The Grain Inspection, Packers and Stockyards Administration (GIPSA) administers and enforces the Packers and Stockyards Act of 1921, as amended and supplemented (7 U.S.C. 181-229) (P&S Act). The P&S Act prohibits unfair, deceptive, and fraudulent practices by livestock market agencies, dealers, stockyard owners, meat packers, swine contractors, and live poultry dealers in the livestock, poultry, and meatpacking industries.

The P&S Act authorizes information collection for the purpose of enforcing the P&S Act and regulations and to conduct studies as requested by Congress. The information is needed for us to carry out our responsibilities under the P&S Act. The information is necessary to monitor and examine financial, competitive, and trade practices in the livestock, meat packing, and poultry industries.

This amendment corrects the displayed control numbers, as required by the Paperwork Reduction Act (44 U.S.C. 3501-3520) and the Office of Management and Budget (OMB) regulations (5 CFR part 1320). OMB regulations provide options for the display of control numbers to show the OMB approval of information collection activities; we will continue to use the option of displaying the OMB control numbers at the end of each regulation that requires recordkeeping, reporting, or other information collection activity.

The information collection activities approved under OMB control number 0580-0015, are the reporting, recordkeeping, and other information collection requirements in 9 CFR part 201, Regulations Under the Packers and Stockyards Act, and in 9 CFR part 203, Statements of General Policy Under the Packers and Stockyards Act. Formerly, these activities were approved under OMB control number 0590-0001 for the Packers and Stockyards Administration. After GIPSA was established, OMB assigned the new control number. Therefore, occurrences of 0590-0001 in the CFR need to be revised to 0580-0015 to reflect the current OMB control number. In addition, we need to add the current OMB control number at the end of section 201.108-1 of the regulations.

There will be no changes to the regulatory text or any information collection change as a result of this technical amendment. Therefore, we find that it is unnecessary to request comments and believe that there is good cause under 5 U.S.C. 553 (d)(3), to make this amendment to parts 201 and 203 final upon publication in the Federal Register .

The Office of Management and Budget (OMB) designated this technical amendment as not significant for the purposes of Executive Order 12866. This technical amendment updates the OMB control numbers published at the end of specific regulations and statements of general policy in the Code of Federal Regulations (CFR) in 9 CFR parts 201 and 203. The information collection requirements approved by OMB under control number 0580-0015 have been previously approved. The current approval expires on September 30, 2004. This technical amendment does not change the information collection requirements.

There will be neither costs imposed by nor benefits resulting from this technical amendment. There are no potential economic effects on small entities. This technical amendment does not make any changes to the projected reporting or recordkeeping burden imposed on small entities. Therefore, as the GIPSA Administrator, I certify that this technical amendment will not significantly impact a substantial number of small entities, as required by the Regulatory Flexibility Act (5 U.S.C. 601-612).

This technical amendment has been reviewed under E.O. 12988, Civil Justice Reform, and is not intended to have retroactive effect. This technical amendment will not pre-empt State or local laws, regulations, or 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 technical amendment.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the information collection or recordkeeping requirements included in this technical amendment have been approved by the Office of Management and Budget (OMB) under OMB control number 0580-0018.

GIPSA is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies, in general, to provide the public option of submitting information or transacting business electronically to the maximum extent possible.

The Nuclear Regulatory Commission is amending the regulations in 10 CFR parts 1, 4, 19, 35, 39, 40, and 50 to correct several miscellaneous errors in regulatory text. These changes in CFR text occurred in the process of preparing and printing of rulemaking documents. The corrections include changing the Zip+4 for Region IV in § 1.5; changing the name of the “Licensing Support System Advisory Review Panel (LSSARP)” to the “Licensing Support Network Advisory Review Panel (LSNARP)” in § 1.19; correcting the reference “20 U.S.C. 7801” to “20 U.S.C. 8801” in § 4.4(g)(2)(ii); correcting the misspelled word “covenant” in § 4.21(b); substituting “Title VI” for “Title VII” in § 19.32; changing the word “Megabecquerels” to “megabecquerels” in § 35.40(a); changing the word “Gigabecquerels” to “gigabecquerels” in §§ 35.390, 392, and 394; correcting the conversion from “MBq” to “GBq” in § 39.55(b); changing the reference from paragraphs (d)(4), (f) and (g) to paragraphs (d)(4), (g) and (h) in § 40.42(l) and correcting the ASTME code title in Appendix H to part 50.

Because these amendments constitute minor administrative corrections to the regulations, the notice and comment provisions of the Administrative Procedure Act do not apply pursuant to 5 U.S.C. 553(b)(B). The amendment is effective upon publication in the Federal Register . Good cause exists under 5 U.S.C. 553(d) to dispense with the usual 30-day delay in the effective date of the final rule, because the amendments are of a minor and administrative nature dealing with corrections to certain CFR sections, which do not require action by any person or entity regulated by the NRC. Nor does the final rule change the substantive responsibilities of any person or entity regulated by the NRC.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget, approval numbers 3150-0053; 3150-0044; 3150-0010; 3150-0130; 3150-0020; and 3150-0011.

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

The final regulations that are the subject of these corrections, revised the bird ingestion type certification standards for aircraft turbine engines to better address the actual bird threat encountered in service, and established nearly uniform bird ingestion standards for aircraft turbine engines certified by the United States under FAA standards and by the Joint Aviation Authorities (JAA) countries under JAA standards, thereby simplifying airworthiness approvals for import and export.

As published, the final regulations contain errors that may prove to be misleading and need to be clarified.

3. In § 33.76, in paragraph (c)(7)(ii), remove the word “level” and add in its place the word “lever”.

4. In § 33.76, in paragraph (c)(7)(iii), remove the figure “175-percent” and add in its place the figure “75-percent”.

5. In § 33.76, in paragraph (c)(7)(viii), remove the sentence “The durations specified are times at the defined conditions with the power lever being moved between each condition in less than 10 seconds.”

6. In § 33.76, in paragraph (c)(7), add a new paragraph (c)(7)(ix) to read as follows:

The FAA issued Special Airworthiness Information Bulletin (SAIB) Number CE-02-44, dated September 4, 2002, for SOCATA—Groupe AEROSPATIALE (SOCATA) Model TBM 700 airplanes, concerning ANJOU seat belts. At that time, FAA did not make a determination of an unsafe condition and take AD action.

Later, FAA issued SAIB Number CE-03-06, dated November 7, 2002, for SOCATA Rallye 150T, Rallye 150ST, Rallye 235E, and Rallye 235C airplanes, concerning ANJOU seat belts. Again, FAA then did not make a determination of an unsafe condition and take AD action.

We continued to receive field reports of inadvertent unbuckling of the ANJOU seat belts. The FAA received two safety recommendations to take AD action (NPRM) to propose to require replacement of certain safety belts and restraint systems.

In light of the field reports and safety recommendations, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all SOCATA Models TB 9, TB 10, TB 20, TB 21, TB 200, TMB 700, Rallye 100S, Rallye 150T, Rallye 150ST, Rallye 235E, and Rallye 235C airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on March 7, 2003 (68 FR 11015). The NPRM proposed to require you to replace certain safety belts and restraint systems.

Comments received on the NPRM suggest that FAA withdraw the proposal and that FAA consider issuing a new NPRM to propose that you:

We agree, and therefore, are withdrawing that NPRM.

These defective safety belts and restraint systems could result in failure of the safety belts and restraint systems. This failure could lead to lack of occupant restraint during normal or crash loads.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain ANJOU (formerly TRW Repa S.A., formerly L'AIGLON) safety belts and restraint systems that are installed in aircraft. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on September 2, 2003 (68 FR 52145). The NPRM proposed to inspect safety belts and restraint systems for defects and service life limits, and, if necessary, repair safety belts and restraint systems that have not reached service life limits; and replace safety belts and restraint systems that have reached service life limits.

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

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

On July 10, 2002, the FAA published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

We estimate that this AD affects 617 aircraft in the U.S. registry that could have the affected ANJOU safety belts and restraint systems installed. Some aircraft have more than one unit installed.

We estimate the following costs to accomplish the inspection and repair:

The applicable service information identifies that replacement parts are available free of charge. For replacement of a safety belt assembly, the parts cost is approximately $150 per seat belt assembly. The number of installed safety belts and restraint systems may vary by individual aircraft configuration. Therefore, we have no way of determining the replacement cost for this AD.

The compliance time of this AD is within 50 hours time-in-service (TIS) or 4 calendar months after the effective date of this AD, whichever occurs first.

Defective safety belts and restraint systems are a direct result of use of the safety belts and restraint systems. However, defective safety belts and restraint systems are not necessarily a result of repetitive airplane operation. For example, defective safety belts and restraint systems could occur on an affected airplane within a short period of airplane operation while you could operate another affected airplane for a considerable amount of time without experiencing defective safety belts and restraint systems. Therefore, to assure that any defective safety belt and restraint system is detected and corrected in a timely manner without inadvertently grounding any of the affected airplanes, we are using a compliance time based upon both hours TIS and calendar time.

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

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

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

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

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

We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2003-CE-31-AD” in your request.

The Ente Nazionale per l'Aviazione Civile (ENAC), the airworthiness authority for Italy, notified the FAA that an unsafe condition may exist on Agusta Model A109E helicopters. The ENAC advises that inspections of the rod-end should be carried out as called for by the manufacturer's service information.

Agusta has issued Bollettino Tecnico (BT) No. 109EP-37, dated July 15, 2003; BT No. 109EP-37, Revision A, dated July 30, 2003; and Errata Corrige, dated September 2, 2003; which specify an inspection of each damper rod-end assembly, part number (P/N) Microtecnica 3637GR85, for seizure or a crack. Agusta reports rod-end fractures due to fatigue failure originating from the thread under cut of the rod-end resulting in increased helicopter vibrations. Also, during the first few hours of operation, the rotational torque of the spherical bearing increases generating additional loads on the rod-end. ENAC has classified this BT as mandatory and issued AD Nos. 2003-231, dated July 18, 2003, and 2003-249, dated August 1, 2003, to ensure the continued airworthiness of these helicopters in Italy.

This helicopter model is manufactured in Italy and is type certificated for operation in the United States under the provisions of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the applicable bilateral agreement, ENAC has kept the FAA informed of the situation described above. The FAA has examined the findings of ENAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

This unsafe condition is likely to exist or develop on other helicopters of the same type design registered in the United States. Therefore, this AD is being issued to prevent failure of the rod-end, extreme vibration, and a subsequent forced landing or loss of control of the helicopter. This AD requires the following:

• Within 25 hours time-in-service (TIS), inspect the rod-end to determine if it can be rotated by hand.

• If the rod-end can be rotated by hand, no further action is required.

• If the rod-end cannot be rotated by hand, determine the torque value required to rotate it by use of a torque wrench.

• If the torque value is less than 20 Newton-meter (Nm) (177 in-lb) within 25 hours TIS, inspect the rod-end for a crack by a magnetic particle inspection. If a crack is found, replace the rod-end assembly with an airworthy part before further flight.

• If the torque value is 20 Nm or more, replace the rod-end assembly with an airworthy part before further flight.

The actions must be done using the BT 109EP-37, Revision A, as amended by the Errata Corrige, described previously. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, within 25 hours TIS, inspecting the rod-end to determine if it can be rotated by hand is required. If the rod-end cannot be rotated by hand, determining the torque value required to rotate the rod end and, if necessary, replacing the rod-end assembly with an airworthy part before further flight are required, and this AD must be issued immediately.

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

The FAA estimates that this AD will affect 34 helicopters of U.S. registry, and the required actions will take approximately 3 work hours per helicopter to accomplish at an average labor rate of $65 per work hour. Required parts will cost approximately $450 per helicopter. Based on these figures, we estimate the total cost of the AD on U.S. operators to be $21,930 ($645 per helicopter). However, Agusta states in its BT that it will supply the parts at no cost and will reimburse up to 2.5 work hours for each terminal at a fixed rate of $40. Assuming the warranty coverage, the estimated total cost impact on U.S. operators would be $3,230 ($95 per helicopter).

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 should 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.

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 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 mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2003-SW-36-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.

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 McDonnell Douglas Model MD-90-30 airplanes was published in the Federal Register on June 11, 2003 (68 FR 34849). That action proposed to require a one-time general visual inspection of the circuit breakers to determine if discrepant circuit breakers are installed, and corrective action if necessary.

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

The commenter, an operator, requests clarification of the applicability listed in the proposed AD. The commenter states that it has nine airplanes that are included in the applicability listed in the proposed AD. Because no Wood Electric circuit breakers were installed on its newly delivered airplanes or installed on any airplane during maintenance, those airplanes fall into “Group 1, Condition 1,” as listed in Boeing Alert Service Bulletin MD90-24A081, Revision 01, dated March 7, 2003 (which was referenced as the appropriate source of service information for accomplishment of the inspection in the proposed AD). For those airplanes, the alert service bulletin states that no action is required. However, the proposed AD would require those airplanes to be inspected to determine if any Wood Electric circuit breaker is installed even though the commenter knows the circuit breakers are not installed.

