, allows the use of AN3 bolts, and accomplishment of the AD is required in accordance with this service bulletin;

3. We do not concur that you may retain the original bolts for the Model Lake LA-4 airplanes. The new design configuration of the wing spar caps with the doublers requires longer bolts than originally utilized; and

4. We do not concur with the need to redesign the doubler. Incorporation of the doubler kit on the affected airplanes restores wing spars to their required strength if a crack is present in the notch area of a spar cap. Incorporation of the doubler kit also provides the strength and stability to prevent future fatigue cracking.

What are the Commenters' Concerns? Two commenters note a difference between the service bulletin and the proposed AD, regarding the dye penetrant inspection procedure. One of these commenters also points out that ASTM E1417-95 was referred to as ASTM E1417-99 in the NPRM.

What is FAA's Response to the Concerns? We concur that there is a difference between the dye penetrant inspection procedure proposed in the NPRM and that contained in the original service bulletin. When the AD and service bulletin differ, the AD takes precedence. In addition, FAA received a revision to the ASTM document (E1417-99 from E1417-95) after preparing the NPRM.

However, as discussed previously, FAA is not requiring the dye penetrant inspection.

What is the Commenters' Concern? Seven commenters recommend that FAA not require the reporting requirement for the dye penetrant inspection. These commenters state that this proposed requirement is irrelevant to the safety of the aircraft.

What is FAA's Response to the Concern? We concur. As discussed previously, FAA is not including this inspection in the AD, so there is no need for the reporting requirement.

We are not including the reporting requirement in the AD.

What are the Commenters' Concerns? Six commenters request that FAA require inspection of the of spar caps and doublers for corrosion any time a wing is removed. The commenters recommend this inspection from the roof rib to the first rib outboard or to the inboard fuel tank.

What is FAA's Response to the Concerns? We do not concur. We have not received any record of wing corrosion on the affected airplanes. The actions in this AD address the unsafe condition.

We are not changing the AD as result of these comments.

What are the Commenters' Concerns? One commenter recommends a redesign of the wing attachment area to correct the unsafe condition. Another commenter suggests that the manufacturer conduct a test of the wing/fuselage attachment area.

What is FAA's Response to the Concerns? We have determined that incorporating the doubler kit restores the wing spars of the affected airplanes to their required strength and addressses the unsafe condition referenced in this AD. We will evaluate any data pertaining to a redesign of the wing attachment area or other alternative method of compliance, as long as it is submitted in accordance with the procedures included in this AD.

We are not changing the AD as a result of these comments.

What are the Commenters' Concerns? Two commenters state that FAA underestimated the costs of implementing the actions proposed in the NPRM. Another commenter states that the cost impact analysis is inadequate because it is designed to address transport category airplanes and not general aviation aircraft. This commenter suggests that the costs of accomplishing this AD could exceed $5,000 per airplane.

What is FAA's Response to the Concerns? We do not concur that the cost analysis is inadequate. The cost impact as proposed in the NPRM is $4,920 per airplane ($2,400 for the inspections and $2,520 for the modification). However, we are not requiring wing removal and a dye penetrant inspection in the AD. We are now only requiring a visual inspection of the wing spar doublers (with replacement if found cracked) and modification. This reduces the time and cost necessary to accomplish the inspection from approximately 40 workhours per airplane to approximately 1 workhour per airplane.

What is the Commenter's Concern? One commenter requests that FAA withdraw the NPRM because the service bulletin is effective.

What is FAA's Response to the Concern? We do not concur. The only way we can assure that all affected airplane owners/operators accomplish the actions in a service bulletin is through the issuance of an AD.

We are not changing the AD as a result of these comments.

What are the Commenters' Concerns? Several commenters request an extension to the compliance time. The commenters state that the available repair/maintenance facilities could not accomplish the work on all affected airplanes within the proposed compliance time.

One commenter recommends requiring repetitive inspections of the bolt holes and only requiring the doubler kit if cracks are found during an inspection.

Two commenters request a reduction in the compliance time to 25 hours time-in-service (TIS) to coincide with the service bulletin. This commenter refers to an incident where the wing spar was cracked on an affected airplane with less than 300 hours TIS.

What is FAA's Response to the Concerns? Since issuance of the NPRM, we have received information regarding wing spar cracks on an airplane with 270 hours TIS. We also have additional reports of wing spar cracking on airplanes with 556 hours TIS and 538 hours TIS.

Based on this information, we do not concur with the request to extend the compliance time. We are reducing the compliance time although not to coincide with the service bulletin. We have determined that the wing spars on all of the affected airplanes should be inspected within 50 hours TIS or 12 months after the effective date of the AD (whichever occur first), regardless of the total number of hours currently accumulated on the wing spar. The NPRM proposed to allow low time airplanes to reach 500 hours total TIS on the wing spar before requiring inspection and modification. Because the latest reports show that cracking could occur prior to 300 hours TIS, we have determined that the 50-hour TIS or 12-month compliance time will eliminate the unsafe condition presented in this AD without inadvertently grounding any of the affected airplanes.

We do not concur with allowing repetitive inspections instead of mandatory modification. Constant removal of the bolts could cause unnecessary damage. The FAA's policy is to require a modification when incorporation of that modification could eliminate or reduce the number of required inspections.

After careful review of all available information related to the subject presented above, including the above-referenced comments, FAA has determined that:

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 93-08-15, amendment 39-8563 (58 FR 27923, May 12, 1993), and AD 93-25-13, amendment 39-8777 (59 FR 1903, January 13, 1994), which are both applicable to certain Airbus Model A320 series airplanes, was published in the Federal Register on February 10, 2000 (65 FR 6566). The action proposed to continue to require modification of the wing rear spar web and cold expansion of certain attachment holes for the forward pintle fitting and certain holes at the actuating cylinder anchorage of the MLG. The AD proposed to add a requirement for repetitive ultrasonic inspections to detect fatigue cracking in certain areas of the wing rear spar, and repair of cracking. The AD also proposed to provide for optional terminating action for the inspections proposed by this AD.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter concurs with the proposed AD. Another commenter states that Airbus Production Modification 24591 is installed on its airplanes; therefore, it is not affected by the proposed AD.

One commenter requests that the proposed AD be revised to allow “Group 2” airplanes to accomplish the initial inspection of the wing rear spar within 12,000 flight cycles after accomplishment of Airbus Service Bulletin A320-57-1060. The commenter defines “Group 1” airplanes as manufacturer's serial numbers (MSN) 002 through 021, on which Airbus Service Bulletins A320-57-1004 and A320-57-1060 are accomplished as retrofit. “Group 2” airplanes are defined as MSN's 022 through 051, on which Airbus Modification 20740 (equivalent to A320-57-1004) has been accomplished in production, and Airbus Service Bulletin A320-57-1060 as retrofit.

The commenter notes that “Group 1” airplanes are granted 12,000 flight cycles after accomplishment of A320-57-1060, yet “Group 2” airplanes are required to undergo inspection prior to accumulation of 17,300 total flight cycles, regardless of when modification per A320-57-1060 was accomplished. The commenter states that “Group 1” and “Group 2” airplanes are in the same configuration and will have a similar fatigue life; therefore, both should have the same inspection threshold.

The FAA does not concur. Although the FAA acknowledges that “Group 1” and “Group 2” airplanes may be in a similar modification configuration, the design configuration of these airplanes is different. “Group 1” airplanes are composed of Model A320-100 series airplanes, and “Group 2” airplanes are composed of Model A320-200 series airplanes. Model A320-200 series airplanes are equipped with a center fuel tank (not installed on Model A320-100 series airplanes) that increases the airplanes' weight. For this reason, it is necessary that “Group 2” airplanes be inspected for cracking prior to accumulation of 17,300 total flight cycles, regardless of when Service Bulletin A320-57-1060 is accomplished. No change is made to the final rule.

One commenter requests that modification in accordance with Airbus Service Bulletin A320-57-1089 be considered as terminating action to all inspection requirements if accomplished prior to the initial inspection interval, or to repetitive inspections if accomplished after the initial inspection interval. The commenter states that terminating action credit is allowed under paragraph (e) of the proposed AD only if accomplished prior to 12,000 total flight cycles. The commenter states that accomplishment of the terminating modification includes a non-destructive test inspection of the inner rear spar at each hole location. Since this inspection during the modification will ensure that the inner rear spar is free of defects, terminating action to the follow-on inspection requirements should also be provided.

The FAA notes that terminating modification to the inspection requirements of the AD is already provided for in paragraph (e) of the proposed AD, and considers that clarification of the provisions for terminating modification is necessary. As stated in the second sentence of paragraph (e) of the AD, the threshold of 12,000 total flight cycles is required only if modification per Service Bulletin A320-57-1089 is chosen in lieu of accomplishing the modifications required by paragraphs (a) and (b) of the AD. However, the modification also constitutes acceptable terminating action for the ultrasonic inspection requirements of the AD, as stated in the first sentence of paragraph (e) of the AD. Paragraph (e) has been revised to more clearly specify the terminating action provisions of the AD.

Two commenters request that the proposed AD be revised to provide correct cost estimates for the optional modification described in Airbus Service Bulletin A320-57-1089. The commenters state that the service bulletin lists the labor cost as 980 work hours, yet the proposed AD provides an estimate of 750 work hours.

The FAA acknowledges that the service bulletin estimate specifies additional work hours (for access and close) that are not included in the proposed AD. However, the cost impact information in an AD typically describes only the “direct” costs of specific actions, and does not include incidental costs, such as the time required to gain access and close up; planning time; or time necessitated by other administrative actions. Because incidental costs may vary significantly from operator to operator, they are almost impossible to calculate. Additionally, since this is an optional modification, operators may choose not to incur such costs, or may minimize costs by accomplishing the modification during scheduled maintenance. No change is made to the final rule.

To clarify actions for airplanes on which modifications have been installed in production and those on which service bulletins have been accomplished as retrofit, the FAA has revised paragraph (c)(2) of the AD to refer to certain modifications as “Airbus Production Modification * * *.” Additionally, a heading has been included to specify the actions required by paragraphs (c) and (d) of the AD.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 126 airplanes of U.S. registry that will be affected by this AD.

It takes approximately 60 work hours per airplane to accomplish the modification of the rear spar web of the wing, as required by AD 93-08-15 and retained in this AD, at an average labor rate of $60 per work hour. Based on these figures, the total cost impact of the modification on U.S. operators is estimated to be $3,600 per airplane.

It takes approximately 600 work hours per airplane to accomplish the cold expansion of certain holes associated with the MLG, as required by AD 93-25-13 and retained in this AD, at an average labor rate of $60 per work hour. Required parts are provided by the manufacturer at no cost to the operators. Based on these figures, the total cost impact of the cold expansion on U.S. operators is estimated to be $36,000 per airplane.

The new inspection that is required by this new AD will take approximately 24 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the new requirements of this AD on U.S. operators is estimated to be $181,440, or $1,440 per airplane, per inspection cycle.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

Should an operator elect to accomplish the optional terminating action specified in this AD, it would take approximately 750 work hours, at an average labor rate of $60 per work hour. The required parts would cost $27,036; $30,595; or $32,727; depending on the airplane configuration. Based on these figures, the cost per airplane of the optional terminating action provided by this AD is estimated to be $72,036; $75,595; or $77,727.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

In July 1996, the United States and thirty-two other countries gave final approval to the establishment of a new multilateral export control arrangement, called the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement). The Wassenaar Arrangement contributes to regional and international security and stability by promoting transparency and greater responsibility in transfers of conventional arms and dual-use goods and technologies, thus preventing destabilizing accumulations of such items.