The FAA agrees that clarification is necessary. Paragraph (a) of the AD does require that all airplanes listed in the applicability statement of the AD be inspected to verify installation of the discrepant circuit breaker. However, the airplane manufacturer has determined that no Model MD-90-30 airplanes were delivered with the subject discrepant circuit breakers installed. Therefore, instead of accomplishing the inspection provided in paragraph (a) of the AD, we will allow operators to review the airplane maintenance records to determine if any discrepant circuit breaker was installed on the airplane after delivery—if the part number of the circuit breakers can be positively determined from that review. We have revised paragraph (a) of this final rule accordingly.

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 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.

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 126 airplanes of the affected design in the worldwide fleet. The FAA estimates that 21 airplanes of U.S. registry will be affected by this AD, that it will take approximately 20 work hours per airplane to accomplish the required inspection of the circuit breakers (over 700 installed on each airplane), and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $27,300, or $1,300 per airplane.

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 cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

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 certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes was published as a supplemental Notice of Proposed Rulemaking in the Federal Register on June 23, 2003 (68 FR 37105). That action proposed to require replacing the existing pressure relief valve on the potable water tank with a new, improved pressure relief valve, which is made of stainless steel and is non-adjustable. For certain airplanes, that action also proposed to require modification of certain piping to re-locate the pressure relief valve. For certain airplanes, that action proposed to revise the earlier proposed AD by correcting procedures for performing the proposed replacement of the pressure relief valve.

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

Two commenters agree with the proposed AD.

One commenter requests that Revision 1 of Boeing Service Bulletin 737-38A1047, dated September 27, 2001, be approved as an acceptable method of compliance for the terminating action requirements of the proposed AD. The commenter notes that Revision 2 of the service bulletin states that no more work is necessary on airplanes changed per Revision 1.

The FAA agrees. We have determined that the work instructions that depict the piping and fittings adjacent to the new relief valve are slightly different between Revision 2 and Revision 1 of Boeing Service Bulletin 737-38A1047. We acknowledge that the figures are similar enough to each other that an operator would correctly install the new relief valve per either Revision 1 or Revision 2 of the service bulletin. Consequently, we have revised paragraph (d) of the final rule to remove the qualifying phrase, “With the exception of airplanes specified as ‘Group 9’ or ‘Group 10’ in Boeing Service Bulletin 737-38A1047, Revision 2, dated July 18, 2002.” Such revision of paragraph (d) will permit, for all airplanes, accomplishment of the actions specified in service bulletins issued prior to Revision 2 to be considered as an acceptable means of compliance with paragraph (d) of the final rule. However, Revision 2 was specified in paragraphs (a)(2), (b), and (c) of the proposed AD because it more accurately reflects the airplane installation than previous revisions, and those paragraphs remain unchanged in the final rule.

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.

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 2,049 Model 737-100, -200, -200C, -300, -400, and -500 series airplanes of the affected design in the worldwide fleet.

We estimate that, of the 1,144 airplanes of U.S. registry, only 2 airplanes will be affected by the required modification of piping to re-locate the pressure relief valve. We estimate that it will take approximately 6 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $780, or $390 per airplane.

We also estimate that all of the 1,144 airplanes of U.S. registry will be affected by the required replacement of the pressure relief valve, that it will take approximately 2 work hours per airplane to accomplish the replacement, and that the average labor rate is $65 per work hour. Required parts will cost approximately $300 per airplane. Based on these figures, the cost impact of the replacement of the pressure relief valve on U.S. operators is estimated to be $491,920, or $430 per airplane.

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 cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

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 .

On November 25, 2003, the FAA issued AD 2003-24-12, Amendment 39-13381 (68 FR 67585, December 3, 2003). That AD requires a one-time visual inspection of the gearbox pressure tube and No. 4 bearing front pressure manifold and the attaching clamp assemblies for correct positioning and for wear and damage, and replacement if necessary. That AD was the result of a report of a failed gearbox pressure tube that resulted in an engine fire. That condition, if not corrected, could result in engine fires caused by failed gearbox pressure tubes or failed No. 4 bearing front pressure manifolds.

Since that AD was issued, errors in the depicted clamping configuration have been found. The clamping configuration must be correct to ensure that AD compliance can be achieved. Also, an operator has requested that as an option to inspecting dented tubing by passing a ball bearing through the tube, to add dent depth limit criteria for each specific part number tube. The manufacturer supports this optional method and we have added it to the AD. This method avoids having to disconnect the tube from the engine.

The unsafe condition described previously is likely to exist or develop on other PW JT9D-3A, -7, -7A, -7F, -7H, -7AH, and -7J turbofan engines of the same type design. We are issuing this AD to prevent an engine fire caused by a failed gearbox pressure tube. This AD requires a one-time visual inspection of the gearbox pressure tube, P/N 697896, the No. 4 bearing front pressure manifold, P/N 670663, and the attaching clamp assemblies, P/Ns ST1594-06, ST1594-08, and ST1594-10, for correct positioning, for wear and damage, and replacement if necessary.

The effective date of this AD is the same as AD 2003-24-12. We discussed the errors depicted in AD 2003-24-12 with the U.S. operators, and adding the optional dent inspection method, and conclude that there is no adverse impact from using the same effective date.

On July 10, 2002, we issued a new version of 14 CFR part 39 (67 FR 47998, July 22, 2002), which governs our AD system. This regulation now includes material that relates to special flight permits, alternative methods of compliance, and altered products. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES. Include “AD Docket No. 2003-NE-52-AD” in the subject line of your comments. If you want us to acknowledge receipt of your mailed comments, send us a self-addressed, stamped postcard with the docket number written on it; we will date-stamp your postcard and mail it back to you. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify it. If a person contacts us verbally, and that contact relates to a substantive part of this AD, we will summarize the contact and place the summary in the docket. We will consider all comments received by the closing date and may amend the AD in light of those comments.

We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications with you. You may get more information about plain language at http://www.faa.gov/language and http://www.plainlanguage.gov .

You may examine the AD Docket (including any comments and service information), by appointment, between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. See ADDRESSES for the location.

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

On October 24, 2003, the FAA issued AD 2003-22-09, Amendment 39-13357 (68 FR 62228, November 3, 2003). That AD requires:

• Borescope inspection of the No. 3 bearing weep tube, on engines with high oil consumption that troubleshooting procedures fail to determine the source of oil loss.

• For all engines, initial and repetitive visual inspections of the turbine exhaust case (TEC) in the vicinity of the No. 3 bearing oil vent tube for evidence of oil wetting or staining. If the vent tube borescope inspection is unsuccessful due to tube blockage, that AD also requires borescope inspections of the HPT assembly for oil wetting or staining.

• Removal of the HPT assembly and replacement of any heat distressed HPT assembly hardware if oil wetting or staining is found.

That AD is the result of engine HPT assembly hardware being damaged as a result of thermal distress from oil igniting after leaking from the No. 3 bearing compartment. That condition, if not corrected, could result in a cracked HPT stage 1 disk or HPT stage 1-2 air seal and an uncontained engine failure.

Since that AD was issued, a comment was received that revealed an error in the compliance section. We have considered that comment.

One commenter states that paragraph (i)(3) of the AD contains an incorrect reference. In that paragraph, the wording “since performing the visual inspection of the TEC specified in paragraph (h)(1) of this AD”, is misleading as it should be referencing borescope inspection and not visual inspection.

We agree. Therefore, we have corrected the wording to read “since performing the borescope inspection of the No. 3 bearing oil vent tube specified in paragraph (i)(1) of this AD'.

The effective date of this AD is the same as AD 2003-22-09. We discussed the reference error in AD 2003-22-09 with the one U.S. operator, and conclude that there is no adverse impact from using the same effective date.

We have reviewed and approved the technical contents of Pratt & Whitney Alert Service Bulletin (ASB) No. PW4G-112-A72-257, Revision 1, dated August 22, 2003, that describes procedures for:

• Borescope inspection of the No. 3 bearing weep tube, on engines with high oil consumption that troubleshooting procedures fail to determine the source of oil loss.

• For all engines, initial and repetitive visual inspections of the TEC, in the vicinity of the No. 3 bearing oil vent tube assembly and borescope inspections of the No. 3 bearing oil vent tube assembly, for evidence of oil wetting or staining.

• Borescope inspection of the HPT assembly for evidence of oil wetting or staining if the borescope inspection of the No. 3 bearing oil vent tube assembly is unsuccessful due to blockage.

• Removal of the engine if oil wetting or staining is found.

Although ASB No. PW4G-112-A72-257, Revision 1, dated August 22, 2003, requires removal of the engine from service if oil wetting or staining is found, this AD requires removal of the HPT assembly and replacement of any heat distressed HPT assembly hardware if oil wetting or staining is found.

The unsafe condition described previously is likely to exist or develop on other Pratt & Whitney PW4074, PW4074D, PW4077, PW4077D, PW4084, PW4084D, PW4090, PW4090D, PW4090-3, and PW4098 turbofan engines of the same type design. We are issuing this AD to prevent thermal distressed HPT assembly hardware to remain in service, which could result in a cracked HPT stage 1 disk or HPT stage 1-2 air seal and an uncontained engine failure. This AD requires:

• Borescope inspection of the No. 3 bearing weep tube on engines with high oil consumption that troubleshooting procedures fail to determine the source of oil loss.

• For all engines, initial and repetitive visual inspections of the TEC, in the vicinity of the No. 3 bearing oil vent tube assembly and borescope inspections of the No. 3 bearing oil vent tube assembly, for evidence of oil wetting or staining.

• Borescope inspections of the HPT assembly for oil wetting or staining, if the vent tube borescope inspection is unsuccessful due to tube blockage.

• Removal of the HPT assembly and replacement of any heat distressed HPT assembly hardware if oil wetting or staining is found.

You must use the service information described previously to perform the actions required by this AD.

Since an unsafe condition exists that requires the immediate adoption of this AD, we have found that notice and opportunity for public comment before issuing this AD are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

On July 10, 2002, we issued a new version of 14 CFR part 39 (67 FR 47998, July 22, 2002), which governs our AD system. This regulation now includes material that relates to special flight permits, alternative methods of compliance, and altered products. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

These actions are interim actions and we may take further rulemaking actions in the future.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES. Include “AD Docket No. 2003-NE-40-AD” in the subject line of your comments. If you want us to acknowledge receipt of your mailed comments, send us a self-addressed, stamped postcard with the docket number written on it; we will date-stamp your postcard and mail it back to you. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify it. If a person contacts us verbally, and that contact relates to a substantive part of this AD, we will summarize the contact and place the summary in the docket. We will consider all comments received by the closing date and may amend the AD in light of those comments.

We are reviewing the writing style we currently use in regulatory documents. We are interested in your comments on whether the style of this document is clear, and your suggestions to improve the clarity of our communications with you. You may get more information about plain language at http://www.faa.gov/language and http://www.plainlanguage.gov .

You may examine the AD Docket (including any comments and service information), by appointment, between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. See ADDRESSES for the location.

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

For the reasons discussed above, I certify that the regulation:

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

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

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

We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2003-NE-40-AD” in your request.

The FAA published this direct final rule with a request for comments in the Federal Register on November 12, 2003 (68 FR 63985). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on February 19, 2004. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on November 19, 2003 (68 FR 65159). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on February 19, 2004. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In the September 23, 2003, Federal Register , (68 FR 55202-55204), BEA published a notice of proposed rulemaking setting forth reporting requirements for the BE-45, Quarterly Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons. No comments on the proposed rule were received. Thus, the proposed rule is adopted without change.

The Bureau of Economic Analysis (BEA), U.S. Department of Commerce, will conduct the survey under the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108). Section 4(a) of the Act (22 U.S.C. 3103(a)) provides that the President shall, to the extent he deems necessary and feasible, conduct a regular data collection program to secure current information related to international investment and trade in services and publish for the use of the general public and United States government agencies periodic, regular, and comprehensive statistical information collected pursuant to this subsection. In section 3 of Executive Order 11961, as amended by Executive Order 12518, the President delegated authority granted under the Act as concerns international trade in services to the Secretary of Commerce, who has redelegated it to BEA.

The major purposes of the survey are to monitor trade in insurance services, analyze its impact on the U.S. and foreign economies, compile and improve the U.S. economic accounts, support U.S. commercial policy on insurance services, conduct trade promotion, and improve the ability of U.S. businesses to identify and evaluate market opportunities.

The first survey conducted under this rule will cover transactions in the first quarter 2004. BEA will send the survey to potential respondents in March of 2004; responses will be due by May 30, 2004. The survey will update the data provided on the universe of insurance services transactions between U.S. insurance companies and foreign persons. Reporting is required from U.S. insurance companies whose covered transactions with foreign persons exceeded $8 million for the previous fiscal year, or are expected to exceed that amount during the current fiscal year. In addition, the reporting threshold for this survey is applied separately to each of the eight individual types of transactions covered by the survey rather than to the sum of the data for all eight types combined. Insurance companies meeting these criteria must supply data on the amount of their insurance transactions for each type of insurance category, disaggregated by country. U.S. insurance companies that do not meet the mandatory reporting requirements are requested to provide voluntary estimates of their covered insurance transactions.