On January 15, 1998, the Bureau of Export Administration (BXA) published an interim rule (63 FR 2452) fulfilling U.S. commitments to the Wassenaar Arrangement by implementing the Wassenaar Arrangement of Dual-Use Goods and Technologies which is a list of dual-use items identified by Export Control Classification Numbers (ECCNs) as being controlled for national security (NS) reasons in the Commerce Control List (CCL). On July 23, 1999, BXA published a final rule (64 FR 40106) that revised a number of these national security controlled entries on the CCL to conform with recent changes in the Wassenaar List of Dual-Use Goods and Technologies. This rule corrects a number of inadvertent errors to the EAR that appeared in the July 23 rule.

The changes are summarized as follows:

In part 742, changes are made to sections 742.8, 742.10, 746.7, and Supplement 2 to part 742 to cross-reference certain paragraph references relating to ECCN 5A991 to reflect the renumbering of these paragraph references in the July rule.

In part 743, changes are made to section 743.1 to cross-reference certain paragraph references relating to ECCN 5A001 to reflect the renumbering of these paragraph references in the July rule.

In part 772, where definition in the EAR are described, the definition for “positioning accuracy” is changed to clarify that the 1988 version of the ISO standard applies to this definition. This clarification is also made to the Notes to the Category 2B (Materials Processing—Test, Inspection, and Production Equipment) of the CCL.

ECCN 3B991 is amended by removing a paragraph which was incorrectly referenced twice.

ECCN 5A001 is amended by adding License Exception LVS eligibility to underwater communications systems.

ECCN 5A991 is amended by fixing incorrect paragraph references made in the July rule.

ECCN 5B001 is amended by revising the phrase “employing coherent transmission” to read “employing coherent optical transmission”. The word “optical” was mistakenly left out of the July rule.

ECCN 5D001 is amended by putting the word “or” in the correct place within the List of Items controlled section. This mistake was inadvertently made in the July rule.

ECCN 5E001 is amended by putting the word “production” in the correct paragraph. This mistake was inadvertently made in the July rule.

ECCN 5E991 is amended by adding descriptions for certain technologies that were removed from national security controls in the July rule. These technologies were removed from ECCN 5E001 in the July rule, and should have been moved into ECCN 5D991, as they continue to be controlled for anti-terrorism reasons.

ECCN 6A003 is amended by adding a dash to the phrase “time-delay-and integration” to read “time-delay-and-integration”. This corrects a typographical error in the July rule.

Specifically this rule makes the following revisions to parts 742, 743, 746, 772 and 774 of the Export Administration Regulations:

(1) In paragraphs 742.8(a)(2), 742.10(a)(2) (Anti-Terrorism Controls), and 746.7(a)(2)(ii) (Embargoes), the phrase “ECCN 5A991.f” is corrected to read “ECCN 5A991.g”. This corresponds to the changes agreed to and implemented by the Wassenaar Arrangement.

(2) In Supplement 2 to part 742 (Anti-Terrorism Controls; Iran, Syria and Sudan Contract Sanctity Dates and Related Topics), in paragraph (c)(29), the phrase “ ECCN 5A001.c” is removed and the phrase “ECCN 5A991.c.1” is revised to read “ECCN 5A991.c”. This corresponds to the changes agreed to and implemented by the Wassenaar Arrangement.

(3) In paragraph 743.1(c)(1)(v) (Special Reporting), the phrase “5A001.b.8” is corrected to read “5A001.b.3”. This corresponds to the changes agreed to and implemented by the Wassenaar Arrangement.

(4) In part 772 (Definitions of Terms), the definition for “positioning accuracy” is amended by adding the parenthetical reference “(1988)” immediately following “ISO 230/2”. This clarifies that the 1988 version of the ISO standard applies.

(5) In Category 2B (Materials Processing—Test, Inspection, and Production Equipment) of the CCL, the Notes for Category 2B section is amended by revising note 5 to add the parenthetical reference “(1988)” immediately following “ISO 230/2”. This clarifies that the 1988 version of the ISO standard applies.

(6) Export Control Classification Number (ECCN) 3B991 is amended by removing paragraph b.2.f.5. These items are already covered in paragraph b.2.f.1 of ECCN 3B991.

(7) ECCN 5A001 is amended by adding License Exception LVS eligibility to paragraph b.1. This corrects the inadvertent removal of LVS eligibility for underwater communications systems.

(8) ECCN 5A991 is amended by revising the paragraph references for paragraphs c.10.c and c.10.d to read c.11 and c.12, respectively. ECCN 5A991 is also amended by revising the phrase “5A001” to read “5A991” in Notes 1 and 2 to paragraph b.7 and in the Note to paragraph c.9.

(9) ECCN 5B001 is amended by revising the phrase “employing coherent transmission” to read “employing coherent optical transmission” in paragraph b.2.c. This corrects an inadvertent omission and is consistent with the changes agreed to and implemented by the Wassenaar Arrangement.

(10) ECCN 5D001 is amended by adding the word “ or ” at the end of paragraph d.2.a and removing the word “ or ” at the end of paragraph d.4.b. This corrects an inadvertent omission and error and is consistent with the changes agreed to and implemented by the Wassenaar Arrangement.

(11) ECCN 5E001 is amended by adding the word “production” in paragraph c and removing the word “production” in the notes to paragraph c.2.e and c.4.b. This corrects an inadvertent omission and errors and is consistent with the changes agreed to and implemented by the Wassenaar Arrangement.

(12) ECCN 5E991 is amended by revising the entry heading by adding “and other ‘technologies’ as follows” and by revising the List of Items Controlled section to include paragraphs a.1 and a.2 for `technology' for the processing and application of coatings to optical fiber specially designed to make it suitable for underwater use and “technology” for the “development” of equipment employing “Synchronous Digital Hierarchy” (“SDH”) or “Synchronous Optical Network” (“SONET”) techniques. These technologies were removed from ECCN 5E001 in the July 23 rule as they are no longer controlled for national security reasons, consistent with the changes agreed to and implemented by the Wassenaar Arrangement. However, anti-terrorism controls for these technologies should have been retained under ECCN 5E991. This rule corrects this inadvertent omission.

(13) ECCN 6A003 is amended by revising the phrase “time-delay-and integration” to read “time-delay-and-integration” in the note to paragraph b.4. This corrects a typographical error and is consistent with the changes agreed to and implemented by the Wassenaar Arrangement.

Although the Export Administration Act (EAA) expired on August 20, 1994, the President invoked the International Emergency Economic Powers Act and continued in effect, the Export Administration Regulations and, to the extent permitted by law, the provisions of the EAA in Executive Order 12924 of August 19, 1994, as extended by the President's notices of August 15, 1995 (60 FR 42767), August 14, 1996 (61 FR 42527), August 13, 1997 (62 FR 43629), August 13, 1998 (63 FR 44121), and August 13, 1999 (64 FR 44101).

1. This final rule has been determined to be not significant for purposes of E.O. 12866.

2. Notwithstanding any other provision of law, no person is required to, nor shall any person be subject to a penalty for failure to comply with a collection of information, subject to the Paperwork Reduction Act (PRA), unless that collection of information displays a currently valid OMB Control Number. This rule involves collection of information approved by the Office of Management and Budget under control numbers 0694-0106 and 0694-0088. This clarifies that the July 23, 1999 rule (64 FR 40106) referenced an incorrect collection of information number, 0694-0086, and instead should have referenced collection number 0694-0106.

3. This rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism assessment under Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Accordingly, this rule is issued in final form. However, comments from the public are always welcome. Comments should be submitted to Kirsten Mortimer, Regulatory Policy Division, Office of Exporter Services, Bureau of Export Administration, Department of Commerce, P.O. Box 273, Washington, DC 20044.

Today we are adopting a new Volume II of the EDGAR Filer Manual (“Filer Manual”), which describes the technical formatting requirements for the preparation and submission of electronic filings through the Electronic Data Gathering, Analysis, and Retrieval (EDGAR) system. 1 Volume II describes the requirements for filing using the new EDGARLink. 2

Previously, the EDGAR Manual was composed of two parts. With the addition of Volume II, the EDGAR Manual will consist of three parts because we will be maintaining two separate software applications for the preparation and transmission of filings until at least November 1, 2000. We are doing this to provide filers abundant time to transition to the new modernized system.

Volume II of the Manual contains all the new technical specifications for filers to submit filings using the new modernized EDGAR system available in Release 7.0. The specifications include features that will be available for the first time to filers using the new EDGARLink software, such as expanded hyperlinks, graphics, and filing over the Internet.

We also plan shortly to adopt revised versions of the remaining parts of the Manual. These revisions will reflect the limited changes effected by EDGAR Release 7.0 to the Legacy EDGAR systems and Form N-SAR filing. Until we do, the provisions of EDGAR Manual Release 6.75 and N-SAR Supplement for Release 6.1 will continue to apply to filers using the Legacy EDGAR system and to filers filing Form N-SAR.

Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format. 3 Filers should consult the Filer Manual in conjunction with our rules governing mandated electronic filing when preparing documents for electronic submission. 4

In a notice published in the Federal Register of March 7, 2000 (65 FR 12015), FDA announced that a food additive petition (FAP 0B4719) had been filed by Tritex Co., Inc., 1001 Boul. Industriel, Saint-Eustache (Quebec), CANADA J7R 6C3 (zip code was incorrectly identified as J7H 6C3 in the March notice). The petition proposed to amend the food additive regulations in § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods (21 CFR 176.170) to provide for the safe use of sodium xylene sulfonated as a component of paper and paperboard intended to contact food. Although the additive was identified as sodium xylene sulfonated in the notice of filing, FDA feels that it is more appropriately listed as sodium xylenesulfonate in this final rule.

FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive is safe, that the additive will achieve its intended technical effect, and therefore, that the regulations in § 176.170 should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has previously considered the potential environmental effects of this rule as announced in the notice of filing for FAP 0B4719. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by June 26, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of September 23, 1997 (62 FR 49638), FDA proposed to amend its regulations to require that all inhalation solutions for nebulization be manufactured sterile. This action was proposed to help ensure the safety and effectiveness of these drug products.

Drug products for oral inhalation are used to treat a variety of breathing disorders and are frequently administered to patients who are immunocompromised, have cystic fibrosis, or have chronic obstructive airway disease. Aqueous-based oral inhalation drug products either in single-dose or multiple-use packaging are administered by oral inhalation into the lungs as a mist or spray created by a nebulizer device. The majority of inhalation drug products on the market are manufactured to be sterile. Those products not manufactured to be sterile are often manufactured under assigned microbial count limits, but current manufacturing methods and safeguards have not prevented dangerous microbial contamination.

Inhalation drug products contaminated with microorganisms are likely to cause lung infections because the contaminating organisms are introduced with the drug product directly into the lungs through the mouth. Thus, microbial contamination of these products may result in serious health consequences. Microbial contamination of these products may also cause degradation of the drug product.

Because of contamination problems with several different aqueous-based drug products for oral inhalation and for the reasons explained in the proposed rule, FDA has determined that current manufacturing methods and safeguards against contamination, including microbial limits tests, have not prevented dangerous microbial contamination of nonsterile aqueous-based drug products for oral inhalation.