The transactions covered by this survey are: reinsurance premiums received, reinsurance premiums paid, reinsurance losses paid, reinsurance losses recovered, primary insurance premiums received, primary insurance losses paid, auxiliary insurance services receipts, and auxiliary insurance services payments. (Auxiliary insurance services include agent's commissions, insurance brokering and agency services, insurance consulting services, evaluation and adjustment services, actuarial services, salvage administration services, and regulatory and monitoring services on indemnities and recovery services.)

This final rule is not significant for purposes of E.O. 12866.

This final rule does not contain policies with federalism implications as that term is defined in E.O. 13132.

The collection of information required in this final rule has been approved by the Office of Management and Budget under the Paperwork Reduction Act. Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection displays a currently valid OMB Control Number; such a Control Number (0608-0066) will be displayed.

The BE-45 survey is expected to result in the filing of approximately 210 reports on a quarterly basis, or 840 responses annually, and the average respondent burden for completing the survey is estimated at 8 hours. Thus, the total respondent burden of the survey is estimated at about 6,720 hours (840 responses times 8 hours average burden). The actual burden will vary from reporter to reporter, depending upon the number and variety of their insurance transactions and the ease of assembling the data. This estimate includes time for respondents to review the instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information.

Comments regarding the burden estimate or any aspect of this collection of information should be addressed to: Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; or faxed (202-395-7245) or e-mailed (pbugg@omb.eop.gov) to the Office of Management and Budget, O.I.R.A., (Attention PRA Desk Officer for BEA).

The Chief Counsel for Regulation, Department of Commerce, has certified to the Chief Counsel for Advocacy, Small Business Administration, under provisions of the Regulatory Flexibility Act (5 U.S.C. 605(b)), that this rule will not have a significant economic impact on a substantial number of small entities as that term is defined in the Regulatory Flexibility Act. The factual basis for the certification was published with the proposed rule. No comments were received regarding the economic impact of the rule. As a result, no final regulatory flexibility analysis was prepared.

In the September 23, 2003, Federal Register , (68 FR 55204-55206), BEA published a notice of proposed rulemaking setting forth reporting requirements for the BE-25, Quarterly Survey of Transactions with Unaffiliated Foreign Persons in Selected Services and in Intangible Assets. No comments on the proposed rule were received. Thus, the proposed rule is adopted without change.

The Bureau of Economic Analysis (BEA), U.S. Department of Commerce, will conduct the survey under the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108). Section 4(a) of the Act (22 U.S.C. 3103(a)) provides that the President shall, to the extent he deems necessary and feasible, conduct a regular data collection program to secure current information related to international investment and trade in services and publish for the use of the general public and United States Government agencies periodic, regular, and comprehensive statistical information collected pursuant to this subsection. In section 3 of Executive Order 11961, as amended by Executive Order 12518, the President delegated authority granted under the Act as concerns international trade in services to the Secretary of Commerce, who has redelegated it to BEA.

The major purposes of the survey are to monitor trade in services and in intangible assets, analyze the impact of this trade on the U.S. and foreign economies, compile and improve the U.S. economic accounts, support U.S. commercial policy on services and intangible assets, conduct trade promotion, and improve the ability of U.S. businesses to identify and evaluate market opportunities.

The BE-25 survey is mandatory and will be conducted under the International Investment and Trade in Services Survey Act. The first survey conducted under this rule will cover transactions in the first quarter of 2004. BEA will send the survey to potential respondents in March of 2004; responses will be due by May 15, 2004. The survey will update the data provided on the universe of transactions between U.S. and unaffiliated foreign persons in selected services and in intangible assets. Reporting is required from U.S. persons whose sales of covered services to unaffiliated foreign persons exceeded $6 million for the previous fiscal year or are expected to exceed that amount during the current fiscal year, or whose purchases of covered services from unaffiliated foreign persons exceeded $4 million for the previous fiscal year or are expected to exceed that amount during the current fiscal year. U.S. persons meeting any of these criteria must supply data on the amount of their sales or purchases for each type of covered service, disaggregated by country. U.S. persons that do not meet the mandatory reporting requirements are requested to provide voluntary estimates of their total sales and purchases of each type of covered service or intangible asset.

The BE-25 survey will cover some of the selected services presently covered by the BE-22, Annual Survey of Selected Services Transactions with Unaffiliated Foreign Persons. It will also cover construction, engineering, architectural, and surveying services presently covered by the BE-47, Annual Survey of Construction, Engineering, Architectural, and Mining Services Provided by U.S. Firms to Unaffiliated Foreign Persons, and will cover the same transactions in intangible rights presently covered by the BE-93, Annual Survey of Royalties, License Fees, and Other Receipts and Payments for Intangible Rights Between U.S. and Unaffiliated Foreign Persons; both of these annual surveys will be discontinued, following a final data collection for 2003.

This final rule is not significant for purposes of E.O. 12866.

This final rule does not contain policies with federalism implications as that term is defined in E.O. 13132.

The collection of information required in this final rule has been approved by the Office of Management and Budget under the Paperwork Reduction Act. Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection displays a currently valid OMB Control Number; such a Control Number (0608-0067) will be displayed.

The BE-25 survey is expected to result in the filing of reports containing mandatory data from about 700 respondents on a quarterly basis, or 2,800 responses annually. The average burden for completing the BE-25 is estimated to be 16 hours. Thus, the total respondent burden of the survey is estimated at 44,800 hours (2,800 responses times 16 hours average burden). The actual burden will vary from reporter to reporter, depending upon the number and variety of their covered services transactions and the ease of assembling the data. This estimate includes time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Comments regarding the burden estimate or any aspect of this collection of information should be addressed to: Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230, and either faxed (202-395-7245) or e-mailed ( pbugg@omb.eop.gov ) to the Office of Management and Budget, O.I.R.A. (Attention PRA Desk Officer for BEA).

The Chief Counsel for Regulation, Department of Commerce, has certified to the Chief Counsel for Advocacy, Small Business Administration, under provisions of the Regulatory Flexibility Act (5 U.S.C. 605(b)), that this rule will not have a significant economic impact on a substantial number of small entities as that term is defined in the Regulatory Flexibility Act. The factual basis for the certification was published with the proposed rule. No comments were received regarding the economic impact of the rule. As a result, no final regulatory flexibility analysis was prepared.

In a notice published in the Federal Register on May 20, 2002 (67 FR 35552), FDA announced that Nutrinova, Inc., 285 Davidson Ave., suite 102, Somerset, NJ 08873, had filed a food additive petition (FAP 2A4735). The petition proposed to amend § 172.800 Acesulfame potassium (21 CFR 172.800) to provide for the safe use of ACK as a general-purpose sweetener and flavor enhancer.

ACK is currently approved under § 172.800 for use in 12 food categories at levels determined by current good manufacturing practice. The existing regulation has resulted from the approval of seven food additive petitions (FAPs). The practical effect of the amendment requested in the current petition would be to broaden the regulation to include any additional food category not allowed by the current regulation, with the exception, as discussed in the following paragraphs, of meat and poultry, and to replace the 12 currently listed uses of ACK with a single-use category for food.

The acceptable daily intake (ADI) of 15 milligrams per kilogram body weight per day (mg/kg bw/d) or 900 mg per person per day (mg/p/d) was established for ACK as a result of FDA's review of FAP 2A3659 (53 FR 28379, July 28, 1988), which resulted in the agency's initial approval of ACK in several food categories. The ADI is the level of consumption that has been determined to be safe for human consumption every day over an entire lifetime. The present petition does not contain any new information that would cause FDA to alter this previously determined ADI for ACK.

FDA's review of the petitions submitted subsequent to FAP 2A3659 involved primarily the following factors: (1) An assessment of the estimated exposure from each additional use; and (2) a determination of whether the cumulative estimated exposure, including the newly requested use, would cause the ADI for ACK to be exceeded over a lifetime by individuals who consume ACK at high levels. In its evaluation of ACK for use in nonalcoholic beverages, including beverage bases, FDA also assessed the safety from exposure to acetoacetamide-N-sulfonic acid (AAS) and acetoacetamide (AAA), the two principal hydrolysis products of ACK (63 FR 36344 at 36346 to 36355, July 6, 1998).

Although the functionality of ACK was addressed in earlier FAPs, in the current petition, Nutrinova, Inc., provided the results from taste panel studies demonstrating the sweetness profile of ACK as a function of concentration in a variety of foods. These data demonstrate that ACK can be used alone or in blends with other intense sweeteners or bulk sweeteners (e.g., sucrose) at self-limiting levels depending on the food application (Ref. 1).

Under the general safety standard provisions of section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular use unless a fair evaluation of the data available to FDA establishes that the additive is safe for that use. FDA's food additive regulations (21 CFR 170.3(i)) define safe as a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”

The food additives anticancer, or Delaney, clause (section 409(c)(3)(A) of the act) further provides that no food additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal. Importantly, however, the Delaney clause applies to the additive itself and not to constituents of the additive. Thus, where an additive has not been shown to cause cancer, even though it contains a carcinogenic impurity, the additive is not subject to the legal effect of the Delaney clause. Rather, the additive is properly evaluated under the general safety standard using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the proposed use of the additive ( Scott v. FDA , 728 F.2d 322 (6th Cir. 1984)).

To determine whether ACK can be safely used as a general-purpose sweetener and flavor enhancer, FDA focused its evaluation on whether human exposure to ACK from these uses would exceed the ADI of 15 mg/kg bw/d, and on the potential health risk from exposure to the primary hydrolysis products, AAS and AAA, and the impurity, methylene chloride.

FDA has determined the cumulative estimated daily intake (CEDI) for ACK from its use as a general-purpose sweetener and flavor enhancer in food for eaters-only at the 90th percentile intake to be 313 mg/p/d (Refs. 2 and 3). This CEDI is based on the following factors: (1) The amount of ACK that may be used in the currently regulated food categories and (2) the maximum use level of ACK in other representative food categories in which the sweetener may be used. FDA concludes that the updated CEDI for ACK is well below the ADI (900 mg/p/d). FDA has determined that the updated CEDIs for AAS and AAA are 250 micrograms per person per day (μg/p/day) and 0.36 μg/p/day, respectively (Refs. 1 and 3). These hydrolysis products are formed only under extreme conditions of temperature and/or pH. The agency has determined that the increase in exposure to AAS and AAA, due to the additional uses, is negligible and does not pose any safety concerns (Refs. 3, 4, and 5).

Methylene chloride, a carcinogenic chemical, is a potential impurity in ACK resulting from its use as a solvent in the initial manufacturing step of the sweetener. Data previously submitted in FAP 0A4212 show that methylene chloride could not be detected in the final product at a limit of detection (LOD) of 40 parts per billion (ppb) as discussed in the July 6, 1998, final rule (63 FR 36344 at 36346). In the past, FDA has assumed that methylene chloride is present in ACK at the LOD of 40 ppb (worst-case scenario) and has evaluated its safety by performing a risk assessment for methylene chloride based on this level. No new information has been received to change FDA's previous risk assessment for methylene chloride. Moreover, FDA does not expect that methylene chloride will be present in ACK due to the following factors: (1) The multi-step purification process used in the manufacture of ACK and (2) the volatility of methylene chloride (Ref. 1).

FDA has reviewed the information available in its files on ACK and its hydrolysis products, as well as the current petition, and concludes that there is a reasonable certainty that no harm will result from the use of ACK as a general-purpose sweetener and flavor enhancer in foods. However, in accordance with a memorandum of understanding between the Food Safety and Inspection Service (FSIS), United States Department of Agriculture, and FDA (65 FR 51758, August 25, 2000), a restriction from use “in meat and poultry” is included in the ACK regulation. This restriction is applied when the petitioner does not specify that the food additive is intended for such use. At this time, FSIS has not evaluated data on the suitability of use of ACK in meat or poultry. Therefore, FDA concludes that the food additive regulations should be amended as set forth in this document.

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. As provided in § 171.1(h), FDA will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

FDA has carefully considered the potential environmental effects of this action. FDA concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday.

This final rule contains no collection 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 Division of Dockets Management (see ADDRESSES ) written or electronic objections on or before January 30, 2004. 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 shall be submitted and shall 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 Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of December 14, 1993 (58 FR 65452), FDA published a final rule in the form of a FM in part 358 (21 CFR part 358, subpart G) establishing conditions under which OTC pediculicide drug products are generally recognized as safe and effective. The effective date of the final rule was December 14, 1994. Since that time, FDA has determined that labeling in the statement of identity, warnings, directions, and certain other required statements in the pediculicide monograph should be amended.

In the Federal Register of March 17, 1999 (64 FR 13254), FDA published a final rule that established a standardized format and standardized content requirements for OTC drug product labeling in § 201.66 (21 CFR 201.66). In that same final rule (64 FR 13254 at 13296), FDA amended the FM for OTC pediculicide drug products and removed the requirement in § 358.650(d)(1) that the direction “Important: Read warnings before using” be printed in all capital letters. The sentence now needs to appear in boldface type with only the word “Important” and the first letter in the word “Read” capitalized.