The final rule reflects FDA's determination that all aqueous-based drug products for oral inhalation be manufactured sterile. Once the final rule becomes effective, failure to comply with the sterility requirement will result in a finding that the drug product is adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351(a)(2)(B)), and misbranded under section 502(j) of the act (21 U.S.C. 352(j)). Failure to comply with the sterility requirement will also result in the agency's refusal to approve a new or abbreviated application for a product, under section 505(d)(1), (d)(2), (d)(3), and (j)(4)(A) of the act (21 U.S.C. 355(d)(1), (d)(2), (d)(3), and (j)(4)(A)).

This final rule amends the regulations governing requirements for specific classes of drugs to include new § 200.51 for aqueous-based drug products for oral inhalation. Section 200.51(a) requires that all prescription and OTC aqueous-based drug products for oral inhalation be manufactured sterile. FDA is taking this action to prevent the public health consequences of the distribution of contaminated aqueous-based drug products for oral inhalation and to help ensure the safety and effectiveness of these products.

In the Federal Register of October 11, 1991 (56 FR 51354), FDA proposed to require that manufacturers use a terminal sterilization process when preparing a sterile drug unless the process adversely affects the drug product. The October 11, 1991, proposed rule would require that manufacturers include in their applications a written justification for not using terminal sterilization if such process is not appropriate. The agency plans to issue a final rule regarding terminal sterilization. When the proposed requirement for terminal sterilization becomes final, manufacturers of aqueous-based drug products for oral inhalation will be subject to its requirements.

The agency has revised the proposed regulation in response to comments received on the proposed rule. The comments and responses are discussed in section III of this document, “Comments on the Proposed Rule.” The agency is revising the title of proposed § 200.51 from “Sterility Requirements for Inhalation Solution Drug Products” to “Aqueous-Based Drug Products for Oral Inhalation.” The new title names the specific class of drugs subject to the rule in conformance with the established format of part 200 (21 CFR part 200), subpart C of the regulations. The agency is removing the phrases “inhalation solution drug products” and “inhalation solutions for nebulization” from proposed § 200.51. These phrases are replaced by the phrase “aqueous-based drug products for oral inhalation.” The agency has added the phrase “for oral inhalation” to clarify that the rule applies to orally administered inhalation drug products and not nasal sprays. The agency has added the modifier “aqueous-based” to the type of drug products covered to exclude metered-dose inhalers from coverage. In addition, the agency has made minor edits to the final rule in response to the President's June 1, 1998, memorandum on plain language in government writing. The agency has increased the amount of time for manufacturers to comply with the sterility requirement from 1 year to 2 years. All manufacturers of nonsterile aqueous-based drug products for oral inhalation will have until 2 years after the date of publication of the final rule to comply with the sterility requirement. As discussed in section IV of this document, “Effective Date,” the agency believes this effective date more realistically reflects the time manufacturers may need to establish the sterility of their products.

Section 200.51(b) states that manufacturers must comply with the requirements of 21 CFR 211.113(b) of FDA's current good manufacturing practice (CGMP) regulations. This section requires that manufacturers establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Such procedures must include validation of any sterilization process.

In addition to the above highlights, the agency notes that persons holding an approved new drug application (NDA) or abbreviated application for a nonsterile aqueous-based drug product for oral inhalation must submit to FDA a supplemental application describing the new manufacturing process under § 314.70(b) or § 314.97 (21 CFR 314.70(b) or 314.97). The proposed rule stated that if a manufacturer intended to sterilize a product by terminal sterilization, the manufacturer must obtain prior FDA approval for such change under § 314.70(b)(2), but if a manufacturer intended to sterilize a product by aseptic processing they may make the change at the time a supplemental application is submitted under § 314.70(c)(1). The agency has now determined that the technological complexity of aseptic processing warrants prior approval of any changes in the manufacturing process. Accordingly, the agency concludes that all manufacturing changes related to sterility requirements require supplemental applications to be submitted and approved under § 314.70(b)(2) prior to making any changes. In November 1999, a guidance related to this topic, entitled “Changes to an Approved NDA or ANDA,” became available. This guidance states that the agency considers a change in the sterilization process, e.g. from aseptic processing to terminal sterilization or vice versa, a major change to any approved application for which the manufacturer should submit a prior approval supplement. The agency notes that a proposed rule entitled “Supplements and Other Changes to an Approved Application,” published in the Federal Register of June 28, 1999 (64 FR 34608). This proposed rule is currently being finalized and may further affect the filing of supplemental applications related to this rule.

The following information should be included in a supplemental application related to this rule:

• Complete validation data for the aseptic process (see November 1994 guidance document entitled “Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products”);

• For abbreviated applications, an executed batch record for a production batch of the product using the approved formulation;

• In-process and release control data;

• Updated release specifications that include sterility;

• Three months accelerated stability data;

• An updated stability protocol to include either sterility or container/closure integrity testing initially and at expiry; and

• A commitment to place the first three commercial batches into the routine stability program and submit the data in annual reports.

The agency received a total of 61 comments on the September 23, 1997, proposed rule. Forty-nine of those comments were from consumers of an OTC aqueous solution of epinephrine sold in a kit with an atomizer. Of the remaining 12 comments, 8 were from industry, 2 were from associations of health care professionals, 1 was from academia, and 1 was from a Federal Government agency. The majority of comments requested clarification of the scope of the rule and the drug products intended to be covered, and also discussed the economic impacts of the proposed rule.

1. The proposed rule stated: “All inhalation solutions for nebulization shall be manufactured to be sterile” (proposed § 200.51(a)). Several comments indicated that the scope of drug products intended to be covered by the proposed rule was either unclear or overbroad. Some of the comments asked whether intranasal sprays would be subject to the rule. One comment asked whether both OTC and prescription drugs were covered. Three comments suggested clarifying that only aqueous-based drug products are subject to the rule. One comment interpreted the proposed rule to cover OTC and prescription drugs dispensed out of a manufacturer's primary packaging container into a separate, secondary and independent device prior to administration to the end user or patient, excluding nebulized or atomized sprays for inhalation. The comment stated that primary formulations should include both single-dose and multiple-use sterile products to eliminate microbial contamination during use. One comment suggested that the rule cover inhalation suspension products, stating that they contain more nutrients that contaminating microorganisms can metabolize than do inhalation solutions, and suggested that the title of the rule be modified to reflect this change.

The agency has considered these comments and agrees that further clarification of products covered by the rule is warranted. In response to these comments, the agency has revised the final rule to state: “All aqueous-based drug products for oral inhalation must be manufactured to be sterile.” Because the rule covers only drug products administered orally, it does not cover nasal sprays. Because the rule covers only aqueous-based drug products, pressurized metered-dose inhalers are not covered. All marketed prescription and OTC drugs are covered by the rule.

The agency agrees with the comment that inhalation suspension products pose contamination risks at least as great as those of inhalation solution products. Aqueous-based suspension drug products for oral inhalation would also bypass many of a patient's natural defense mechanisms and, if contaminated, pose similar risks. However, all currently marketed inhalation suspension drug products are metered-dose inhalers and, because they are metered-dose inhalers, are not subject to this final rule. Any aqueous-based oral inhalation suspension drug products approved in the future that are not metered-dose inhalers are subject to this rule.

2. One comment asked whether the proposed rule would cover solutions for oral inhalation compounded under applicable practice of pharmacy provisions and regulations. Another comment stated that a large fraction of nebulizer solutions sold in the United States are compounded in pharmacies and suggested that such facilities use chemicals of dubious quality, that such solutions are dispensed in unsafe vials, and that preservatives used are contraindicated in anti-asthma products. This comment supported the rule and suggested that the rule would resolve issues of compounding in pharmacies which, the comment stated, results in millions of dollars in Medicare fraud.

Compounding occurs when a pharmacist or physician mixes, combines, or alters ingredients to create a customized drug product for an individual patient. The issue of pharmacy compounding is addressed in section 127 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115). Section 127 adds section 503A to the act (21 U.S.C. 353a). Section 503A(b)(3)(A) of the act provides that a drug product may qualify for exemptions from certain provisions of the act, including CGMP requirements (section 501(a)(2)(B) of the act) if, among other conditions, the drug product is not identified by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. FDA intends to issue regulations to implement section 503A(b)(3)(A) of the act. During the course of that rulemaking, the agency intends to consider, among other issues, whether aqueous-based drug products for oral inhalation present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. Compounded aqueous-based drug products for oral inhalation that fail to meet any of the conditions of section 503A of the act are subject to the statutory CGMP provision (section 501(A)(2)(B) of the act) and, therefore, are subject to the requirements of this final rule.

3. Several comments asked whether the proposed rule addresses maintaining the sterility of multiple-use containers after the container is opened and closed for later use. These comments stated that there is a high risk of contamination of inhalation drug products when multiple-use containers, e.g., bottles with droppers, are opened and used in a nonsterile environment. One comment asked whether the rule would require single-dose containers for one-time use. Two comments noted that new packaging is either on the market or in development that would eliminate the need to transfer aqueous-based drugs into separate secondary receptacles, thus reducing the potential for microbial contamination.

The agency recognizes that multiple-use containers raise issues of microbial contamination when aseptic handling procedures are not used either by a patient at home or in a hospital setting. However, the intent of this rule is to ensure sterility from the point of manufacture. The rule is intended to prevent contaminated products from being distributed by manufacturers. While the agency encourages the use of single-dose containers, the agency is not requiring their use at this time. The agency supports innovations in new packaging that would reduce the likelihood of microbial contamination. The agency has no current plans, however, to require the use of such packaging by manufacturers.

4. One comment suggested that the proposed rule was a “simplistic fix” for a series of complex problems including inadequate antimicrobial preservation systems for in-use contamination control, inadequate U.S. Pharmacopeia (USP) microbiological testing methods, and defective hospital infection control procedures. The comment questioned the adequacy of microbial limits testing, in particular USP procedure <61>, to reliably detect the prevalent contaminants of inhalation drug products. The comment also suggested that there is no evidence for the assumption underlying the proposed rule that contaminating organisms have developed resistance to the antimicrobial preservative systems used. The comment stated that organisms historically known to be resistant to benzalkonium chloride have been noted and that mistakes have occurred when companies have made errors designing a product's antimicrobial preservative system. The comment also noted the inadvisability of using a single preservative in the manufacturing process and suggested that the proposed rule shows that the agency now believes preservatives are to be used to address inadequate manufacturing contamination controls that were previously considered to be serious CGMP violations.

Another comment acknowledged that some antimicrobial preservatives are no longer effective because resistance to them in certain bacterial strains has developed, and expressed concern as to whether this problem would be addressed by the rule. Similarly, a different comment noted microbial contamination in spite of preservatives. This comment indicated support for sterile, additive-free solutions, noting that one disadvantage of preservatives is that they may be contraindicated in anti-asthmatic products. This comment stated that benzalkonium chloride is a known bronchoconstrictor contraindicated in anti-asthmatic products and that edetic acid, while not as potent as benzalkonium chloride, causes bronchospasm and would not be present in an ideal nebulizer solution.

Antimicrobial preservatives are added to dosage forms to protect them from microbial contamination. The USP states that antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing practices. The USP sets forth tests for estimating the presence, or absence, of microorganisms. USP procedure <61> sets forth tests for the estimation of the number of viable aerobic microorganisms present and the absence of designated microbial species in both raw materials and finished form drug products. FDA recognizes that both sterile and nonsterile drug products may contain preservative systems to control bacteria and fungi that may be inadvertently introduced during manufacturing or use.

Concerning the comment that the proposed rule represents an inappropriate policy change in allowing preservatives to be used to address inadequate manufacturing contamination controls, this rule does not change the agency's policy of considering such use of preservatives a serious CGMP violation. To the extent agency policy is reflected in the USP, the USP clearly states that while situations may arise where the use of an antimicrobial preservative may be necessary to minimize the proliferation of microorganisms, all useful antimicrobial agents are toxic substances.

The agency agrees with the comment acknowledging that some antimicrobial preservatives are no longer fully effective because certain bacterial strains have developed resistance. The agency disagrees with the comment that suggests there is no evidence that contaminating organisms have developed resistance to antimicrobial preservatives. Bacteria best identified as belonging to the Pseudomonas family have been known for many years to survive and grow in commercial preparations of quanternary ammonium compounds such as benzalkonium chloride. (See, for example, Adair, F.W., S.G. Geftic, and J. Gelzer, “Resistance of Pseudomonas to Quaternary Ammonium Compounds: I. Growth in Benzalkonium Chloride Solution,” Applied Microbiology , vol. 18, pp. 299-302, 1969. See also, Dixon, R.E., et al., “Aqueous Quaternary Ammonium Antiseptics and Disinfectants,” Journal of the American Medical Association , vol. 236, pp. 2415-2417, 1976.) In fact, the albuterol sulfate product recalled in January 1994, discussed in the proposed rule, contained benzalkonium chloride, an antimicrobial preservative, yet the preservative failed to prevent microbial contamination of the product. As of October 28, 1997, the agency's Spontaneous Reporting System (SRS) reported that this albuterol sulfate incident was associated with a total of 2,846 cases including 1,498 serious cases, 1,163 hospitalizations, and 441 deaths.

The agency acknowledges the public health need for sterile, additive-free, aqueous-based drug products for oral inhalation for the segment of the population for whom antimicrobial products are contraindicated (e.g., sensitive patients with asthma and other pulmonary diseases). To this end, the agency encourages the manufacture of sterile, additive-free, single-dose drug products for oral inhalation. However, the agency is not at this time requiring that all aqueous-based drug products for oral inhalation be manufactured in single-dose containers.

The agency recognizes that microbial limits tests have not prevented serious microbial contamination of nonsterile inhalation drug products in the past. Endproduct microbial limits tests performed prior to distribution may not be capable of detecting low levels of contamination. Products that initially pass the microbial limits test may support the growth of contaminating organisms that could later increase to unacceptable levels. The agency believes that requiring the sterility of such products from the point of manufacture will reduce the likelihood of microbial contamination.

The agency recognizes that contamination of these products may occur during usage. Such contamination may occur because of inadequate handling procedures, including defective hospital infection control procedures, or patient handling errors. The agency notes that the National Center for Infectious Diseases of the Centers for Disease Control and Prevention is sponsoring initiatives on preventing nosocomial transmission of antimicrobial-resistant microorganisms and directs those interested to their Internet at www.cdc.gov/ncidod/ for related information. The agency encourages hospital personnel and patients to follow instructions in the labeling for such products, including any precautions for use. The agency emphasizes the importance of following proper handling technique when transferring these products from their original container into an atomizer or nebulizer. FDA has determined that the best way for it to prevent future public health problems associated with contaminated aqueous-based drug products for oral inhalation is to require sterility at the point of manufacture.

In the proposed rule, FDA estimated that the affected industry would incur total annual compliance costs of $192,000 to $1,210,000 (after amortization over 10 years at a 7 percent interest rate), mostly for constructing clean rooms in the five manufacturing facilities believed to be using a nonsterile production process. Several of the comments addressed aspects of FDA's original analysis of economic impacts.

5. Three comments stated that FDA had underestimated the costs of compliance and two comments provided estimates of compliance costs for their companies, although they did not provide the bases for these estimates.

FDA has considered these estimates and has revised its compliance cost estimates for the final rule, as described in section V of this document, “Analysis of Economic Impacts.” The agency's full cost analysis is based on a report prepared by its contractor, Eastern Research Group (ERG) (available in the docket) entitled “Cost Impact on the Pharmaceutical Industry of Final Sterility Requirements for Inhalation Solution Products,” and the comments mentioned above.

6. The U.S. Small Business Administration (SBA) commented that there was insufficient information on the record to evaluate the need for the regulation, as measured by the incidence of illness, against the enormous cost of compliance.

The proposed rule listed several incidents of contaminated inhalation drug products that jeopardized the public health and safety and were the subject of product recalls (62 FR 49638 at 49639). The proposed rule did not, however, provide data on adverse events associated with these recalls. The agency notes that as of October 28, 1997, FDA's SRS reported that the albuterol sulfate product recalled in January 1994, discussed in the proposed rule, was associated with 2,846 reports of adverse events including 441 deaths. FDA believes that this evidence, along with the resistance to microbial preservatives and the growth potential of the Pseudomonas family of bacteria, provides the public health and safety justification for this rule. Further, as the revised compliance costs of the final rule are estimated at $10.1 million per year, the agency believes that public health and safety concerns outweigh the compliance burdens.

7. SBA noted the lack of training costs for sterility procedures in the agency's original cost estimates. FDA agrees with this comment, and training costs are now included in its final estimate.

8. One comment suggested that enforcement of CGMP regulations and monitoring of unethical repackaging operations would be more effective and less costly then requiring firms to convert to sterile processes.

The agency has determined that adherence to CGMP regulations without appropriate sterilization procedures does not provide an adequate level of assurance that aqueous-based drug products for oral inhalation will be free of contaminants. Based on past incidents of serious health risks to users, the agency has determined that enforcement of CGMP's is not enough to ensure these products are contaminant-free when they leave the manufacturer for distribution. Antimicrobial preservatives used in these products may not be effective because many bacteria, including Pseudomonas spp., have developed resistance to these preservatives. The albuterol sulfate product recalled in January 1994, discussed in the proposed rule, contained benzalkonium chloride, an antimicrobial preservative, yet the preservative failed to prevent microbial contamination of the product. Resistance to preservatives is not species specific; strains of many species are resistant. Furthermore, use of a single preservative in a nonsterile inhalation drug product for an extended period may actually select for preservative-resistant strains of Pseudomonas spp. or other bacteria. Similarly, although the agency recognizes the importance of the enforcement of repackaging regulations, this rule is intended to help ensure that products are sterile at the point of manufacture.

9. SBA recommended the use of a HACCP program, like that used for the food industry. SBA stated that a HACCP program would reduce compliance costs.

HACCP is a preventive system of hazard control used primarily in the food industry. The HACCP concept is a systematic approach to the identification and assessment of the risk of biological, chemical, and physical hazards that may occur in a particular production process or practice and the control of those hazards. Under HACCP, the producer develops a plan that anticipates and identifies the points in the production process where a failure would likely result in a hazard being created or allowed to persist. These points are referred to as critical control points (CCP's). Under HACCP, identified CCP's are systematically monitored to ensure that critical limits are not exceeded, and records are kept of that monitoring. Corrective actions are taken when control of a CCP is lost and these actions are documented. The effectiveness of HACCP is also systematically verified by the processor.

Because of the potential public health consequences of contaminated aqueous-based drug products for oral inhalation, as shown by the incidents cited earlier in this document, the agency concludes that a HACCP system is not an adequate substitute for sterilization requirements.

10. Another comment stated that the proposed rule would limit the use of each clean room to one product and questioned the necessity of this.

FDA is aware that the trade press has reported that the proposed rule would require one product per clean room. FDA is clarifying that this interpretation of the proposed rule is inaccurate. FDA did not intend to limit, and is not limiting, each clean room to the manufacture of only one inhalation product.

11. The agency received 49 comments from consumers of an OTC asthma inhalant, Breatheasy, as well as one comment from the manufacturer of the Breatheasy product, Pascal Co., Inc., of Bellevue, WA. Pascal Co., Inc., distributed a letter to consumers of its product stating the agency's new policy would require that all inhalants be manufactured in clean rooms and suggesting that overhead costs to produce clean rooms would far exceed annual sales of this product. Pascal stated that the rule would be cost prohibitive for the company and would require it to discontinue manufacture of the product. The 49 letters from consumers of this product indicated that they had been informed by Pascal Co., Inc., that the new policy would require the manufacturer to discontinue manufacture of the product. These letters testified to individual experiences with the product, stating duration of use, some for as many as 50 or 60 years, lack of any ill effects or quality problems, unique needs met by the product exclusive of any other available remedy, and the low cost of the product.

The agency has reviewed the concerns of individuals who have used this product for many years and who are understandably concerned about it being discontinued. The agency contacted Pascal, Inc., and reviewed the labeling of the product to determine if it is the type of product intended to be covered by the rule.

The Breatheasy product is a 2-percent buffered aqueous solution of epinephrine that comes in a kit that contains an atomizer. Breatheasy is the type of product that has raised serious concerns about the health and safety of individuals using such products and it is an example of the type of product intended to be covered by the final rule. The agency has determined that other, alternative OTC epinephrine inhalation products, which do not raise the safety concerns of this product, are available on the market to treat the symptoms of these individuals. Should Breatheasy become unavailable, the agency suggests that individuals consult their health care practitioners for the identity of an appropriate alternative OTC product.

12. Two comments stated that the time for implementation was too short and impractical for conversion to sterile processes. Both comments requested up to a 2-year phase-in period to allow development time for packaging, stability data, and facility modifications. SBA stated that allowing a 1-year transition period, as proposed, was not sufficient. The comment requested a transition period of 2 years.

FDA has considered these comments and has decided to lengthen the effective date to 2 years after publication of the final rule to give each firm a longer period of time to implement the new sterility requirements.

The final rule prohibits all manufacturers of nonsterile aqueous-based drug products for oral inhalation, including those products currently approved, from introducing or delivering for introduction into interstate commerce any such products that are nonsterile beginning 2 years after the date of publication of the final rule in the Federal Register .

Holders of approved NDA's and abbreviated new drug applications (ANDA's) must submit supplemental applications to FDA to establish sterility of these products within 2 years after the publication of the final rule in the Federal Register .

Any NDA or ANDA for a nonsterile aqueous-based drug product for oral inhalation under review by FDA on or after the date of publication of the final rule, but before the effective date of the final rule may be approved if the application is otherwise approvable and the applicant agrees to establish the sterility of its drug product in a supplemental application by the effective date. On or after the effective date of the final rule, FDA will refuse to approve an NDA or ANDA for an aqueous-based drug product for oral inhalation if the applicant has not established the sterility of the product.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. The Unfunded Mandates Reform Act requires agencies to prepare an assessment of anticipated costs and benefits before enacting any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

FDA concludes that this final rule is consistent with the principles set forth in the Executive Order and in these two statutes. FDA estimates that the final rule would impose annual compliance costs on industry of about $10.1 million. In addition, the final rule is a significant regulatory action as defined by the Executive Order and was subject to review under the Executive Order. FDA has also determined, as explained later in this section, that the final rule may have a significant economic impact on a substantial number of small entities. This section, along with the report by FDA's contractor ERG, constitutes the agency's final regulatory flexibility analysis as required under the Regulatory Flexibility Act. Further, because this final rule makes no mandates on government entities and will result in expenditures of less than $100 million in any one year, FDA need not prepare additional analyses under the Unfunded Mandates Reform Act.

FDA is amending its regulations to require that all prescription and OTC aqueous-based inhalation solutions or suspensions in single-dose or multiple- use primary packaging administered orally via a secondary device or other ancillary hardware (e.g., an atomizer, nebulizer, or pump), be manufactured to be sterile. This does not include inhalation solutions administered by pressurized metered dose inhalers. FDA believes this action is necessary to help ensure the safety and efficacy of these products, due to reports of adverse drug experiences from contaminated nonsterile inhalation solutions and recalls of these products.