In the Federal Register of May 10, 2002 (67 FR 31739), FDA published a proposed rule to amend the FM for OTC pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements to increase the probability of treatment success with these products. In response to that proposal, one OTC trade association and a professor of clinical toxicology submitted comments, which FDA is responding to in this document.

(Comment 1) One comment agreed completely with the proposed recommended label changes. Another comment agreed with the following proposed changes:

• New statement of identity (i.e., remove “pediculicide” and just state “Lice treatment” by itself);

• Simplified indications under the heading “Uses”;

• Formatting changes using subheadings (i.e., “Do not use,” “Ask a doctor before use,” “When using this product,” and “Stop use and ask a doctor if”);

• Bulleted statements under each subheading.

(Comment 2) One comment contended that the proposed additional directions are too extensive to fit on pediculicide product carton labels. The comment stated that lengthy, detailed directions for environmental control of lice and combing the hair and “other information” would be more appropriately provided in a package insert than on a carton label. The comment agreed that essential treatment directions should be on the outer label, but that consumers do not need to be able to read the entire detailed instructions at the point of purchase. The comment recommended that the outer package have a statement directing consumers to an insert for more complete directions. The comment suggested “See brochure inside for other important information to help get rid of lice.” The comment also added that a statement about use of a comb should be optional on the outer label and should instruct consumers to see the package insert for complete directions and could incorporate a reference to a comb provided in the package.

FDA considered the length of the additional directions and provided in the May 10, 2002 proposal (§ 358.650(e)) that the detailed information required under the heading “Other information” may appear in a package insert. If that occurs, the “Other information” section on the outer label only needs to include a statement that refers to the package insert for additional information. The information about use of a comb is part of the essential treatment directions (§ 358.650(d)(5)) and, thus, needs to appear on the outer label. If the product does not have a comb with it, consumers would need to know at the point of purchase that they may also need to purchase a special comb to use with the product. FDA is clarifying the introductory paragraph in § 358.650(e) to read that if a package insert is used, the “Other information” section on the outer label shall include a statement referring to the package insert for additional information.

(Comment 3) One comment recommended that the directions proposed in § 358.650(d)(4)(i) or (d)(4)(ii), (d)(6), (d)(7), and (d)(8) appear both on the outer package label and in the package insert. The information includes the following provisions:

• Application directions for shampoo or nonshampoo products,

• Directions for a followup treatment,

• Instructions to see doctor if the infestation continues,

• Instruction to consult a doctor for children under 2 years of age.

FDA agrees with the comment. Directions that appear on the outer package label in accordance with § 201.66(c) may be restated in a package insert.

(Comment 4) One comment disagreed with the agency's change from 2 weeks to 4 weeks for the time items that cannot be washed should be sealed in a plastic bag(§ 358.650(e)(1)). The comment stated that FDA gave no rationale for doubling the time and pediculicide manufacturers know of no evidence showing more than 2 weeks is needed to prevent reinfestation.

FDA initiated the change for sealing items that cannot be washed in a plastic bag from 2 to 4 weeks for greater assurance of preventing head lice reinfestation. In the last few years, pediculosis fact sheets have recommended longer sealing times. One sheet (Ref. 1) instructs to “pack the items in a sealed plastic bag for a minimum of two weeks.” Another sheet (Ref. 2) instructs to “pack non-washable items in a sealed plastic bag for 21 days to eliminate the risk from dormant nits.” Based on these recent recommendations, the agency has determined that a 4-week time period will give greater assurance of preventing head lice reinfestation.

(Comment 5) One comment stated that the amended final monograph should allow for special instructions specific to particular products to enhance product-specific directions. The comment gave examples of “shake the product well before use,” “apply to dry hair,” or conditions for storage. The comment requested that the monograph state that “a reasonable degree of flexibility will be given to companies choosing to amplify the directions appropriately.”

The agency disagrees with the need to include the comment's suggested statements in the FM for OTC pediculicide drug products. That monograph does not prohibit manufacturers from including statements such as “shake well before using” or information about conditions for storage in the product's labeling. The direction under the heading “Treat” for shampoo and nonshampoo products in § 358.650(d)(4)(i) and (d)(4)(ii) imply that the hair is dry before the product is first applied. FDA is amending these sections to give the option of adding the word “dry” before “hair”.

(Comment 6) One comment asked FDA to coordinate the revised NDA labeling for OTC pediculicide drug products marketed under NDAs and under the OTC drug monograph. The comment stated that the implementation for all products should occur at the same time.

FDA strives for consistency in labeling of similar products that are marketed OTC under an OTC drug monograph or an NDA. The effective date for the amended labeling in this final rule is 18 months after the date of publication in the Federal Register . The agency intends to notify NDA holders to make changes in labeling consistent with this final rule and believes these changes can be completed by the effective date.

Based on the available evidence, FDA is issuing a final rule amending the FM for OTC pediculicide drug products to make the following changes:

• Statement of Identity . We revised the “Statement of identity” to read “lice treatment” and eliminated the term “pediculicide.”

• Warnings .

(1) We shortened some warnings and stated all warnings in the new format in § 201.66 using the subheadings “Do not use”, “Ask a doctor before use if you are”, “When using this product”, and “Stop use and ask a doctor if”.

(2) We revised one warning for greater clarity by adding a few words after the statement “See a doctor” to read “Do not use • near eyes • inside nose, mouth, or vagina • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.”

• Directions . We added the following:

(1) Two introductory statements entitled “Important: Read warnings before use”[statement shall appear first and in bold type] and “adults and children 2 years and over” [in bold type];

(2) Headings entitled “Inspect”, “Treat”, and “Remove lice and their eggs (nits)”;

(3) “Dry” as an optional word before “hair” in the first sentence in the heading for “Treat” for shampoo and nonshampoo products.

• Other information .

(1) We allow information to appear in a package insert.

(2) We expanded the time for sealing items in a plastic bag from 2 to 4 weeks.

(3) We added the statement “ • vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people”.

Mandating warnings in an OTC drug monograph does not require a finding that any or all of the OTC drug products covered by the monograph actually caused an adverse event, and FDA does not so find. Nor does FDA's requirement of warnings repudiate the prior OTC drug monographs and monograph rulemakings under which the affected drug products have been lawfully marketed. Rather, as a consumer protection agency, FDA has determined that warnings are necessary to ensure that these OTC drug products continue to be safe and effective for their labeled indications under ordinary conditions of use as those terms are defined in the Federal Food, Drug, and Cosmetic Act. This judgment balances the benefits of these drug products against their potential risks (see 21 CFR 330.10(a)).

FDA's decision to act in this instance need not meet the standard of proof required to prevail in a private tort action ( Glastetter v. Novartis Pharmaceuticals Corp ., 252 F.3d 986, 991 (8th Cir. 2001)). To mandate warnings, or take similar regulatory action, FDA need not show, nor do we allege, actual causation. For an expanded discussion of case law supporting FDA's authority to require such warnings, see Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use final rule (67 FR 72555, December 6, 2002).

No OTC pediculicide drug product that is marketed under part 358, subpart G, and that contains a nonmonograph condition may be initially introduced or initially delivered for introduction into interstate commerce unless it is the subject of an approved NDA:

• 24 months after the date of publication of this final rule in the Federal Register for products with sales less than $25,000;

• 18 months after the date of publication in the Federal Register for all other such drug products.

Further, any OTC drug product subject to this final rule that is repackaged or relabeled after the compliance dates in the final rule must be in compliance with part 358, subpart G regardless of the date the product was initially introduced or initially delivered for introduction into interstate commerce. Manufacturers are encouraged to comply voluntarily as soon as possible.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq .). 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. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any 1 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 out in Executive Order 12866 and in these two statutes. The final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. As discussed in this section, FDA has determined that this final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 does not require FDA to prepare a statement of costs and benefits for this final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.

The purpose of this final rule is to revise and improve the statement of identity, warnings, directions, and other required labeling statements for OTC pediculicide drug products. The revised labeling provides more detailed information on the proper use of the product and should improve consumers' self-use.

The final rule requires relabeling of OTC pediculicide drug products containing pyrethrum extract with piperonyl butoxide. FDA's drug listing system identifies about 23 manufacturers and 36 marketers of approximately 75 stockkeeping units (SKU) (individual products, packages, and sizes) of OTC pediculicide drug products. There may be a few additional marketers and products that are not identified in the sources FDA reviewed.

FDA does not believe that manufacturers would need to increase the package size to add the additional labeling information. Almost all of these products are marketed in an outer carton which should have adequate space for the additional information. In addition, manufacturers may include the “Other information” section of the labeling in a package insert, which generally has a nominal cost. Assuming that there are about 75 affected OTC SKUs in the marketplace, FDA estimates (based on information provided by OTC drug manufacturers) that the rule would impose total one-time compliance costs on industry for relabeling of about $3,000 to $4,000 per SKU, for a total cost of $225,000 to $300,000.

FDA believes the actual cost could be lower for several reasons. First, most of the labeling changes will be made by private label small manufacturers that tend to use simpler and less expensive labeling.

Second, FDA is providing a period of 18 months (24 months for products with annual sales less than $25,000) for manufacturers to implement the new labeling. Thus, manufacturers should be able to use up existing labeling stocks and to make the labeling changes in the normal course of business. Further, manufacturers will not incur any expenses determining how to state the product's labeling because the final rule provides that information. The final rule does not require any new reporting and recordkeeping activities. Therefore, no additional professional skills are needed.

FDA considered but rejected several labeling alternatives: (1) A shorter or longer implementation period, and (2) an exemption from coverage for small entities. While the agency believes that consumers would benefit from having this new labeling in place as soon as possible, the agency also acknowledges that a shorter implementation period could significantly increase the compliance costs and these costs could be passed through to consumers. A longer time period would unnecessarily delay the benefit of new labeling to consumers who self-medicate with these drug products. The agency rejects an exemption for small entities because the new labeling information is also needed by consumers who purchase products marketed by those entities. However, a longer compliance date (24 months) is being provided for products with annual sales less than $25,000.

OTC pediculicide drug products are not the sole products produced by manufacturers affected by this final rule. FDA believes that the incremental costs of this final rule will be less than 1 percent of any of the manufacturer's total sales. Therefore, FDA certifies that this final rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required under the Regulatory Flexibility Act (5 U.S.C. 605(b)).

FDA concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Rather, the statement of identity, warnings, directions, and other information are a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA 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 substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency concludes that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register .)

1. Fact sheet from Mason County, Washington State Government Services, “Head Lice (Pediculosis),” http://www.co.mason.wa.us/health/Headlice.shtml .

2. Fact sheet from King County, Washington State Government Services, “Communicable Disease Fact Sheet Head Lice (Pediculosis),” http://www.metrokc.gov/health/prevcont/headlice.htm .

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * * and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Indiana program effective July 29, 1982. 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 32071). You can also find later actions concerning the Indiana program and program amendments at 30 CFR 914.10, 914.15, 914.16, and 914.17.

By letter dated September 3, 2003 (Administrative Record No. IND-1719), IDNR sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ). IDNR proposed to amend its program by adding new definitions, application requirements, and performance standards concerning the protection of ground water quality. IDNR is amending the Indiana program because the Indiana Groundwater Protection Act of 1989 (Indiana Code (IC) 13-18-17) requires any State agency with jurisdiction over an activity that may affect the quality of Indiana's ground water to adopt rules to apply the groundwater quality standards established by the Indiana Water Pollution Control Board (WPCB). In accordance with IC 13-18-17, WPCB adopted ground water quality standards at 327 Indiana Administrative Code (IAC) 2-11. WPCB's rule at 327 IAC 2-11-2 specifically requires IDNR to adopt rules to apply the standards established in 327 IAC 2-11 to the facilities, practices, and activities it regulates.

We announced receipt of the proposed amendment in the October 15, 2003, Federal Register (68 FR 59352). 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. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on November 14, 2003. We received comments from one industry group, one citizens group, and one Federal agency.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below.

Indiana added the definitions discussed below from WPCB's definitions at 327 IAC 2-11-3(5), (8) and (11). Indiana added these definitions to help in implementing its new performance standards concerning the protection of ground water quality at 312 IAC 25-6-12.5 and 25-6-76.5.

1. At 312 IAC 25-1-45.5, Indiana is adding the following definition for “drinking water well.”

Although there is no direct Federal counterpart definition for a drinking water well, Indiana's proposed definition is not inconsistent with the Federal definition of “drinking, domestic, or residential water supply” at 30 CFR 701.5. The Federal definition means, in part, water received from a well for direct human consumption or household use. Therefore, we are approving Indiana's definition at 312 IAC 25-1-45.5.