In the preamble to the proposed rule published September 23, 1997, FDA estimated that the affected industry would incur total annual compliance costs of $192,000 to $1,210,000 (after amortization over 10 years at a 7 percent interest rate), mostly for constructing clean rooms in the five manufacturing facilities believed to be using a nonsterile production process. Several of the comments to the proposed rule addressed aspects of FDA's original analysis of economic impacts. These comments are addressed in section III of this document and below.

FDA has reviewed its original compliance cost estimates in light of the comments to the proposed rule, and has determined that it underestimated compliance costs to industry. The agency's revised estimates are fully described in the ERG report on compliance costs (available in the docket).

In the proposed rule, FDA estimated that up to five firms may still be using a nonsterile manufacturing process for inhalation solutions. ERG found that eight firms would be affected by the final rule because they use nonsterile manufacturing processes. The ERG estimate assumes that some products with an uncertain classification were actually nonsterile.

ERG concluded that the final rule would impose a total annual cost of $10.1 million (after amortization of capital costs over 10 years at a 7 percent interest rate). The majority of these annual costs ($8 million) are attributed to the increase in annual operating costs for two large manufacturers. This estimate was derived from the comment of one of the large companies, which indicated that its operating costs would increase by $4 million, primarily due to the lower labor productivity that results from the extra activities necessary when operating in a sterile environment. One-time capital and related costs are estimated at about $8.3 million for converting to the sterile production process, including the planning, constructing and equipping of clean rooms, training of employees, and revalidation of production processes. On an annualized basis (after amortizing over 10 years at a 7 percent discount rate), these costs are projected at $600,000 per year for each of these two large manufacturers.

The other six manufacturers, which produce nonsterile inhalation products with much lower annual revenues (about $1 million or less), are not expected to convert their production processes, due to the relatively high compliance costs compared to the revenues from these products. Instead, ERG projected that one-half of these firms would transfer production of these products to a contract manufacturer, with an estimated increase in manufacturing costs of about 30 percent, resulting in an additional $900,000 per year in costs. The other one-half of these small volume manufacturers, those with the smallest revenues, are expected to discontinue these products altogether. Consumers of the discontinued products are expected to switch to alternative products. FDA believes, based on the small volume of affected sales, the wide availability of competing products, and the probable low elasticity of product demand, that the loss of consumer and producer value due to this regulation would be extremely small.

After further review, FDA also decided to require inhalation suspension products, other than suspensions in pressurized metered dose inhalers, to be sterile although they had not been included in the proposal. There are currently five approved inhalation suspension products. Because they are all metered-dose inhalers, however, they are not covered under the final rule. Further, FDA does not expect to receive any new applications for inhalation suspensions that are nonsterile, as the current procedures for new products are likely to include a sterilization process. Thus, FDA has not raised its compliance cost estimates due to the addition of inhalation suspension products for oral inhalation in the final rule.

As stated above, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities, unless the rule is not expected to have a significant economic impact on a substantial number of small entities.

SBA limits the definition of small businesses in the pharmaceutical industry to those with less than 750 employees. ERG estimated that five small manufacturers with a total of eight products will be affected by this rule, although the data necessary to make this determination are scarce and often rely on sales volume rather than number of employees. About one-half of these manufacturers (two or three) are expected to transfer production to a contract manufacturer, which is estimated to increase operating costs by about $180,000 each per year per product. In addition, these companies may experience a loss of jobs as these products are transferred to the contract manufacturers. The other two or three companies are expected to cease production of their product completely, thereby incurring the loss of profits on those products. While neither ERG nor FDA has quantified these impacts, it expects them to be low due to the low product sales volume.

Affected firms will need to acquire some new professional skills, because this rule deals with a new manufacturing process that will require technicians to have a knowledge of sterility procedures. Any other skills necessary for implementation of this rule (e.g., skills associated with preparing the supplemental application) should already exist within the firms and should not need to be newly acquired. No other compliance costs are estimated for these manufacturers.

FDA has considered alternatives to this rule. FDA considered exempting small entities. However, as stated in the proposal, the alternative of exempting small businesses from the rule is not feasible, because most firms using a nonsterile process are small firms and thus granting small businesses an exemption would negate the purpose of the rule.

One alternative mentioned in the comments discussed in section III.H of this document was the creation of a HACCP program whereby the most critical points in the production process would be monitored for microbial safety problems, possibly resulting in lower compliance costs for small businesses. As discussed above, FDA has rejected a HACCP program for these drug products because of the potential public health consequences of contaminated products, as shown by the cited earlier incidents involving aqueous-based drug products for oral inhalation.

Another alternative to the final rule would have been to retain the 1-year effectiveness date as required by the proposed rule. Instead, FDA has responded to public comments by delaying the effectiveness date an extra year in order to give industry members additional time to adjust to the new requirements and mitigate costs as much as possible. In doing so, FDA has eliminated compliance costs for 1 year, the present value of which is $10.1 million.

Another alternative mentioned in the comments and discussed in section III.G of this document was more uniform enforcement of CGMP's and monitoring of unethical repackaging. Based on past incidents of serious health risk to users, the agency has determined that enforcement of CGMP's is not enough to ensure these products are contaminant free when they leave the manufacturer for distribution. Similarly, one comment suggested end-testing the product in batches prior to shipment from the manufacturing facility. This comment incorrectly stated that all contaminated products to date have been caught prior to reaching or harming patients. As discussed in section III.E of this document, contaminated products have caused serious harm to patients. For this reason, the agency has determined that end-testing and/or enforcement of CGMP's are not adequate to address the serious public health and safety concerns raised by such incidents.

Due to contamination problems with several different inhalation solution drug products and adverse experience reports, FDA has determined that current manufacturing methods and safeguards against contamination, including microbial limits tests, have not prevented dangerous microbial contamination of nonsterile aqueous-based drug products for oral inhalation. Based on the significant health risk to users, FDA is requiring that all aqueous-based drug products for oral inhalation be manufactured sterile.

One alternative considered was to supply consumers and providers with information related to the potential risks of aqueous-based drug products for oral inhalation that are not manufactured to be sterile, instead of mandating sterility in this market. FDA is concerned that many prescribers and consumers may not understand the potential risks of such products, given that these products are approved and therefore regarded as safe and effective when used according to the labeling. In many circumstances, additional information would assist prescribers and users in making informed choices, and if it were possible to provide correct and complete information to all prescribers and consumers in this market, they should make the optimal choice for their situation. However, FDA does not believe that such information could be developed for nonsterile aqueous-based oral inhalation drug products that would be consistent with FDA's mandate under the Federal Food, Drug, and Cosmetic Act to assure that drug products are safe and effective. Additionally, even if such information could be developed, the cost associated with providing the information to the relevant parties would be too large, and FDA believes that these costs would overshadow any expected benefits of allowing fully informed consumers to make their own choice in this market.

The agency previously considered the environmental effects of this rule as announced in the proposed rule (62 FR 49638). At that time, the agency determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

Title: Sterility Requirements for Aqueous-based drug products for oral inhalation.

Description: The final rule requires that all aqueous-based drug products for oral inhalation, including those currently approved, be manufactured sterile. Respondents will be required to submit a supplemental application under § 314.70(b) or § 314.97, describing their new manufacturing process for achieving sterility of their aqueous-based drug products for oral inhalation. FDA needs this information to determine compliance with this new regulation and will use information collected to make decisions on approval of supplemental applications. Applicants will have 2 years after the date of publication of the final rule to comply with the sterility requirement.

Description of Respondents: Respondents are businesses engaged in the manufacture of aqueous-based drug products for oral inhalation.

The collection of information described in the proposed rule was approved by OMB under control number 0910-0353. However, based on new data collected by its contractor, ERG, FDA has revised its estimate of the number of respondents in the original proposal for reporting and recordkeeping burden. Because the number of respondents has changed, the estimate of the total hours has changed. The economic analysis of the proposed rule estimated 5 manufacturers, while the economic analysis of the final rule estimates 8 manufacturers with 11 nonsterile products based on new data collected by ERG (see Ref. 1). However, four of the manufacturers are estimated to cease manufacturing, leaving four companies manufacturing seven products. These companies are estimated to cease manufacturing because they may lack the in-house technical capability to convert their operations or might find the prospective investments in sterile production technologies to be unattractive. Because each nonsterile product will require an annual report (21 CFR 314.81(b)(2)(iv)), the number of annual responses for nonsterile products has increased to seven. Based on a review of FDA's past experience with applicants submitting supplemental applications under § 314.97, we estimate 160 hours to prepare a supplemental application. Therefore, due to the increased estimate of respondents, the total hours for the annual reporting burden for manufacturers of nonsterile products has increased from 800 hours in the proposed rule to 1,120 hours in the final rule. The agency's review of the estimated reporting burden for manufacturers of sterile products in the proposed rule and its experience with the annual reporting burden for manufacturers of sterile products supported the estimate provided in the proposed rule. Therefore, the estimated reporting burden for manufacturers of sterile products in the final rule is the same as in the proposed rule.

Because of the estimated increase from the proposed rule to the final rule in the number of respondents for nonsterile products, the number of recordkeepers in the recordkeeping burden of Table 2 has increased by two from the proposed rule. FDA estimated a total of seven recordkeepers in the proposed rule and now estimates a total of nine recordkeepers as a result of new data collected by ERG. The proposed rule estimated 2 hours per record, and FDA's review of that estimate and its experience with the control and validation of microbiological contamination supports this proposed estimate. Therefore, the total number of hours for the recordkeeping burden has increased from 14 hours to 18 hours.

Individuals and organizations may submit comments on these burden estimates or on any other aspect of these information collection provisions, including suggestions for reducing the burden, and should direct them to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

The following reference is on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Eastern Research Group, “Cost Impact on the Pharmaceutical Industry of Final Sterility Requirements for Inhalation Solution Products,” 1998.

Section 1309(a) of the Foreign Relations Authorization Act for Fiscal Years 2000 and 2001 provides that the Secretary of State shall establish a regulatory regime for licensing the export of commercial satellites, satellite technologies, their components, and systems which shall include expedited approval, as appropriate, of the licensing for export by U.S. companies of such items to NATO allies and major non-NATO allies. Pursuant to § 1309(a) the regime should include expedited processing of requests for export authorizations that are time critical (including information exchange relating to satellite failures or anomalies); are required to submit bids to foreign persons for procurements; are related to re-export of unimproved materials, products, or data; or are required to obtain launch and on-orbit insurance.

Within this legislative framework, the Department of State (Office of Defense Trade Controls) and the Department of Defense (Defense Threat Reduction Agency/Technology Policy) convened in January 2000 a task force of U.S. aerospace industry experts who were members of the State Department's federal advisory committee for defense trade matters, the Defense Trade Advisory Group (DTAG). This DTAG task force met regularly with State and Defense in the period January-April 2000 for the purpose of setting forth a special licensing regime involving U.S. allies that would reflect experience gained since the transfer of commercial communications satellites to the U.S. Munitions List, which became effective March 15, 1999. This task force also drew on the technical and business expertise of other U.S. aerospace industry representatives in discrete product lines (particularly those involved in the supply of components and systems) and held a town hall discussion of the special licensing regime included herein at the April 2-4, 2000 Spring Conference of the Society for International Affairs, a non-profit association comprised of defense firms, held at Laguna Beach, California.

The ITAR amendment herein concerns the special satellite regime involving U.S. allies, provided for by authorizing legislation for exports and re-exports of U.S. Munitions List controlled articles for satellites to, within and among the territories of the member countries of NATO (Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Iceland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain, Turkey, United Kingdom and the United States) and countries that have been designated pursuant to the Foreign Assistance Act of 1961, as amended, as major non-NATO allies (Australia, New Zealand, Japan, Israel, Egypt, Jordan, Republic of Korea and Argentina). This coverage also includes exports and re-exports of U.S. Munitions List controlled articles for approved satellite projects to be launched from the United States or the territory of a NATO or major non-NATO ally. Importantly, unless otherwise specifically authorized at the time of license approval, this special satellite regime does not apply to any other country in any measure, including but not limited to intermediate consignment occurring during the initial export; temporary re-transfer or re-export; or launch into outer space of USML-controlled articles, whether or not incorporated ( e.g., embedded) in a satellite when that activity involves a country that is not a member of NATO or a major non-NATO ally of the United States.

The special satellite regime has three principal features. The first is the ability to use high volume licenses ( e.g., known in the trade as “bulk” licenses) for exports of specifically designed or modified components, parts, systems, accessories, attachments and certain associated technical data for commercial communications satellites under specified conditions for multiple shipments to any of the NATO or major non-NATO allies.

The second principal feature concerning use of this regime is that all eligible articles for export must be confined to an approved list of foreign aerospace firms located within the territories of U.S. allies for use in an approved list of commercial communications satellite programs of U.S. allies. The lists of foreign aerospace firms and commercial communications satellite programs included within the coverage of this regime will be kept under scrutiny by the U.S. Government and made publicly available on ODTC's Website and by other means. New firms and programs will be added to these lists following scrutiny within the U.S. Government (and approved for inclusion within the regime) in light of proposals from U.S. aerospace firms through export license applications.

Third, when exporting pursuant to the special regime, it is not necessary under specified conditions for U.S. exporters to provide in advance the details of purchase orders or contracts, or non transfer and end use certificates ( e.g., form DSP-83) where they may be required. While all of this documentation will continue to be mandatory, and while exporters will continue to be required to ascertain the specific end users and end uses prior to export or re-export, the required documentation will only be required to be furnished to ODTC within 15 days following shipment from the United States (or re-transfer within the approved territory), at which time U.S. exporters will report the appropriate shipping information (discussed further below) and furnish the required documentation.

For sensitive components, such as MTCR-controlled items, the long standing controls of the ITAR, including non-transfer and end use certificates, parts control plans, and the like, will continue to be required. But, in most cases, such documentation may be furnished within 15 days of shipment, as described below. Restrictions may also be imposed on such licenses, however, in view of the specific items proposed for export as appropriate in furtherance of the security and foreign policy of the United States ( e.g., to meet missile nonproliferation objectives). Further, for particularly sensitive articles or information, the U.S. Government retains the discretion to require a separate license when necessary in furtherance of the security and foreign policy of the United States.

The principal articles envisaged for the special regime are: (1) The supply of satellite components, parts, systems, attachments, accessories and associated technical data, including for off-shore procurement; and, (2) technical information needed to respond to bids, to requests for quotations, plant visits, acceptance testing of equipment and the like. Technical data for satellite insurance purposes, including for on-orbit anomalies, involving exports to insurance firms and their brokers and consultants located within the territories of U.S. allies has also been discussed extensively within DTAG and will be the subject of separate, informal guidelines not requiring an amendment to the ITAR.

Exports of complete commercial communications satellites for sale to, or launch by, U.S. allies have been proceeding expeditiously consistent with the Department of State's January 1999 report to Congress concerning implementation of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999. Such exports invariably involve contracts of $50 million or more, requiring notification to Congress pursuant to section 36(c) of the Arms Export Control Act before an export license may be issued. As such, these exports do not lend themselves to the special regime provided for herein and no rule change to that effect is being undertaken at this time. As suggested in the referenced report, the Department of State and the interested Committees of Congress have used all appropriate opportunities to ensure that U.S. aerospace companies are able to meet contract deadlines and launch schedules consistent with the security and foreign policy of the United States. The details of communications satellite notifications to Congress that have taken place since March 15, 1999, are available on the Website of the Office of Defense Trade Controls (HYPERLINK http://www.pmdtc.org.).

In carrying out this directive Part 123, Licenses for the Export of Defense Articles is being amended.

This amendment involves a foreign affairs function of the United States and therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554. It is exempt from review under Executive Order 12866 but has been reviewed internally by the Department to ensure consistency with the purposes thereof. This rule does not require analysis under the Regulatory Flexibility Act or the Unfunded Mandates Reform Act. It has been found to be a minor rule within the meaning of the Small Business Regulatory Enforcement Act of 1966. It will not have substantial direct effects on the States, the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with § 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant application of Executive Order Nos. 12372 and 13123. However, interested parties are invited to submit written comments to the Department of State, Office of Defense Trade Controls, ATTN: Regulatory Change, Part 123—Commercial Communications Satellites Components, Systems, Parts, and Accessories, 13th Floor, Room H1304, SA-1, Washington, D.C. 20520-0113. Such persons must be so registered with the Department's Office of Defense Trade Controls (ODTC) pursuant to the registration requirements of § 38 of the Arms Export Control Act.

On July 29, 1982, the Secretary of the Interior conditionally approved the Indiana program. You can find background information on the Indiana program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the July 26, 1982 Federal Register (47 FR 32107). You can find later actions on the Indiana program at 30 CFR 914.10, 914.15, 914.16, and 914.17.

By letter dated February 25, 2000 (Administrative Record No. IND-1686), the Indiana Department of Natural Resources (department) sent us an amendment to its program under SMCRA and the Federal regulations at 30 CFR 732.17(b). The department sent the amendment at its own initiative. The amendment concerns revisions to the Indiana Surface Coal Mining and Reclamation Act at Indiana Code (IC) 14-34-6-15. The revisions made to IC 14-34-6-15 will allow the department to use money from its post-1977 abandoned mine reclamation fund to replace domestic water supplies disrupted or affected by surface coal mining and reclamation operations.

We announced receipt of the amendment in the March 9, 2000, Federal Register (65 FR 12492). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on April 10, 2000. Because no one requested a public hearing or meeting, we did not hold one.

Following, under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are our findings concerning the amendment.

Indiana revised IC 14-34-6-15(b) and (c) to read as follows:

Indiana's post-1977 abandoned mine reclamation fund (fund) consists of both bond forfeiture and civil penalty monies. However, only the monies collected for civil penalties may be used for the purposes specified in IC 14-34-6-15(b). Under IC 14-34-6-16(f), the bond forfeiture monies are to be used solely for the purpose of reclaiming the forfeiture sites to which the bonds apply. Under IC 14-34-6-16(d), any excess forfeited bond money must be returned to the person from whom the amount was received. Under IC 14-34-6-15(b)(1), the civil penalty money in the fund may be used to restore land affected by surface mining activity after August 3, 1977, if the land is not eligible for Federal funding. Under the new provision at IC 14-34-6-15(b)(2), the civil penalty money in the fund may be used to replace domestic water supplies disrupted or affected by a surface coal mining and reclamation operation, if the operation is completed and is no longer subject to the requirements of the Indiana program under IC 14-34. Indiana revised its exception provision at IC 14-34-6-15(c) to clarify that the $500,000 that is dedicated as collateral for the Indiana bond pool may not be used for replacement of water. The Federal regulation at 30 CFR 845.21(a) authorizes the expenditure of money collected from the assessment of civil penalties under section 518 of SMCRA for reclamation of lands adversely affected by coal mining practices after August 3, 1977. The Federal regulation is silent regarding the use of Federal civil penalty money to replace domestic water supplies. However, section 518(i) of SMCRA does not place conditions on the use of money collected by the States from the assessment of civil penalties. Nor is there a requirement in SMCRA or the Federal regulations that State programs include rules comparable to 30 CFR 845.21. Therefore, we find that Indiana's revised statutory requirements at IC 14-34-6-15(b) and (c) are not inconsistent with the requirements of section 518(i) of SMCRA or the Federal regulations at 30 CFR 845.21. We are approving the proposed revisions to IC 14-34-6-15.

On March 2, 2000, under section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Indiana program (Administrative Record No. IND-1688). We did not receive any comments.

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain the written concurrence of the EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Indiana proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA for its concurrence.

On March 2, 2000, under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA (Administrative Record No. IND-1688). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP for amendments that may have an effect on historic properties. On March 2, 2000, we requested comments on Indiana's amendment (Administrative Record No. IND-1688), but neither responded to our request.

OSM requested public comments on the proposed amendment, but did not receive any.

Based on the above findings, we approve the amendment as sent to us by Indiana on February 25, 2000.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 914, which codify decisions concerning the Indiana program. We are making this final rule effective immediately to expedite the State program amendment process and to encourage Indiana to bring its program into conformity with the Federal standards. SMCRA requires consistency of State and Federal standards.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations.

This rule does not have federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary under SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments since each such program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

On January 19, 1981, the Secretary of the Interior conditionally approved the Oklahoma program. You can find background information on the Oklahoma program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the January 19, 1981, Federal Register (46 FR 4902). You can find later actions concerning the Oklahoma program at 30 CFR 936.15 and 936.16.

By letter dated January 13, 2000 (Administrative Record No. OK-985.01), Oklahoma sent us an amendment to its approved regulatory program under the Federal regulations at 732.17(b). Oklahoma sent the amendment in response to our letter dated December 6, 1999 (Administrative Record No. OK-985), that we sent to Oklahoma concerning regulation changes in its program that we did not approve. Oklahoma proposed to amend the Oklahoma Administrative Code (OAC). We announced receipt of the amendment in the March 31, 2000, Federal Register (65 FR 17213). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. The public comment period closed on May 1, 2000. Because no one requested a public hearing or meeting, we did not hold one.

Following, under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are our findings concerning the amendment to the Oklahoma permanent regulatory program.

Any revisions that we do not discuss below are about misspelled words, minor wording changes, or revised cross-references and paragraph notations to reflect organizational changes resulting from this amendment.

Oklahoma proposed to add a new paragraph (4) to read as follows:

This paragraph authorizes the Director of the Oklahoma Department of Mines to file with the Oklahoma Governor's Office, Director of Appointments all statements and supplements received according to 45 O.S. Supp. 1980, Section 765 from members of advisory boards and the Oklahoma Mining Commission. We are approving this addition because the federal regulations at 30 CFR 705.3(b) allow the state regulatory authority to expand the provisions of 30 CFR Part 705—Restrictions on Financial Interests of State Employees, in order to meet the particular needs within the State and because the addition is not inconsistent with the federal regulations. However, in a letter dated March 29, 2000 (Administrative Record No. OK-985.05), we notified Oklahoma that the reference to Section 765 should be Section 767. We advised the state to make this reference correction in a future rulemaking.