2. At 312 IAC 25-1-60.5, Indiana is adding the following definition for “Ground water management zone.”

There is no Federal counterpart definition for the term “ground water management zone.” However, Indiana's proposed definition is not inconsistent with sections 515(b)(10) and 516(b)(9) of SMCRA or the Federal requirements at 30 CFR 816.41 and 817.41 concerning protection of the hydrologic balance, including ground water quality protection. Therefore, we are approving Indiana's definition at 312 IAC 25-1-60.5.

3. At 312 IAC 25-1-109.5, Indiana is adding the following definition for “Property boundary.”

There is no Federal counterpart definition for the term “property boundary.” However, Indiana's proposed definition is not inconsistent with the Federal definition of “permit area” at 30 CFR 701.5 or the Federal requirements concerning permit boundaries at 30 CFR 779.24 and 783.24. Therefore, we are approving Indiana's definition at 312 IAC 25-1-109.5.

1. At 312 IAC 25-4-43, Indiana is adding subdivision (4). This new subdivision requires the maps and plans of the proposed permit and adjacent areas to include all monitoring locations used to demonstrate compliance with 312 IAC 25-6-12.5.

There is no direct Federal counterpart to subdivision (4). However, the proposed provision is not inconsistent with the requirements of the Federal regulations at 30 CFR 780.21(i) concerning ground water monitoring plans. The Federal regulation at 30 CFR 780.21(i)(1) requires the ground water monitoring plan to include identification of site locations for ground water monitoring. Therefore, we are approving 312 IAC 25-4-43(4).

2. At 312 IAC 25-4-47(b), protection of hydrologic balance, Indiana is adding subdivision (9). This new subdivision requires the reclamation plan to contain a description, with appropriate maps and cross section drawings, of a plan to demonstrate compliance with 312 IAC 25-6-12.5.

Although there is no direct Federal counterpart to subdivision (9), the proposed provision is not inconsistent with the requirements of the Federal regulation at 30 CFR 780.21(h) concerning hydrologic reclamation plans. The Federal regulation at 30 CFR 780.21(h) requires the hydrologic reclamation plan to contain steps to be taken to meet applicable Federal and State water quality laws and regulations. Therefore, we are approving 312 IAC 25-4-47(b)(9).

1. At 312 IAC 25-4-85(b), protection of hydrologic balance, Indiana is adding subdivision (8). This new subdivision requires the reclamation plan to contain a description, with appropriate maps and cross section drawings, of a plan to demonstrate compliance with 312 IAC 25-6-76.5.

Although there is no direct Federal counterpart to subdivision (8), the proposed provision is not inconsistent with the requirements of the Federal regulation at 30 CFR 784.14(g) concerning hydrologic reclamation plans. The Federal regulation at 30 CFR 784.14(g) requires hydrologic reclamation plans to contain steps to be taken to meet applicable Federal and State water quality laws and regulations. Therefore, we are approving 312 IAC 25-4-85(b)(8).

2. At 312 IAC 25-4-93, Indiana is adding subdivision (4). This new subdivision requires the maps and plans of the proposed permit and adjacent areas to include all monitoring locations used to demonstrate compliance with 312 IAC 25-6-76.5.

Although there is no direct Federal counterpart to subdivision (4), the proposed provision is not inconsistent with the requirements of the Federal regulation at 30 CFR 784.14(h) concerning ground water monitoring plans. The Federal regulation at 30 CFR 784.14(h)(1) requires the ground water monitoring plan to include identification of site locations for ground water monitoring. Therefore, we are approving 312 IAC 25-4-93(4).

Indiana is adding a new rule at 312 IAC 25-6-12.5 to read as follows:

There is no direct Federal counterpart to the proposed regulation at 312 IAC 25-6-12.5. However, we find that the requirements of 312 IAC 25-6-12.5 are not inconsistent with Section 515(b)(10) of SMCRA or the Federal regulations at 30 CFR 780.21(h) and 816.41(a), concerning protection of the hydrologic balance. The Federal regulation at 30 CFR 780.21(h), concerning hydrologic reclamation plans, requires plans to contain steps to be taken to meet applicable Federal and State water quality laws and regulations. Section 515(b)(10) of SMCRA and the Federal regulation at 30 CFR 816.41(a) allow the regulatory authority to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. Therefore, we are approving 312 IAC 25-6-12.5.

Indiana is adding a new rule at 312 IAC 25-6-76.5 to read as follows:

There is no direct Federal counterpart to the proposed regulation at 312 IAC 25-6-76.5. However, we find that the requirements of 312 IAC 25-6-76.5 are not inconsistent with Section 516(b)(9) of SMCRA or the Federal regulations at 30 CFR 784.14(g) and 817.41(a), concerning protection of the hydrologic balance. The Federal regulation at 30 CFR 784.14(g), concerning hydrologic reclamation plans, requires plans to contain steps to be taken to meet applicable Federal and State water quality laws and regulations. Section 516(b)(9) of SMCRA and the Federal regulation at 30 CFR 817.41(a) allow the regulatory authority to require additional preventative, remedial, or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented. Therefore, we are approving 312 IAC 25-6-76.5.

On October 15, 2003, we asked for public comments on the amendment (68 FR 59352), and received comments from one industry group and one citizens group.

Industry Group . We received comments from the Indiana Coal Council, Inc. (ICC) on October 31, 2003 (Administrative Record No. IND-1723). ICC commented that the proposed amendment is not inconsistent with any provision of SMCRA or of OSM's permanent program regulations, and should be approved. ICC also commented that the proposed amendment would not repeal or revise the requirement of Indiana's counterpart to 30 CFR 816.41(a) that surface mining and reclamation activities be conducted to prevent material damage to the hydrologic balance outside the permit area. ICC provided support for these comments.

We agree with ICC's comments. As shown above in section III, OSM's Findings, we found that the provisions of Indiana's proposed amendment are not inconsistent with SMCRA or the Federal regulations concerning protection of the hydrologic balance.

Citizens Group . We received comments from the Hoosier Environmental Council (HEC) on November 14, 2003 (Administrative Record No. IND-1724).

Response to Comment 1 . We disagree with the commenter. Indiana’s proposed rules do require protection for nondrinking water supply wells. Specifically, Indiana's proposed rules at 312 IAC 25-6-12.5(c) for surface mining and 25-6-76.5(c) for underground mining provide that coal mining and reclamation operations must be planned and conducted to prevent impacts to the ground water in a drinking water well or a nondrinking water supply well, including an industrial, commercial, or agricultural supply well. The operations must prevent impacts to the ground water that result in a contaminant concentration that, based on best scientific information, renders the well unusable for its current use. These rules also provide remedies if a drinking water well or a nondrinking water supply well is affected by contamination, diminution, or interruption proximately resulting from mining activities. Indiana's rules at 312 IAC 25-4-33 and 312 IAC 25-6-25 govern water replacement for surface mining activities and 312 IAC 25-4-74 and 312 IAC 25-6-88 govern water replacement for underground mining activities. Although Indiana did not add a definition for non-drinking water supply wells, neither did the Water Pollution Control Board in its rules at 327 IAC 2-11.

Response to Comment 2. Indiana’s proposed rules are in addition to Indiana's existing rules for the protection of the hydrologic balance at 312 IAC 25-6, which apply to the entire permit area and adjacent areas. The proposed rules do not replace or restrict the requirements of IC 14-34-10-2(13) or of Indiana's implementing rules at 312 IAC 25-6-12 and 25-6-21 through 25-6-23.

Response to Comment 3. We disagree with the commenter. As discussed in our response to Comment 2 above, the proposed rules do not replace or restrict Indiana's existing rules concerning protection of the hydrologic balance, including ground water. Although Indiana's proposed rules at 312 IAC 25-6-12.5 and 25-6-76.5 will specifically enforce the ground water quality standards under 327 IAC 2-11, Indiana's existing rules enforce the hydrologic balance standards, including ground water, required by SMCRA and I-SMCRA.

On September 9, 2003, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Indiana program (Administrative Record No. IND-1720). The U.S. Fish and Wildlife Service responded on October 8, 2003 (Administrative Record No. IND-1721), that it had no specific comments on the program amendment.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from 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 these air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

On September 9, 2003, under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from EPA (Administrative Record No. IND-1720). 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 September 9, 2003, we requested comments on Indiana's amendment (Administrative Record No. IND-1720), but neither responded to our request.

Based on the above findings, we approve the amendment Indiana sent us on September 3, 2003.

We approve the rules proposed by Indiana with the provision that they be fully promulgated in identical form to the rules submitted to and reviewed by OSM and the public.

To implement this decision, we are amending the Federal regulations at 30 CFR part 914, which codify decisions concerning the Indiana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

The revisions made at the initiative of the State that do not have Federal counterparts have been reviewed and a determination made that they do not have takings implications. This determination is based on the fact that the provisions have no substantive effect on the regulated industry.

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

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that 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 because 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 the Federal regulations at 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.

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 pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. This determination is based on the fact that the Indiana program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Indiana program has no effect on Federally-recognized Indian tribes.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

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 certifies that the provisions in this rule that are not based upon counterpart Federal regulations 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. ). This determination is based upon the fact that the provisions are not expected to have a substantive effect on the regulated industry.

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; and (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 provisions are not expected to have a substantive effect on the regulated industry.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State provisions are not expected to have a substantive effect on the regulated industry.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Kentucky program on May 18, 1982. You can find background information on the Kentucky program, including the Secretary's findings, the disposition of comments, and conditions of approval in the May 18, 1982, Federal Register (47 FR 21404). You can also find later actions concerning Kentucky's program and program amendments at 30 CFR 917.11, 917.12, 917.13, 917.15, 917.16, and 917.17.

The required amendment at 30 CFR 917.16(k) reads as follows:

On March 28, 2003, OSM forwarded a letter to Kentucky requesting that the required amendment at 30 CFR 917.16(k) be addressed by forwarding to OSM a policy statement that established its procedures on mailing of Conference Officer's Reports and the date that begins the administrative petition process. In response to this request we received a letter from the Kentucky Natural Resources and Environmental Protection Cabinet, Office of Administrative Hearings, dated April 3, 2003, requesting that its policy of requiring all Conference Officer's Reports be sent by certified mail be considered by us as fulfilling the requirements of the above-mentioned amendment (Administrative Record No. KY-1576). Included in the letter was a copy of a memorandum, dated April 2, 2002, sent from the Chief Hearing Officer to the Penalty Assessments Coordinator and the Assessment Conference Officer. This memorandum reminded its recipients that, according to policy, all Conference Officer's Reports should be mailed via certified mail, return receipt requested, and that, in calculating the time for the filing of an administrative petition, the beginning date should be the date of service of the Conference Officer's Report, rather than the mailing date. The memorandum acknowledged that Kentucky's regulation, which allows service by regular mail, had been found by OSM to be less effective than a corresponding Federal regulation (Administrative Record No. KY-1605).

Based on the commitments included in the above-referenced letter and accompanying memorandum, we announced our proposal to remove this required amendment on October 3, 2003, in the Federal Register (68 FR 57398). In the same notice we opened the public comment period and provided an opportunity for a public hearing or meeting on whether the policy letter discussed above meets the requirements of the required amendment, thereby eliminating the need for a revision to the Kentucky regulatory program. We did not hold a public hearing or meeting because no one requested one. The public comment period closed on November 3, 2003. We received comments from two Federal agencies (U.S. Department of the Interior, Fish and Wildlife Service and the U.S. Army Corps of Engineers). We also received comments from the Kentucky Resources Council, Inc.

In our August 6, 1993, decision we determined that the required amendment was necessary because we were concerned that 405 KAR 7:092 section 4(5) was less effective than its Federal counterpart found at 30 CFR 845.18 because of the way in which Conference Officer's Reports were administratively handled (58 FR 42001, 42006). Although Kentucky has not amended its regulations in response to this required amendment, Kentucky's policy has been to serve all Conference Officer's Reports by certified mail and to begin the period for filing an administrative petition from the date of service of the report (Administrative Record No. KY-1605). Our analysis of this policy indicates that it clarifies the language of the Kentucky regulation, which requires service by “mail”, without specifying whether the service must be made by “certified” or “regular” mail. 405 KAR 7:092, section 4(5). In addition, Kentucky's policy of starting the appeal period from the date of service indicates that the State interprets its regulation at 405 KAR 7:092, section 6(1)(b), which begins the appeal period on the mailing date, in a manner consistent with its policy, and with the Federal regulations. In other words, it is apparent that Kentucky interprets the term “mailing” to include service, i.e. , receipt, of the Conference Officer's Report. Furthermore, the record is devoid of any indication that Kentucky has failed to follow this policy in the last decade. With these policy clarifications now in place, these aspects of the Kentucky program clearly meet the requirements of, and are therefore consistent with, the Federal regulations at 30 CFR 845.17 and 845.18.

We do recognize that this determination is being made based on program implementation based on a State policy, rather than via a statutory or regulatory change. Should we find that in the future the State's actions concerning Conference Officer's Reports are no longer consistent with the requirements of 30 CFR 845.17 and 845.18, we will take the necessary action at that time to bring their program into compliance with this decision.

Therefore, we have determined that the required amendment at 30 CFR 917.16(k) is no longer needed and will be removed.

The Kentucky Citizens Coal Law Project (KCCLP), a division of the Kentucky Resources Council, submitted comments dated October 28, 2003 (Administrative Record No. KY-1603). These comments primarily relate to two specific concerns which we address below:

(1) KCCLP does not believe the Kentucky policy resolves the conflict between State and Federal regulations concerning the timing for appeal of the Conference Officer's Report.

As we discussed in the above finding, Kentucky has stated, in its policy, that the date for filing an administrative petition begins on the date of service. Therefore, we have determined that the implementation of this program is consistent with the Federal requirements. If we subsequently find that Kentucky is no longer able or willing to enforce its program in a manner consistent with Federal regulations, we will take appropriate action to bring the program back into compliance.

(2) KCCLP does not believe that a Kentucky policy of serving Conference Officer's Reports by certified mail is as effective as its Federal counterpart and violates State and Federal law. This comment appears to rest with both 30 U.S.C. 1253(1)-(7), which requires that State laws and regulations be consistent, and in accordance, with Federal requirements, and Kentucky Revised Statutes (KRS) 13A.130, which prohibits agencies in Kentucky from adopting or enforcing any policy that modifies or alters a regulation.

We agree with the commenter that 30 U.S.C. 1253(a)(1)-(7) require laws and regulations consistent with and in accordance with Federal requirements. We also agree with the commenter on what the Federal requirement is regarding service of Conference Officer Reports. However, we have determined that Kentucky's implementation of its program is consistent with the Federal requirements. The State regulation at issue, 405 KAR 7:092, section 4(5), sets forth that “[t]he Conference Officer's Report shall be promptly served by mail * * *” (Emphasis added.) The regulation does not specify, however, the type of mail delivery required. For example, it does not require the report to be served by “regular” mail. As such, a policy specifying that service be accomplished by “certified” mail is not inconsistent with the State regulatory requirement. Further, since documentation of receipt is an integral part of the certified mail process, a policy that begins the period for appeal upon receipt of the certified mail is not inconsistent with the State regulations even though it may not be expressly mandated by that regulation. Kentucky has been operating in a manner consistent with this policy and the Federal requirements for the past decade. Therefore that policy constitutes ample grounds for removing the required amendment. Nevertheless, if in the future we determine that Kentucky is not implementing its program in a manner consistent with the Federal requirements we will revisit this issue and take whatever action is necessary to ensure the State's administrative handling of Conference Officer's Reports occurs in accordance with Federal requirements.

Regarding the State's law, we believe that any step taken by OSM to analyze and interpret KRS 13A.130 in a manner inconsistent with Kentucky's documented policy and practice in applying that law is clearly outside the scope of our jurisdiction. We believe it is within the discretion of the Kentucky Natural Resources and Environmental Protection Cabinet to determine that it is complying with Kentucky's statutory limits in interpreting its regulation in the above-described way.

The U.S. Department of the Interior, Fish and Wildlife Service submitted a letter dated October 29, 2003 (Administrative Record No. KY-1605), in which they indicated it has no substantive comments regarding the removal of the required amendment.

The U.S. Army Corps of Engineers submitted a statement dated October 31, 2003 (Administrative Record No. KY-1606), in which it indicated it had no comments on the proposed rule.

Based on the above findings we have determined that the required amendment at 30 CFR 917.16(k) is no longer needed and will be removed.

This rule is a technical amendment and does not have takings implications.

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

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section.

This rule is a technical amendment and does not have federalism implications.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. This determination is based on the fact that the Kentucky program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Kentucky program has no effect on federally-recognized Indian tribes.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and will not have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an Environmental Impact Statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed state regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

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 certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The rule is a technical amendment that does not impose any additional requirements on small entities.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. For the reasons stated above, 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; and (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 rule is a technical amendment and will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year.

We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD07-03-171), indicate the specific section of this document to which each comment applies, and give the reason for each comment. The Coast Guard is especially interested in comments concerning the size and boundaries of this security zone and any economic impact this rule may have on you .

Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this rule in view of them.

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a Notice of Proposed Rulemaking (NPRM). Publishing an NPRM would be contrary to public safety interests and national security. These regulations are needed to protect the public, the ports and waterways and the national security of the United States from the potential of subversive acts against vessels and port facilities and infrastructure during port embarkation operations occurring within the security zone. For the security concerns noted, it is in the public interest to have these regulations in effect during the port embarkation operations. In addition, notifications will be made via marine information broadcasts.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

Based on the September 11, 2001, terrorist attack on the World Trade Center in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive terrorist activity could be launched by vessels or persons in close proximity to the Port of Charleston, South Carolina, against military installations or operations occurring within the security zone. This temporary security zone is necessary to protect the safety of life and property on the navigable waters, prevent potential terrorist threats aimed at military installations during strategic port of embarkation operations occurring within the security zone. The temporary security zone will encompass all waters under the Don Holt I-526 Bridge over the Cooper River to the entrance of Foster Creek on the Cooper River.

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

We expect the economic impact of this rule to be so minimal so that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. The limited geographic area impacted by the security zone will not restrict the movement or routine operation of commercial or recreational vessels through the Port of Charleston. Also, an individual may request a waiver of these regulations from the Coast Guard Captain of the Port.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because the limited geographic area encompassed by the security zone will not restrict the movement or routine operation of commercial or recreational vessels through the Port of Charleston. Also, an individual may request a waiver of these regulations from the Coast Guard Captain of the Port of Charleston.

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

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

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

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

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

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

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

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

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

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

We considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

These final regulations make technical corrections to the existing regulations for the Perkins, FFEL, and Direct Loan programs in 34 CFR parts 674, 682, and 685. The existing regulations contain technical errors, erroneous cross-references, and language that is inconsistent with other regulations and the provisions of the HEA. These final regulations make the technical corrections, correct the cross-references, and remove or modify language that is obsolete, outdated, or otherwise inconsistent with other regulations and the HEA.

Under the Administrative Procedure Act (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, these regulations merely reflect needed technical corrections to the Perkins, FFEL, and Direct Loan program regulations. These corrections do not affect the substantive rights or obligations of individuals or institutions and do not establish or affect substantive policy. Thus, the Secretary has concluded that these regulations are technical in nature and do not necessitate public comment. Therefore, under 5 U.S.C. 553(b)(B), the Secretary has determined that proposed regulations (and, accordingly, negotiated rulemaking under section 492(b)(2) of the HEA) are unnecessary and contrary to the public interest.

The Secretary certifies that these regulations will not have a significant economic impact on a substantial number of small entities. The small entities that are affected by these regulations are small institutions of higher education. These regulations also affect lenders and guaranty agencies that participate in the title IV, HEA programs, and individual loan borrowers. These regulations contain technical corrections to current regulations. The changes will not have a significant economic impact on any of the entities affected.

These regulations do not contain any information collection requirements.

Based on our own review, we have determined that these final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: www.ed.gov/news/fedregister.

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.

You may also view this document in PDF at the following site: ifap.ed.gov.

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

• Crop production (NAICS 111), e.g., Agricultural workers; Greenhouse, nursery, and floriculture workers; Farmers.

• Animal production (NAICS 112), e.g., Cattle ranchers and farmers, Dairy cattle farmers, Livestock farmers.

• Food manufacturing (NAICS 311), e.g., Agricultural workers; Farmers; Greenhouse, nursery, and floriculture workers; Ranchers; Pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., Agricultural workers; Commercial applicators; Farmers; Greenhouse, nursery, and floriculture workers; Residential users.

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0377. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/ , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm /.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of May 14, 2003 (68 FR 25883) (FRL-7301-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 9F6050) by Dow AgroSciences LLC, 9330 Zionville Road, Indianapolis, IN 46268. That notice included a summary of the petition prepared by Dow AgroSciences LLC, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.535 be amended by establishing tolerances for combined residues of the herbicide fluroxypyr 1-methylheptyl ester [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic acid, 1-methylheptyl] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic acid], free and conjugated, all expressed as fluroxypyr, in or on the following raw agricultural commodities: Sweet corn at 0.02 parts per million (ppm) for kernels plus cob with husk removed, and forage and stover at 1.0 ppm. Tolerances for residues of fluroxypyr in or on field corn are being proposed in support of this registration as follows: grain, 0.02 ppm; forage, 1.0 ppm; and stover, 0.5 ppm. Tolerances for residues of fluroxypyr in or on sorghum as follows: Grain, 0.02 ppm; forage, 2.0 ppm; and stover, 4.0 ppm. Tolerances for residues of fluroxypyr in or on grasses as follows: Forage, 120 ppm; hay, 160 ppm; and grass silage, 100 ppm. Increased tolerances are also proposed for fluroxypyr in or on the following animal commodities: Milk of cattle, goats, hogs, horses and sheep at 0.3 ppm; and kidney of cattle, goats, hogs, horses and sheep at 1.5 ppm.

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

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

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of fluroxypyr on or in field corn, grain at 0.02 ppm; field corn, forage at 1.0 ppm; field corn, stover at 0.5 ppm; on or in sweet corn, kernels plus cob with husks removed at 0.02 ppm; sweet corn, forage at 1.0 ppm; sweet corn, stover at 2.0 ppm; on or in sorghum, grain at 0.02 ppm; sorghum, forage at 2.0 ppm; sorghum, stover (fodder) at 4.0 ppm; on or in grass, forage at 120 ppm; grass, hay at 160 ppm; and a tolerance for combined residues of fluroxypyr on cattle, milk; goat, milk; hog, milk; horse, milk; and sheep, milk at 0.3 ppm; and on cattle, kidney; goat, kidney; hog, kidney; horse, kidney; and sheep, kidney at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by fluroxypyr are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or uncertainty factors may be used: “Traditional uncertainty factors;” the “special FQPA safety factor;” and the “default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 - 5 ), one in a million (1 X 10 - 6 ), or one in ten million (1 X 10 - 7 ). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

A summary of the toxicological endpoints for fluroxypyr used for human risk assessment is shown in Table 2 of this unit:

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0394. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of November 12, 2003 (68 FR 64102) (FRL-7333-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 8E5012) by Interregional Research Project Number 4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902. This notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.532 be amended by extending tolerances for residues of the fungicide cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on onion, dry bulb at 0.60 parts per million (ppm), onion, green at 4.0 ppm, and strawberry at 5.0 ppm. The tolerance will expire on December 31, 2004.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA , for tolerances for residues of cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine on onion, dry bulb at 0.60 ppm, onion, green at 4.0 ppm, and strawberry at 5.0 ppm ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by cyprodinil are discussed in Unit III.A. of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

A summary of the toxicological endpoints for cyprodinil used for human risk assessment is discussed in Unit III.B. of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.532) for the residues of cyprodinil, in or on a variety of raw agricultural commodities. Acute, and chronic exposure assessments conducted by EPA to assess dietary exposures from cyprodinil are discussed in Unit III.C.1 of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

2. Dietary exposure from drinking water . PRZM/EXAMS and SCI-GROW model estimated environmental concentrations (EECs) for cyprodinil for acute and chronic exposures are discussed in Unit III.C.2 of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

3. From non-dietary exposure . Cyprodinil is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether cyprodinil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that cyprodinil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . Prenatal and postnatal sensitivity are discussed in Unit III.D.1.(ii) of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

3. Conclusion . There is a complete toxicity data base for cyprodinil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be reduced to 1X. For further discussion, see Unit III.D.1.(iii) of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . The acute risk assessment for cyprodinil is discussed in Unit III.E.1 of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

2. Chronic risk . The chronic risk assessment for cyprodinil is discussed in Unit III.E.2 of the final rule on Cyprodinil Time-Limited Pesticide Tolerance published in the Federal Register of June 22, 2001 (66 FR 33478) (FRL-6778-7).

3. Aggregate cancer risk for U.S. population . Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to assess the carcinogenic potential, cyprodinil was classified as not likely to be carcinogenic to humans. Therefore, cyprodinil is not expected to pose a cancer risk to humans.

4. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to cyprodinil residues.

The results of Multiresidue Method testing of cyprodinil and its metabolite CGA -232449 have been forwarded to the Food and Drug Administration (FDA). Cyprodinil was tested according to the FDA Multiresidue protocols (Protocols C, D, and E), and acceptable recoveries were obtained for cyprodinil fortified in apples at 0.50 ppm using Protocol D. The petitioner is proposing the Method AG-631A as a tolerance enforcement method for residues of cyprodinil in/on the subject crops. The method includes confirmatory procedures using gas chromatography/nitrogen/phosphorus detector (GC/NPD). The method has successfully undergone radiovalidation using 14C-labeled tomato samples and independent laboratory validation. In addition, the method has been the subject of acceptable Agency petition method validations on stone fruits and almond nutmeat and hulls.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

Canada, Codex, and Mexico do not have maximum residue limits (MRLs) for residues of cyprodinil in/on the proposed crops. Therefore, harmonization is not an issue.

Therefore, the tolerance is established for residues of cyprodinil, 4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on onion, dry bulb at 0.60 ppm, onion, green at 4.0 ppm, and strawberry at 5.0 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0394 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before March 1, 2004.