Previously, the Director of the Oklahoma Department of Mines was to file his or her statement with the Director of OSM. Also, all other employees and members of advisory boards and commissions representing multiple interests, as provided in Section 460:20-5-7, were to file their statements with the Director of the Oklahoma Department of Mines or such other official as may be designated by state law or regulation. The Director of the Oklahoma Department of Mines will continue to file his or her statement with the Director of OSM. Oklahoma proposed to have members of advisory boards and commissions representing multiple interests, as provided in Section 460:20-5-7, file their statements with the Governor's Office, Director of Appointments, or such other official as may be designated by state law or regulation. The state also proposed to have all other employees file their statement with the Director of the Oklahoma Department of Mines according to the requirements of 45 O.S. Supp. 786 and 460:20-5. We are approving these changes because they meet the requirements of 30 CFR 705.15 which states that all employees (except the head of the state regulatory authority) and members of advisory boards and commissions representing multiple interests must file their statements with the head of the state regulatory authority or such other official as may be designated by state law or regulation. However, in a letter dated March 29, 2000 (Administrative Record No. OK-985.05), we notified Oklahoma that the reference to Section 786 should be Section 767. We advised the state to make this reference correction in a future rulemaking.

Oklahoma proposed to revise paragraph (c)(3) to read as follows:

Oklahoma proposed to clarify that the Director of the Oklahoma Department of Mines is responsible for determining the existence of a direct or indirect financial interest for employees and that the Governor's Office, Director of Appointments, is responsible for making the same type of determination for Commission members. We are approving this amendment because it is consistent with 30 CFR 705.17(c)(3).

On March 22, 2000, under section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations, we requested comments from various Federal agencies with an actual or potential interest in the Oklahoma amendment (Administrative Record No. OK-985.04). The U.S. Army Corps of Engineers responded on April 17, 2000 (Administrative Record No. OK-985.08), that it found the proposed amendment to be satisfactory.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written agreement from the EPA for those provisions of the proposed program amendment that relate to air or water quality standards promulgated under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Oklahoma proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA to agree on the amendment.

Under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA on March 22, 2000 (Administrative Record No. OK-985.02). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On March 22, 2000, we requested comments on Oklahoma's amendment (Administrative Record No. OK-985.03), but neither responded to our request.

We requested public comments on the amendment, but did not receive any.

Based on the above findings, we approve the amendment as sent to us by Oklahoma on January 13, 2000. To implement this decision, we are amending the Federal regulations at 30 CFR Part 936, which codify decisions concerning the Oklahoma program. We are making this final rule effective immediately to expedite the State program amendment process and to encourage Oklahoma to bring its program into conformity with the Federal standards. SMCRA requires consistency of State and Federal standards.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart federal regulation.

This rule does not have federalism implications. SMCRA delineates the roles of the federal and state governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that state laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that state programs contain rules and regulations “consistent with” regulations issued by the Secretary under SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of state regulatory programs and program amendments since each program is drafted and promulgated by a specific state, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed state regulatory programs and program amendments submitted by the states must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides a decision on a proposed state regulatory program provision does not constitute major federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The state submittal which is the subject of this rule is based upon counterpart federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Therefore, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the state. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the state submittal which is the subject of this rule is based upon counterpart federal regulations for which an analysis was prepared and a determination made that the federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

On April 19, 1999, the Postal Service announced in the Federal Register (62 FR 19039-19042) the introduction of Priority Mail Global Guaranteed on an interim basis.

The U.S. Postal Service, through an alliance with DHL Worldwide Express Inc., is offering an enhanced expedited service, Priority Mail Global Guaranteed, from selected locations in the United States to selected countries. This service offers day-certain delivery with postage refund guarantee and document reconstruction coverage of $100 for allowable contents.

On November 4, 1999, the Postal Service announced in the Federal Register (64 FR 60106-60109) an amendment to the interim rule to add more U.S. acceptance locations and to extend the service to more destination countries. Public comments were requested by December 6, 1999, and by that date two comments were received. Both comments related to the way in which the Postal Service categorized the U.S. acceptance offices and how the acceptance offices were selected.

The acceptance offices were selected on their ability to meet the stringent service standards for this service based on local considerations such as timely transportation, mail processing capabilities, and access to national transportation.

The presentation of acceptance offices has been changed. ZIP Code ranges can overlap metropolitan areas and state boundaries. Accordingly, the chart of acceptance offices has been changed to delete the reference to metropolitan areas and only state names are used as a guide to determining where service is available. The use of state designations is not meant to limit service within the specified ZIP Code ranges, since they are intended only to serve as a guide to the areas that offer Priority Mail Global Guaranteed service.

The Postal Service is now extending service to more countries and redesigning the rates to reflect the cost of providing service to these additional countries. Service will be available to all country destinations listed in the International Mail Manual except Afghanistan, Ascension, China, Iraq, Japan, Democratic People's Republic of Korea (North), Libya, Pitcairn Island, Saint Helena, Sudan, and Tristan de Cunha.

Although each network country has been placed into one of eight rate groups, rate groups 1 and 2, 3 and 7, and 4 and 6, respectively, contain duplicate rates at the present time. The applicable rates and the destination countries that are associated with each rate group are as follows:

Although the Postal Service is exempted by 39 U.S.C. 410(a) from the advance notice requirements of the Administrative Procedure Act regarding proposed rulemaking (5 U.S.C. 553), the Postal Service invites public comment on the amendment to the interim rule at the above address.

The Postal Service is amending International Mail Manual chapter 2, Conditions for Mailing, which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 20.1.

A transmittal letter changing the relevant pages in the International Mail Manual will be published and automatically transmitted to all subscribers. Notice of issuance of the transmittal will be published in the Federal Register as provided by 39 CFR 20.3.

EPA is approving Bay Area Air Quality Management District (BAAQMD) Rule 8.45, Motor Vehicle and Mobile Equipment Coating Operations; South Coast Air Quality Management District (SCAQMD) Rule 1151, Motor Vehicle and Mobile Equipment Non-Assembly Line Coating Operations; San Diego County Air Pollution Control District (SDCAPCD) Rule 67.19, Coatings and Printing Inks Manufacturing Operations, and Monterey Bay Unified Air Pollution Control District (MBUAPCD) Rule 425, Use of Cutback Asphalt. These rules were submitted by the California Air Resources Board (CARB) to EPA on August 1, 1997, February 16, 1999, October 18, 1996, and June 3, 1997, respectively.

On January 19, 2000 (see 65 FR 2921) EPA proposed to approve the following rules: BAAQMD Rule 8.45, Motor Vehicle and Mobile Equipment Coating Operations; SCAQMD Rule 1151, Motor Vehicle and Mobile Equipment Non-Assembly Line Coating Operations; SDCAPCD Rule 67.19, Coatings and Printing Inks Manufacturing Operations, and MBUAPCD Rule 425, Use of Cutback Asphalt. BAAQMD adopted Rule 8.45 on November 6, 1996; SCAQMD adopted Rule 1151 on December 11, 1998; SDCAPCD adopted Rule 67.19 on May 15, 1996; and MBUAPCD adopted Rule 425 on March 26, 1997. These rules were submitted in response to EPA's 1988 SIP Call and the CAA section 182(a)(2)(A) requirement that nonattainment areas fix their reasonable available control technology (RACT) rules for ozone in accordance with EPA guidance that interpreted the requirements of the pre-amendment Act. A detailed discussion of the background for each of the above rules and nonattainment areas is provided in the proposed rule (PR) cited above.

EPA has evaluated all of the above rules for consistency with the requirements of the CAA and EPA regulations and EPA's interpretation of these requirements as expressed in the various EPA policy guidance documents referenced in the PR. EPA is finalizing the proposed approval of these rules in order to strengthen the SIP. A discussion of the submitted rules are as follows:

BAAQMD Rule 8.45, Motor Vehicle and Mobile Equipment Coating Operations includes the following significant changes from the current SIP:

• Section 231, Volatile Organic Compounds, was amended by adding acetone, parachlorobenzotrifluoride (PCBTF), and cyclic, branched, or linear, fully methylated siloxanes (VMS) to the list of exempt compounds in conformance with EPA and CARB action.

• Section 601, “Analysis of Samples” was amended by adding BAAQMD Method 41 to analyze samples containing PCBTF, and BAAQMD Method 43 to analyze samples containing VMS.

• Section 602, “Determination of Emissions” was amended by adding the following sentence: For the purpose of determining abatement device efficiency, any acetone, PCBTF or VMS shall be included as a VOC.

SCAQMD Rule 1151, Motor Vehicles and Mobile Equipment Non-Assembly Line Coating Operations, includes the following significant changes from the current SIP:

• Effective December 12, 1998 and until April 1, 1998 the Group II multistage topcoat composite VOC limit was raised to 4.5 lbs/gal. The pre-December 12, 1998 limit of 3.5 lbs/gal limit was reinstated on April 1, 1999;

• A 10% usage limitation on a monthly basis was added for specialty coatings;

• Expanded the prohibition of sale clause;

• Added the requirement that manufacturers must offer for sale by January 1, 1999 clearcoats having VOC content of 2.1 lbs/gal or less; and

• Added an exemption for topcoats applied to prototype motor vehicles.

There is currently no version of SDCAPCD's Rule 67.19, Coatings and Printing Inks Manufacturing Operations, in the SIP. The submitted rule includes the following provisions:

• Applicability section;

• Exemption for sources emitting less than 15 lbs/day;

• Sources emitting less than 50 tons/year are exempted from the requirements of emission control systems;

• Storage tanks of less than 550 gal capacity, or those used exclusively for epoxies or water based coatings are exempted from the requirements of submerged fill pipes;

• A definition section;

• Equipment and workmanship standards;

• Option to comply by using abatement equipment;

• Recordkeeping provisions; and

• Test methods.

Earlier versions of this rule were adopted on June 7, 1994, and March 7, 1995. While EPA can only act on the most recently submitted version, EPA reviewed relevant materials associated with the superseded versions. MBUAPCD submitted Rule 425, Use of Cutback Asphalt, includes the following significant changes from the current SIP:

• Use of the term “petroleum solvent” is now used consistently throughout the rule. Prior to this revision, the term organic solvents and petroleum solvents were used interchangeably leading to confusion in the implementation and enforcement of the rule. The rule has been revised to enhance clarity.

• An additional change was made to the “effective date” section. The rule as revised is now effective on the date of adoption.

A detailed discussion of the rules provisions and evaluation has been provided in the PRs and in technical support documents (TSDs) available at EPA's Region IX office. TSDs prepared by EPA are dated November 2, 1998 for MBUAPCD Rule 425, December 1999 for SDCAPCD Rule 67.19, SCAQMD Rule 1151, and BAAQMD Regulation 8-45.

A 30-day public comment period was provided in the PR (see 65 FR 2921). EPA received no comments during this period and one comment after the 30 days expired. This comment was submitted by the National Paint & Coatings Association (NPCA), dated February 25, 2000, and only concerned SCAQMD Rule 1151. Although this comment was submitted and received after close of the comment period, we are acknowledging the comment in this action and summarizing NPCA's primary concern.

NPCA is concerned with the prohibition of sale provision contained in Rule 1151, paragraph (d)(2). NPCA specifically objects to EPA's characterization in proposing approval of Rule 1151, that SCAQMD has “expanded the prohibition of sale clause.” EPA believes this characterization is correct, however, and directs the commenter to page 9 of the December 1998 final staff report associated with SCAQMD's adoption of the submitted rule.

Nothing in this comment has caused EPA to change the rationale for proposing approval of SCAQMD 1151 or the other rules.