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

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0394, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

In FR Doc. 03-27791 of November 7, 2003 (68 FR 63398), there were several technical errors as well as a number of public comments that were received timely, but that we inadvertently failed to address. The errors include incorrect or potentially misleading responses, and in Addenda A and B, omissions and typographical errors. In addition, we are adding information to the addenda that was not available when we published the final rule. This additional information does not affect payment under the hospital outpatient prospective payment system (OPPS). We ordinarily provide a 30-day delay in the effective date of the provisions of a notice. Section 553(d) of the Administrative Procedure Act (5 U.S.C. 553(d)) ordinarily requires a 30-day delay in the effective date of final rules after the date of their publication in the Federal Register . This 30-day delay in effective date can be waived, however, if an agency finds good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the finding and its reasons in the notice issued. In addition, section 1871(e)(1) of the Social Security Act, as amended by section 903(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (DIMA), also requires that a substantive change in a regulation shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published the substantive change. Section 1871(e)(1) of the Social Security Act, as amended by section 903(b)(1) of DIMA, provides an exception to that requirement if the Secretary finds that the waiver of such 30-day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. We find good cause to waive the 30-day delay in effective date for this correction notice as set forth in section III, “Waiver of 30-Day Delay in Effective Date,” below.

On page 63423, first column, fifth sentence, we stated: “The case of APC 0108, we used the external device cost data that was used to set the median for the 2003 OPPS because we received no outside data for the 2004 OPPS for this APC and because the proposed median of $28,685.30 set forth in the proposed rule was considerably higher than the final rule data median of $23,944.80, which resulted when additional claims were used to calculate the median cost.”

We subsequently determined that external data that met our preferred criteria for use in setting payment rates had been furnished as part of a timely, properly submitted comment for APC 0108. Therefore, we have revised the median cost and payment rate ($23,641.27) that was in the final rule for this APC using the data submitted in the comment. The new payment rate is $24,699.74. See Table 1 below for the complete revised values information.

To correct this error, we remove the fifth sentence in column 1 on page 63423 and replace it with the following: “In the case of APC 0108, we used external device cost data submitted in a comment on the proposed rule to set the median for the 2004 OPPS. The proposed median of $28,685.30 set forth in the proposed rule was considerably higher than the median calculated for the final rule, $23,944.80, which resulted when additional claims were used to calculate the median cost. The use of this external data raised the payment rate to a level we believe is more appropriate.”

Comment: A commenter asserted that the claims data for Physicians' Current Procedural Terminology (CPT) codes 38230 (bone marrow harvesting), 38240 (bone marrow/stem cell transplantation, allogenic), and 38241 (bone marrow/stem cell transplantation, autologous) are seriously flawed. For instance, the median cost for CPT code 38230 (using data for 35 claims) was $74.81. The commenter stated that CPT code 38230 involves a 60-90 minute operating room procedure performed under general anesthesia, with costs more closely approaching the payment rate for APC 0111 (paying $718.67) than APC 0123 (paying $288.53), its current APC placement. The commenter expressed similar concern over the claims data for CPT codes 38240 and 38241, asserting that their placement in APC 0123 results in inadequate payment to cover the costs of bone marrow and stem cell transplantation.

The commenter urged us to move CPT codes 38230, 38240, and 38241 from APC 0123 (bone marrow harvesting/stem cell transplant, paying $288.53) to APC 0111 (blood product exchange, paying $718.67).

Response: We agree with the commenter that the claims data for CPT code 38230 appear to be based on flawed claims. We believe that the costs involved in performing CPT code 38230 (bone marrow harvesting) are more similar to the costs involved in performing CPT codes 38205 and 38206 (stem cell harvesting, placed in APC 0111); therefore, we will move CPT code 38230 from APC 0123 to APC 0111. We will maintain the payment rate for APC 0111 at $718.67 as stated in the November 7, 2003 final rule, since we believe the claims for CPT code 38230 represent aberrant data and should not be used to recalculate the payment rate for APC 0111.

In contrast, we do not believe that the claims data for CPT codes 38240 and 38241 are flawed. The resource utilization of performing bone marrow and stem cell transplantations is similar to the resource utilization of performing infusion therapy services (which are paid $210 in APC 0110), since bone marrow and stem cell transplantations involve no incision and no unusual instruments or equipment. Therefore, we believe that the APC placement of CPT codes 38240 and 38241 in APC 0123 sufficiently captures the costs involved in performing these services. Although these codes will remain in APC 0123, their payment rate in APC 0123 will increase by $47.01 (from $288.53 to $335.54) above the rate stated in the November 7, 2003 final rule, as a result of moving CPT code 38230 out of APC 0123 and recalculating the median for APC 0123 based on CPT codes 38240 and 38241 that remain in APC 0123.

Comment: A commenter requested that we combine CPT codes G0242 (Cobalt 60-based stereotactic radiosurgery plan) and G0243 (Cobalt 60-based stereotactic radiosurgery delivery). The commenter explained that, before 2000, we allowed Cobalt 60-based stereotactic radiosurgery to be appropriately billed using CPT code 61793 (stereotactic radiosurgery—particle beam, gamma ray or linear accelerator—one or more sessions), the same code that non-Medicare payers continue to use for this procedure. However, our current guidelines for coding this procedure necessitate the billing of two codes (planning and delivery), and therefore, correct billing of this treatment using the current codes results in a multiple procedure claim. The commenter asserted that because we calculate medians using only single claims, the APC placement of Healthcare Common Procedure Coding System (HCPCS) codes G0242 and G0243 was based on aberrant single claims.

The commenter requested that these codes (G0242 and G0243) be combined into a single procedure code (that is, CPT code 61793) in order for us to accurately capture the costs of this treatment in a single claim because both parts of this treatment (planning and delivery) are always delivered on the same day in one surgical procedure. Based on resource consumption and clinical homogeneity, the commenter suggested that we place this single procedure code in one of the following APCs: 0222 (paying $12,670), 0226 (paying $7,437), or 0227 (paying $8,775).

Response: In addition to the above comment, we received several other comments stating that HCPCS code G0242 (Cobalt 60-based stereotactic radiosurgery plan) was being used inappropriately for linear accelerator-based stereotactic radiosurgery (SRS) planning in addition to Cobalt 60-based SRS planning, due to the nonexistence of a code to bill for linear accelerator-based SRS planning. Considering the current misuse of HCPCS code G0242 and the potential for causing greater confusion by combining CPT codes G0242 and G0243, we created a planning code for linear accelerator-based SRS (G0338) to distinguish this procedure from Cobalt 60-based SRS planning. Since the claims data for G0242 represent costs for linear accelerator-based SRS planning (due to misuse of the code) in addition to Cobalt 60-based SRS planning, we are uncertain of how to combine these data with G0243 (Cobalt 60-based SRS delivery) to determine an accurate payment rate for a combined code for planning and delivery of Cobalt 60-based SRS. Therefore, we will solicit input from the APC Panel at its next meeting in early 2004.

In the meantime, we will maintain two separate HCPCS codes (G0242 and G0243) for the planning and delivery of Cobalt 60-based SRS treatment, consistent with the use of two G codes for the planning (G0338) and delivery (G0173, G0251, G0339, G0340, as applicable) of each type of linear accelerator-based SRS treatment, as described below.

Correct Coding for Various Types of Stereotactic Radiosurgery (SRS):

Comment: A commenter urged us to recognize the cost and clinical differences between HCPCS codes G0243 and G0173 by placing them in separate APCs.

Response: We believe that the low volume of single claims for HCPCS code G0243 (172 single claims out of 1,033 total claims = 17 percent of total claims) does not substantiate movement of this code into a procedural APC at this time, and there is no clinical reason for a reassignment. Therefore, we will keep HCPCS code G0243 in new technology APC 1528 with a payment of $5,250 for CY 2004.

Comment: The manufacturer of ProstaScint (indium capromab pendetide), a diagnostic agent used for the imaging of prostate cancer, indicated that this product's proposed payment rate is significantly below the cost that hospitals incur in acquiring ProstaScint. The manufacturer stated that reduced payment would restrict hospitals from providing ProstaScint studies to Medicare beneficiaries and have a significant negative effect on the treatment and outcomes of patients at risk for prostate cancer. The commenter submitted a survey of hospitals demonstrating their costs of purchasing ProstaScint.

Response: We agree with the commenter that the use of only hospital claims data to set the payment rate for ProstaScint may adversely impact beneficiary access. We believe that the external data submitted by the manufacturer meets our preferred criteria; therefore, we will use the external data to establish an adjusted median cost for this product by blending the median cost derived from our dampening methodology with the external cost data on a one-to-one ratio.

Comment: One commenter requested that we assign CPT code 29827 to APC 0042 (Level II Arthroscopy). The code was new for 2003 and was assigned to APC 0041 (Level I Arthroscopy). The commenter provided information to support the assertion that the procedure described by CPT code 29827 is very similar to that described by CPT code 29826 with regard to operating room time required, equipment requirements, and complexity. However, procedures coded as CPT code 29826 are assigned to APC 0042.

Response: Our medical staff evaluated this request and decided that they would like the advice of the APC Panel before making a determination. In their analysis of the assignments for CPT codes 29826 and 29827, they determined that it would be appropriate to solicit input from the APC Panel regarding the clinical coherence of both APCs 0041 and 0042. The APC Panel will meet in early 2004, and we plan to include these APCs on the agenda for its consideration. The date for the APC Panel meeting and registration information will be published in the Federal Register and on the CMS OPPS Web site at least 60 days before the meeting date.

Comment: Several commenters urged us to increase payment for CPT codes 52647 and 52648 (photoselective vaporization of the prostate (PVP)). They expressed concern that other less effective procedures requiring less skill have a significantly higher proposed payment rate. Commenters stated that the proposed payment rate for PVP under APC 0163 does not cover the costs of providing access to this new technology.

Response: Based on our claims data, we believe that CPT codes 52647 and 52648 are appropriately placed in APC 0163 for CY 2004, but the commenters may want to consider applying for a new CPT/HCPCS code for this procedure so that it is identifiable separately from other procedures. Alternatively, PVP may be a candidate for consideration under the OPPS new technology process. We refer interested parties to our Web site www.cms.hhs.gov/providers/hopps/ for further information on the new technology application and evaluation process.

Comment: We received a comment requesting that we remove several codes from the inpatient-only list. The codes are: 44901 (Incision and drainage of appendiceal abscess; percutaneous); 49021 (Drainage of peritoneal abscess or localized peritonitis, exclusive of appendiceal abscess; percutaneous); 49041 (Drainage of subdiaphragmatic or subphrenic abscess; percutaneous); and 49061 (Drainage of retroperitoneal abscess; percutaneous). The commenters based their request on the fact that codes they believe are similar to 44901, 49021, 49041, and 49061 are not on the inpatient-only list. Codes that they used as examples included 32201 (Pneumonostomy; with percutaneous drainage of abscess or cyst); and 50021 (Drainage of perirenal or renal abscess; percutaneous).

Response: The information provided by the commenter did not provide an adequate basis for our medical staff to make a decision. Instead, our physicians will solicit input from additional specialty groups that provide care to the patients undergoing these procedures. We will also present this issue to the APC Panel for consideration at its next meeting in early 2004.

Comment: We received a comment requesting that we create a new “G” code for neutron radiotherapy so that these procedures can be assigned to a new APC. At this time, the procedures are coded using a CPT code that includes other procedures that the commenter does not believe are related to neutron radiotherapy. The commenter believes the combination of procedures in the CPT code is inappropriate.

Response: We evaluated this request and continue to believe that the current coding is appropriate. We do not believe that creation of a new “G” code is warranted in this case because there is a CPT code that specifically describes this procedure.

Comment: We received a comment requesting that we assign magnetic resonance imaging and magnetic resonance angiography to separate APCs. These procedures are currently assigned to APCs 0336 and 0337.

Response: We evaluated this request and continue to believe that the current assignments are appropriate and result in accurate payment for the procedures.

Comment: We received one comment requesting that we reassign codes for fetal echocardiograms (CPT 76825 through 76827) to APC 0269. The codes are currently assigned to APCs 0671 and 0697.

Response: We believe that the APC assignments for these CPT codes continue to be appropriate. We used most of the submitted claims for calculating medians for these codes. We believe the resource use and clinical coherence in the current APCs are appropriate.

Comment: We received a comment requesting that arsenic trioxide (Trisenox) be considered as a single-indication orphan drug for Medicare OPPS. The drug has orphan status from the FDA for treatment of multiple myeloma, myelodysplastic syndrome, chronic myeloid leukemia, and chronic lymphocystic anemia.

Response: After careful evaluation, we agree that arsenic trioxide does meet our criteria for special payment as a single indication orphan drug. As we stated in our final rule (68 FR 63453), we are setting payment under the 2004 OPPS for single indication orphan drugs at 88 percent of the average wholesale price listed for these drugs in the April 1, 2003 single drug pricer unless we are presented with verifiable information that shows that our payment rate does not reflect the price that is widely available to the hospital market. For 2004, the payment rate for Trisenox will be $34.32 per unit.

As a result of a HCPCS coding change, the relative weight, payment rate, and minimum unadjusted copayment for APC 0012 as published on page 63478, are incorrect. Code 11057 moved from APC 0012 to APC 0013, and we failed to update the APCs in time for the final rule. The correct values for APC 0012 are: relative weight, 0.7612; payment rate, $41.53; and minimum unadjusted copayment amount, $8.31. The correct values for APC 0013 are relative weight, 1.1302; payment rate, $61.66; and the minimum unadjusted copayment is unchanged. These values are listed in bold type in Table 1 below.

As a result of our use of external data, APC 0108 has new values in Addendum A on page 63479. The correct relative weight is 452.6995, the payment rate increases to $24,669.74, and the minimum unadjusted copayment becomes $4,939.95. These values are listed in bold type in Table 1 below.

In response to a comment, we moved HCPCS code 43752 from APC 0272 to APC 0121. This move resulted in new Addendum A values for both of these APCs. The incorrect values on page 63479 for APC 0121 are corrected as follows: relative weight, 2.1114; payment rate, $115.2; and minimum unadjusted copayment amount, $23.04.

On page 63481, the incorrect values for APC 0272 are corrected as follows: relative weight, 1.4184; payment rate, $77.39; and minimum unadjusted copayment, $15.48.

In response to a comment that we overlooked, we moved CPT code 38230 from APC 0123 to APC 0111. This resulted in new values for APC 0123 in Addendum A. The values on page 63479 are corrected as follows: relative weight, 6.1499; payment rate, $335.54; and minimum unadjusted copayment amount, $67.11. There are no changes to the values for APC 0111. These values are listed in bold type in Table 1 below.

On page 63482, the values for APC 0321 are incorrect due to a change in the status indicator for HCPCS code 90901. The status indicator was changed to “A” and, therefore, does not contribute to the calculation of the APC median. We correct the values for APC 0321 by replacing the values on page 63482 with the following: relative weight, 1.4817; payment rate, $80.84; and minimum unadjusted copayment amount, $16.17. These values are listed in bold type in Table 1 below.

The status indicator for HCPCS code 96105 was changed to “A” and, therefore, should not contribute to the calculation of the APC median. The values for APC 0373 on page 63482 are incorrect because the code (96105) was used under its previous status indicator “X” and was therefore included in the media calculation. We replace the values in Addendum A on page 63482 with the following correct values: relative weight, 2.3288; payment rate, $127.06; and minimum unadjusted copayment amount, $25.41. These values are listed in bold type in Table 1 below.

The relative weight, copayment and payment rates are incorrect for APC 0384 as published on page 63482. Two HCPCS codes (43268 and 43269) were moved from APC 0151 into APC 0384, and those changes were not reflected in the published Addendum A. We replace the values for APC 0384 with the following: relative weight, 36.54; payment rate, $1,993.66; national unadjusted copayment, $433.01; and minimum unadjusted copayment, $398.73. The values for APC 0151 do not change. These values are listed in bold type in Table 1 below.

APC 0413 was listed in Addendum A on page 63483 in error. No codes are assigned to this APC, so it no longer exists. We remove APC 0413.

We correct Addenda A and B by adding the relative weight for APC 0734 on page 63484 in Addendum A and for CPT/HCPCS codes C1774 and Q0137 on pages 63610 and 36350, respectively, in Addendum B. The relative weight is 0.0594 for both of these codes.

The values for APC 1604 are incorrect as published on page 63486. Additional data were available but inadvertently were not used in the median calculation for this APC. The new values reflect use of the additional data. We correct the values for APC 1604 as follows: relative weight, 20.2752; payment rate, $1,106.24; and minimum unadjusted copayment, $221.25. These values are listed in bold type in Table 1 below.

On page 63487, the payment rate for APC 9012 is corrected to reflect its new status as a single-indication orphan drug. We correct the payment rate to $34.32 and the minimum unadjusted copayment to $6.86.

On page 63488, the descriptor for APC 9116 is incorrect. We correct it to read “Inj. Ertapenem sodium, per 500 mg.”

For the following CPT/HCPCS codes on the pages identified, beginning on page 63488 and concluding on page 63644, we listed outdated descriptors. We correct the descriptor on page 63488 for code 0002T; page 63496 for code 15852; page 63548 for code 55870; page 63619 for code E0141; page 63622 for codes E0973 and E0974; page 63623 for code E0978; page 63624 for code E1226; page 63627 for codes G0210, G0213, G0214, G0215, G0230, G0246, G0247, G0248; page 63630 for code J1563; page 63631 for codes J2260 and J2324; page 63633 for code J8700; page 63636 for code K0560; page 63637 for codes K0600, K0607, K0614, K0615, K0616, and K0617; page 63643 for codes L4350, L4360, and L4386; and on page 63644 for codes L5646 and L5648. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

On page 63627, CPT/HCPCS G0244 is listed with an incorrect relative weight, payment rate, and copayment amount. We correct the current relative weight, payment rate, and copayment, by inserting 6.6961, $365.35, and $73.07, respectively. See Table 2 below for the corrected values.

On page 63634, CPT/HCPCS J9017 is listed with an incorrect relative weight, payment rate, and copayment. J9017 is an orphan drug and is reimbursed at 88 percent of AWP. We correct the addendum by replacing current values with a payment rate of $34.32 and minimum unadjusted copayment of $6.86.

On page 63590, we incorrectly assigned status indicator A to CPT/HCPCS 90918 through 90925. These codes are replaced by G0320 through G0327. Therefore, codes 90918 through 90925 are assigned status indicator E. On page 63590, for CPT/HCPCS 90918, 90919, 90920, 90921, 90922, 90924, and 90925, we remove the status indicator A and insert status indicator E. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

The following CPT/HCPCS codes were omitted from Addendum B of the November 7, 2003, final rule: 99375, status indicator E, home health care supervision, effective 1/1/03; 99378, status indicator E, hospice care supervision, effective 1/1/03; G0308, status indicator A, condition NI, ESRD related svc 4+mo<2yrs; G0309, status indicator A, condition NI, ESRD related svc 2-3mo<2rs; G0310, status indicator A, condition NI, ESRD related svc 1vst<2yr; G0311, status indicator A, condition NI, ESRD related svs 4+mo 2-11 yr; G0312, status indicator A, condition NI, ESRD related svs 2-3 mo 2-11 yr; G0313, status indicator A, condition NI, ESRD related svs 1 mon 2-11 yr; G0314, status indicator A, condition NI, ESRD related svs 4+mo 12-19; G0315, status indicator A, condition NI, ESRD related svs 2-3 mo 12-19; G0316, status indicator A, condition NI, ESRD related svs 1 vst 12-19y; G0317, status indicator A, condition NI, ESRD related svs 4+mo 20+yrs; G0318, status indicator A, condition NI, ESRD related svs 2-3 mo 20+y; G0319, status indicator A, condition NI, ESRD related svs 1 visit 20+y; G0320, status indicator A, condition NI, ESRD related svs home under 2; G0321, status indicator A, condition NI, ESRD related svs home mo<2ys; G0322, status indicator A, condition NI, ESRD related svs home mo12-19; G0328, status indicator A, condition NI, fecal blood scrn immunoassay; all effective 1/1/04; and P9603, status indicator A, One-way allow prorated miles, effective 1/1/92. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

On page 63608, we incorrectly assigned status indicator B and condition NI to CPT/HCPCS A9527, I-131 tositumomab therapeutic. New code A9534, with the same descriptor, replaces A9527, effective 1/1/04. A9527 is removed effective 1/1/04, with no grace period. On page 63608, for CPT/HCPCS A9527, we remove the status indicator of B and insert a status indicator of D. We remove the condition NI and insert a condition of DNG. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the code identified above.

For the CPT/HCPCS codes on the pages identified, beginning on page 63490 and concluding on page 63653, we incorrectly listed status indicator E instead of status indicator B. We correct the status indicator on page 63490 for codes 0054T, 0055T, 0056T, 0057T, 0060T, and 0061T; page 63598 for codes 99002 and 99140; page 63604 for codes A4671, A4672, and A4673; page 63605 for codes A4674 and A4728; page 63624 for code E1634; page 63633 for J7330; page 63641 for L3350; and page 63653 for code V2761. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

For the following CPT/HCPCS codes on the pages identified, beginning on page 63490 and concluding on page 63619, we incorrectly listed condition DG (deleted with grace). These codes are not deleted for 2004, and the condition should be blank. We correct the condition on page 63490 for codes 00546, 00548, 00550, 00560, 00562, 00563, and 00566; and page 63539 for codes 47135, 47136, 47300, and 47350; and page 63619 for E0165. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

On page 63569, CPT/HCPCS 76977 was inadvertently assigned an incorrect status indicator. We remove status indicator S and insert status indicator X. The payment rates are correct as is. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the code identified above.

On page 63590, CPT/HCPCS 92019 was assigned an incorrect status indicator. We remove status indicator S and insert status indicator T. The payment rates are correct as is. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the code identified above.

On page 63608, CPT/HCPCS A9700 was incorrectly assigned an APC, relative weight, payment rate, and copayment. A9700 is not payable under OPPS, and no payment should be made for this service. We remove the APC, relative weight, payment rate, and minimum unadjusted copayment. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the code identified above.

On page 63588, CPT/HCPCS codes 90296 and 90581 are incorrectly assigned a status indicator, APC, relative weight, payment rate, and copayment. Effective 1/1/04, codes 90296 and 90581 are packaged services and therefore are assigned status indicator N. For codes 90296 and 90581, we remove status indicator K, APC, payment rate, and minimum unadjusted copayment, and insert status indicator N. See Table 2—Corrections to Addendum B of the November 7, 2003, Final Rule for corrections to Addendum B for the codes identified above.

On page 63623, CPT/HCPCS code E1065 omits condition DG. This code is deleted with grace period effective January 1, 2004. We correct this by inserting DG in the condition column.

Many codes were incorrectly listed with status indicator A that should be listed with the new status indicator Y, indicating that the code is not paid under OPPS, but should be billed to the Durable Medical Equipment Regional Carrier (DMERC). They are listed in Tables 3-5. In addition, codes A4232, A4632, E0188, E0189, E0218, E0602, E0740, E0760, E0765, K0610, K0611, K0612, and K0613 were incorrectly listed with status indicator E, but should be listed with status indicator Y. Codes E0967, E0969, E0977, E0980, E0994, E0997, E0998, E0999, E1001, E1035, E1065, and E1227 were incorrectly listed with status indicator B, but should be listed with status indicator Y. For all these codes, we remove the current status indicator and insert status indicator Y. See Tables 3-5 for a list of codes for which the status indicator has changed from A, E, or B to Y.

On page 63471 of the November 7, 2002 Final Rule, we specify that HCPCS codes for drugs, biologicals, and radiopharmaceuticals that are new for 2004 yet have no predecessor will be assigned packaged status for 2004.

On pages 63608 and 63652, HCPCS codes A9526 and Q4078, respectively, were incorrectly assigned a status indicator, APC, relative weight, payment rate, and copayment. Effective 1/1/04, codes A9526 and Q4078 are packaged services and therefore are assigned status indicator N. For these codes, we remove status indicator K, APC, payment rate, and minimum unadjusted copayment, and insert status indicator N.

On page 63415 of the November 7, 2003 Final Rule, we state that we plan to delete HCPCS C1088 effective 1/1/04. Addendum B does not list this code as deleted. For HCPCS C1088, we remove status indicator T, APC, payment rate, and minimum unadjusted copayment, and insert status indicator D and condition DNG (deleted with no grace period).

We ordinarily provide a 30-day delay in the effective date of the provisions of a notice. Section 553(d) of the Administrative Procedure Act (5 U.S.C. 553(d)) ordinarily requires a 30-day delay in the effective date of final rules after the date of their publication in the Federal Register . This 30-day delay in effective date can be waived, however, if an agency finds good cause that the delay is impracticable, unnecessary, or contrary to the public interest. In addition, section 1871(e)(1) of the Social Security Act, as amended by section 903(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (DIMA), also requires that a substantive change in a regulation shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published the substantive change. Section 1871(e)(1) of the Social Security Act, as amended by section 903(b)(1) of DIMA, provides an exception to that requirement if the Secretary finds that the waiver of such 30-day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. The agency must incorporate a statement of the good cause finding and rationale in the published rule.

In this case, we believe that it is in the public interest to make the corrections identified above effective January 1, 2004 without the 30-day delay in effective date. In most cases, these errors were the result of our inadvertent failure to address a number of public comments that were received timely, incorrect or potentially misleading responses, and omissions and typographical errors in Addenda A and B. In addition, we have added information to the addenda that was not available when we published the November 7, 2003 final rule. This information does not affect payment under the OPPS. A delay in the effective date of this notice would result, in most cases, in underpayment of hospitals beginning January 1, 2004. If we did not make these changes, hospitals would be paid improperly, and beneficiaries' access to care may be impeded. Therefore, we find good cause to waive the 30-day delay in effective date.