EPA is finalizing action to approve BAAQMD Rule 8.45, Motor Vehicle and Mobile Equipment Coating Operations; SCAQMD Rule 1151, Motor Vehicle and Mobile Equipment Non-Assembly Line Coating Operations; SDCAPCD Rule 67.19, Coatings and Printing Inks Manufacturing Operations, and MBUAPCD Rule 425, Use of Cutback Asphalt for inclusion into the California SIP. EPA is approving these rules under section 110(k)(3) as meeting the requirements of section 110(a) and Part D of the CAA. This approval action will incorporate these rules into the federally approved SIP. The intended effect of approving these rules are to regulate emissions of VOCs according to requirements of the CAA.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.

In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Executive Order 13121, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

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), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 25, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Throughout this document wherever “we,” or “our” are used, we mean EPA. On April 7, 2000 (65 FR 18249), we published a final rulemaking action announcing our approval of the Allegheny County, Pennsylvania hospital/medical/infectious waste incinerator (HMIWI) 111(d)/129 plan submitted by the Commonwealth of Pennsylvania. In the text of that document, we inadvertently made two minors. Neither the rationale for nor the intent of the April 7, 2000 direct final rule was affected by these minor errors. This action simply corrects the erroneous language in the published final rulemaking.

To the final rule (FR Docket 00-8660) published in the Federal Register on April 7, 2000 (65 FR 18249), we are making the following corrections:

(1) On page 18251 in the first column, the revised rule language to the second answer (A.) is corrected to read, “* * * meeting the maximum achievable control technology * * *”.

The word “available” was inadvertently inserted in place of “achievable”.

(2) On page 18252 in the third column under § 62.9662 Effective Date, the text is revised to read, “The effective date of the plan is June 6, 2000.”

The phrase “* * * for municipal solid waste landfills * * *” was inadvertently included in the sentence and is hereby deleted.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedures are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because we are merely correcting minor errors in the text of a previous action. Thus, notice and public procedures are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the Supplementary Information section above, 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 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). 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 governments, as specified by 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 technical correction action 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. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). 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, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of June 6, 2000. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . These corrections to the preamble and 40 CFR 62.9662 for Pennsylvania is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Transportation is delegating to the Maritime Administrator his authority relating to the protection of property and persons at the United States Merchant Marine Academy located in Kings Point, New York. The Secretary of Transportation obtained the authority to enforce laws for the protection of property and persons at the United States Merchant Marine Academy from the Administrator of General Services on March 23, 2000.

Previously, the Administrator of General Services had delegated this authority to the Secretary of Transportation who redelegated the authority to the Maritime Administrator. The delegation expired on May 1, 2000. As a result, this delegation of authority from the Secretary of Transportation to the Maritime Administrator relating to the protection of property and persons at the United States Merchant Marine Academy is necessary to ensure the continued authority of the Maritime Administrator to appoint uniformed personnel as special police, establish the rules and regulations governing conduct on the affected property, and execute agreements with other Federal, State, or local authorities. The Maritime Administration has previously had the responsibility for the Academy and related property, and currently has the experience and requisite expertise to promptly effect the actions prescribed by the statutes.

This amendment revises 49 CFR 1.66(q) to reflect the Secretary of Transportation's delegation of his authority relating to the protection of the Merchant Academy to the Maritime Administrator for an indefinite period of time. Since this amendment relates to departmental organization, procedure and practice, notice and comment are unnecessary under 5 U.S.C. 553(b). Further, since the amendment expedites the Maritime Administration's ability to meet the statutory intent of the applicable laws and regulations covered by this delegation, the Secretary finds good cause under 5 U.S.C. 553(d)(3) for the final rule to be effective on the date of publication in the Federal Register .

The Anti Car Theft Act of 1992, Pub. L. 102-519, amended the law relating to the parts-marking of major component parts on designated high-theft vehicle lines and other motor vehicles. The Anti Car Theft Act amended the definition of “passenger motor vehicle” in 49 U.S.C. 33101(10) to include a “multipurpose passenger vehicle or light duty truck when that vehicle or truck is rated at not more than 6,000 pounds gross vehicle weight.” Since “passenger motor vehicle” was previously defined to include passenger cars only, the effect of the Anti Car Theft Act is that certain multipurpose passenger vehicle (MPV) and light-duty truck (LDT) lines may be determined to be high-theft vehicles subject to the Federal motor vehicle theft prevention standard (49 CFR part 541).

The purpose of the theft prevention standard is to reduce the incidence of motor vehicle theft by facilitating the tracing and recovery of parts from stolen vehicles. The standard seeks to facilitate such tracing by requiring that vehicle identification numbers (VINs), VIN derivative numbers, or other symbols be placed on major component vehicle parts. The theft prevention standard requires motor vehicle manufacturers to inscribe or affix VINs onto covered original equipment major component parts, and to inscribe or affix a symbol identifying the manufacturer and a common symbol identifying the replacement component parts for those original equipment parts, on all vehicle lines selected as high-theft.

The Anti Car Theft Act also amended 49 U.S.C. 33103 to require NHTSA to promulgate a parts-marking standard applicable to major parts installed by manufacturers of “passenger motor vehicles (other than light duty trucks) in not to exceed one-half of the lines not designated under 49 U.S.C. 33104 as high-theft lines.” Section 33103(a) further directed NHTSA to select only lines not designated under section 33104 of this title as high theft lines. NHTSA lists each of these selected lines in appendix B to part 541. Since section 33103 did not specify marking of replacement parts for below-median lines, the agency does not require marking of replacement parts for these lines. NHTSA published a final rule amending 49 CFR part 541 to include the definitions of MPV and LDT, and major component parts. See 59 FR 64164, December 13, 1995.

49 U.S.C. 33104(a)(3) specifies that NHTSA shall select high-theft vehicle lines, with the agreement of the manufacturer, if possible. Section 33104(d) provides that once a line has been designated as likely high-theft, it remains subject to the theft prevention standard unless that line is exempted under section 33106. Section 33106 provides that a manufacturer may petition to have a high-theft line exempted from the requirements of section 33104, if the line is equipped with an antitheft device as standard equipment. The exemption is granted if NHTSA determines that the antitheft device is likely to be as effective as compliance with the theft prevention standard in reducing and deterring motor vehicle thefts.

The agency annually publishes the names of the lines which were previously listed as high-theft, and the lines which are being listed for the first time and will be subject to the theft prevention standard beginning in a given model year. It also identifies those lines that are exempted from the theft prevention standard for a given model year under section 33104. Additionally, this listing identifies those lines (except light-duty trucks) in appendix B to part 541 that have theft rates below the 1990/1991 median theft rate but are subject to the requirements of this standard under section 33103.

On May 25, 1999, the final listing of high-theft lines for the MY 2000 vehicle lines was published in the Federal Register (64 FR 28110). The final listing identified five vehicle lines that were listed for the first time and became subject to the theft prevention standard beginning with the 2000 model year.

For MY 2001, the agency identified eight new vehicle lines that are likely to be high-theft lines, in accordance with the procedures published in 49 CFR part 542. The new lines are the Daewoo Musso (MPV), the Honda Acura MDX (MPV), the Kia Motors Rio and Optima, the Suzuki MPV (nameplate not available), the Toyota Highlander (MPV), the Toyota Lexus IS300 and the Toyota MR2 Spyder. In addition to these eight vehicle lines, the list of high-theft vehicle lines includes all lines previously designated as high-theft and listed for prior model years. Appendix A also has been amended to reflect a nameplate change for the Isuzu Amigo vehicle line to Isuzu Rodeo Sport beginning with MY 2001.

The list of lines that have been exempted by the agency from the parts-marking requirements of Part 541 includes high-theft lines newly exempted in full beginning with MY 2001. The four vehicle lines newly exempted in full are the Ford Mercury Sable, the General Motors Chevrolet Malibu, the Nissan Pathfinder and the Volkswagen Audi Allroad Quattro.

Subsequent to publishing the MY 2000 listing, the agency granted BMW of North America, Inc., an exemption from the parts-marking requirements of the theft prevention standard for its X5 vehicle line beginning with the 2000 model year. Therefore, the BMW X5 vehicle line has been added to Appendix A-I of this listing. Furthermore, Appendix A-I has been amended to reflect a nameplate change for the General Motors Chevrolet Lumina/Monte Carlo car line. The Chevrolet Lumina/Monte Carlo car line nameplate was changed to Chevrolet Impala/Monte Carlo beginning with MY 2000.

Appendix A-II has also been amended to reflect a MY 1994 nameplate change for the General Motors Cadillac Sixty Special to General Motors Cadillac Concours.

Additionally, since the agency granted Ford Motor Company an exemption from the parts-marking requirements for its Mercury Sable car line, it has been deleted from Appendix B.

The vehicle lines listed as being subject to the parts-marking standard have previously been designated as high-theft lines in accordance with the procedures set forth in 49 CFR part 542. Under these procedures, manufacturers evaluate new vehicle lines to conclude whether those new lines are likely to be high theft. The manufacturer submits these evaluations and conclusions to the agency, which makes an independent evaluation; and, on a preliminary basis, determines whether the new line should be subject to the parts-marking requirements. NHTSA informs the manufacturer in writing of its evaluations and determinations, together with the factual information considered by the agency in making them. The manufacturer may request the agency to reconsider the preliminary determinations. Within 60 days of the receipt of these requests, the agency makes its final determination. NHTSA informs the manufacturer by letter of these determinations and its response to the request for reconsideration. If there is no request for reconsideration, the agency's determination becomes final 45 days after sending the letter with the preliminary determination. Each of the new lines on the high-theft list has been the subject of a final determination under either 49 U.S.C. 33103 or 33104.

The vehicle lines listed as being exempt from the standard have previously been exempted in accordance with the procedures of 49 CFR part 543 and 49 U.S.C. 33106.

Similarly, the low-theft lines listed as being subject to the parts-marking standard have previously been designated in accordance with the procedures set forth in 49 U.S.C. 33103.

Therefore, NHTSA finds for good cause that notice and opportunity for comment on these listings are unnecessary. Further, public comment on the listing of selections and exemptions is not contemplated by 49 U.S.C. Chapter 331.

For the same reasons, since this revised listing only informs the public of previous agency actions and does not impose additional obligations on any party, NHTSA finds for good cause that the amendment made by this notice should be effective as soon as it is published in the Federal Register .

NHTSA has analyzed this rule and determined that it is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures. The agency has also considered this notice under Executive Order 12866. As already noted, the selections in this final rule have previously been made in accordance with the provisions of 49 U.S.C. 33104, and the manufacturers of the selected lines have already been informed that those lines are subject to the requirements of 49 CFR part 541 for MY 2001. Further, this listing does not actually exempt lines from the requirements of 49 CFR part 541; it only informs the general public of all such previously granted exemptions. Since the only purpose of this final listing is to inform the public of actions for MY 2001 that the agency has already taken, a full regulatory evaluation has not been prepared.

The agency has also considered the effects of this listing under the Regulatory Flexibility Act. I hereby certify that this rule will not have a significant economic impact on a substantial number of small entities. As noted above, the effect of this final rule is simply to inform the public of those lines that are already subject to the requirements of 49 CFR part 541 for MY 2001. The agency believes that the listing of this information will not have any economic impact on small entities.

In accordance with the National Environmental Policy Act of 1969, the agency has considered the environmental impacts of this rule, and determined that it will not have any significant impact on the quality of the human environment.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this final rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment.

This final rule does not have a retroactive effect. In accordance with section 33118 when the Theft Prevention Standard is in effect, a State or political subdivision of a State may not have a different motor vehicle theft prevention standard for a motor vehicle or major replacement part. 49 U.S.C. 33117 provides that judicial review of this rule may be obtained pursuant to 49 U.S.C. 32909. Section 32909 does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.